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May 15, 2026 9:55 pm

ENHERTU® (fam-trastuzumab deruxtecan-nxki) approved in the US for two new indications for patients with HER2-positive early breast cancer

ENHERTU^® (fam-trastuzumab deruxtecan-nxki) approved in the US for two new indications for patients with HER2-positive early breast cancer

Approved for use before surgery based on DESTINY-Breast11 Phase III trial

Approved for use following surgery based on DESTINY-Breast05 Phase III trial

Two new indications bring AstraZeneca and Daiichi Sankyo’s ENHERTU into curative-intent setting, reinforcing its role across stages of HER2-positive breast cancer

WILMINGTON, Del.–(BUSINESS WIRE)–
AstraZeneca and Daiichi Sankyo’s ENHERTU^® (fam-trastuzumab deruxtecan-nxki) has been approved by the US Food and Drug Administration (FDA) for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer based on results from the DESTINY-Breast11 and DESTINY-Breast05 Phase III trials, respectively.

In the neoadjuvant setting, ENHERTU followed by a taxane, trastuzumab, and pertuzumab (THP) has been approved for the treatment of adult patients with HER2-positive Stage II or Stage III breast cancer. In the adjuvant setting, ENHERTU has been approved for the treatment of adult patients with HER2-positive breast cancer who have residual invasive disease following trastuzumab (with or without pertuzumab) and taxane-based treatment.

Shanu Modi, MD, Medical Oncologist, Memorial Sloan Kettering Cancer Center, said: “HER2-positive breast cancer is an aggressive disease, and our goal is to reduce the risk of recurrence for patients as early as possible to achieve the best long-term outcomes. The neoadjuvant setting offers the earliest opportunity to improve outcomes, while the adjuvant setting provides another important chance to prevent recurrence for patients with residual disease after surgery. These two new indications in HER2-positive early breast cancer will evolve how we treat patients in these settings and support trastuzumab deruxtecan as a potential new standard of care in early-stage disease.”

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “HER2-positive early disease is considered highly curable, however up to one in four patients still experience disease recurrence, underscoring the need for new options in this setting. These approvals mark an important step forward, expanding the possibility of cure to more patients for the first time in many years and positioning ENHERTU as a foundational treatment in early breast cancer.”

Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. said: “ENHERTUhas redefined the treatment of HER2-expressing breast cancer with practice-changing data across six breast cancer indications in seven years. ENHERTUis now approved in the US across both early and metastatic HER2-positive breast cancer, accomplishing what we set out to achieve a little over a decade ago for patients at the start of our comprehensive clinical development program.”

Victoria Smart, Senior Vice President, Mission, Susan G. Komen, said: “Providing patients with early breast cancer more options to help prevent progression to metastatic disease can lead to improved outcomes. Progression and recurrence remain among the most significant unmet needs for those diagnosed with early breast cancer, and continued advances in treatment bring new hope to patients and families facing this disease.”

In DESTINY-Breast11, ENHERTU followed by THP as a neoadjuvant treatment demonstrated a pathologic complete response (pCR) rate of 67.3% compared with 56.3% for dose-dense doxorubicin and cyclophosphamide followed by THP [ddAC-THP], an improvement of 11.2% (95% confidence interval [CI] 3.9-18.3; p=0.003). At the time of the pCR analysis, 29 patients (4.5%) had event-free survival (EFS) events, and 12 patients (1.9%) had overall survival (OS) events. The results were published in Annals of Oncology.¹

In DESTINY-Breast05, ENHERTUas an adjuvant treatment reduced the risk of invasive disease recurrence or death (invasive disease-free survival [IDFS]) by 53% compared to trastuzumab emtansine (T-DM1) in patients with HER2-positive breast cancer with residual invasive disease following neoadjuvant therapy (hazard ratio [HR] 0.47; 95% CI 0.34-0.66; p<0.0001). At three years, 92.4% of patients in the ENHERTU arm were alive and free of invasive disease, compared with 83.7% of those in the T-DM1 arm, with 51 (6%) events in the ENHERTU arm and 102 (12%) in the T-DM1 arm. The results were published in The New England Journal of Medicine.²

Data from both trials were presentedat the 2025 European Society for Medical Oncology (ESMO) Congress.

Based on the DESTINY-Breast05 results, trastuzumab deruxtecan (ENHERTU) has been included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) as a Category 1 recommended treatment in the adjuvant setting for patients with HER2-positive early breast cancer with residual disease and a high risk of recurrence following preoperative therapy. See NCCN Guidelines^® for detailed recommendations.

No new safety concerns were identified with ENHERTU in the DESTINY-Breast11 or DESTINY-Breast05 trials.

In DESTINY-Breast11,ENHERTU followed by THP showed similar rates of drug-related overall adverse events (AEs) and interstitial lung disease (ILD)/pneumonitis as ddAC-THP, and lower rates of Grade 3 or higher AEs, serious AEs, AEs leading to treatment interruptions, left ventricular dysfunction and hematological toxicities.

In DESTINY-Breast05, ENHERTU and T-DM1 showed similar rates of overall drug-related AEs and Grade 3 or higher AEs. Adjudicated drug-related ILD/pneumonitis occurred in 9.6% of patients in the ENHERTU arm and 1.6% of patients in the T-DM1 arm. The majority of ILD/pneumonitis events were low grade in both arms. There were seven Grade 3 events and two deaths (Grade 5) in the ENHERTUarm.

The DESTINY-Breast11 and DESTINY-Breast05 US regulatory submissions were both reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. Separate regulatory applications for both trials are also under review in other countries. DESTINY-Breast05 previously received Priority Review and Breakthrough Therapy Designation by the FDA.

ENHERTU is already approved in more than 95 countries, including the US, as a treatment for patients with HER2-positive metastatic breast cancer.

ENHERTU is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.

Financial Considerations

Following these approvals in the US, an amount of $155 million is due from AstraZeneca to Daiichi Sankyo as milestone payments for both these indications. Sales of ENHERTU in the US are recognized by Daiichi Sankyo. For further details on the financial arrangements, please consult the collaboration agreement from March 2019.

ENHERTU U.S. Indications and Important Safety Information

Indications

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for:

HER2-Positive Early Breast Cancer

As neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test followed by a taxane, trastuzumab, and pertuzumab (THP)

As adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment

HER2-Positive Metastatic Breast Cancer

In combination with pertuzumab as first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-authorized test

As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or, in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy

HER2-Low and HER2-Ultralow Metastatic Breast Cancer

As monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-authorized test, that has progressed on one or more endocrine therapies in the metastatic setting

As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-authorized test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy

HER2-Mutant Unresectable or Metastatic Non-Small Cell Lung Cancer (NSCLC)

As monotherapy for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-authorized test, and who have received a prior systemic therapy

This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

HER2-Positive Locally Advanced or Metastatic Gastric Cancer

As monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen

HER2-Positive (IHC 3+) Unresectable or Metastatic Solid Tumors

As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options

This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Important Safety Information

WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY

Interstitial lung disease (ILD) and pneumonitis, including severe, life-threatening, and fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and to immediately report symptoms.

Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception.

Contraindications

None.

Warnings and Precautions

Interstitial Lung Disease / Pneumonitis

Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU. A higher incidence of Grade 1 and 2 ILD/pneumonitis has been observed in patients with moderate renal impairment. Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU until resolved to Grade 0, then if resolved in ≤28 days from date of onset, maintain dose. If resolved in >28 days from date of onset, reduce dose 1 level. Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate systemic corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks. In the adjuvant HER2+ breast cancer setting, if drug-induced ILD is suspected, rule out radiotherapy-related pneumonitis. If only radiotherapy-related pneumonitis is suspected, consider interruption of ENHERTU for Grade 2 and permanently discontinue ENHERTU for Grade ≥3.

HER2-Positive, HER2-Low, and HER2-Ultralow Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg)

ENHERTU as Monotherapy

In patients treated with ENHERTU 5.4 mg/kg, ILD occurred in 12% of patients. Median time to first onset was 5.5 months (range: 0.9 to 31.5). Fatal outcomes due to ILD and/or pneumonitis occurred in 0.9% of patients treated with ENHERTU.

ENHERTU in Combination with Pertuzumab

In patients treated with ENHERTU 5.4 mg/kg in combination with pertuzumab (N=431), ILD occurred in 12% of patients. Median time to first onset was 8.0 months (range: 0.6 to 33.8). Fatal outcomes due to ILD and/or pneumonitis occurred in 0.5% of patients treated with ENHERTU in combination with pertuzumab.

ENHERTU followed by THP

In patients treated with ENHERTU 5.4 mg/kg followed by THP in DESTINY-Breast11, ILD occurred in 4.4% of patients. Median time to first onset was 2.7 months (range: 1.1 to 6.0). Fatal outcomes due to ILD and/or pneumonitis occurred in 1 patient (0.3%) treated with ENHERTU followed by THP.

HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg)

In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, ILD occurred in 10% of patients. Median time to first onset was 2.8 months (range: 1.2 to 21).

Neutropenia

Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU. Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] <1.0 to 0.5 x 10⁹/L), interrupt ENHERTU until resolved to Grade 2 or less, then maintain dose. For Grade 4 neutropenia (ANC <0.5 x 10⁹/L), interrupt ENHERTU until resolved to Grade 2 or less, then reduce dose by 1 level. For febrile neutropenia (ANC <1.0 x 10⁹/L and temperature >38.3º C or a sustained temperature of ≥38º C for more than 1 hour), interrupt ENHERTU until resolved, then reduce dose by 1 level.

HER2-Positive, HER2-Low, and HER2-Ultralow Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg)

ENHERTU as Monotherapy

In patients treated with ENHERTU 5.4 mg/kg, a decrease in neutrophil count was reported in 65% of patients. Nineteen percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 22 days (range: 2 to 939). Febrile neutropenia was reported in 1% of patients.

ENHERTU in Combination with Pertuzumab

In patients treated with ENHERTU 5.4 mg/kg in combination with pertuzumab (N=431), decreased neutrophil count occurred in 79% of patients. Median time to first onset was 22 days (range: 5 to 994). Twenty-nine percent had Grade 3 or 4 decreased neutrophil count. Febrile neutropenia was reported in 2.6% of patients.

ENHERTU followed by THP

In patients treated with ENHERTU 5.4 mg/kg followed by THP in DESTINY-Breast11, a decrease in neutrophil count was reported in 58% of patients. Seventeen percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 42 days (range: 11 to 165). Febrile neutropenia was reported in 0.9% of patients.

HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg)

In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, a decrease in neutrophil count was reported in 72% of patients. Fifty-one percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 16 days (range: 4 to 187). Febrile neutropenia was reported in 4.8% of patients.

Left Ventricular Dysfunction

Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular dysfunction (LVD) has been observed with anti-HER2 therapies, including ENHERTU. Assess left ventricular ejection fraction (LVEF) prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. Manage LVD through treatment interruption. When LVEF is >45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is <10%, continue treatment with ENHERTU and repeat LVEF assessment within 3 weeks. When LVEF is 40-45% and absolute decrease from baseline is 10-20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF has not recovered to within 10% from baseline, permanently discontinue ENHERTU. If LVEF recovers to within 10% from baseline, resume treatment with ENHERTU at the same dose. When LVEF is <40% or absolute decrease from baseline is >20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF of <40% or absolute decrease from baseline of >20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment.

HER2-Positive, HER2-Low, and HER2-Ultralow Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg)

ENHERTU as Monotherapy

In patients treated with ENHERTU 5.4 mg/kg, LVD was reported in 4.6% of patients, of which 0.6% were Grade 3 or 4.

ENHERTU in Combination with Pertuzumab

In patients treated with ENHERTU 5.4 mg/kg in combination with pertuzumab (N=431), LVEF decrease was reported in 11% of patients, of which 2.1% were Grade 3 or 4.

ENHERTU followed by THP

In patients treated with ENHERTU 5.4 mg/kg followed by THP in DESTINY-Breast11, LVD was reported in 1.3% of patients, of which 0.3% were Grade 3.

HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg)

In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, no clinical adverse events of heart failure were reported; however, on echocardiography, 8% were found to have asymptomatic Grade 2 decrease in LVEF.

Embryo-Fetal Toxicity

ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of ENHERTU. Advise females of reproductive potential to use effective contraception during treatment and for 7 months after the last dose of ENHERTU. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for 4 months after the last dose of ENHERTU.

Additional Dose Modifications

Thrombocytopenia

For Grade 3 thrombocytopenia (platelets <50 to 25 x 10⁹/L) interrupt ENHERTU until resolved to Grade 1 or less, then maintain dose. For Grade 4 thrombocytopenia (platelets <25 x 10⁹/L) interrupt ENHERTU until resolved to Grade 1 or less, then reduce dose by 1 level.

Adverse Reactions

HER2-Positive, HER2-Low, and HER2-Ultralow Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg)

ENHERTU as Monotherapy

The pooled safety population reflects exposure to ENHERTU 5.4 mg/kg intravenously every 3 weeks in 2233 patients in Study DS8201-A-J101 (NCT02564900), DESTINY-Breast01, DESTINY-Breast02, DESTINY-Breast03, DESTINY-Breast04, DESTINY-Breast06, DESTINY-Lung01, DESTINY-Lung02, DESTINY-CRC02, and DESTINY-PanTumor02. Among these patients, 67% were exposed for >6 months and 39% were exposed for >1 year. In this pooled safety population, the most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (73%), nausea (72%), decreased hemoglobin (67%), decreased neutrophil count (65%), decreased lymphocyte count (60%), fatigue (55%), decreased platelet count (48%), increased aspartate aminotransferase (46%), increased alanine aminotransferase (43%), increased blood alkaline phosphatase (39%), vomiting (38%), alopecia (37%), constipation (32%), decreased blood potassium (32%), decreased appetite (31%), diarrhea (30%), and musculoskeletal pain (24%).

ENHERTU in Combination with Pertuzumab

The pooled safety population reflects exposure to ENHERTU 5.4 mg/kg in combination with pertuzumab intravenously every 3 weeks in 431 patients in DESTINY-Breast07 (n=50), and DESTINY-Breast09 (n=381). Among these patients, 86% were exposed for >6 months and 73% were exposed for >1 year. In this pooled safety population, the most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (86%), decreased hemoglobin (80%), decreased neutrophil count (79%), nausea (74%), increased alanine aminotransferase (65%), diarrhea (64%), increased aspartate aminotransferase (63%), decreased lymphocyte count (61%), decreased platelet count (55%), increased blood alkaline phosphatase (54%), decreased blood potassium (54%), fatigue (53%), alopecia (48%), vomiting (46%), upper respiratory tract infection (32%), constipation (31%), decreased appetite (31%), decreased weight (28%), musculoskeletal pain (23%), increased blood bilirubin (23%), and abdominal pain (22%).

HER2-Positive Early Breast Cancer

DESTINY-Breast11

The safety of ENHERTU followed by THP was evaluated in 320 patients with HER2-positive (IHC 3+ or ISH+) early breast cancer who received at least 1 dose of ENHERTU 5.4 mg/kg followed by THP in DESTINY-Breast11. ENHERTU was administered by intravenous infusion once every three weeks for 4 cycles followed by THP for 4 cycles. The median duration of treatment was 5.6 months (range: 0.7 to 9.1) for patients who received ENHERTU followed by THP.

Serious adverse reactions occurred in 11% of patients receiving ENHERTU followed by THP, including COVID-19 (0.9%) and ILD/pneumonitis (0.6%). Fatal adverse reactions occurred in 0.6% of patients, including ILD/pneumonitis and death not otherwise specified (1 patient each).

In patients treated with ENHERTU followed by THP, the permanent discontinuation of ENHERTU due to adverse reactions occurred in 1.3%, of which ILD/pneumonitis accounted for 0.6%. Dose interruptions of ENHERTU due to adverse reactions occurred in 11% of patients. The most frequent adverse reactions (>2%) associated with dose interruption were decreased neutrophil count and COVID-19. Dose reductions of ENHERTU occurred in 2.5% of patients treated with ENHERTU.

The most common (≥20%) adverse reactions in patients treated with ENHERTU followed by THP, including laboratory abnormalities, were decreased hemoglobin (83%), increased alanine aminotransferase (79%), increased aspartate aminotransferase (74%), decreased white blood cell count (67%), nausea (65%), peripheral neuropathy (59%), diarrhea (59%), decreased neutrophil count (58%), alopecia (48%), fatigue (41%), decreased lymphocyte count (40%), rash (31%), musculoskeletal pain (30%), decreased blood potassium (29%), constipation (29%), vomiting (29%), stomatitis (23%), and decreased appetite (20%).

DESTINY-Breast05

The safety of ENHERTU was evaluated in 806 patients with HER2-positive breast cancer with residual invasive disease following neoadjuvant HER2-targeted therapy who then received at least one dose of ENHERTU 5.4 mg/kg. ENHERTU was administered by intravenous infusion once every three weeks for 14 cycles. The median duration of treatment was 10 months (range: 0.7 to 16) for patients who received ENHERTU.

Serious adverse reactions occurred in 17% of patients receiving ENHERTU. Serious adverse reactions in ≥1% of patients who received ENHERTU were ILD/pneumonitis, radiation pneumonitis, pneumonia, and platelet count decreased. Fatal adverse reactions occurred in 0.4% of patients including ILD/pneumonitis (2 patients) and respiratory tract infection (1 patient).

Permanent discontinuation of ENHERTU due to an adverse reaction occurred in 18% of patients. The adverse reaction which resulted in permanent discontinuation of ENHERTU >2% included ILD/pneumonitis. Dose interruptions of ENHERTU due to an adverse reaction occurred in 50% of patients. Adverse reactions which required dosage interruptions in >2% included radiation pneumonitis, neutrophil count decreased, COVID-19, white blood cell count decreased, ILD/pneumonitis, platelet count decreased, upper respiratory tract infection, fatigue, cough, and pyrexia. Dose reductions of ENHERTU due to an adverse reaction occurred in 26% of patients. Adverse reactions which required dose reductions in >2% of patients included nausea, fatigue, platelet count decreased, ILD/pneumonitis, and neutrophil count decreased.

The most common (≥20%) adverse reactions, including laboratory abnormalities, in patients receiving ENHERTU were decreased white blood cell count (80%), decreased lymphocyte count (72%), decreased neutrophil count (72%), nausea (71%), decreased hemoglobin (61%), increased aspartate aminotransferase (60%), fatigue (54%), increased alanine aminotransferase (53%), decreased platelet count (46%), increased blood alkaline phosphatase (39%), constipation (32%), vomiting (31%), decreased blood potassium (27%), diarrhea (23%), musculoskeletal pain (23%), and decreased appetite (20%).

ILD was reported in 17% of patients receiving ENHERTU, which included COVID-19 pneumonia, interstitial lung disease, lung opacity, organizing pneumonia, pneumocystis jirovecii pneumonia, pneumonia, and pneumonitis which was adjudicated as ILD (irrespective of causality). Adjudicated drug-related ILD for ENHERTU was 10% for all Grades and 0.9% for Grades 3 or 4.

HER2-Positive Metastatic Breast Cancer

DESTINY-Breast09

The safety of ENHERTU 5.4 mg/kg in combination with pertuzumab was evaluated in DESTINY-Breast09, a randomized, three-arm, multicenter study including 763 patients with HER2-positive (IHC 3+ or ISH+) unresectable or metastatic breast cancer. Three hundred eighty-one patients received ENHERTU in combination with pertuzumab and 382 patients received THP (taxane [docetaxel or paclitaxel], trastuzumab, and pertuzumab). Among patients who received ENHERTU in combination with pertuzumab, the median duration of treatment was 22 months (range: 0.3 months to 44.5 months).

Serious adverse reactions occurred in 27% of patients receiving ENHERTU in combination with pertuzumab. Serious adverse reactions in >1% of patients were diarrhea, pneumonia, febrile neutropenia, hypokalemia, vomiting, ILD, pulmonary embolism, and sepsis. Fatalities due to adverse reactions occurred in 3.4% of patients including pneumonia (n=3), ILD (n=2), sepsis (n=2), pulmonary embolism, septic shock, acute kidney injury, dyspnea, febrile neutropenia, and intestinal ischemia (1 patient each).

ENHERTU was discontinued for adverse reactions in 21% of patients. The most frequent adverse reaction (>2%) associated with permanent discontinuation was ILD/pneumonitis (6%). Dose interruptions due to adverse reactions occurred in 69% of patients. The most frequent adverse reactions (>2%) associated with dose interruption were COVID-19, neutropenia, upper respiratory tract infection, fatigue, anemia, hypokalemia, ILD/pneumonitis, thrombocytopenia, pneumonia, diarrhea, transaminase increased, leukopenia, cough, pyrexia, decreased appetite, and blood bilirubin increased. Dose reductions occurred in 46% of patients treated with ENHERTU in combination with pertuzumab. The most frequent adverse reactions (>2%) associated with dose reduction were fatigue, neutropenia, nausea, diarrhea, ILD/pneumonitis, thrombocytopenia, vomiting, transaminases increased, decreased weight, febrile neutropenia, and hypokalemia.

The most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (87%), decreased hemoglobin (80%), decreased neutrophil count (78%), nausea (75%), increased alanine aminotransferase (66%), diarrhea (64%), increased aspartate aminotransferase (62%), decreased lymphocyte count (62%), decreased platelet count (56%), increased blood alkaline phosphatase (55%), decreased blood potassium (54%), fatigue (53%), alopecia (48%), vomiting (46%), upper respiratory tract infection (33%), constipation (33%), decreased appetite (32%), decreased weight (30%), COVID-19 (28%), musculoskeletal pain (24%), increased blood bilirubin (23%), and abdominal pain (23%).

DESTINY-Breast03

The safety of ENHERTU was evaluated in 257 patients with unresectable or metastatic HER2-positive breast cancer who received at least 1 dose of ENHERTU 5.4 mg/kg intravenously once every 3 weeks in DESTINY-Breast03. The median duration of treatment was 14 months (range: 0.7 to 30) for patients who received ENHERTU.

Serious adverse reactions occurred in 19% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were vomiting, ILD, pneumonia, pyrexia, and urinary tract infection. Fatalities due to adverse reactions occurred in 0.8% of patients including COVID-19 and sudden death (1 patient each).

ENHERTU was permanently discontinued in 14% of patients, of which ILD/pneumonitis accounted for 8%. Dose interruptions due to adverse reactions occurred in 44% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, leukopenia, anemia, thrombocytopenia, pneumonia, nausea, fatigue, and ILD/pneumonitis. Dose reductions occurred in 21% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were nausea, neutropenia, and fatigue.

The most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (76%), decreased white blood cell count (74%), decreased neutrophil count (70%), increased aspartate aminotransferase (67%), decreased hemoglobin (64%), decreased lymphocyte count (55%), increased alanine aminotransferase (53%), decreased platelet count (52%), fatigue (49%), vomiting (49%), increased blood alkaline phosphatase (49%), alopecia (37%), decreased blood potassium (35%), constipation (34%), musculoskeletal pain (31%), diarrhea (29%), decreased appetite (29%), headache (22%), respiratory infection (22%), abdominal pain (21%), increased blood bilirubin (20%), and stomatitis (20%).

HER2-Low and HER2-Ultralow Metastatic Breast Cancer

DESTINY-Breast06

The safety of ENHERTU was evaluated in 434 patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer who received ENHERTU 5.4 mg/kg intravenously once every 3 weeks in DESTINY-Breast06. The median duration of treatment was 11 months (range: 0.4 to 39.6) for patients who received ENHERTU.

Serious adverse reactions occurred in 20% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were ILD/pneumonitis, COVID-19, febrile neutropenia, and hypokalemia. Fatalities due to adverse reactions occurred in 2.8% of patients including ILD (0.7%); sepsis (0.5%); and COVID-19 pneumonia, bacterial meningoencephalitis, neutropenic sepsis, peritonitis, cerebrovascular accident, general physical health deterioration (0.2% each).

ENHERTU was permanently discontinued in 14% of patients. The most frequent adverse reaction (>2%) associated with permanent discontinuation was ILD/pneumonitis. Dose interruptions due to adverse reactions occurred in 48% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were COVID-19, decreased neutrophil count, anemia, pyrexia, pneumonia, decreased white blood cell count, and ILD. Dose reductions occurred in 25% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were nausea, fatigue, decreased platelet count, and decreased neutrophil count.

The most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (86%), decreased neutrophil count (75%), nausea (70%), decreased hemoglobin (69%), decreased lymphocyte count (66%), fatigue (53%), decreased platelet count (48%), alopecia (48%), increased alanine aminotransferase (44%), increased blood alkaline phosphatase (43%), increased aspartate aminotransferase (41%), decreased blood potassium (35%), diarrhea (34%), vomiting (34%), constipation (32%), decreased appetite (26%), COVID-19 (26%), and musculoskeletal pain (24%).

DESTINY-Breast04

The safety of ENHERTU was evaluated in 371 patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who received ENHERTU 5.4 mg/kg intravenously once every 3 weeks in DESTINY-Breast04. The median duration of treatment was 8 months (range: 0.2 to 33) for patients who received ENHERTU.

Serious adverse reactions occurred in 28% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were ILD/pneumonitis, pneumonia, dyspnea, musculoskeletal pain, sepsis, anemia, febrile neutropenia, hypercalcemia, nausea, pyrexia, and vomiting. Fatalities due to adverse reactions occurred in 4% of patients including ILD/pneumonitis (3 patients); sepsis (2 patients); and ischemic colitis, disseminated intravascular coagulation, dyspnea, febrile neutropenia, general physical health deterioration, pleural effusion, and respiratory failure (1 patient each).

ENHERTU was permanently discontinued in 16% of patients, of which ILD/pneumonitis accounted for 8%. Dose interruptions due to adverse reactions occurred in 39% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, fatigue, anemia, leukopenia, COVID-19, ILD/pneumonitis, increased transaminases, and hyperbilirubinemia. Dose reductions occurred in 23% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were fatigue, nausea, thrombocytopenia, and neutropenia.

The most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (76%), decreased white blood cell count (70%), decreased hemoglobin (64%), decreased neutrophil count (64%), decreased lymphocyte count (55%), fatigue (54%), decreased platelet count (44%), alopecia (40%), vomiting (40%), increased aspartate aminotransferase (38%), increased alanine aminotransferase (36%), constipation (34%), increased blood alkaline phosphatase (34%), decreased appetite (32%), musculoskeletal pain (32%), diarrhea (27%), and decreased blood potassium (25%).

HER2-Mutant Unresectable or Metastatic NSCLC (5.4 mg/kg)

DESTINY-Lung02 evaluated 2 dose levels (5.4 mg/kg [n=101] and 6.4 mg/kg [n=50]); however, only the results for the recommended dose of 5.4 mg/kg intravenously every 3 weeks are described below due to increased toxicity observed with the higher dose in patients with NSCLC, including ILD/pneumonitis.

The safety of ENHERTU was evaluated in 101 patients with HER2-mutant unresectable or metastatic NSCLC who received ENHERTU 5.4 mg/kg intravenously once every 3 weeks until disease progression or unacceptable toxicity in DESTINY‑Lung02. The median duration of treatment was 8 months (range: 0.7 to 28) for patients who received ENHERTU.

Serious adverse reactions occurred in 40% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were ILD/pneumonitis, pleural effusion, thrombocytopenia, dyspnea, nausea, pneumonia, vomiting, myocarditis, pulmonary embolism, and increased troponin I. Fatalities due to adverse reactions occurred in 3% of patients including ILD/pneumonitis, cerebrovascular accident, and pneumococcal sepsis (1 patient each).

ENHERTU was permanently discontinued in 17% of patients. Adverse reactions which resulted in permanent discontinuation of ENHERTU were ILD/pneumonitis, pneumonia, blood bilirubin increased, hypokalemia, metastases to meninges, and myocarditis. Dose interruptions of ENHERTU due to adverse reactions occurred in 50% of patients. Adverse reactions which required dose interruption (>2%) included neutropenia, COVID-19, ILD/pneumonitis, fatigue, anemia, and pneumonia. Dose reductions due to an adverse reaction occurred in 20% of patients. The most frequent adverse reactions (>2%) associated with dose reduction were neutropenia, fatigue, and decreased appetite.

The most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (68%), nausea (67%), decreased white blood cell count (66%), decreased neutrophil count (59%), decreased lymphocyte count (56%), increased aspartate aminotransferase (51%), decreased albumin (50%), decreased platelet count (49%), fatigue (48%), increased alanine aminotransferase (41%), decreased appetite (41%), constipation (38%), increased alkaline phosphatase (37%), vomiting (32%), decreased blood potassium (29%), diarrhea (24%), alopecia (22%), and musculoskeletal pain (21%).

HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg)

The safety of ENHERTU was evaluated in 187 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma in DESTINY-Gastric01. Patients intravenously received at least 1 dose of either ENHERTU (N=125) 6.4 mg/kg every 3 weeks or either irinotecan (N=55) 150 mg/m² biweekly or paclitaxel (N=7) 80 mg/m² weekly for 3 weeks. The median duration of treatment was 4.6 months (range: 0.7 to 22.3) for patients who received ENHERTU.

Serious adverse reactions occurred in 44% of patients receiving ENHERTU 6.4 mg/kg. Serious adverse reactions in >2% of patients who received ENHERTU were decreased appetite, ILD, anemia, dehydration, pneumonia, cholestatic jaundice, pyrexia, and tumor hemorrhage. Fatalities due to adverse reactions occurred in 2.4% of patients: disseminated intravascular coagulation, large intestine perforation, and pneumonia occurred in 1 patient each (0.8%).

ENHERTU was permanently discontinued in 15% of patients, of which ILD accounted for 6%. Dose interruptions due to adverse reactions occurred in 62% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, anemia, decreased appetite, leukopenia, fatigue, thrombocytopenia, ILD, pneumonia, lymphopenia, upper respiratory tract infection, diarrhea, and decreased blood potassium. Dose reductions occurred in 32% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were neutropenia, decreased appetite, fatigue, nausea, and febrile neutropenia.

The most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (75%), decreased white blood cell count (74%), decreased neutrophil count (72%), decreased lymphocyte count (70%), decreased platelet count (68%), nausea (63%), decreased appetite (60%), increased aspartate aminotransferase (58%), fatigue (55%), increased blood alkaline phosphatase (54%), increased alanine aminotransferase (47%), diarrhea (32%), decreased blood potassium (30%), vomiting (26%), constipation (24%), increased blood bilirubin (24%), pyrexia (24%), and alopecia (22%).

HER2-Positive (IHC 3+) Unresectable or Metastatic Solid Tumors

The safety of ENHERTU was evaluated in 347 adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who received ENHERTU 5.4 mg/kg intravenously once every 3 weeks in DESTINY-Breast01, DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02. The median duration of treatment was 8.3 months (range 0.7 to 30.2).

Serious adverse reactions occurred in 34% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were sepsis, pneumonia, vomiting, urinary tract infection, abdominal pain, nausea, pneumonitis, pleural effusion, hemorrhage, COVID-19, fatigue, acute kidney injury, anemia, cellulitis, and dyspnea. Fatalities due to adverse reactions occurred in 6.3% of patients including ILD/pneumonitis (2.3%), cardiac arrest (0.6%), COVID-19 (0.6%), and sepsis (0.6%). The following events occurred in 1 patient each (0.3%): acute kidney injury, cerebrovascular accident, general physical health deterioration, pneumonia, and hemorrhagic shock.

ENHERTU was permanently discontinued in 15% of patients, of which ILD/pneumonitis accounted for 10%. Dose interruptions due to adverse reactions occurred in 48% of patients. The most frequent adverse reactions (>2%) associated with dose interruption were decreased neutrophil count, anemia, COVID-19, fatigue, decreased white blood cell count, and ILD/pneumonitis. Dose reductions occurred in 27% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were fatigue, nausea, decreased neutrophil count, ILD/pneumonitis, and diarrhea.

The most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (75%), nausea (69%), decreased hemoglobin (67%), decreased neutrophil count (66%), fatigue (59%), decreased lymphocyte count (58%), decreased platelet count (51%), increased aspartate aminotransferase (45%), increased alanine aminotransferase (44%), increased blood alkaline phosphatase (36%), vomiting (35%), decreased appetite (34%), alopecia (34%), diarrhea (31%), decreased blood potassium (29%), constipation (28%), decreased sodium (22%), stomatitis (20%), and upper respiratory tract infection (20%).

Use in Specific Populations

Pregnancy: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. There are clinical considerations if ENHERTU is used in pregnant women, or if a patient becomes pregnant within 7 months after the last dose of ENHERTU.

Lactation: There are no data regarding the presence of ENHERTU in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with ENHERTU and for 7 months after the last dose.

Females and Males of Reproductive Potential:Pregnancy testing: Verify pregnancy status of females of reproductive potential prior to initiation of ENHERTU. Contraception: Females: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with ENHERTU and for 7 months after the last dose. Males: Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for 4 months after the last dose. Infertility: ENHERTU may impair male reproductive function and fertility.

Pediatric Use: Safety and effectiveness of ENHERTU have not been established in pediatric patients.

Geriatric Use: ENHERTU as Monotherapy:Of the 2233 patients treated with ENHERTU 5.4 mg/kg, 28% were ≥65 years and 6% were ≥75 years. No overall differences in efficacy within clinical studies were observed between patients ≥65 years compared to younger patients. There was a higher incidence of Grade 3-4 adverse reactions observed in patients aged ≥65 years (56%) as compared to younger patients (49%). Of the 125 patients with HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg in DESTINY-Gastric01, 56% were ≥65 years and 14% were ≥75 years. No overall differences in efficacy or safety were observed between patients ≥65 years of age compared to younger patients. ENHERTU in Combination with Pertuzumab:In patients with HER2-positive unresectable or metastatic breast cancer treated with ENHERTU 5.4 mg/kg in combination with pertuzumab (N=431), 17% were ≥65 years and 3% were ≥75 years. No overall differences in efficacy or safety were observed between patients ≥65 years compared to younger patients. ENHERTU followed by THP: Of the 320 patients with HER2-positive early breast cancer treated with ENHERTU 5.4 mg/kg followed by THP, 12% were ≥65 years and 1.6% were ≥75 years. No overall differences in efficacy were observed between patients ≥65 years compared to younger patients. There was a higher incidence of Grade 3-4 adverse reactions observed in patients ≥65 years (38%) as compared to younger patients (30%).

Renal Impairment: A higher incidence of Grade 1 and 2 ILD/pneumonitis has been observed in patients with moderate renal impairment. Monitor patients with moderate renal impairment more frequently. The recommended dosage of ENHERTU has not been established for patients with severe renal impairment (CLcr <30 mL/min).

Hepatic Impairment: In patients with moderate hepatic impairment, due to potentially increased exposure, monitor for increased adverse reactions related to the topoisomerase inhibitor, DXd. The recommended dosage of ENHERTU has not been established for patients with severe hepatic impairment (total bilirubin >3 times ULN and any AST).

To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or fda.gov/medwatch.

Please see accompanying full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

Notes

HER2-positive early breast cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.³ More than two million breast cancer cases were diagnosed in 2022, with an estimated 665,000 deaths globally.³ In the US, more than 320,000 cases of breast cancer are diagnosed annually with over 42,000 deaths.⁴

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors, including breast cancer.⁵HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.⁵An estimated one in five cases of breast cancer is considered HER2-positive.⁶ Approximately one in three patients with HER2-positive early-stage breast cancer is considered high-risk, meaning they are more likely to experience disease recurrence and have a poor prognosis, and up to one in four will experience disease recurrence.^7,8

HER2‑positive early breast cancer is generally treated across two phases: the neoadjuvant (pre‑surgical) phase and the adjuvant or post-neoadjuvant (post‑surgical) phase.

In the neoadjuvant setting, the current standard of care in many regions of the world involves combination chemotherapy regimens.⁹ In the US, the current standard of care consists of a combination regimen of carboplatin, trastuzumab, pertuzumab and a taxane.^9,10 For patients with HER2-positive early breast cancer, achieving pCR, defined as no evidence of invasive cancer cells in the removed breast tissue or lymph nodes following treatment with neoadjuvant treatment, is an early indicator of improved long-term survival.¹¹ Approximately half of patients (39-66%) who receive neoadjuvant treatment do not reach pCR, putting them at increased risk of disease recurrence.^12-16

In the adjuvant setting, despite receiving additional treatment with current standard of care for residual disease, some patients still experience invasive disease or death.¹⁷ Once patients are diagnosed with metastatic disease, the five-year survival rate drops from nearly 90% to approximately 30%.¹⁸

DESTINY-Breast11

DESTINY-Breast11 is a global, multicenter, randomized, open-label, Phase III trial evaluating the efficacy and safety of neoadjuvant ENHERTU (5.4mg/kg) monotherapy or ENHERTU followed by THP compared to ddAC-THP in patients with high-risk HER2-positive early-stage breast cancer.

Patients were randomized 1:1:1 to receive either eight cycles of ENHERTU monotherapy; four cycles of ENHERTU followed by four cycles of THP; or four cycles of ddAC followed by four cycles of THP.

The ENHERTU monotherapy arm was closed early following a recommendation from the Independent Data Monitoring Committee.

The primary endpoint of DESTINY-Breast11 is rate of pCR – defined as no evidence of invasive cancer cells in the removed breast cancer tissue or lymph nodes following treatment. Secondary endpoints include EFS, invasive disease-free survival, overall survival and safety.

DESTINY-Breast11 enrolled 927 patients across multiple sites in Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov.

DESTINY-Breast05

DESTINY-Breast05 is a global, multicenter, randomized, open-label, Phase III trial evaluating the efficacy and safety of ENHERTU (5.4mg/kg) versus T-DM1 in patients with HER2-positive early breast cancer with residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy and a high risk of recurrence. High risk of recurrence was defined as presentation with inoperable cancer (prior to neoadjuvant therapy) or pathologically positive axillary lymph nodes following neoadjuvant therapy.

Patients were randomized 1:1 to receive 14 cycles of ENHERTU or T-DM1.

The primary endpoint of DESTINY-Breast05 is investigator-assessed IDFS, which is defined as the time from randomization until first invasive local, axillary or distant recurrence or death from any cause. Secondary endpoints include investigator-assessed DFS, overall survival, distant recurrence-free interval, brain metastasis-free interval and safety.

DESTINY-Breast05 enrolled 1,635 patients in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.

ENHERTU

ENHERTU is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTUis the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

ENHERTU (5.4mg/kg) is approved in the US as an adjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial.

ENHERTU (5.4mg/kg) followed by THP is approved in the US and China as a neoadjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer based on the results from the DESTINY-Breast11 trial. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (5.4mg/kg) in combination with pertuzumab is approved in the US, Switzerland, United Arab Emirates and Saudi Arabia as a 1st-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer based on the results from the DESTINY-Breast09 trial.

ENHERTU (5.4mg/kg) is approved in more than 95 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4mg/kg) is approved in more than 95 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

ENHERTU (5.4mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally authorized test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

ENHERTU (5.4mg/kg) is approved in more than 75 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials.

ENHERTU (5.4mg/kg) is approved in more than 15 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and/or HERALD trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU clinical development program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy, in combination or sequentially with other cancer medicines across multiple HER2-targetable cancers.

Daiichi Sankyo collaboration

AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and datopotamab deruxtecan-dlnk in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTUand datopotamab deruxtecan-dlnk.

AstraZeneca in breast cancer

Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumor environment.

With ENHERTU, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer, and expanding its potential in earlier lines of treatment and in new breast cancer settings.

In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines fulvestrant and goserelin and aims to reshape the HR-positive space with first-in-class AKT inhibitor, capivasertib, the TROP-2-directed ADC, datopotamab deruxtecan-dlnk, and next-generation oral SERD and potential new medicine camizestrant.

PARP inhibitor olaparib is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with Merck & Co., Inc., known as MSD outside the US and Canada, continue to research olaparib in these settings. AstraZeneca is also exploring the potential of saruparib, a potent and selective inhibitor of PARP1, in combination with camizestrant in BRCA-mutated, HR-positive, HER2-negative advanced breast cancer.

To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of datopotamab deruxtecan-dlnk alone and in combination with immunotherapy durvalumab.

AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca

AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca. The contents of AstraZeneca’s website do not form part of this document and no one should rely on such websites or the contents thereof in reading this document.

References

Harbeck N, Modi S, Pusztai L, et al. Neoadjuvant trastuzumab deruxtecan alone or followed by paclitaxel, trastuzumab, and pertuzumab for high-risk HER2-positive early breast cancer (DESTINY-Breast11): a randomised, open-label, multicentre, phase III trial. Ann Oncol. 2026;37(2):166-179.

Loibl S, et al. Trastuzumab deruxtecan in residual HER2-positive early breast cancer. N Engl J Med. 2026;394(9):845-857.

World Health Organization. Available at: Breast Fact Sheet. Accessed May 2026.

Siegel RL, et al. Cancer statistics, 2026. CA Cancer J Clin. 2026;76(1):e70043.

Cheng X. A comprehensive review of HER2 in cancer biology and therapeutics. Genes. (Basel). 2024;15(7):903.

Tarantino P, et al. ESMO expert consensus statements (ECS) on the definition, diagnosis, and management of HER2-low breast cancer. Ann Oncol. 2023;34(8):645-659.

Mahtani R, et al. Human epidermal growth factor receptor 2-positive (HER2+) early breast cancer treatment and outcomes by risk of recurrence: a retrospective US electronic health records study. Cancers (Basel). 2025;17(9):1848.

Joyce O, et al. Risk of recurrence in patients with HER2+ early-stage breast cancer: Literature analysis of patient and disease characteristics. Clinical Breast Cancer. 2023;23(4):350-362.

NCCN Clinical Practice Guidelines in Oncology. Breast Cancer. Version 2. 2026

Wang J, et al. Breast cancer: an overview of current therapeutic strategies, challenge, and perspectives. Breast Cancer. 2023;15:721-730.

Spring LM, et al. Pathological complete response after neoadjuvant chemotherapy and impact on breast cancer recurrence and survival: a comprehensive meta-analysis. Clin Cancer Res. 2020;26(12):2838-2848.

Schneeweiss A, et al. Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA). Ann Oncol. 2013;24(9):2278-2284.

Swain SM, et al. Pertuzumab, trastuzumab, and standard anthracycline- and taxane-based chemotherapy for the neoadjuvant treatment of patients with HER2-positive localized breast cancer (BERENICE): a phase II, open-label, multicenter, multinational cardiac safety study. Ann Oncol. 2018;29(3):646-653.

Huober J, et al. Atezolizumab with neoadjuvant anti-human epidermal growth factor receptor 2 therapy and chemotherapy in human epidermal growth factor receptor 2-positive early breast cancer: primary results of the randomized phase III IMpassion050 trial. J Clin Oncol. 2022;40(25):2946-2956.

Masuda N, et al. A randomized, 3-arm, neoadjuvant, phase 2 study comparing docetaxel + carboplatin + trastuzumab + pertuzumab (TCbHP), TCbHP followed by trastuzumab emtansine and pertuzumab (T-DM1+P), and T-DM1+P in HER2-positive primary breast cancer. Breast Cancer Res Treat. 2020;180(1):135-146.

Gao HF, et al. De-escalated neoadjuvant taxane plus trastuzumab and pertuzumab with or without carboplatin in HER2-positive early breast cancer (neoCARHP): a multicentre, open-label, randomised, phase 3 trial. Presented at the ASCO Annual Meeting 2025.

Geyer CE, et al. Survival with trastuzumab emtansine in residual HER2-positive breast cancer. N Engl J Med. 2025;392(3):249-257.

National Cancer Institute. SEER Cancer Stat Facts: Female Breast Cancer. Available at: https://seer.cancer.gov/statfacts/html/breast.html. Accessed May 2026

Disclosure: Dr. Modi provides consulting and advisory services to AstraZeneca (and Daiichi Sankyo).

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Last Updated 05/26

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Posted on May 15, 2026 8:35 pm
Starbucks Corporation Announces Early Results and Upsizing of its Tender Offers for Eight Series of Notes

Starbucks Corporation Announces Early Results and Upsizing of its Tender Offers for Eight Series of Notes

SEATTLE–(BUSINESS WIRE)–
Starbucks Corporation (Nasdaq: SBUX) (“Starbucks,” “we,” “us” or the “Company”) today announced the early results of its previously announced tender offers to purchase (each offer a “Tender Offer” and collectively, the “Tender Offers”) for cash the notes of the series listed in the table below (collectively, the “Notes”). The Tender Offers were made pursuant to the Offer to Purchase, dated May 4, 2026 (the “Offer to Purchase”), which sets forth a more comprehensive description of the terms and conditions of the Tender Offers. Capitalized terms used but not defined in this announcement have the meanings given to them in the Offer to Purchase.

In addition, Starbucks has exercised its previously disclosed right to amend the terms of the Tender Offers to increase (i) the Aggregate Cap for all Notes validly tendered and accepted for purchase pursuant to the Tender Offers to $1.3 billion; (ii) the Pool 1 Maximum Amount to $600 million; and (iii) the Pool 2 Maximum Amount to $700 million. Except as described in this press release, the terms and conditions of the Tender Offers set forth in the Offer to Purchase remain unchanged.

According to information provided by D.F. King & Co., Inc., the Tender and Information Agent in connection with the Tender Offers, $2,598,857,000 aggregate principal amount of the Notes were validly tendered prior to or at 5:00 p.m., Eastern Time on May 15, 2026 (the “Early Tender Date”) and not validly withdrawn. The table below provides certain information about the Tender Offers, including the aggregate principal amount of each series of Notes validly tendered and not validly withdrawn prior to the Early Tender Date.

Title of

Security

CUSIP/ISIN

Aggregate Principal

Amount Outstanding

Maximum

Amount⁽¹⁾

Acceptance Priority

Level⁽²⁾

Tender Sub Cap⁽³⁾

Aggregate Principal Amount Validly

Tendered and Not Validly

Withdrawn as of Early Tender Date

Pool 1

Tender

Offers

4.800% Senior

Notes due

2030

855244BL2/

US855244BL23

$500,000,000

$600,000,000

1

——

$321,824,000

4.500% Senior

Notes due

2028

855244BN8/

US855244BN88

$750,000,000

2

——

$564,970,000

4.000% Senior

Notes due

2028

855244AR0/

US855244AR02

$750,000,000

3

——

$356,531,000

Pool 2

Tender

Offers

4.500% Senior

Notes due

2048

855244AS8/

US855244AS84

$1,000,000,000

$700,000,000

1

$200,000,000

$290,150,000

5.400% Senior

Notes due

2035

855244BM0/

US855244BM06

$500,000,000

2

——

$410,249,000

5.000% Senior

Notes due

2034

855244BJ7/

US855244BJ76

$500,000,000

3

——

$251,065,000

4.900% Senior

Notes due

2031

855244BH1/

US855244BH11

$500,000,000

4

——

$177,449,000

4.800% Senior

Notes due

2033

855244BF5/

US855244BF54

$500,000,000

5

——

$226,619,000

(1)

The Pool 1 Maximum Amount of $600,000,000 represents the maximum aggregate purchase price of Pool 1 Notes that the Company is offering to purchase in the Pool 1 Tender Offers. The Pool 2 Maximum Amount of $700,000,000 represents the maximum Aggregate Purchase Price of Pool 2 Notes that the Company is offering to purchase in the Pool 2 Tender Offers.

(2)

Subject to the Aggregate Cap, the Maximum Amounts, the Tender Sub Cap (as defined below) and proration, if applicable, the aggregate principal amount of each series of Notes that is purchased in the Tender Offer for that series will be determined in accordance with the applicable Acceptance Priority Level (in numerical priority order) specified in this column.

(3)

The Tender Offer with respect to the 4.500% Senior Notes due 2048 (the “2048 Notes”) will be subject to an aggregate principal amount sublimit of $200,000,000 (the “Tender Sub Cap”).

Pursuant to the terms of the Offer to Purchase, Starbucks expects to accept for purchase, up to the Aggregate Cap, the Maximum Amounts and the Tender Sub Cap for the 2048 Notes and subject to proration, if applicable, the Notes validly tendered and not validly withdrawn as of the Early Tender Date in accordance with the Acceptance Priority Levels specified in the table above. Because the aggregate purchase price of the Notes validly tendered and not validly withdrawn at or prior to the Early Tender Date exceeds the Aggregate Cap and the Maximum Amounts, Starbucks does not expect to accept any further tenders of Notes.

The applicable consideration (the “Total Consideration”) offered per $1,000 principal amount of each series of Notes validly tendered and not validly withdrawn and accepted for purchase pursuant to the applicable Tender Offer will be determined in the manner described in the Offer to Purchase by reference to the applicable fixed spread for such Notes (the “Fixed Spread”) specified in the table on the front cover of the Offer to Purchase plus the applicable yield based on the bid-side price of the applicable U.S. Treasury Reference Security specified in the table on the front cover of the Offer to Purchase as displayed on the applicable Bloomberg Reference Page specified in the table on the front cover of the Offer to Purchase at 10:00 a.m., Eastern Time on May 18, 2026.

Holders of any Notes that were validly tendered and not validly withdrawn prior to or at the applicable Early Tender Date and that are accepted for purchase will receive the applicable Total Consideration. The Total Consideration, as calculated using the Fixed Spread for each series of Notes set forth in the table on the front cover of the Offer to Purchase, includes the Early Tender Payment, and the Early Tender Payment does not constitute additional or increased payment.

In addition to the Total Consideration, all Holders of Notes accepted for purchase will also receive accrued and unpaid interest on Notes validly tendered, not validly withdrawn and accepted for purchase from the applicable last interest payment date up to, but not including, the applicable Settlement Date, payable on such Settlement Date. The Company reserves the right, in its sole discretion, to make payment for Notes that are validly tendered prior to or at the Early Tender Date and that are accepted for purchase on the date referred to as the “Early Settlement Date.” It is anticipated that the Early Settlement Date will be May 20, 2026.

In accordance with the terms of the Offer to Purchase, the withdrawal deadline was 5:00 p.m., Eastern Time on May 15, 2026 (the “Withdrawal Deadline”). As a result, tendered Notes may no longer be withdrawn, except in certain limited circumstances where additional withdrawal rights are required by law (as determined by the Company).

The Tender Offers are subject to the satisfaction of certain conditions as set forth in the Offer to Purchase. The Company reserves the right, subject to applicable law, to (i) waive any and all conditions to any of the Tender Offers, (ii) extend or terminate any of the Tender Offers, (iii) increase or decrease the Aggregate Cap, (iv) increase or decrease either of the Maximum Amounts, (v) increase or decrease the Tender Sub Cap or (vi) otherwise amend any of the Tender Offers in any respect. The Company may take any action described in clauses (i) through (vi) above with respect to one or more Tender Offers without having to do so for all Tender Offers. In the case of clauses (i) through (vi) above, the Company does not intend to extend the Withdrawal Deadline or reinstate withdrawal rights, subject to applicable law. Holders should refer to the Offer to Purchase, as amended by this press release, for the complete terms and conditions for the Tender Offers.

The Company has retained (i) Morgan Stanley & Co. LLC, U.S. Bancorp Investments, Inc. and Wells Fargo Securities, LLC as Lead Dealer Managers, (ii) BofA Securities, Citigroup Global Markets Inc., Scotia Capital (USA) Inc., J.P. Morgan Securities LLC and Goldman Sachs & Co. LLC as Co-Dealer Managers and (iii) D.F. King & Co., Inc. as the Tender and Information Agent, in each case, in connection with the Tender Offers. Any questions or requests for assistance concerning the Tender Offers may be directed to (i) Morgan Stanley & Co. LLC at [email protected] or by calling toll-free at (800) 624-1808 or collect at (212) 761-1057, (ii) U.S. Bancorp Investments, Inc. at [email protected] or by calling toll-free at (800) 479-3441 or collect at (917) 558-2756 or (iii) Wells Fargo Securities, LLC at [email protected] or by calling toll-free at (866) 309-6316 or collect at (704) 410-4759. Requests for additional copies of the Offer to Purchase or any other documents may be directed to D.F. King & Co., Inc. at [email protected] or by calling (888) 288-0951 (toll-free) or (646) 582-9168 (collect for banks and brokers).

The Company is making the Tender Offers only by, and pursuant to, the terms of the Offer to Purchase, as amended by this press release. None of the Company or its affiliates, their respective boards of directors, officers, employees, agents or affiliates, the Dealer Managers, the Tender and Information Agent or the trustee with respect to any series of Notes is making any recommendation as to whether Holders should tender any Notes in response to any of the Tender Offers, and neither the Company nor any such other person has authorized any person to make any such recommendation. Holders must make their own decision as to whether to tender any of their Notes, and, if so, the Aggregate Principal amount of such Notes to tender. The Tender Offers are not being made to holders of the Notes in any jurisdiction in which the making or acceptance thereof would not be in compliance with the securities, blue sky or other laws of such jurisdiction. In any jurisdiction in which the securities laws or blue sky laws require the Tender Offers to be made by a licensed broker or dealer, the Tender Offers will be deemed to be made on behalf of the Company by the Dealer Managers or one or more registered brokers or dealers that are licensed under the laws of such jurisdiction.

This press release does not constitute an offer to purchase securities or a solicitation of an offer to sell any securities or an offer to sell or the solicitation of an offer to purchase any securities nor does it constitute an offer or solicitation in any jurisdiction in which such offer or solicitation is unlawful.

About Starbucks

Since 1971, Starbucks Coffee Company has been committed to responsibly sourcing and roasting high-quality arabica coffee. Today, with a global footprint of more than 41,000 company-operated and licensed coffeehouses and a growing presence in consumer-packaged goods, we are the world’s premier purveyor of specialty coffee. Through our unwavering commitment to excellence and our guiding principles, we bring the unique Starbucks Experience to life for every customer through every cup. To share in the experience, please visit us in our stores or online at about.starbucks.com or www.starbucks.com.

Forward-Looking Statements

This press release includes certain “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding future events and the potential future results of Starbucks Corporation (together with its subsidiaries) that are based on our current expectations, estimates, forecasts, and projections about, among other things, our business, our results of operations, the industry in which we operate, our economic and market outlook, and the beliefs and assumptions of our management. Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts. All statements other than statements of historical fact, including statements regarding guidance, industry prospects, or future results of operations or financial position, made in or incorporated by reference into this prospectus are forward-looking. We use words such as “believes,” “continues,” “anticipates,” “forecasts,” “estimates,” “expects,” “future,” “plan,” “seeks” or words of similar meaning, or future or conditional verbs, such as “will,” “should,” “could,” “would,” “may,” “aims,” “intends,” or “projects” and similar expressions intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. By their nature, forward-looking statements involve risks, uncertainties, and other factors (many beyond our control) that could cause our actual results to differ materially from our historical experience or from our current expectations or projections. Forward-looking statements reflect the Company’s current expectations and are inherently uncertain. Although we believe we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can or will be achieved, and readers are cautioned not to place undue reliance on such statements which speak only as of the date they are made. Although we undertake no obligation to revise or update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law, readers are advised to consult any additional disclosures we make in our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the SEC.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260515012591/en/

For Investors:

Catherine Park

[email protected]

For Media:

Emily Albright

[email protected]

KEYWORDS: Washington United States North America

INDUSTRY KEYWORDS: Food/Beverage Retail

MEDIA:

Logo

Posted on May 15, 2026 8:22 pm
Regeneron Provides Update on Phase 3 Trial of Fianlimab (LAG-3 Inhibitor) Combination in First-Line Unresectable or Metastatic Melanoma

The trial did not reach statistical significance for the primary endpoint of improvement in progression-free survival (PFS)

A numeric improvement of 5.1 months in median PFS was observed for the high-dose fianlimab combination compared to pembrolizumab monotherapy

Phase 3 head-to-head trial of the high-dose fianlimab combination versus Opdualag
^®
(nivolumab and relatlimab-rmbw) is ongoing

TARRYTOWN, N.Y., May 15, 2026 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today reviewed results from the Phase 3 trial evaluating two dose levels of fianlimab (LAG-3 inhibitor) in combination with cemiplimab (PD-1 inhibitor) as a first-line treatment for patients with unresectable locally advanced or metastatic melanoma. The trial did not reach statistical significance for the primary endpoint of improvement in progression-free survival (PFS) compared to pembrolizumab (PD-1 inhibitor) monotherapy. No new safety signals were identified with the fianlimab combination.

High-Dose
Combination

(n=508) Low-Dose
Combination

(n=422) Pembrolizumab
Monotherapy

(n=462) Cemiplimab
Monotherapy*

(n=154)

Primary endpoint:
median PFS, months
(95% Confidence
Interval [CI])
11.5 (6.3, 16.8)
9.6 (6.2, 13.9)
6.4 (4.4, 11.1)
6.3 (4.0, 17.2)

Hazard Ratio (95%
CI)
Relative to
Pembrolizumab
0.845 (0.709,
1.008) 0.931 (0.773,
1.122)^#

p-Value p=0.0627 p=0.4661^#

*Cemiplimab was used to define contribution of components and was not used in the statistical comparison
^# Low dose combination compared against subset of concurrently randomized patients on pembrolizumab (n=421)

Detailed results from the trial will be presented at an upcoming medical meeting.

A Phase 3 head-to-head trial, also in first-line unresectable or metastatic melanoma, evaluating the high-dose fianlimab combination versus Opdualag^®(nivolumab and relatlimab-rmbw) is ongoing.

The potential uses of fianlimab and cemiplimab described above are investigational, and safety and efficacy of this combination have not been evaluated by any regulatory authority.

About the Phase 3 Trial

This randomized, double-blind Phase 3 trial is investigating the combination of fianlimab and cemiplimab versus pembrolizumab in patients 12 years of age or older with unresectable locally advanced or metastatic melanoma who have not received a previous systemic treatment for advanced disease. The trial enrolled 1,546 patients who were randomized to receive either: 1600 mg fianlimab and 350 mg cemiplimab (high-dose combination) every 3 weeks; 400 mg fianlimab and 350 mg cemiplimab (low-dose combination) every 3 weeks; placebo and 200 mg pembrolizumab every 3 weeks; or placebo and 350 mg cemiplimab every 3 weeks.

About Regeneron

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite^®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center^® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.

Forward-Looking Statements and Use of Digital Media

This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without fianlimab (LAG-3 inhibitor); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as fianlimab in combination with cemiplimab as a first-line treatment for patients with unresectable locally advanced or metastatic melanoma; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release (such as the Phase 3 trial evaluating two dose levels of fianlimab in combination with cemiplimab as a first-line treatment for patients with unresectable locally advanced or metastatic melanoma and the Phase 3 head-to-head trial in first-line unresectable or metastatic melanoma evaluating the high-dose fianlimab and cemiplimab combination versus Opdualag
^®
(nivolumab and relatlimab-rmbw)), on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates (such as fianlimab in combination with cemiplimab); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates (such as fianlimab in combination with cemiplimab) and new indications for Regeneron’s Products; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as fianlimab in combination with cemiplimab) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron’s pricing strategy, including in connection with Regeneron’s April 2026 agreements with the U.S. government; other changes in laws, regulations, and policies affecting the healthcare industry; competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees (including those discussed or referenced in this press release) may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron’s business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney’s Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA
^®
(aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2025 and its Form 10-Q for the quarterly period ended March 31, 2026. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron’s media and investor relations website (

https://investor.regeneron.com

) and its LinkedIn page (

https://www.linkedin.com/company/regeneron-pharmaceuticals

).

Contacts:

Media Relations

Ashley Buford Fredericks

Tel: +1 914-356-2235
[email protected] Investor Relations

Ryan Crowe

Tel: +1 914-839-2614
[email protected]

Posted on May 15, 2026 7:53 pm
INVESTOR NOTICE: Medpace Holdings Inc. (MEDP) Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit

PR Newswire

SAN DIEGO, May 15, 2026 /PRNewswire/ — Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Medpace Holdings Inc. (NASDAQ: MEDP) common stock between April 22, 2025 and February 9, 2026, both dates inclusive (the “Class Period”), have until Monday, June 8, 2026 to seek appointment as lead plaintiff of the Medpace class action lawsuit. Captioned Durbin v. Medpace Holdings Inc., No. 26-cv-00346 (S.D. Ohio), the Medpace class action lawsuit charges Medpace as well as certain of Medpace’s top executives with violations of the Securities Exchange Act of 1934.

If you suffered substantial losses and wish to serve as lead plaintiff of the

Medpace

class action lawsuit, please provide your information here:

https://www.rgrdlaw.com/cases-medpace-holdings-inc-class-action-lawsuit-medp.html

You can also contact attorneys

Ken Dolitsky

or

Michael Albert

of Robbins Geller by calling 800/851-7783 or via e-mail at

[email protected]

.

CASE ALLEGATIONS: Medpace is a clinical contract research organization (CRO) focused on providing scientifically-driven outsourced clinical development services to the biotechnology, pharmaceutical, and medical device industries.

The Medpace class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (i) Medpace consistently oversold Medpace’s projected book-to-bill ratio for fourth quarter 2025; (ii) Medpace knew or recklessly disregarded the impact that cancellations have on Medpace’s book-to-bill ratio; (iii) Medpace frequently claimed that the projection of a 1.15 book-to-bill ratio for fourth quarter 2025 was reasonable and achievable and that cancellations were not a sign of a weak business environment; (iv) Medpace reassured investors that Medpace was not concerned about the lack of diversity in its pre-backlog; and (v) Medpace management stated that, despite the uptick in metabolic growth, Medpace’s upside was broad-based and not isolated to any handful of studies.

The Medpace class action lawsuit further alleges that on February 9, 2026, Medpace released fourth quarter 2025 earnings results revealing a book-to-bill ratio of 1.04, well below Medpace’s guidance. On this news, the price of Medpace common stock fell nearly 16%, according to the complaint.

THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or acquired Medpace common stock during the Class Period to seek appointment as lead plaintiff in the Medpace class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Medpace class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Medpace class action lawsuit. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the Medpace class action lawsuit.

ABOUT ROBBINS GELLER: Robbins Geller Rudman & Dowd LLP is one of the world’s leading law firms representing investors in securities fraud and shareholder rights litigation. Our Firm ranked #1 on the most recent ISS Securities Class Action Services Top 50 Report, recovering more than $916 million for investors in 2025. This marks our fourth #1 ranking in the past five years. And in those five years alone, Robbins Geller recovered $8.4 billion for investors – $3.4 billion more than any other law firm. With 200 lawyers in 10 offices, Robbins Geller is one of the largest plaintiffs’ firms in the world, and the Firm’s attorneys have obtained many of the largest securities class action recoveries in history, including the largest ever – $7.2 billion – in In re Enron Corp. Sec. Litig. Please visit the following page for more information:

https://www.rgrdlaw.com/services-litigation-securities-fraud.html

Past results do not guarantee future outcomes.
Services may be performed by attorneys in any of our offices.

Contact:
          Robbins Geller Rudman & Dowd LLP
          Ken Dolitsky
          Michael Albert
          655 W. Broadway, Suite 1900, San Diego, CA 92101
          800/851-7783
          [email protected]

View original content to download multimedia:https://www.prnewswire.com/news-releases/investor-notice-medpace-holdings-inc-medp-investors-with-substantial-losses-have-opportunity-to-lead-class-action-lawsuit-302766517.html

SOURCE Robbins Geller Rudman & Dowd LLP

Posted on May 15, 2026 7:05 pm
Planet Fitness, Inc. Investigation Initiated: Levi & Korsinsky Investigates the Officers and Directors of Planet Fitness (PLNT)

PR Newswire

Planet Fitness, Inc. stock dropped sharply after the Company reiterated weaker-than-expected FY EPS grown guidance of approximately 9%-10% — well below prior investor expectations

NEW YORK, May 15, 2026 /PRNewswire/ — Shareholders of Planet Fitness, Inc. (NYSE: PLNT) who lost money when the stock dropped after the Company slashed its FY 2026 earnings outlook are encouraged to submit their information to Levi & Korsinsky . You may also contact Joseph E. Levi, Esq. via email at [email protected] or by telephone at (212) 363-7500.

Planet Fitness, Inc. issued FY 2026 adjusted diluted EPS guidance that fell below analyst expectations. On the Company’s Q4 2025 earnings call on February 24, 2026, CFO Jay Stasz had guided for adjusted diluted EPS to increase between 9% and 10%, based on approximately 80 million adjusted diluted weighted-average shares outstanding and a plan to repurchase approximately $150 million worth of shares in 2026. The updated outlook signaled weaker-than-expected earnings growth relative to the Company’s earlier framework.

The Company attributed the cut to an extended equipment-replacement cycle, the sale of eight corporate-owned clubs in California, higher anticipated interest expense related to refinancing activity, and weather-related disruptions affecting approximately 2,000 clubs. While some of these pressures became more pronounced after the Company issued its February 24, 2026 guidance, investors had not previously been informed of their full anticipated impact on 2026 results. Levi & Korsinsky is investigating whether Planet Fitness may have failed to adequately disclose known headwinds at the time it provided its original FY 2026 earnings outlook.

PLNT investors who suffered losses are encouraged to contact Levi & Korsinsky to discuss their legal rights . You may also reach Joseph E. Levi, Esq. at [email protected] or (212) 363-7500.

ABOUT THE FIRM — For over two decades, Levi & Korsinsky has represented shareholders in securities investigations and actions. Ranked in ISS Top 50 for seven consecutive years.

Frequently Asked Questions About the PLNT Investigation

Q: How much did PLNT stock drop? A: Planet Fitness, Inc. shares declined sharply after the Company issued weaker-than-expected FY 2026 earnings guidance, disappointing investors who had previously been told to expect approximately 9%-10% adjusted EPS growth by management. Investors who purchased shares at higher prices may be eligible to participate in the investigation.

Q: Which statements are being investigated as potentially misleading? A: The investigation concerns whether Planet Fitness adequately disclosed known risks — including an extended equipment-replacement cycle, the sale of eight corporate-owned clubs, a $400 million debt refinancing, and weather-related disruptions — at the time CFO Jay Stasz guided for 9%-10% EPS growth on February 24, 2026.

Q: Who is eligible to participate in the PLNT investigation? A: Investors who purchased PLNT stock and suffered financial losses may be eligible. Eligibility is based on purchase date and documented losses — not on whether you still hold the shares.

Q: What do PLNT investors need to do right now? A: Gather brokerage records including purchase dates, share quantities, and prices paid. Contact Levi & Korsinsky for a free, no-obligation evaluation at [email protected] or (212) 363-7500. No immediate action is required to remain eligible to participate in the investigation.

Q: What if I already sold my PLNT shares — can I still recover losses? A: Yes. Eligibility is based on when you purchased, not whether you still hold the shares. Investors who bought PLNT and sold at a loss may still participate in the investigation.

Q: What does it cost me to participate? A: Nothing. Securities investigations are handled on a pure contingency basis. No upfront fees, no retainer, no out-of-pocket costs.

Q: What if my PLNT losses are small — is it still worth contacting a lawyer? A: Yes. There is no minimum loss amount required to participate in the investigation.

CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
33 Whitehall Street, 27th Floor
New York, NY 10004
[email protected]
Tel: (212) 363-7500
Fax: (212) 363-7171

View original content to download multimedia:https://www.prnewswire.com/news-releases/planet-fitness-inc-investigation-initiated-levi–korsinsky-investigates-the-officers-and-directors-of-planet-fitness-plnt-302773913.html

SOURCE Levi & Korsinsky, LLP

Posted on May 15, 2026 7:05 pm
Biogen Inc. Investigation Initiated: Levi & Korsinsky Investigates the Officers and Directors of Biogen Inc. (BIIB)

PR Newswire

Biogen shares dropped 6.4% after Phase 2 CELIA trial data revealed information absent from the Company’s filings.

NEW YORK, May 15, 2026 /PRNewswire/ — Biogen Inc. (NASDAQ: BIIB) investors lost approximately 6.4% per share on May 14, 2026, after Phase 2 “CELIA” topline data for diranersen missed its primary dose-response endpoint. Shareholders who lost money on BIIB are encouraged to submit their information to Levi & Korsinsky. You may also contact Joseph E. Levi, Esq. via email at [email protected] or by telephone at (212) 363-7500.

Biogen published a press release on May 14, 2026, announcing that CELIA did not meet its primary endpoint assessing dose response;. The Company further stated that based on the strength of the biomarker and efficacy data, Biogen plans to advance diranersen to registrational development anyway.

If you purchased Biogen shares and suffered a loss, click here to discuss your legal rights with Levi & Korsinsky. You may also contact Joseph E. Levi, Esq. via email at [email protected] or by telephone at (212) 363-7500.

Levi & Korsinsky, LLP — Top 50 securities litigation firm (ISS, seven consecutive years). Over 70 professionals. Hundreds of millions recovered.

Frequently Asked Questions About the BIIB Investigation

Q: Who is eligible to participate in the BIIB investigation?A: Investors who purchased BIIB stock or securities and suffered financial losses may be eligible. Eligibility is based on purchase date and documented losses — not on whether you still hold the shares.

Q: Which statements are being investigated as potentially misleading?A: The investigation concerns whether Biogen made materially false or misleading statements regarding the failure of CELIA to meet its primary endpoint. When the Phase 2 CELIA data became public, the stock price declined sharply.

Q: How much did BIIB stock drop?A: Shares fell approximately 6.4% on May 14, 2026, after the Company released Phase 2 CELIA topline data for diranersen showing the trial failed to meet its primary dose-response endpoint.

Q: What do BIIB investors need to do right now?A: Gather brokerage records including purchase dates, share quantities, and prices paid. Contact Levi & Korsinsky for a free, no-obligation evaluation at [email protected] or (212) 363-7500. No immediate action is required to remain eligible to participate in the investigation.

Q: What happens after I contact Levi & Korsinsky?A: An attorney will review your trading history at no cost and provide an initial assessment of your potential recovery.

Q: What does it cost me to participate?A: Nothing. Securities investigations and any resulting actions are handled on a pure contingency basis. No upfront fees, no retainer, no out-of-pocket costs.

Q: What if I already sold my BIIB shares — can I still recover losses?A: Yes. Eligibility is based on when you purchased, not whether you still hold the shares. Investors who bought BIIB and sold at a loss may still participate in the investigation.

CONTACT:\

Levi & Korsinsky, LLP\

Joseph E. Levi, Esq.\

Ed Korsinsky, Esq.\

33 Whitehall Street, 27th Floor\

New York, NY 10004\

[email protected]\

Tel: (212) 363-7500\

Fax: (212) 363-7171

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SOURCE Levi & Korsinsky, LLP

Posted on May 15, 2026 6:54 pm
Faraday Future Announces $25 Million in New Financing, Demonstrating Institutional Investors’ Confidence in the Company’s Prospects; Recent Total of $70 Million in Financing to Sufficiently Support the Phase I Goals of Its Robotics Business Plan

Faraday Future Announces $25 Million in New Financing, Demonstrating Institutional Investors’ Confidence in the Company’s Prospects; Recent Total of $70 Million in Financing to Sufficiently Support the Phase I Goals of Its Robotics Business Plan

Combined with the $45 million announced in April, the Company has secured a total of $70 million in financing over the past two months, enough to fully support the Phase 1 (by end of 2026) objective of FF EAI robotics strategy. Driven by rising demand across the FF’s four primary product lines and key application scenarios, including education, security inspection, reception and guided tours, performance, and university research, as well as the upcoming new products, the Company raised the full-year shipment target to 1,500 units.

With improved strategy, fundamentals, and the latest recent financing, for the first time in years, FF has the room to shift financing decisions from liquidity-driven to capital-structure-driven. With near-term runway pressure materially eased, the Company believes it is now positioned to systematically select the financing mix that best serves long-term stockholder value, rather than accept terms dictated by short-term liquidity needs. For its EAI Vehicle business, FF expects to gradually move away from a high-cost short-term funding approach toward a business-phase fit financing mix of operating cash flow, industry partnerships, and long-term capital to accelerate returns for its stockholders.

Following the conclusion of the SEC investigation with no penalties and the full return of the founding team, FF is upgrading its previous “Ten-Punch Combo” strategy into “Five Key Transformations” under AI-First philosophy. The full strategic plan set to be unveiled in YT’s Investor Weekly Report this coming Sunday.

LOS ANGELES–(BUSINESS WIRE)–
Faraday Future Intelligent Electric Inc. (Nasdaq: FFAI) (“FF”, “Faraday Future”, or the “Company”), a California-based global Embodied AI (EAI) ecosystem company, today announced it has entered into a Securities Purchase Agreement (the “Agreement”) with investors to issue convertible promissory notes in an aggregate principal amount of $25 million USD. The Company expects proceeds from the financing to accelerate the implementation of FF’s EAI strategy to maintain FF’s first-mover advantage as the first U.S. company to deliver both humanoid and bionic robots.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260515336285/en/

Faraday Future Announces $25 million in New Financing, Demonstrating Institutional Investors’ Confidence in the Company’s Prospects; Recent Total of $70 million in Financing to Sufficiently Support the Phase I Goals of Its Robotics Business Plan

Pursuant to the Agreement, the investors purchased from the Company convertible promissory notes in an aggregate principal amount of $25 million USD. The shares of common stock underlying the convertible promissory notes issued in the financing are currently unregistered, subject to trading restrictions, and not immediately tradable. Of this amount, $12.5 million will be remitted directly to the Company’s operating account. The remaining $12.5 million will be deposited, pursuant to controlled account agreements with each investor, into control accounts under the control of such investor and will be released to the Company upon satisfaction of certain conditions. For more information on the key terms of this financing, please refer to the Company’s Form 8-K to be filed with the U.S. Securities and Exchange Commission (SEC) on or about May 15, 2026.

Combined with the $45 million financing announced in April, the Company has secured a total of $70 million in financing over the past two months, enough to fully support the Phase 1 (by end of 2026) objective of FF EAI robotics strategy. Driven by rising demand across the FF’s four primary product lines and key application scenarios, including education, security inspection, reception and guided tours, performance, and university research, as well as the upcoming new products, the Company raised the full-year shipment target to 1,500 units.

Evolving into a Physical AI company with the “AI First” philosophy, FF is focusing on two product engines: Embodied AI (EAI) humanoid and bionic robots, and EAI automotive robots. By building a “Three-in-One ecosystem” of “Device, Data, and Brain & Open-Source and Open Developer Platform,” the Company aims to create an evolutionary flywheel, with the goal of maximizing commercial value.

The significance of this financing is not the amount itself, but that — for the first time in years with near-term runway pressure materially eased — the Company believes it can shift financing decisions from liquidity-driven to capital-structure-governance-driven. With improved strategy and fundamentals, FF expects to gradually move its EAI Vehicle business away from high-cost short-term funding approach, toward a business-phase fit financing mix of operating cash flow, industry partnerships, and long-term capital to accelerate returns for its stockholders.

ABOUT FARADAY FUTURE

Founded in 2014, Faraday Future (FF) is a U.S.-based Physical AI ecosystem company dedicated to reshaping the future of robotics and mobility solutions through AI innovation and technologies. FF focuses on two major product strategies within the Embodied AI (EAI) robotics business: EAI humanoid and bionic robots, and EAI automotive-focused robots. By building a Three-in-One ecosystem of “Device, Data, EAI Brain & Open-Source and Open Platform,” FF aims to create an evolutionary flywheel: scaled device delivery, data collection and training, continuous evolution of the EAI Brain, stronger product capability, and even larger-scale delivery and deployment. Through this flywheel, FF seeks to maximize its commercial value and lead to the advancement of Physical AI. For more information, please visit Faraday Future’s official website: https://www.ff.com/

FORWARD LOOKING STATEMENTS

This press release includes “forward looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. When used in this press release, the words “plan to,” “can,” “will,” “should,” “future,” “potential,” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements, which include statements regarding FF’s entry into the embodied AI robotics market, involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the Company’s control, which could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements.

Important factors, among others, that may affect actual results or outcomes include, among others: the Company’s ability to maintain its listing on Nasdaq; the availability of sufficient share capital to execute on its strategy, which the Company currently lacks; the agreement of stockholders to substantially increase the Company’s share capital, which could result in substantial additional dilution; the Company’s ability to homologate FX vehicles for sale; the Company’s ability to secure the necessary funding to execute on the FX strategy, which will be substantial; demand for the Super One; demand for the Company’s robotics products; competition in the robotics industry, which includes companies with far superior experience, funding and name recognition; the Company’s reliance on a single OEM for most of its robotics products; the Company’s ability to get the planned robotics products to comply with all applicable U.S. rules and regulations; the ability of the robotics OEM to timely supply robotics to the Company; tariff uncertainty for imported products, particularly from China; the ability of the U.S. Department of Commerce to review, condition, or prohibit robotics-related transactions with a China OEM; demand from automobile dealers for robotics products; the Company’s ability to timely regain compliance with Nasdaq’s $1.00 minimum bid price requirement; that the Company’s common stock will be suspended from trading on Nasdaq if the closing price of its Class A common stock is $0.10 or less for 10 consecutive trading days; the ability to secure the necessary agreements to upgrade the Super One to an 800V architecture or to develop the AIHER model, none of which have been finalized; the Company’s ability to design and develop AIHER technology; the Company’s ability to secure financing for the 800V architecture of the Super One; the Company’s ability to secure an occupancy certificate for its Hanford facility; the Company’s ability to continue as a going concern and improve its liquidity and financial position; the Company’s ability to pay its outstanding obligations; the Company’s ability to remediate its material weaknesses in internal control over financial reporting and the risks related to the restatement of previously issued consolidated financial statements; the Company’s limited operating history and the significant barriers to growth it faces; the Company’s history of losses and expectation of continued losses; the success of the Company’s payroll expense reduction plan; the Company’s ability to execute on its plans to develop and market its vehicles and robots and the timing of these development programs; the Company’s estimates of the size of the markets for its vehicles and robots and cost to bring those vehicles to market; the rate and degree of market acceptance of the Company’s vehicles; the Company’s ability to cover future warranty claims; the success of other competing manufacturers; the performance and security of the Company’s vehicles; current and potential litigation involving the Company; the Company’s ability to receive funds from, satisfy the conditions precedent of and close on the various financings described elsewhere by the Company; the result of future financing efforts, the failure of any of which could result in the Company seeking protection under the Bankruptcy Code; the Company’s indebtedness; the Company’s ability to use its “at-the-market” program; insurance coverage; general economic and market conditions impacting demand for the Company’s products; potential negative impacts of a reverse stock split; potential cost, headcount and salary reduction actions may not be sufficient or may not achieve their expected results; circumstances outside of the Company’s control, such as natural disasters, climate change, health epidemics and pandemics, terrorist attacks, and civil unrest; risks related to the Company’s operations in China; the success of the Company’s remedial measures taken in response to the Special Committee findings; the Company’s dependence on its suppliers and contract manufacturer; the Company’s ability to develop and protect its technologies; the Company’s ability to protect against cybersecurity risks; and the ability of the Company to attract and retain employees, any adverse developments in existing legal proceedings or the initiation of new legal proceedings, and volatility of the Company’s stock price. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of the Company’s Form 10-K for the year ended December 31, 2025 filed with the SEC on March 31, 2026, and other documents filed by the Company from time to time with the SEC.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260515336285/en/

Investors (English):[email protected]

Investors (Chinese):[email protected]

Media:[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Hardware Robotics Technology Artificial Intelligence Software

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Faraday Future Announces $25 million in New Financing, Demonstrating Institutional Investors’ Confidence in the Company’s Prospects; Recent Total of $70 million in Financing to Sufficiently Support the Phase I Goals of Its Robotics Business Plan

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Posted on May 15, 2026 6:18 pm
Liberty Broadband Corporation Declares Quarterly Cash Dividend on Series A Cumulative Redeemable Preferred Stock

Liberty Broadband Corporation Declares Quarterly Cash Dividend on Series A Cumulative Redeemable Preferred Stock

ENGLEWOOD, Colo.–(BUSINESS WIRE)–
Liberty Broadband Corporation (Nasdaq: LBRDA, LBRDK, LBRDP) today announced that its Board of Directors declared the regular quarterly cash dividend payable to holders of its Series A Cumulative Redeemable Preferred Stock (the “Preferred Stock”) (Nasdaq: LBRDP). The per share amount of the quarterly cash dividend will be $0.43750001, payable in cash on July 15, 2026 to holders of record of the Preferred Stock at the close of business on June 30, 2026 (the “Record Date”).

About Liberty Broadband Corporation

Liberty Broadband Corporation’s (Nasdaq: LBRDA, LBRDK, LBRDP) principal asset consists of its interest in Charter Communications.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260515612247/en/

Liberty Broadband Corporation

Hooper Stevens, +1 720-875-5406

KEYWORDS: Colorado United States North America

INDUSTRY KEYWORDS: Technology Telecommunications

MEDIA:

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Posted on May 15, 2026 6:03 pm
United Therapeutics Corporation Announces FDA Clearance to Proceed with UHeart Xenotransplantation Clinical Trial

United Therapeutics Corporation Announces FDA Clearance to Proceed with UHeart Xenotransplantation Clinical Trial

First-ever human clinical trial of a xenoheart intended to support potential registration through the submission of a Biologics License Application to the U.S. FDA

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–
United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance under the company’s Investigational New Drug application to proceed with a clinical study of its investigational UHeart™ derived from a pig with 10 gene edits. The study, known as EXPRESS,will enroll an initial cohort of up to two participants. United Therapeutics will provide the FDA with safety and efficacy data from the first UHeart xenotransplant recipient in the study before enrolling a second participant. Following FDA review of available safety and efficacy data from the initial two transplants, the study may then be further expanded, with the intent to support a Biologics License Application (BLA) with the FDA.

“Moving a porcine-derived heart into human clinical trials represents another defining advancement for the field of xenotransplantation,” said Kristina DeSmet, Ph.D., DABT, Senior Director, Product Development at United Therapeutics. “The heart is one of the most complex solid organs to transplant, and proceeding into the clinic reflects years of coordinated scientific progress. For United Therapeutics, this milestone represents our third clinical trial in xenotransplantation and underscores the breadth of our platform, spanning end-stage renal disease and now life-threatening heart disease. Together, these programs reinforce our commitment to expanding transplant options for patients who currently have no other alternatives.”

Noah Byrd, Ph.D., RAC,Vice President, Global Regulatory Affairs at United Therapeutics, added: “Patients with end stage heart disease continue to face profound limitations in available treatment options. This FDA clearance to proceed with our EXPRESS clinical trial will allow us to begin evaluating an innovative therapeutic option designed to address this unmet need.”

About EXPRESS

Study Design

The study will start at a single center enrolling up to two participants. If safety and efficacy data from these initial participants are supportive, United Therapeutics intends to expand the study to enroll participants at additional centers to support submission of a BLA. The study is designed as a phase 1/2/3 trial (sometimes referred to as a “phaseless” study) to evaluate safety and efficacy of the UHeart seamlessly without moving through separate phase 1, phase 2, and phase 3 studies that are typically associated with conventional drug approvals. Participants will receive a UHeart transplant followed by a 24-week post-transplant follow-up period, including the evaluation of all study endpoints and safety assessments. After the 24-week post-transplant follow-up period, participants who received a UHeart will continue to be followed for the rest of their lives, including for survival, UHeart survival, and screening for zoonotic infections.

Safety and efficacy data will be reviewed frequently by an independent Data Monitoring Committee. After at least 12 weeks post-transplant of the first participant, United Therapeutics will provide data to FDA prior to initiating a second transplant. If safety and efficacy results from the first 2 participants are supportive, the study sample size will be increased to enable the study to support registration.

Efficacy Endpoints

Efficacy endpoints include participant survival rate, UHeart survival rate, UHeart function¹, change in quality of life in participants² at 24 weeks post-transplant, and participant exercise capacity³. Overall survival time of participants receiving a UHeart and overall survival time of the UHearts themselves are also efficacy endpoints.

Safety Endpoints

Safety endpoints include the incidence of adverse events and serious adverse events, all-cause mortality, and the incidence of arrythmias, thromboembolic and ischemic strokes, zoonotic infections, and opportunistic infections.

Key Participation Criteria

Key participation criteria include those ≥50 years of age, diagnosed with end-stage or advanced heart failure (HF) classified as American College of Cardiology/American Heart Association stage D and New York Heart Association Class IV, and no remaining therapeutic options. Participants will be screened using a crossmatch assay to assess expected immunological compatibility with the UHeart. Participants must not need multiple organ transplants; must not have had a prior solid organ transplant; must not have support with venoarterial ECMO; must not have severe medical co-morbidities, including but not limited to chronic liver disease, severe central vascular disease, severe neurologic diseases, and uncontrolled diabetes; and must not have a history of medical noncompliance that may preclude adherence to the demands and requirements of xenotransplantation.

Full inclusion and exclusion criteria for this study will be provided in a future listing on the clinicaltrials.gov website.

About Advanced Heart Failure

According to the Journal of Cardiac Failure, in the United States nearly 6.7 million adults 20 years of age or older have HF, and in 2023, HF was responsible for 14.6% of all causes of death according to a CDC report⁴. In 2023, only a fraction of Americans with HF were considered candidates and waitlisted for a human heart transplant (0.12% or 8,000 Americans), and only approximately 4,000 heart transplants were performed⁵.

About UHeart

United Therapeutics’ xenoheart, known by the proposed trade name UHeart, is an investigational xenoheart from a pig with 10 gene edits. Six human genes are added to the pig genome to facilitate immunological acceptance and compatibility of the organ in the human recipient. Four porcine genes are inactivated or “knocked out” to reduce the risk of organ rejection and to moderate growth.

About United Therapeutics

Founded by CEO Martine Rothblatt to discover a cure for her daughter’s life-threatening rare disease, pulmonary arterial hypertension, United Therapeutics transforms the treatment of rare diseases and pioneers alternatives to expand the supply of transplantable organs. From our innovative therapies to our groundbreaking manufactured organs, we are bold and unconventional. We move quickly from scientific theory to practical technologies that can save lives. As a public benefit corporation, even our legal structure reflects our commitments. We serve patients, act with integrity, create long-term shareholder value, and operate with sustainable practices that protect the future we are working to build. Visit us at www.unither.com and follow us on LinkedIn, Facebook, and Instagram.

Forward-Looking Statements

Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others: our plans with respect to the conduct of the EXPRESS study of our UHeart product, including the potential to expand the study following review of data from the first two participants; our plan to submit a BLA seeking FDA approval of the UHeart; our commitment to expanding transplant options for patients through our xenotransplant programs; our belief that presentations of data from our clinical studies will provide important clinical insights that can meaningfully reshape how diseases are managed and improve outcomes; and our goals of expanding the supply of transplantable organs, developing practical technologies that can save lives, creating long-term shareholder value, and operating with sustainable practices. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language, and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of May 15, 2026, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.

UHEART is a trademark of United Therapeutics Corporation.

____________________

¹ UHeart function defined as left ventricular ejection fraction, global longitudinal strain, and right ventricular free-wall strain.

² Quality of life will be measured using the following three surveys: the EuroQol 5-Dimension 5-Level, the Kansas City Cardiomyopathy Questionnaire-23, and the Patient Global Impression of Change.

³ Exercise capacity will be measured by change in 6-minute walk distance from baseline to 24 weeks post transplant.

⁴ About Heart Failure, Centers for Disease Control, https://www.cdc.gov/heart-disease/about/heart-failure.html.

⁵ Organ Procurement and Transplantation Network/Scientific Registry of Transplant Recipients 2025.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260515765117/en/

For Further Information Contact:

Investor Inquiries

https://ir.unither.com/contact-ir

Media Inquiries

[email protected]

KEYWORDS: North Carolina Maryland United States North America

INDUSTRY KEYWORDS: Cardiology Biotechnology Pharmaceutical General Health Health FDA Clinical Trials Other Health

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Posted on May 15, 2026 6:03 pm
USA Compression Partners Announces 2025 K-3 Tax Package Availability

USA Compression Partners Announces 2025 K-3 Tax Package Availability

DALLAS–(BUSINESS WIRE)–
USA Compression Partners, LP (NYSE: USAC) (“USA Compression”) today announced that its 2025 Schedule K-3 reflecting items of international tax relevance is available online. Unitholders requiring this information may access their Schedule K-3 at taxpackagesupport.com/usac.

A limited number of unitholders (primarily foreign unitholders, unitholders computing a foreign tax credit on their tax return and certain corporate and/or partnership unitholders) may need the detailed information disclosed on Schedule K-3 for their specific reporting requirements. To the extent Schedule K-3 is applicable to your federal income tax return filing needs, we encourage you to review the information contained on this form and refer to the appropriate federal laws and guidance or consult with your tax advisor.

To receive an electronic copy of your Schedule K-3 via email, unitholders may call Tax Package Support toll free at 855-521-8151. Tax Package Support is available Monday through Friday from 8:00 am to 5:00 pm Central Time.

ABOUT USA COMPRESSION PARTNERS, LP

USA Compression Partners, LP is one of the nation’s largest independent providers of natural gas compression services in terms of total compression fleet horsepower. USA Compression partners with a broad customer base composed of producers, processors, gatherers, and transporters of natural gas and crude oil. USA Compression focuses on providing midstream natural gas compression services to infrastructure applications primarily in high-volume gathering systems, processing facilities, and transportation applications. More information is available at usacompression.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260515044591/en/

USA Compression Partners, LP

Mitchell Freer

Sr. Director, Finance

[email protected]

KEYWORDS: Texas United States North America

INDUSTRY KEYWORDS: Energy Utilities Oil/Gas

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