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Alumis’ Envudeucitinib Delivers Early and Robust Improvements in Skin Clearance, Quality of Life and Psoriasis Symptoms in Two Phase 3 Trials, Underscoring Its Potential as a Leading Oral Therapy for Plaque Psoriasis

  • Envudeucitinib achieved robust PASI responses by Week 16, with significant continued improvements by Week 24 in PASI 90 (68.0%, 62.1%) and PASI 100 (41.0%, 39.5%)

  • Quality‑of‑life improvements and itch relief emerged ahead of PASI 90 skin clearance, and clear or almost clear scalp psoriasis emerged by Week 4, highlighting envudeucitinib’s early onset and broad clinical benefit

  • Envudeucitinib demonstrated a favorable safety and tolerability profile consistent with the Phase 2 program

  • Results presented as a late-breaking oral presentation at the 2026 American Academy of Dermatology (AAD) Annual Meeting

  • Conference call and webcast scheduled for March 29, 2026, at 5:00 pm MDT / 7:00 pm EDT

SOUTH SAN FRANCISCO, Calif., March 28, 2026 (GLOBE NEWSWIRE) — Alumis Inc. (Nasdaq: ALMS), a late-stage biopharmaceutical company developing next-generation targeted therapies for patients with immune-mediated diseases, today announced new data from its Phase 3 ONWARD1 and ONWARD2 clinical trials evaluating envudeucitinib, a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor for moderate-to-severe plaque psoriasis. The data were presented in a late-breaking oral session at the 2026 AAD Annual Meeting.

Envudeucitinib demonstrated robust skin clearance, achieving high thresholds of clinical response at Week 16 that continued to deepen through Week 24 in both trials. Psoriasis Area and Severity Index (PASI) 90 responses, which emerged as early as Week 4, were achieved by 59.9% and 53.1% of envudeucitinib patients at Week 16 (and by 4.8% and 4.3% of placebo patients), increasing to 68.0% and 62.1% at Week 24. PASI 100 responses followed a similar trajectory, with 29.4% and 27.7% of envudeucitinib patients achieving complete skin clearance at Week 16 (as compared to 0.9% and 0.9% of placebo patients), rising to 41.0% and 39.5% at Week 24.

Envudeucitinib also demonstrated improvements in scalp psoriasis, a high-impact, difficult-to-treat area marked by profound effects on quality of life. At Week 24, approximately three out of four envudeucitinib patients1 achieved clear or almost clear scalp psoriasis, measured by the Scalp Specific Physician’s Global Assessment (ss‑PGA 0/1), with over 30% responding as early as Week 4.

Broad and meaningful clinical benefits emerged early. Notably, quality-of-life and itch improvements appeared before PASI 90 skin clearance responses and continued to deepen through Week 24 across both trials.

  • By Week 12, approximately 50% of envudeucitinib patients2 achieved Dermatology Life Quality Index (DLQI) 0/1, demonstrating minimal to no impact of disease on quality of life.
  • By Week 16, envudeucitinib patients achieved an average improvement of more than 4 points from baseline on the 0–10 Worst Pruritus Numeric Rating Scale (NRS), with clinically meaningful itch relief as early as Week 2—one of the most burdensome symptoms of psoriasis.

“What stands out with envudeucitinib in these trials is how quickly patients begin to feel relief from symptoms, and how deeply those improvements continue to build,” said leading dermatologist and psoriasis expert Dr. Andrew Blauvelt. “For people living with the daily burden of plaque psoriasis, this degree of skin clearance and symptom improvement from an oral investigational drug is impressive, especially when high‑impact sites are involved.”

Treatment with envudeucitinib was generally well tolerated through Week 24 in both trials, with a safety profile consistent with the Phase 2 program, including its long-term extension study. No clinically significant laboratory abnormalities or cases of tuberculosis reactivation were observed. Treatment-emergent adverse events were mostly mild, transient, self-limited, or responding to standard therapy, with the most common being headache, nasopharyngitis, upper respiratory tract infection, and acne. No new safety signals were observed.

“Envudeucitinib delivered the level of skin clearance, symptom relief, and safety in Phase 3 that the TYK2 mechanism has long promised but that has not been fully realized—until now—with sustained, maximal 24-hour inhibition of the IL-23 / IL-17 pathways,” said Dr. Jörn Drappa, Chief Medical Officer of Alumis. “The depth of clinical response, together with the favorable safety profile observed, underscores a differentiated clinical profile among marketed and investigational oral options and supports envudeucitinib’s potential to play a leading role in the treatment of patients with moderate‑to‑severe plaque psoriasis.”

Alumis is continuing to evaluate the long-term efficacy and safety of envudeucitinib in the ONWARD3 long-term extension trial and plans to submit a New Drug Application to the U.S. Food and Drug Administration in the second half of this year.

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1 Based on patients with baseline ss‑PGA ≥3
2 Based on patients with baseline DLQI ≥2

Conference Call, Presentation and Webcast Details

Alumis will host a webcast for the investment community to review the Phase 3 ONWARD results presented at AAD which will begin at 5:00 pm MDT / 7:00 pm EDT on Sunday, March 29, 2026. The live webcast can be accessed via this link or on the Events tab on the Investors section of the Company’s website. A replay of the webcast will be made available on the Company’s website following the call. In addition, Alumis has posted the AAD presentation under the Publications section of the Company’s website.

About the Phase 3 ONWARD Clinical Program

The Phase 3 ONWARD clinical program includes two parallel global, multicenter, randomized, double-blind, placebo and active-comparator-controlled 24week trials—ONWARD1 (NCT06586112) and ONWARD2 (NCT06588738)—evaluating the efficacy and safety of envudeucitinib in adults with moderate-to-severe plaque psoriasis. More than 1,700 patients were enrolled and randomized 2:1:1 to receive envudeucitinib 40 mg twice daily, placebo, or apremilast. Co-primary endpoints at Week 16 were the proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 and static Physician’s Global Assessment (sPGA) 0/1 compared with placebo. Patients completing Week 24 were eligible to enter ONWARD3 (NCT06846541), an ongoing long-term extension study assessing durability, greater maintenance of response, and long-term safety. The ONWARD clinical trials did not have a fasting requirement.

About Envudeucitinib

Envudeucitinib is a next-generation, highly selective, oral allosteric inhibitor of tyrosine kinase 2 (TYK2) precision‑engineered for maximal 24‑hour TYK2 inhibition to correct immune dysregulation across a range of diseases driven by proinflammatory mediators, including IL-23, IL-17, and Type I interferon. It is the only TYK2 inhibitor shown to deliver maximal target inhibition over 24 hours in humans. Clinical data indicate its selective targeting delivered sustained, maximal 24-hour inhibition in patients with psoriasis while minimizing off-target binding and effects. Alumis is currently evaluating the long-term efficacy and safety of envudeucitinib in the Phase 3 ONWARD3 clinical program for moderate-to-severe plaque psoriasis. Envudeucitinib is also being evaluated in LUMUS, a potentially pivotal Phase 2b clinical trial in patients with systemic lupus erythematosus, with topline data expected in the third quarter of 2026.

About Plaque Psoriasis

Plaque psoriasis is a chronic, immune-mediated disease driven by dysregulated IL-23 and IL-17 pathways that cause painful, itchy, scaly patches. It affects more than 8 million adults in the U.S. and often involves high-impact areas such as the scalp, face, hands, feet, and nails, significantly disrupting daily life. According to the National Psoriasis Foundation, about one in four patients has moderate-to-severe disease, based on quality-of-life impact and body surface area involved. Many remain inadequately controlled on current oral and topical treatments, underscoring the need for more effective, safe, and durable oral options that address the full burden of disease.

About TYK2 in Immune-Mediated Disease

Tyrosine kinase 2 (TYK2) is a key immune-signaling enzyme that regulates pathways across innate and adaptive immunity, including the IL-23/IL-17 axis and Type I interferon signaling that drive many high-burden immune-mediated diseases. Selective TYK2 inhibition has been widely validated as an effective, safe, and well-tolerated therapeutic approach. Genomic analyses conducted by Alumis highlight TYK2’s broad therapeutic potential, showing that it contributes to the pathogenesis of roughly 20 immune-driven conditions—including psoriasis, lupus, psoriatic arthritis, rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. Additional evidence supports a genetic rationale for TYK2 inhibition in neuroinflammatory and neurodegenerative diseases where targeting TYK2 may offer a novel approach to treatment.

About Alumis

Alumis is a late-stage biopharma company developing next-generation targeted therapies with the potential to significantly improve patient health and outcomes across a range of immune-mediated diseases. Leveraging its proprietary data analytics platform and precision approach, Alumis is developing a pipeline of oral tyrosine kinase 2 inhibitors, consisting of envudeucitinib for the treatment of systemic immune-mediated disorders, such as moderate-to-severe plaque psoriasis and systemic lupus erythematosus, and A-005 for the treatment of neuroinflammatory and neurodegenerative diseases. In addition, the pipeline includes lonigutamab, a subcutaneously delivered anti–insulin-like growth factor 1 receptor therapy for the treatment of thyroid eye disease, as well as several preclinical programs identified through this precision approach. For more information, visit www.alumis.com or follow us on LinkedIn or X.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements. All statements, other than statements of historical facts, including without limitation those regarding Alumis’ plans to submit an NDA in the second half of 2026, the potential for envudeucitinib to play a leading role in the treatment of patients with moderate‑to‑severe plaque psoriasis, the timing of Alumis’ topline readout in its LUMUS Phase 2b program and statements regarding Alumis’ future plans and prospects, including development of its clinical pipeline; and any assumptions underlying any of the foregoing, are forward-looking statements. Any forward-looking statements in this press release are based on Alumis’ current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in Alumis’ forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to whether regulatory authorities determine that envudeucitinib in moderate-to-severe plaque psoriasis is sufficiently safe and efficacious and grant regulatory approval; whether regulatory authorities accept for filing Alumis’ planned NDA submission; Alumis’ ability to obtain regulatory approval of and ultimately commercialize Alumis’ clinical candidates, the timing and results of preclinical and clinical trials, Alumis’ ability to fund development activities and achieve development goals, and Alumis’ ability to protect its intellectual property. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Alumis’ filings and reports with the Securities and Exchange Commission (SEC) under the heading “Risk Factors” and elsewhere in such filings and reports, including any future reports Alumis may file with the SEC from time to time. Alumis explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.



Alumis Contact Information
Teri Dahlman
Red House Communications
[email protected]

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Arcutis Presents New Phase 2 Results in Infants with Atopic Dermatitis in Late-Breaking Session Today at the 2026 American Academy of Dermatology Annual Meeting

  • Investigational ZORYVE® (roflumilast) cream 0.05% was well tolerated with safety findings consistent with prior pediatric experience in the INTEGUMENT program
  • ZORYVE cream improved signs and symptoms of mild to moderate atopic dermatitis in infants aged 3 months to less than 24 months over four weeks
  • Caregivers reported rapid improvement in itch in as little as 10 minutes in nearly half of infants
  • Results from additional studies across the ZORYVE portfolio being presented in three poster presentations

WESTLAKE VILLAGE, Calif. and DENVER, March 28, 2026 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced new data from the INTEGUMENT-INFANT Phase 2 trial demonstrating that ZORYVE® (roflumilast) cream 0.05% reduced signs and symptoms of atopic dermatitis, the most common form of eczema, in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis. These results build upon the topline results announced last month and further support the potential of investigational ZORYVE cream as a treatment option for this youngest and very vulnerable population. The results were presented today during a late-breaking podium presentation at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, CO.

“Infantile atopic dermatitis presents daily challenges for affected patients and their families, and clinicians have limited topical options to treat it,” said Lawrence F. Eichenfield, MD, of Rady Children’s Hospital San Diego and the University of California San Diego School of Medicine, and presenting author of the INTEGUMENT‑INFANT data. “The rashes and itch of eczema result in disrupted sleep and significant distress for both infants and their families. In this Phase 2 study, once‑daily ZORYVE cream 0.05% provided meaningful improvements in severity of the signs and symptoms of disease over four weeks, with caregivers reporting rapid relief of itch in as little as 10 minutes. The study results show that ZORYVE cream was effective with a safe and well-tolerated profile in infants down to 3 months of age.”

The INTEGUMENT-INFANT open-label trial evaluated the safety and tolerability of once-daily ZORYVE cream 0.05% in infants (n=101) aged 3 months to less than 24 months with mild to moderate atopic dermatitis over four weeks. The Phase 2 study results reinforce the consistency of the safety and tolerability profile of ZORYVE cream 0.05% already seen in the four-week pivotal INTEGUMENT-PED clinical trial in children aged 2 to 5 years. The most frequently reported adverse events (≥3%; n=101) included: diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting. Only one trial participant discontinued the study due to an adverse event, and there were no serious adverse events. In addition, based on investigator-rated local tolerability assessments, ≥97.9% of infants experienced no application site irritation throughout the four weeks.

In new data released today, among participants who completed four weeks of treatment (n=96), 34.4% achieved Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) success (defined as a score of 0 (Clear) or 1 (Almost Clear) with a ≥2-grade improvement). In addition, 49% of infants achieved a vIGA-AD score of Clear or Almost Clear (0 or 1) at Week 4, and 24% already at Week 2. For those infants with at least mild scalp involvement at baseline (n=40), 67.5% achieved vIGA-scalp success (scalp Clear or Almost Clear (0 or 1) with ≥2-point improvement from baseline) at Week 4. As previously reported, 58.3% of infants achieved at least a 75% reduction in Eczema Area and Severity Index (EASI-75) at Week 4 (n=96), and 34% of infants at Week 2 (n=100).

In addition, caregivers reported improvement in itch. Itch improvement, as assessed by caregivers using the Worst Scratch Itch Numeric Rating Scale (WSI-NRS)—a measure validated in patients aged 6 months to 6 years—showed that 72.7% of infants achieved WSI-NRS success, defined as a ≥4-point improvement at the end of the study, at Week 4 (n=77) and 60.3% at Week 2 (n=73). Furthermore, 66.7% of infants achieved at least a 25% improvement from baseline in pruritus based on the Dynamic Pruritus Scale (DPS-25) at four hours (n=87), 58.6% at one hour (n=87), and 46.6% at 10 minutes (n=88).

“Atopic dermatitis often begins in the first months of life, underscoring the need for therapies that are both safe and effective and can be used anywhere on the body for these youngest of patients,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer, Arcutis. “Findings from the INTEGUMENT-INFANT study add important clinical evidence for investigational ZORYVE cream 0.05% in infants 3 to <24 months, including demonstrating that ZORYVE cream is effective as measured by multiple clinical endpoints, and well-tolerated, with minimal to no evidence of irritation at the application site. Arcutis is committed to advancing effective and well-tolerated non-steroidal treatment options for patients with atopic dermatitis, especially for this vulnerable population.”

These data will support Arcutis’ planned supplemental New Drug Application for ZORYVE cream 0.05% in infants aged 3 months to less than 24 months, which the Company expects to submit in the second quarter of 2026. The findings further expand the body of evidence supporting ZORYVE as an advanced targeted topical therapy across age groups, body areas, and disease severities.


Key Results from Additional Studies Supporting the ZORYVE Portfolio Presented in Posters:

New results from the INTEGUMENT-OLE Phase 3 trial (poster presentation) demonstrate that ZORYVE cream 0.05% was well tolerated and provided durable improvements in caregiver-reported outcomes that are maintained over the long term in children aged 2 to 5 years with mild to moderate atopic dermatitis. These follow the recent publication of the full results of INTEGUMENT-OLE published in the journal Pediatric Dermatology earlier this month.

Findings from a STRATUM Phase 3 trial subgroup analysis (e-poster) show that ZORYVE foam 0.3% was well tolerated and improved signs and symptoms of seborrheic dermatitis through 8 weeks of treatment in individuals with seborrheic dermatitis including those with face and/or scalp involvement. The analysis supports ZORYVE foam 0.3% as a suitable potential treatment of anatomical areas where topical steroid use is limited by safety considerations, such as the face.

Further analysis from the previously published Phase 3 DERMIS-1/2 and ARRECTOR trials (e-poster) found that ZORYVE cream 0.3% and foam 0.3% improved psoriasis severity, reducing Psoriasis Area and Severity Index (PASI) total and component scores more than vehicle cream or vehicle foam. Mean improvements in psoriasis were reported with ZORYVE cream and foam across body regions: head and neck, trunk, and upper and lower extremities. These results confirm that both ZORYVE cream 0.3% and foam 0.3% provide consistent benefit across body regions affected by psoriasis, offering a treatment alternative to commonly used topical steroids.

About ZORYVE® (roflumilast)

ZORYVE is the number-one prescribed branded topical therapy across three major inflammatory dermatoses combined—atopic dermatitis, seborrheic dermatitis, and plaque psoriasis. ZORYVE is a topical formulation of roflumilast, an advanced targeted topical phosphodiesterase type 4 (PDE4) inhibitor. Inhibiting PDE4, an intracellular enzyme that is an established target in dermatology, decreases the production of pro-inflammatory mediators. This decreases inflammation in the skin and balances the skin’s immune system.

Demonstrating both clinical impact and broad industry recognition, ZORYVE has been honored with multiple prestigious awards and recommendations. ZORYVE was awarded by Allure with the “2025 Best of Beauty Breakthrough Award,” making it the first FDA-approved medication for atopic dermatitis, plaque psoriasis, and seborrheic dermatitis to win this prominent award. ZORYVE cream 0.3% and ZORYVE foam 0.3% were also awarded the National Psoriasis Foundation’s Seal of Recognition—the first FDA-approved prescription brand to receive the honor. Additionally, the AAD issued a strong recommendation for the use of ZORYVE cream 0.15% in adult patients with mild to moderate atopic dermatitis, according to updated guidelines released in June 2025. In 2024, ZORYVE cream 0.15% was awarded Glamour’s Beauty and Wellness Award for “Best Eczema Product.”

About Arcutis

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to develop differentiated therapies against biologically validated targets, and has produced a robust pipeline for a range of inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X.

INDICATIONS

ZORYVE cream, 0.05%, is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age.

ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older.

ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older.

ZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older.

ZORYVE topical foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.

IMPORTANT SAFETY INFORMATION

ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application.

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.05% for pediatric patients with atopic dermatitis 2 to 5 years of age were upper respiratory tract infection (4.1%), diarrhea (2.5%), vomiting (2.1%), rhinitis (1.6%), conjunctivitis (1.4%), and headache (1.1%).

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.15% for patients with atopic dermatitis 6 years of age or older were headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.3% for plaque psoriasis were diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).

The most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for plaque psoriasis were headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%).

The most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis were nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).

Please see full Prescribing Information for ZORYVE foam and full Prescribing Information for ZORYVE cream.

ZORYVE is for topical use only and not for ophthalmic, oral, or intravaginal use.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on The Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential FDA approval of ZORYVE cream 0.05% for infants 3 to <24 months, and the potential for ZORYVE cream and ZORYVE foam to advance the standard of care in atopic dermatitis, plaque psoriasis, seborrheic dermatitis, and other inflammatory dermatological conditions. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Contacts:



Media



Amanda Sheldon, Head of Corporate Communications
[email protected]



Investors



Brian Schoelkopf, Head of Investor Relations
[email protected]



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Kymera Therapeutics Presents KT-621 BroADen Data in Late-Breaking Research Session at the American Academy of Dermatology (AAD) Annual Meeting

Featured presentation highlights positive BroADen Phase 1b atopic dermatitis trial results supporting KT-621’s compelling oral profile

Parallel Phase 2b trials, BROADEN2 in atopic dermatitis and BREADTH in asthma, ongoing with data expected by mid-2027 and late-2027, respectively

WATERTOWN, Mass., March 28, 2026 (GLOBE NEWSWIRE) — Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, today announced that the positive results from the BroADen Phase 1b atopic dermatitis (AD) clinical trial of KT-621, its first-in-class, oral STAT6 degrader, were featured in a late-breaking oral presentation at the American Academy of Dermatology (AAD) Annual Meeting. The meeting is being held March 27-31, 2026, in Denver, CO.

“We’re proud to share our compelling KT-621 Phase 1b results with the dermatology community at AAD. Our goal is to advance the standard of care for patients around the world, and we believe these findings bring us an important step closer to that objective,” said Jared Gollob, MD, Chief Medical Officer, Kymera Therapeutics. “People living with atopic dermatitis and other Type 2 inflammatory diseases are often forced to navigate difficult tradeoffs between efficacy, safety and convenience when choosing treatment. With our novel targeted protein degradation approach, we believe KT-621 has the potential to offer a first-in-class, once-daily oral option and open new possibilities for patients. These early data showing encouraging biological and clinical activity highlight the potential to expand treatment options and improve outcomes for those with chronic immuno-inflammatory conditions.”

“Despite systemic therapy advances in recent years, only a fraction of patients with moderate to severe atopic dermatitis actually go onto these treatments due to access challenges or concerns related to chronic injections or safety,” said Emma Guttman-Yassky, MD, PhD, Waldman Professor of Dermatology and Immunology and Health System Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai*. “Targeting the Type 2 inflammatory pathway through STAT6 degradation is an exciting mechanism. The early data showing impact on both biomarkers and clinical measures support further development and the potential of this novel oral drug to benefit a larger proportion of atopic dermatitis patients.”

Data shared at AAD from the BroADen Phase 1b single-arm, open-label trial showed consistent impact across multiple pharmacodynamic and clinical measures evaluated in 22 patients with moderate-to-severe AD. After 28 days of once-daily oral dosing, KT-621 demonstrated deep STAT6 degradation across both the 100 and 200 mg dose groups tested, with median reductions of 94% in skin and 98% in blood. KT-621 also showed robust reductions in disease-relevant Type 2 inflammatory biomarkers in blood, including median TARC reduction of 74% in patients with baseline levels comparable to dupilumab studies, up to 73% reduction of Eotaxin-3, up to 56% reduction of IL-31, and up to 14% reduction of IgE. These biological effects translated into encouraging clinical activity with similar results across both dose groups. KT-621 demonstrated an overall mean 63% reduction in EASI, 29% EASI-75 and 19% vIGA-AD of 0 or 1, 49% reduction in BSA, and 40% reduction in peak pruritus NRS, reflecting improvements in both skin lesion severity and burden as well as itch. There was also an overall mean 9-point reduction in POEM, demonstrating a clinically meaningful improvement in patient-assessed disease severity. KT-621 was well tolerated with a favorable safety profile.

Parallel KT-621 Phase 2b trials in atopic dermatitis and asthma are ongoing, with data expected by mid-2027 and late-2027, respectively. These studies are intended to accelerate KT-621 development for subsequent parallel Phase 3 registration studies across multiple Type 2 inflammatory diseases.


AAD 2026 Late-Breaking Presentation Details

  • Abstract Title: Clinical Activity and Safety of KT-621, an Oral STAT6 Degrader, in Moderate-to-Severe Atopic Dermatitis: Phase 1b Trial Results
  • Session Title: Late-Breaking Research: Session 1
  • Session Type: Oral Presentation
  • Presentation Date/Time: Saturday, March 28, 2026, 9:24 AM MT
  • Presenter: Mahta Mortezavi, MD, Senior Medical Director, Kymera Therapeutics
  • Location: Bellco Theatre

A copy of the presentation will be available in the Resource Library section of Kymera’s website after the session. Kymera is also hosting a booth (#3551) in the congress exhibit hall.

*Dr.
Emma Guttman-Yassky is a paid consultant for Kymera Therapeutics

About KT-621

KT-621 is an investigational, first-in-class, once-daily oral degrader of STAT6, the specific transcription factor responsible for IL-4/IL-13 signaling and the central driver of Type 2 inflammation. KT-621 is currently being evaluated in parallel Phase 2b clinical trials in atopic dermatitis (BROADEN2) and asthma (BREADTH). By selectively targeting STAT6 for degradation, KT-621 has the potential to provide a novel oral approach for patients living with Type 2 inflammatory diseases, which affect more than 140 million people worldwide.

About Kymera Therapeutics

Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X or LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about our expectations regarding strategy, business plans and objectives on the development of our clinical and preclinical pipeline, including the therapeutic potential, clinical benefits and safety thereof. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target,” “upcoming” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from any forward-looking statements contained in this press release, including, without limitation, risks associated with: that preclinical and clinical data, including the results from the Phase 1 trials of KT-621, are not predictive of, may be inconsistent with, or more favorable than, data generated from future or ongoing clinical trials of the same product candidate, uncertainties inherent in the initiation, timing and design of future clinical trials, the availability and timing of data from ongoing and future clinical trials and the results of such trials, the ability to successfully demonstrate the safety and efficacy of drug candidates, the unexpected emergence of adverse events or other undesirable side effects during preclinical and clinical development, and other factors. These risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in the most recent Quarterly Report on Form 10-Q and in subsequent filings with the SEC. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Investor Contact: 
Justine Koenigsberg
[email protected]
857-285-5300 

Media Contact:

Bridgette Chandhoke
[email protected]
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Arrowhead Pharmaceuticals Presents New Long-Term Efficacy and Safety Data for Plozasiran Across a Spectrum of Hypertriglyceridemia at the American College of Cardiology’s 75th Annual Scientific Session and Expo

Arrowhead Pharmaceuticals Presents New Long-Term Efficacy and Safety Data for Plozasiran Across a Spectrum of Hypertriglyceridemia at the American College of Cardiology’s 75th Annual Scientific Session and Expo

– Patients with severe hypertriglyceridemia (sHTG) achieved an 83% median reduction in triglycerides (TG), with 96% of patients achieving TG levels below 500 mg/dL, a threshold associated with increased risk of acute pancreatitis

– No adjudicated acute pancreatitis events occurred in any patient receiving plozasiran during the 2-year Phase 2b Open-Label Expansion (OLE) Study

– Favorable and durable improvements in atherogenic lipoproteins, including remnant cholesterol, non-HDL cholesterol, and ApoB, were observed, with a safety profile consistent with earlier trials

PASADENA, Calif.–(BUSINESS WIRE)–Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced long-term efficacy and safety data from a two-year long open-label extension (OLE) study of investigational plozasiran supporting its potential as therapeutic solution for a diverse spectrum of patients with hypertriglyceridemia (HTG).

The data were presented by Dr. Christie M. Ballantyne, MD, professor at Baylor College of Medicine, member of the Texas Heart Institute at Baylor, and Principal Investigator of the 2-year OLE study, during an oral presentation at the American College of Cardiology 75th Annual Scientific Session & Expo (ACC.26) in New Orleans and published in the American Journal of Preventive Cardiology.

“With a new therapy, it is always important to see longer term data to better understand both efficacy and safety. In a long-term open-label extension study, plozasiran treatment was associated with dramatic and meaningful reductions in TGs. In addition, the lack of any acute pancreatitis events during two years of treatment in a patient population that includes those at high risk was particularly reassuring,” said Dr. Ballantyne. “These data reinforce the importance of APOC3 silencing as a central mechanism in promoting triglyceride clearance. The study provides promising evidence that plozasiran treatment may lead to durable, sustained reductions in triglycerides and atherogenic lipoproteins across the hypertriglyceridemia spectrum.”

Plozasiran is designed to reduce the hepatic production of apolipoprotein C-III (APOC3) through targeted RNA interference. APOC3 is a key regulator of triglyceride metabolism that inhibits both lipoprotein lipase (LPL)-dependent and LPL-independent pathways involved in triglyceride catabolism and clearance, leading to elevated triglyceride levels. Individuals with genetic loss-of-function variants in APOC3 typically have markedly lower triglyceride levels and a reduced risk of atherosclerotic cardiovascular disease.

The ACC.26 presentation builds on positive findings from two Phase 2b double-blind, placebo-controlled studies of plozasiran: SHASTA-2, conducted in adults with severe hypertriglyceridemia (sHTG), and MUIR, which enrolled patients with hypertriglyceridemia, both of which demonstrated short-term efficacy and safety. With the same patient populations, the company initiated an extension phase in which both groups received plozasiran 25 mg quarterly via subcutaneous injections.

During the two-year OLE, patients saw median reductions in their triglycerides by -83% in sHTG patients from SHASTA-2 and -67% in HTG patients from MUIR with favorable reductions in remnant cholesterol and non-HDL-cholesterol.

In both studies, the majority of patients achieved TG levels below thresholds for acute pancreatitis (AP) risk or below normal thresholds. 96% of sHTG patients achieved TGs below 500 mg/dL and 63% achieved TGs below 150 mg/dL, a threshold associated with increased risk of ASCVD. 93% of HTG patients achieved TGs below 150 mg/dL. These findings support the potential of plozasiran as a promising approach for managing patients with moderate to severe HTG phenotypes who are at risk of AP and potentially other cardiometabolic comorbidities.

Plozasiran demonstrated a consistent long-term safety and tolerability profile across both sHTG and HTG patient populations, with stable glycemic parameters, no clinically meaningful differences in routine clinical laboratory measurements, and no new safety signals. Common treatment-emergent adverse events included diabetes, COVID-19, upper respiratory tract infection, and back pain, consistent with prior studies; HbA1c levels remained stable. In SHASTA-2, mean placebo-adjusted liver fat content, as assessed by MRI-PDFF, did not change significantly over time with 25 mg plozasiran treatment.

“We’re pleased with the consistent, positive clinical results we’re seeing with plozasiran across the spectrum of hypertriglyceridemias and we’re excited about what this could mean for patients,” said Christopher Anzalone, Ph.D., President and CEO at Arrowhead. “In the four months since its FDA approval for treating FCS, plozasiran is already making a meaningful difference for the FCS community, and we believe it has the potential to become an important therapy for people living with severe hypertriglyceridemia as well. These advances, enabled by our innovative TRiM™ platform, reflect our commitment to developing targeted RNAi therapeutics to silence genes associated with cardiometabolic disorders as well as serious diseases in numerous tissue types throughout the body.”

Arrowhead is on schedule to complete the SHASTA-3, SHASTA-4, and MUIR-3 Phase 3 clinical studies, the company’s global Phase 3 clinical studies designed to support regulatory submissions for marketing approval of plozasiran for the treatment of severe hypertriglyceridemia, in mid-2026 and intends to submit a supplemental New Drug Application (sNDA) to the U.S. FDA by year-end 2026. Arrowhead also plans to seek regulatory approval with additional global regulatory authorities thereafter.

The ACC.26 presentation can be accessed on the Events and Presentations page under the Investors section of the Arrowhead website and the data have also been published in the American Journal of Preventive Cardiology.

About Severe Hypertriglyceridemia

Severe hypertriglyceridemia (SHTG) is characterized by triglyceride (TG) levels greater than 500 mg/dL, with the most severe form being familial chylomicronemia syndrome (FCS) where TGs typically exceed 880 mg/dL. SHTG significantly increases the risk of acute pancreatitis (AP), which can often include recurrent attacks requiring repeat hospital admissions and worsening outcomes. AP risk is proportional to the number, characteristics, and concentration of triglyceride rich lipoproteins (TRLs), particularly chylomicrons, and increases as TGs rise. Elevated TGs can also increase the risk of atherosclerotic cardiovascular disease (ASCVD). Limited treatment options exist to sustainably reduce TGs below guideline directed risk thresholds.

About FCS

Familial chylomicronemia syndrome (FCS) is a severe and rare disease leading to extremely high triglyceride (TG) levels, typically over 880 mg/dL. Such severe elevations can lead to various serious signs and symptoms including acute and potentially fatal pancreatitis, chronic abdominal pain, diabetes, hepatic steatosis, and cognitive issues. Currently, there are limited therapeutic options to adequately treat FCS.

About Plozasiran

Plozasiran is a first-in-class investigational RNA interference (RNAi) therapeutic designed to reduce production of apolipoprotein C-III (apoC-III) which is a component of triglyceride rich lipoproteins (TRLs) and a key regulator of triglyceride metabolism. ApoC-III increases triglyceride levels in the blood by inhibiting breakdown of TRLs by lipoprotein lipase and uptake of TRL remnants by hepatic receptors in the liver. The goal of treatment with plozasiran is to reduce the level of apoC-III, thereby reducing triglycerides and restoring lipids to more normal levels.

Plozasiran is being investigated in the SHASTA-3, SHASTA-4, and SHASTA-5 Phase 3 studies in patients with severe hypertriglyceridemia and the MUIR Phase 3 study in patients with mixed hyperlipidemia.

About REDEMPLO® (plozasiran)

REDEMPLO (plozasiran) is approved by the U.S. Food and Drug Administration, Health Canada, and the Chinese National Medical Products Administration as an adjunct to diet to reduce triglycerides for adults with Familial Chylomicronemia Syndrome (FCS). REDEMPLO is an siRNA therapeutic designed to suppress the production of apoC-III, a protein produced in the liver that raises triglyceride levels by slowing their breakdown and clearance. By targeting apoC-III with sustained silencing, REDEMPLO delivers significant reductions in triglyceride levels. REDEMPLO is the first and only siRNA FDA-approved treatment studied in both genetically confirmed and clinically diagnosed patients living with FCS.

For more information about REDEMPLO, visit Our Medicines.

About Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals (NASDAQ: ARWR) is a commercial-stage pharmaceutical company developing medicines that treat intractable diseases by silencing the genes that cause them, harnessing the natural RNA interference (RNAi) mechanism. The company has built a broad portfolio of clinical and commercial RNAi therapeutics through its industry-leading targeted RNAi molecule (TRiM™) platform, which can precisely silence genes in a wide range of cell types, including liver, lung, muscle, adipose, and central nervous system tissue. At Arrowhead, we rapidly advance potential best- and first-in-class RNAi treatments for diseases with significant unmet medical need, because every day matters to the patients we serve.

For more information, please visit www.arrowheadpharma.com, or follow us on X (formerly Twitter) at @ArrowheadPharma, LinkedIn, Facebook, and Instagram. To be added to the Company’s email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts.

Safe Harbor Statement under the Private Securities Litigation Reform Act:

This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “hope,” “intend,” “plan,” “project,” “could,” “estimate,” “continue,” “target,” “forecast” or “continue” or the negative of these words or other variations thereof or comparable terminology are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline or product candidates, including anticipated regulatory submissions and clinical program results, prospects or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; our expectations regarding the potential benefits of the partnership, licensing and/or collaboration arrangements and other strategic arrangements and transactions we have entered into or may enter into in the future; our beliefs and expectations regarding milestone, royalty or other payments that could be due to or from third parties under existing agreements; and our estimates regarding future revenues, research and development expenses, capital requirements and payments to third parties. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the safety and efficacy of our product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.

Source: Arrowhead Pharmaceuticals, Inc.

Arrowhead Pharmaceuticals, Inc.

Vince Anzalone, CFA

626-304-3400

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Visa, Street Soccer USA and Bank of America to Bring Visa Street Soccer Parks to Every FIFA World Cup 2026™ Host City in the U.S.

Visa, Street Soccer USA and Bank of America to Bring Visa Street Soccer Parks to Every FIFA World Cup 2026™ Host City in the U.S.

With 75 days to go until the FIFA World Cup 2026™, Visa and partners expand community investment—bringing additional access to sport, education and opportunity to communities across the U.S.

SAN FRANCISCO & CHARLOTTE, N.C.–(BUSINESS WIRE)–
Visa, the Official Payment Technology Partner of the FIFA World Cup 26™, together with national nonprofit Street Soccer USA and Bank of America, the Official Bank Sponsor of the FIFA World Cup 26™, today announced a significant expansion of Visa Street Soccer Parks, bringing a new park to every host city in the U.S. ahead of this summer’s tournament.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260328341048/en/

Youth soccer players at inaugural Visa Street Soccer Park opening.

Youth soccer players at inaugural Visa Street Soccer Park opening.

Designed to serve communities at the neighborhood level, Visa Street Soccer Parks transform underutilized spaces into vibrant, accessible hubs for sport, learning and connection. As the tournament approaches, the expansion will bring community-driven infrastructure and programming to all 11 U.S. FIFA World Cup 26™ Host Cities, including new parks in Boston, Dallas/Fort Worth, Houston, Los Angeles, Miami, Philadelphia and Seattle/Tacoma. This community-focused infrastructure investment reflects a shared commitment to harnessing the unifying power of sport to uplift local communities

Alongside the expansion of Visa Street Soccer Parks, Visa will activate Visa & Main, its new small business engagement program, to support local entrepreneurs in the neighborhoods surrounding each park.

“With the FIFA World Cup™ just months away, we’re shifting from preparation to execution,” said Kim Lawrence, Regional President, North America, Visa. “This tournament is a global moment, but its legacy is built locally—in the neighborhoods that will host fans, families and the next generation of players. By expanding Visa Street Soccer Parks and supporting the local businesses and people who activate them every day, we’re turning tournament momentum into meaningful opportunity that lasts well beyond the final match.”

Each park is custom designed to support meaningful, ongoing use by the communities it serves and features two professional grade Bank of America fields, lighting for extended play, learning centers and flexible gathering spaces. Programming is delivered in collaboration with community partners and tailored to local needs—supporting recreational play, academic enrichment, workforce readiness and community engagement.

“Communities are built on accessible opportunities for connection, healthy activity and growth,” said David Tyrie, President, Marketing, Digital and Specialized Consumer Client Solutions at Bank of America. “These are more than just places to play; they are spaces where people of all ages can find common ground through the game of soccer, develop essential life skills and forge lasting bonds that strengthen our community fabric.”

Since opening the first park in San Francisco last year, the initiative is already demonstrating its impact on the ground with additional parks in Denver, Kansas City and New York City actively hosting youth and adult leagues, after-school academic support, financial education sessions and job readiness programming in partnership with local organizations. Previously announced parks in Nashville and Atlanta remain in development, with opening dates to be shared as planning is finalized.

“This is not about short-term excitement—it’s about building something that lasts,” said Lawrence Cann, Co-Founder and President of Street Soccer USA. “These parks are designed to create consistency and access, but more importantly, they belong to the communities that activate them every day. Rooted in community leadership, they create a bottom-up, durable legacy built and sustained by the people who call these neighborhoods home. As we expand these efforts into additional cities across the country, the focus is permanence and ensuring this work endures long after the tournament ends.”

The FIFA World Cup 26™ will bring unprecedented global attention to the United States. Through Visa Street Soccer Parks—and by supporting the people and small businesses that activate them—Visa, Street Soccer USA and Bank of America are already delivering community-driven impact, building spaces that will serve local communities well beyond the tournament itself.

About Visa

Visa (NYSE: V) is a world leader in digital payments, facilitating transactions between consumers, merchants, financial institutions and government entities across more than 200 countries and territories. Our mission is to connect the world through the most innovative, convenient, reliable and secure payments network, enabling individuals, businesses and economies to thrive. We believe that economies that include everyone everywhere, uplift everyone everywhere and see access as foundational to the future of money movement. Learn more at Visa.com.

About Street Soccer USA

Street Soccer USA is a national non-profit organization dedicated to addressing social issues through soccer-based programs, providing underserved communities with pathways to achieve their potential. With a focus on accessible soccer programming and park development, SSUSA fosters safe, community-driven environments that empower individuals and strengthen neighborhoods. Through long standing relationships with municipal and state partners, thousands of donors, and key foundation, brands and pro soccer partners like Adam R. Scripps Foundation, UNIQLO, Borussia Dortmund, Serie A among others, SSUSA has grown to serve tens of thousands of youth and families each year across 16 cities, nationally, and growing.

About Bank of America

Bank of America is one of the world’s leading financial institutions, serving individual consumers, small and middle-market businesses and large corporations with a full range of banking, investing, asset management and other financial and risk management products and services. The company provides unmatched convenience in the United States, serving nearly 70 million clients with approximately 3,600 retail financial centers, approximately 15,000 ATMs (automated teller machines) and award-winning digital banking with approximately 59 million verified digital users. Bank of America is a global leader in wealth management, corporate and investment banking and trading across a broad range of asset classes, serving corporations, governments, institutions and individuals around the world. Bank of America offers industry-leading support to approximately 4 million small business households through a suite of innovative, easy-to-use online products and services. The company serves clients through operations across the United States, its territories and more than 35 countries. Bank of America Corporation stock (NYSE: BAC) is listed on the New York Stock Exchange.

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INDUSTRY KEYWORDS: Technology General Sports Family Finance Consumer Banking Soccer Professional Services Payments Sports Marketing Children Communications Fintech

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Youth soccer players at inaugural Visa Street Soccer Park opening.
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Visa Street Soccer Park at Skyline Park in Denver, CO.
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Open Label Outpatient Switch Study Demonstrates Symptom Stability During Transition from Oral Atypical Antipsychotics to Cobenfy™ (xanomeline and trospium chloride)

Open Label Outpatient Switch Study Demonstrates Symptom Stability During Transition from Oral Atypical Antipsychotics to Cobenfy™ (xanomeline and trospium chloride)

High treatment completion and no discontinuations due to lack of efficacy observed across faster and slower switch strategies

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced data from a Phase 4 clinical trial evaluating the symptom stability, safety and tolerability of Cobenfy (xanomeline and trospium chloride) when switching adult outpatients with schizophrenia from an oral atypical antipsychotic to Cobenfy monotherapy. Through 8 weeks, patients remained stable with mean Positive and Negative Syndrome Scale (PANSS) total scores remaining below baseline,and no new safety signals were observed, regardless of cross-titration duration. These findings provide important evidence to help inform treatment switch strategies in clinical practice. Data were presented at the 2026 Annual Congress of the Schizophrenia International Research Society (SIRS) taking place March 25-29 in Florence, Italy.

“While transitioning patients is common in schizophrenia, clinicians have historically had limited data to help guide these decisions, especially for differentiated treatments like Cobenfy,” said David Walling, PhD, principal investigator and chief clinical officer at Cenexel – CNS. “The data presented today provide much-needed insight into what happens during a switch to Cobenfy, notably that patients remained stable through 8 weeks of treatment regardless of a slower or faster cross-titration, which will help healthcare professionals make informed treatment decisions for adults living with schizophrenia.”

This 8-week, open-label trial evaluated two cross-titration strategies in adults with schizophrenia (n=105): tapering the existing atypical antipsychotic down over the faster 2 week (n=52) or slower 4 week (n=53) period while simultaneously up-titrating Cobenfy to the target dose of 125/30 mg BID, over two weeks in both arms. Patients were required to have a PANSS total score at or below 80 at screening and baseline, Clinical Global Impression-Severity (CGI-S) score of ≤4, and to be on a stable dose of an oral atypical antipsychotic for at least 6 weeks.

The primary objective of the trial was to evaluate the rate of all-cause Cobenfy discontinuation over a period of 8 weeks. Key secondary endpoints included Cobenfy discontinuation due to a lack of efficacy, incidence of, and discontinuations due to adverse events (AEs), change from baseline (CFB) to week 8 in the PANSS total score, CGI-S, Personal and Social Performance (PSP), and Medication Satisfaction Questionnaire (MSQ).

In the trial, approximately 86% of patients completed 8 weeks of treatment, with discontinuation rates of 15.1% (n=8) and 13.5% (n=7) in the slower and faster transition groups. No patients discontinued treatment with Cobenfy due to lack of efficacy. Mean changes in PANSS total scores from baseline to week 8 were −4.2 in the slower transition group and −3.1 in the faster transition group. Mean change in CGI-S scores was −0.2 in both the slower and faster transition groups. From baseline to week 8, mean PSP scores improved by 1.1 and 0.7 in the slower and faster transition groups, respectively.

Across both cross-titration groups, treatment with Cobenfy was generally well tolerated, with no new safety or tolerability issues emerging. In the trial, 49% of patients had ≥1 treatment-emergent adverse event (TEAE) and none were serious. TEAE rates were consistent with those reported in the EMERGENT trials. In the slower and faster transition groups, 1 (1.9%) patient and 2 (3.8%) patients, respectively, discontinued treatment early due to TEAEs.

“Cobenfy represents a fundamentally different approach to treating schizophrenia as the first novel mechanism in decades, and physicians are naturally curious as to how they can switch and transition adult patients with schizophrenia to this innovative medication,” said Harald Hampel, MD, PhD, senior vice president, worldwide head of neuroscience, global medical affairs, at Bristol Myers Squibb. “We carefully designed this trial with the scientific rigor and curiosity in mind, knowing that treatment decisions are not made lightly, and patient benefit, safety and stability is our ultimate goal.”

About Schizophrenia

Schizophrenia is a persistent and often disabling mental illness impacting how a person thinks, feels and behaves. There are three symptom domains of schizophrenia, which include positive symptoms (e.g., hallucinations, delusions, disordered thinking and speech), negative symptoms (e.g., lack of motivation, lack of emotional expression/flat affect, social withdrawal) and cognitive dysfunction (e.g., impaired attention, deficits in memory, concentration and decision-making). The symptoms of schizophrenia can affect all areas of people’s lives, making it difficult to maintain employment, live independently, and manage relationships. Schizophrenia affects nearly 24 million people worldwide, including 2.8 million people in the United States, and is one of the top 15 leading causes of disability worldwide.

About Cobenfy™ (xanomeline and trospium chloride)

Cobenfy™ (xanomeline and trospium chloride), formerly KarXT, is an oral medication for the treatment of schizophrenia in adults. Cobenfy combines xanomeline, a dual M1– and M4-preferring muscarinic receptor agonist, with trospium chloride, a muscarinic receptor antagonist that does not appreciably cross the blood-brain barrier, primarily confining its effects on peripheral tissues. While the exact mechanism of action of Cobenfy is unknown, its efficacy is thought to be due to the agonist activity of xanomeline at M1 and M4 muscarinic acetylcholine receptors in the central nervous system.

INDICATION

COBENFY™ (xanomeline and trospium chloride) is indicated for the treatment of schizophrenia in adults.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

COBENFY is contraindicated in patients with:

  • urinary retention

  • moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment

  • gastric retention

  • history of hypersensitivity to COBENFY or trospium chloride. Angioedema has been reported with COBENFY and trospium chloride.

  • untreated narrow-angle glaucoma

WARNINGS AND PRECAUTIONS

Risk of Urinary Retention: COBENFY can cause urinary retention. Geriatric patients and patients with clinically significant bladder outlet obstruction and incomplete bladder emptying (e.g., patients with benign prostatic hyperplasia (BPH), diabetic cystopathy) may be at increased risk of urinary retention.

COBENFY is contraindicated in patients with pre-existing urinary retention and is not recommended in patients with moderate or severe renal impairment.

In patients taking COBENFY, monitor for symptoms of urinary retention, including urinary hesitancy, weak stream, incomplete bladder emptying, and dysuria. Instruct patients to be aware of the risk and promptly report symptoms of urinary retention to their healthcare provider. Urinary retention is a known risk factor for urinary tract infections. In patients with symptoms of urinary retention, consider reducing the dose of COBENFY, discontinuing COBENFY, or referring patients for urologic evaluation as clinically indicated.

Risk of Use in Patients with Hepatic Impairment: Patients with hepatic impairment have higher systemic exposures of xanomeline, a component of COBENFY, compared to patients with normal hepatic function, which may result in increased incidence of COBENFY-related adverse reactions.

COBENFY is contraindicated in patients with moderate or severe hepatic impairment. COBENFY is not recommended in patients with mild hepatic impairment.

Assess liver enzymes prior to initiating COBENFY and as clinically indicated during treatment.

Risk of Use in Patients with Biliary Disease: In clinical studies with COBENFY, transient increases in liver enzymes with rapid decline occurred, consistent with transient biliary obstruction due to biliary contraction and possible gallstone passage.

COBENFY is not recommended for patients with active biliary disease such as symptomatic gallstones. Assess liver enzymes and bilirubin prior to initiating COBENFY and as clinically indicated during treatment. The occurrence of symptoms such as dyspepsia, nausea, vomiting, or upper abdominal pain should prompt assessment for gallbladder disorders, biliary disorders, and pancreatitis, as clinically indicated.

Discontinue COBENFY in the presence of signs or symptoms of substantial liver injury such as jaundice, pruritus, or alanine aminotransferase levels more than five times the upper limit of normal or five times baseline values.

Decreased Gastrointestinal Motility: COBENFY contains trospium chloride. Trospium chloride, like other antimuscarinic agents, may decrease gastrointestinal motility. Administer COBENFY with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention. Use COBENFY with caution in patients with conditions such as ulcerative colitis, intestinal atony, and myasthenia gravis.

Risk of Angioedema: Angioedema of the face, lips, tongue, and/or larynx has been reported with COBENFY and trospium chloride, a component of COBENFY. In one case, angioedema occurred after the first dose of trospium chloride. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, discontinue COBENFY and initiate appropriate therapy and/or measures necessary to ensure a patent airway. COBENFY is contraindicated in patients with a history of hypersensitivity to trospium chloride.

Risk of Use in Patients with Narrow-angle Glaucoma: Pupillary dilation may occur due to the anticholinergic effects of COBENFY. This may trigger an acute angle closure attack in patients with anatomically narrow angles. In patients known to have anatomically narrow angles, COBENFY should only be used if the potential benefits outweigh the risks and with careful monitoring.

Increases in Heart Rate: COBENFY can increase heart rate. Assess heart rate at baseline and as clinically indicated during treatment with COBENFY.

Anticholinergic Adverse Reactions in Patients with Renal Impairment: Trospium chloride, a component of COBENFY, is substantially excreted by the kidney. COBENFY is not recommended in patients with moderate or severe renal impairment (estimated glomerular filtration rate (eGFR) <60 mL/min). Systemic exposure of trospium chloride is higher in patients with moderate and severe renal impairment. Therefore, anticholinergic adverse reactions (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) are expected to be greater in patients with moderate and severe renal impairment.

Central Nervous System Effects: Trospium chloride, a component of COBENFY, is associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported with trospium chloride, including dizziness, confusion, hallucinations, and somnolence. Monitor patients for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how COBENFY affects them. If a patient experiences anticholinergic CNS effects, consider dose reduction or drug discontinuation.

Most Common Adverse Reactions (≥5% and at least twice placebo): nausea, dyspepsia, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia, dizziness, and gastroesophageal reflux disease.

Use in Specific Populations:

  • Moderate or Severe Renal Impairment: Not recommended

  • Mild Hepatic Impairment: Not recommended

COBENFY (xanomeline and trospium chloride) is available in 50mg/20mg, 100mg/20mg, and 125mg/30mg capsules.

Please see U.S. Full Prescribing Information, including Patient Information.

About Bristol Myers Squibb: Transforming Patients’ Lives Through Science

At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com and follow us on LinkedIn, X, YouTube, Facebook and Instagram.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date and that Cobenfy (xanomeline and trospium chloride) may not receive any additional regulatory approvals for the treatment of schizophrenia for adults described in this release, any marketing approvals, if granted, may have significant limitations on their use, and, whether Cobenfy will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2025, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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Rocket Lab Successfully Launches 85th Mission and First Dedicated Launch for European Space Agency

MAHIA, New Zealand, March 28, 2026 (GLOBE NEWSWIRE) — Rocket Lab Corporation (Nasdaq: RKLB) (“Rocket Lab” or the “Company”), a global leader in launch services and space systems, today successfully completed its first dedicated launch for the European Space Agency (ESA), demonstrating Electron’s key and growing role in supporting space agency missions with repeatable and reliable commercial launch services.

The launch, named “Daughter Of The Stars”, lifted off from Rocket Lab Launch Complex 1 in New Zealand on March 28th at 10:14 pm NZT to successfully deliver ESA’s “Celeste” mission to orbit: the first two spacecraft of a satellite navigation demonstration mission in low Earth orbit at 510 km. ESA’s Celeste mission will demonstrate how a low Earth orbit fleet of satellites can work in combination with the Galileo constellation in medium Earth orbit that provide Europe’s own global navigation system. Built by two consortia led by GMV (Spain) and Thales Alenia Space (France), the pair of ESA spacecraft will test next-generation technologies for a broad variety of future uses in autonomous vehicles, maritime navigation, wireless networks, emergency services, and critical infrastructure projects across Europe.

This launch continues Rocket Lab’s record of 100% mission success for national space programs including NASA, JAXA, KASA, and now ESA, underscoring Electron’s importance to space access both domestically and internationally with its consistently precise, reliable, and responsive launches.

Rocket Lab founder and CEO, Sir Peter Beck, says: “Orbital accuracy is critical for the beginning of a new constellation. It’s why satellite operators across all mission types choose Electron for a dedicated launch, because they know they can rely on our rocket’s precision and accuracy to establish a solid foundation in orbit. This mission for ESA is just the latest example of Electron’s constancy as the launch industry leader globally for small sat missions and a proud moment for the team to deliver mission success for such a prestigious organization as ESA.”

“We are pleased to see our first two Celeste satellites starting their important mission, as they open a new era for satellite navigation in Europe. Over the past two decades, Galileo and EGNOS have become a total success, fuelling our society, generating economic growth and ensuring European independence and security. Now, ESA’s Celeste will demonstrate how a complementary layer in low Earth orbit can enhance Europe’s current navigation systems, making them more resilient, more robust, and capable of delivering entirely new services,” adds Francisco-Javier Benedicto Ruiz, ESA’s Director of Navigation.

“Daughter Of The Stars” was Rocket Lab’s 6th launch of the year and 85th launch overall. Upcoming launches in 2026 include missions for commercial Earth observation, international space agencies, national security, and hypersonic technology development.

Rocket Lab Media Contact

[email protected]

About Rocket Lab

Founded in 2006, Rocket Lab is an end-to-end space company with an established track record of mission success. We deliver reliable launch services, satellite manufacture, spacecraft components, and on-orbit management solutions that make it faster, easier, and more affordable to access space. Headquartered in Long Beach, California, Rocket Lab designs and manufactures the Electron small orbital launch vehicle, the HASTE suborbital launch vehicle for hypersonic tests, a family of flight proven spacecraft, and the larger Neutron launch vehicle for constellation deployment. Since its first orbital launch in January 2018, Rocket Lab’s Electron launch vehicle has become the second most frequently launched U.S. rocket annually. Rocket Lab has deployed more than 250 payloads from its launch sites in the United States and New Zealand for private and public sector organizations, enabling operations in national security, scientific research, space debris mitigation, Earth observation, climate monitoring, and communications. Rocket Lab’s family of spacecraft have been selected to support NASA missions to the Moon and Mars, as well as the first private commercial mission to Venus. Rocket Lab has three launch pads at two launch sites, including two launch pads at a private orbital launch site located in New Zealand and a third launch pad in Virginia. To learn more, visit www.rocketlabusa.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements contained in this press release other than statements of historical fact, including, without limitation, statements regarding our launch and space systems operations, launch schedule and window, safe and repeatable access to space, Neutron development, operational expansion and business strategy are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “potential,” “continue,” “anticipate,” “intend,” “expect,” “strategy,” “future,” “could,” “would,” “project,” “plan,” “target,” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including but not limited to the factors, risks and uncertainties included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission (the “SEC”), accessible on the SEC’s website at www.sec.gov and the Investor Relations section of our website at www.rocketlabusa.com, which could cause our actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/00c98efc-ee04-4e07-a014-c50f8c281dfc



Posted on

INVESTOR ALERT: Navan, Inc. (NAVN) Investors with Substantial Losses Have Opportunity to Lead Investor Class Action – RGRD Law

SAN DIEGO, March 27, 2026 (GLOBE NEWSWIRE) — Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Navan, Inc. (NASDAQ: NAVN) common stock pursuant and/or traceable to Navan’s offering documents issued in connection with Navan’s October 31, 2025 initial public offering (“IPO”), have until Friday, April 24, 2026 to seek appointment as lead plaintiff of the Navan class action lawsuit. Captioned McCown v. Navan, Inc., No. 26-cv-01550(N.D. Cal.), the Navan class action lawsuit charges Navan as well as certain of Navan’s top executives and directors and underwriters of the IPO with violations of the Securities Act of 1933.

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

Navan

class action lawsuit, please provide your information here:


https://www.rgrdlaw.com/cases-navan-inc-class-action-lawsuit-navn.html

You can also contact attorney

J.C. Sanchez

of Robbins Geller by calling 800/449-4900 or via e-mail at

[email protected]

.

CASE ALLEGATIONS: Navan operates an AI-powered software platform to simplify the travel and expense experience, benefiting users, customers, and suppliers. According to the Navan class action lawsuit, on or about October 31, 2025, Navan conducted its IPO, issuing nearly 37 million shares to the public at the offering price of $25.00 per share.

The Navan class action lawsuit alleges that the IPO’s offering documents were materially false and/or misleading and/or omitted to state that Navan would increase its sales and marketing expenses by 39% just months after the IPO to sustain its revenue, Gross Booking Volume, and usage yield growth.

The Navan class action lawsuit further alleges that on December 15, 2025, Navan reported its earnings for the quarter ended October 31, 2025, and disclosed that it increased its sales and marketing expenses to nearly $95 million, a 39% increase from its $68.5 million sales and marketing expenses in the quarter ending July 31, 2025. On this news, the price of Navan stock fell nearly 12%, according to the Navan class action lawsuit.

The complaint alleges that by the commencement of the Navan class action lawsuit, the price of Navan stock has traded as low as $9.20 per share, a nearly 63% decline from the $25.00 per share IPO price.

THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or acquired Navan common stock pursuant and/or traceable to the IPO to seek appointment as lead plaintiff in the Navan 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 Navan investor class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Navan shareholder class action lawsuit. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the Navan 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
        J.C. Sanchez
        655 W. Broadway, Suite 1900, San Diego, CA 92101
        800-449-4900
        [email protected]



Posted on

Shareholders who lost money in Concorde International Group Ltd. (NASDAQ: CIGL) Should Contact Wolf Haldenstein Immediately

Lead Plaintiff Deadline is May 18, 2026

NEW YORK, March 27, 2026 (GLOBE NEWSWIRE) — Wolf Haldenstein Adler Freeman & Herz LLP , announces that a class action lawsuit has been filed against Concorde International Group Ltd. (“Concorde” or the “Company”) (NASDAQ: CIGL) in the United States District Court for the Southern District of New York on behalf of all persons and entities who purchased or otherwise acquired Concorde securities between April 21, 2025, and July 14, 2025, both dates inclusive (the “Class Period”).

Investors have until May 18, 2026 to apply to the Court to be appointed as lead plaintiff in the lawsuit.


PLEASE CLICK HERE TO JOIN THE CASE AND SUBMIT CONTACT INFORMATION

According to the filed complaint, throughout the Class Period, defendants made false and/or misleading statements and/or failed to disclose that:

  • Concorde was the subject of a fraudulent stock promotion scheme involving social media-based misinformation and impersonated financial professionals;
  • insiders and/or affiliates used offshore or nominee accounts to facilitate the coordinated dumping of shares during a price inflation campaign;
  • Concorde’s public statements and risk disclosures omitted any mention of the false rumors and artificial trading activity driving the stock price; and
  • as a result of the foregoing, defendants’ positive statements about Concorde’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

                       Why Wolf Haldenstein Adler Freeman & Herz LLP?:

This illustrious firm, founded in 1888, is steadfast in their pursuit of justice for investors who have suffered financial harm due to these misrepresented statements. The law firm brings to the fore over 125 years of legal expertise in securities litigation and has a proven track record of protecting the rights of investors.

We encourage all investors who have been affected or have information that will assist in our investigation, to contact Wolf Haldenstein Adler Freeman & Herz LLP.

Contact:

Firm Website:
 Wolf Haldenstein Adler Freeman & Herz LLP

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.



Posted on

SMR INVESTOR ALERT: NuScale Power Corporation Investors with Substantial Losses Have Opportunity to Lead Investor Class Action Filed by RGRD Law

SAN DIEGO, March 27, 2026 (GLOBE NEWSWIRE) — The law firm of Robbins Geller Rudman & Dowd LLP announces that purchasers of NuScale Power Corporation (NYSE: SMR) Class A common stock between May 13, 2025 and November 6, 2025, inclusive (the “Class Period”), have until Monday, April 20, 2026 to seek appointment as lead plaintiff of the NuScale class action lawsuit. Captioned Truedson v. NuScale Power Corporation, No. 26-cv-00328 (D. Or.), the NuScale class action lawsuit charges NuScale, certain NuScale top executive officers, as well as Fluor Corporation with violations of the Securities Exchange Act of 1934.

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

NuScale

class action lawsuit, please provide your information here:


https://www.rgrdlaw.com/cases-nuscale-power-class-action-lawsuit-smr.html

You can also contact attorney

J.C. Sanchez

of Robbins Geller by calling 800/449-4900 or via e-mail at

[email protected]

.

CASE ALLEGATIONS: NuScale’s core technology, the NuScale Power Module (“NPM”), is a small modular nuclear reactor designed to generate energy within a broader power plant. Prior to the start of the Class Period, NuScale entered into a global commercialization partnership with ENTRA1 Energy LLC and NuScale and its executives claimed that this critical partnership would allow NuScale to take its NPM technology from the development stage to deployment. NuScale’s reliance on ENTRA1 as an exclusive commercialization partner appeared to be validated when, on September 2, 2025, ENTRA1 and the Tennessee Valley Authority (“TVA”) jointly announced an agreement to develop power plants to provide the TVA with up to six gigawatts of new nuclear power generation.

However, the NuScale class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (i) ENTRA1 had never built, financed, or operated any significant projects – let alone projects in the highly technical and complicated field of nuclear power generation – during its entire operating history; (ii) NuScale had entrusted its commercialization, distribution, and deployment of its NPMs and hundreds of millions of dollars of NuScale capital to an entity that lacked any significant prior experience owning, financing, or operating nuclear energy generation facilities; (iii) the purported experience and qualifications attributed to ENTRA1 by defendants during the Class Period in fact referred to the purported experience and qualifications of the principals of the Habboush Group, a distinct entity without significant experience in the field of nuclear power generation; and (iv) as a result, NuScale’s commercialization strategy was exposed to material, undisclosed risks of failure, delays, regulatory challenges, or other negative setbacks.

The NuScale investor class action further alleges that on November 6, 2025 NuScale revealed that NuScale’s general and administrative expenses had ballooned more than 3,000% to $519 million during its third fiscal quarter, up from $17 million in the prior year period, due largely to NuScale’s payment of $495 million to ENTRA1 for its TVA agreement. As a result, NuScale’s quarterly net loss skyrocketed to $532 million, up from $46 million in the prior year period. During the corresponding conference call, analysts pressed NuScale management regarding whether ENTRA1 was sufficiently experienced to own and operate the energy generation facilities contemplated by the TVA agreement. NuScale’s CEO, defendant John L. Hopkins, further revealed during the call that the agreement between ENTRA1 and TVA contemplated as many as 72 NPMs, meaning NuScale’s milestone payments to ENTRA1 could potentially exceed more than $3 billion. On this news, the price of NuScale Class A shares declined more than 12% over a two-day trading period.

The plaintiff is represented by Robbins Geller, which has extensive experience in prosecuting investor class actions including actions involving financial fraud. You can view a copy of the complaint by clicking here.

THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased NuScale Class A common stock during the Class Period to seek appointment as lead plaintiff in the NuScale 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 NuScale class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the NuScale class action lawsuit. An investor’s ability to share in any potential future recovery of the NuScale class action lawsuit is not dependent upon serving as lead plaintiff.

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
        J.C. Sanchez
        655 W. Broadway, Suite 1900, San Diego, CA 92101
        800-449-4900
        [email protected]