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Lead Plaintiff Deadline: December 28, 2026. Investors who purchased (NASDAQ: TENX) securities between November 13, 2023 and August 7, 2026 may be eligible to recover losses.

NEW YORK, Nov. 08, 2026 (GLOBE NEWSWIRE) — Attorney Advertising — This lawsuit seeks to recover damages against Defendants for alleged violations of the federal securities laws on behalf of all persons and entities that purchased or otherwise acquired Tenax securities between November 13, 2023 and August 7, 2026, both dates inclusive (the “Class Period”). Such investors are encouraged to join this case by visiting the firm’s site: bgandg.com/cases/tenax-therapeutics-inc-tenx-class-action-lawsuit.

Tenax Case Details

The Complaint alleges that throughout the Class Period, Defendants made statements that were materially false and/or misleading and/or failed to disclose that:

1. the Company’s lead clinical program, TNX-103 was less effective than defendants had led investors to believe;
2. accordingly, TNX-103’s overall clinical, regulatory, and commercial prospects were overstated; and
3. as a result, the Company’s public statements were materially false and misleading at all relevant times.

What’s Next for Tenax Investors?


A class action lawsuit has already been filed. If you wish to review a copy of the Complaint, you can visit the firm’s site: bgandg.com/cases/tenax-therapeutics-inc-tenx-class-action-lawsuit. or you may contact Peretz Bronstein, Esq. or his Client Relations Manager, Nathan Miller, of Bronstein, Gewirtz & Grossman, LLC at 917-590-0911. If you suffered a loss in Tenax you have until December 28, 2026, to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn’t require that you serve as lead plaintiff.

No Cost to Tenax Investors

We, Bronstein, Gewirtz & Grossman LLC, represent investors in class actions on a contingency fee basis. That means we will ask the court to reimburse us for out-of-pocket expenses and attorneys’ fees, usually a percentage of the total recovery, only if we are successful.

Why Bronstein, Gewirtz & Grossman, LLC for Tenax Securities Class Action?

Bronstein, Gewirtz & Grossman, LLC is a nationally recognized firm that represents investors in securities fraud class actions and shareholder derivative suits. Our firm has recovered hundreds of millions of dollars for investors nationwide. More at www.bgandg.com

“Our practice centers on restoring investor capital and ensuring corporate accountability, which serves to uphold the essential integrity of the marketplace,” said Peretz Bronstein, Founding Partner of Bronstein, Gewirtz & Grossman, LLC.

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Peretz Bronstein, Esq. or Nathan Miller
Bronstein, Gewirtz & Grossman, LLC
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Attorney advertising.
Prior results do not guarantee similar outcomes.

Systemic sclerosis (SSc) data presented at ACR Convergence 2026 showed 83% (5/6) of patients receiving standard lymphodepletion achieved a clinical response (rCRISS-25) at Month 3, with all responders maintaining response

Zugo-cel has been well tolerated in all 21 patients dosed to date, with no cytokine release syndrome (CRS) above Grade 2 and no immune effector cell-associated neurotoxicity syndrome (ICANS) or immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS)

All nine patients with idiopathic inflammatory myopathy (IIM) achieved a moderate or major Total Improvement Score (TIS) response

ZUG, Switzerland and BOSTON, Nov. 08, 2026 (GLOBE NEWSWIRE) — CRISPR Therapeutics (Nasdaq: CRSP), today provided an update on zugocabtagene geleucel (zugo-cel; formerly CTX112™), its investigational CRISPR/Cas9 gene-edited allogeneic CAR-T cell therapy targeting CD19, in the ongoing Phase 1 basket trial in refractory rheumatologic autoimmune diseases, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and idiopathic inflammatory myopathy (IIM). Preliminary clinical data from the Phase 1 study have been encouraging, and zugo-cel has been well tolerated to date. As of October 15, 2026, 21 patients have been dosed across the SLE, SSc and IIM cohorts. Data from the SSc cohort were presented in a poster session at the American College of Rheumatology (ACR) Convergence 2026.

“Patients living with refractory autoimmune diseases such as systemic sclerosis, myositis and lupus often face progressive disease and a lifelong burden of immunosuppressive treatment,” said Naimish Patel, M.D., Chief Medical Officer of CRISPR Therapeutics. “The responses we are seeing across these indications, together with a favorable tolerability profile, are encouraging and reinforce our belief that an off-the-shelf allogeneic CAR-T therapy has the potential to offer these patients a meaningful new treatment option. We are grateful to the patients and investigators participating in this study and look forward to continuing to advance zugo-cel.”

Systemic Sclerosis Data Presented at ACR Convergence 2026

As of the data cut-off on July 21, 2026, seven patients with SSc dosed at the 100 million CAR+ cell dose level had at least three months of follow-up:

• At Month 3, 83% (5/6) of patients who received standard lymphodepletion achieved a revised Composite Response Index in Systemic Sclerosis (rCRISS)-25 response, including two patients who achieved the more stringent rCRISS-50 response.
• All five responders have maintained their response, including four patients who have completed at least six months of follow-up.
• The seventh patient, who received reduced lymphodepletion, showed improvement in multiple rCRISS components at Month 3.

Update Across the Rheumatology Basket Trial

As of October 15, 2026, 21 patients have been dosed in the rheumatology basket: four in the SLE cohort, eight in the SSc cohort and nine in the IIM cohort. The SSc cohort includes one patient dosed after the July 21, 2026 data cut-off for the ACR presentation. Encouraging results are being observed across indications:

• All nine patients with IIM, including two with immune-mediated necrotizing myopathy (IMNM), two with dermatomyositis (DM) and five with antisynthetase syndrome (ASyS), achieved a moderate or major Total Improvement Score (TIS) response.
• In SLE, two of three evaluable patients have maintained drug-free DORIS remission through at least Month 9, including one patient beyond one year.
• Zugo-cel has been well tolerated in all 21 patients, with no dose-limiting toxicities, CRS above Grade 2, ICANS, IEC-HS, severe infections, clinically significant hypogammaglobulinemia, prolonged cytopenias, GvHD or deaths reported to date.
• Dose escalation is ongoing, with the six patients dosed to date at the 200 million CAR+ cell dose level showing higher CAR-T cell expansion than at the 100 million CAR+ cell dose level.

In addition to the rheumatology basket, zugo-cel is being evaluated in a Phase 1 basket trial in autoimmune hematologic diseases and in a Phase 1 trial in autoimmune neurologic diseases.

About Zugocabtagene Geleucel (zugo-cel; formerly CTX112)

Zugocabtagene geleucel (zugo-cel) is a wholly-owned, allogeneic chimeric antigen receptor (CAR) T cell therapy product candidate targeting Cluster of Differentiation 19 (CD19), in development for both autoimmune and immuno-oncology indications. The off-the-shelf therapy leverages CRISPR/Cas9 for targeted gene knockout and CAR insertion, enabling immune evasion and enhanced T effector cell potency, and is administered following a standard lymphodepletion regimen without the need for human leukocyte antigen (HLA) matching. In autoimmune disease, zugo-cel is being investigated in three ongoing basket trials. The rheumatology basket trial is enrolling adult patients with systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and idiopathic inflammatory myopathy (IIM). The hematology basket trial is enrolling patients with immune thrombocytopenic purpura (ITP) and warm autoimmune hemolytic anemia (wAIHA). The autoimmune neurologic basket trial is enrolling patients with progressive multiple sclerosis (PMS), neuromyelitis optica spectrum disorder (NMOSD), myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), N-methyl-D-aspartate receptor (NMDAR) and leucine-rich glioma-inactivated protein 1 (LGI1) autoimmune encephalitis (AIE), and stiff person syndrome (SPS). In immuno-oncology, zugo-cel is being investigated in a trial in adult patients with relapsed or refractory B-cell malignancies.

About CRISPR Therapeutics

CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. Founded over a decade ago as an early pioneer in CRISPR/Cas9 gene editing, the Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY^® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. Today, CRISPR Therapeutics is advancing a broad, diversified pipeline spanning hemoglobinopathies, cardiovascular disease, autoimmune disease, oncology, regenerative medicine and rare diseases. The Company is also expanding its gene editing toolkit through SyNTase™ editing, its novel, proprietary platform designed to enable precise, efficient, and scalable gene correction. To accelerate its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. To learn more, visit www.crisprtx.com.

CRISPR THERAPEUTICS^® standard character mark and design logo, CTX112™ and SyNTase™ are trademarks and registered trademarks of CRISPR Therapeutics AG. All other trademarks and registered trademarks are the property of their respective owners.

CRISPR Therapeutics Forward-Looking Statement

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements made by Dr. Patel in this press release, as well as regarding any or all of the following: (i) CRISPR Therapeutics preclinical studies, clinical trials and pipeline products and programs, including, without limitation, status of such studies and trials, potential expansion into new indications and expectations regarding data, safety and efficacy generally; (ii) data included in this press release and the above-described poster presentation, as well as the ability to use data from ongoing and planned clinical trials for the design and initiation of further clinical trials; and (iii) the therapeutic value, development, and commercial potential of gene editing technologies and therapies, including CRISPR/Cas9, as well as other technologies. Risks that contribute to the uncertain nature of the forward-looking statements include, without limitation, the risks and uncertainties discussed under the heading “Risk Factors” in CRISPR Therapeutics most recent annual report on Form 10-K and in any other subsequent filings made by CRISPR Therapeutics with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. We disclaim any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

This press release discusses investigational therapies and is not intended to convey conclusions about efficacy or safety as to those investigational therapies or uses of such investigational therapies. There is no guarantee that any investigational therapy will successfully complete clinical development or gain approval from applicable regulatory authorities.

Investor Contact:

+1-617-307-7503
[email protected]

Media Contact:

+1-617-315-4493
[email protected]

Clinically meaningful improvement in disease activity among 8 of 9 evaluable patients, including rapid and marked reductions in proteinuria with complete renal responses 

Deep and sustained reduction in pathogenic autoantibodies and IgG reduction underscore potential in plasma-cell driven diseases

Favorable safety profile in patients with refractory SLE

CAMBRIDGE, Mass., Nov. 08, 2026 (GLOBE NEWSWIRE) — Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, today announced clinical data from the ongoing Genrix Bio Phase 1b/2a study of velinotamig (GR1803) in patients with active, refractory, moderate-to-severe systemic lupus erythematosus (SLE). The results will be presented at the American College of Rheumatology (ACR) Convergence 2026 on November 8 in Poster #0272, “Initial Results of Velinotamig (GR1803, BCMAxCD3 TCE) Therapy in Patients with Refractory Systemic Lupus Erythematosus: a Phase 1b/2a Study.”

As of the September 8, 2026 data cutoff, 12 patients had been treated across three multi-dose cohorts. Velinotamig demonstrated a favorable safety profile, with no dose-limiting toxicities, no immune effector cell-associated neurotoxicity (ICANS), and no Grade 3 or higher cytokine release syndrome (CRS). CRS occurred in two patients and was limited to Grade 1 or 2 events that resolved with standard management. No Grade 2 events were observed after modifications to the step-up dosing regimen.

Among the first nine patients with at least four weeks of follow-up, clinical activity was observed across measures of disease activity, serologic markers, and renal function. Eight of nine evaluable patients achieved a clinically meaningful reduction of at least four points in SLEDAI-2K. Among seven evaluable patients with urine protein excretion greater than 500 mg/24 hours at baseline, five experienced rapid and marked reductions in proteinuria, and four of these patients achieved a complete renal response as demonstrated by proteinuria levels below 500 mg/24 hours, within 24 weeks. Reductions in anti-double-stranded DNA antibodies and blood IgG, improvement in complement C3, and depletion of CD19-positive B cells were also observed. 

“These compelling early findings demonstrate consistent and meaningful clinical, serological, and pharmacodynamic evidence in most treated patients, further validating the therapeutic potential of velinotamig as a short-duration BCMA-directed therapy,” said Jeffrey Jones, MD, MBA, Chief Medical Officer of Cullinan Therapeutics. “Combined with the favorable safety profile observed to date, these data reinforce our confidence in the global development plan for velinotamig, including our initial focus on autoimmune cytopenias, where pathogenic autoantibody-producing plasma cells play a central role in disease pathogenesis. Our unique and complementary clinical stage BCMA- and CD19-directed T cell engager portfolio positions us to address the diverse biology of autoimmune diseases, with the goal of bringing differentiated and tailored treatment options to more patients across a broad range of conditions.”

About the Genrix Bio Phase 1b/2a Velinotamig Study 

The open-label, multicenter, dose-escalation Phase 1b/2a study (NCT07348055) is evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of velinotamig in patients with active, refractory, moderate-to-severe SLE despite at least three months of standard-of-care therapy. Patients receive four intravenous doses on Days 1, 4, 8, and 29, with follow-up for up to 48 weeks. Key assessments include adverse events, CRS, ICANS, DLTs, SLEDAI-2K, 24-hour proteinuria, estimated glomerular filtration rate, anti-double-stranded DNA antibodies, complement C3/C4, and B cell depletion.

About Velinotamig (CLN-803, GR1803) 

Velinotamig is a BCMAxCD3 T cell engager designed to redirect cytotoxic T cells to target BCMA-expressing cells, including pathogenic, autoantibody-producing plasma cells. Velinotamig is engineered with high-affinity binding to BCMA and lower-affinity binding to CD3, with the goal of enhancing target-cell depletion while minimizing nonspecific T cell activation and associated cytokine-related toxicity. By targeting BCMA-expressing cells, velinotamig has the potential to address autoimmune diseases driven by pathogenic autoantibodies. 

Cullinan holds a global (ex-Greater China), all-indication, exclusive license to velinotamig from Genrix Bio. Genrix Bio is evaluating velinotamig in a Phase 1b/2a clinical trial in patients with refractory SLE in China (NCT07348055). Cullinan Therapeutics is also evaluating subcutaneously administered velinotamig in a global Phase 1b/2a study in patients with relapsing and refractory immune thrombocytopenia and warm autoimmune hemolytic anemia (NCT07738822).

About Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosus (SLE) is a chronic, heterogeneous autoimmune disease in which the immune system attacks a patient’s own tissues. The most common manifestations of SLE include skin rashes, arthritis, extreme fatigue, and low fevers. Lupus nephritis (LN) is a kidney disease and the most common severe manifestation of SLE. Approximately 40% of patients with SLE develop LN, which has a 10-year 30% mortality rate.^1,2 The prevalence of SLE in the US is estimated at 160,000 to 320,000 cases and SLE affects approximately 3.4 million individuals globally.^3,4 SLE is more prevalent in women and people of color.⁵ It occurs most often in people between the ages of 15 and 45 years but can occur in childhood or later in life as well.⁶ Currently available treatments can reduce the signs and symptoms of SLE; however, they do not routinely induce treatment-free remission, and most patients require lifelong immune suppression that treats symptoms without modifying the course of disease.^7-9

About Cullinan Therapeutics 

Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company developing potential first- or best-in-class, disease-modifying T cell engagers for autoimmune diseases and cancer. Cullinan pursues promising therapeutic targets while leveraging core expertise in T cell engagers, which are established in oncology and are now advancing into autoimmune diseases. With a clinical-stage pipeline built on a rigorous scientific approach and purposeful innovation, Cullinan is advancing its mission to deliver new standards of care for patients. Learn more about Cullinan at https://cullinantherapeutics.com/, and follow Cullinan on LinkedIn and X.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the Company’s beliefs and expectations regarding: our clinical development plan and timeline for velinotamig, the clinical and therapeutic potential of velinotamig, our plans regarding future data presentations, our beliefs regarding the broader potential of our BCMA- and CD 19-directed T cell engager portfolio in the treatment of autoimmune diseases, and other statements that are not historical facts. The clinical trial referenced in this press release is ongoing, and the data described are interim, subject to change, and based on data available as of a specified date. As patient enrollment continues and additional follow-up data is obtained, the reported safety profile and other clinical outcomes may change materially. There can be no assurance that the interim results will be predictive of final clinical trial results or that additional data will confirm or support these observations. The words “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “plan,” “potential,” “project,” “pursue,” “will,” and similar 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 of future events and are subject to known and unknown risks and uncertainties 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. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; the risk that any INDs, NDAs or other global regulatory submissions we may file with the FDA or other global regulatory agencies are not cleared or approved on our expected timelines, or at all; the success of our clinical trials and preclinical studies; the risks related to our ability to protect and maintain our intellectual property position; the risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; the effect of changes in global economic conditions, including uncertainties related to international trade policies, tariffs and supply chain dynamics on our business and operations; and the success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in 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, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the Company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. 

C
ontacts

Investors

Nick Smith
+1 401.241.3516
[email protected]

Media 

Rose Weldon
+1 215.801.7644
[email protected]

References

1. Mahajan, A. et al. (2020). Systemic lupus erythematosus, lupus nephritis and end-stage renal disease: A pragmatic review mapping disease severity and progression. Lupus, 29(9), 1011–1020. https://doi.org/10.1177/0961203320932219  
2. Hocaoglu, M. et al. (2023). Incidence, prevalence, and mortality of lupus nephritis: A population-based study over four decades using the Lupus Midwest Network. Arthritis & Rheumatology, 75(4), 567–573. https://doi.org/10.1002/art.42375  
3. Tian, J. et al. (2022). Global epidemiology of systemic lupus erythematosus: A comprehensive systematic analysis and modelling study. Annals of the Rheumatic Diseases, 82(3), 351–356. https://doi.org/10.1136/ard-2022-223035
4. Dall’Era, M. (2013). Chapter 21. Systemic lupus erythematosus. In J. B. Imboden, D. B. Hellmann, & J. H. Stone (Eds.), CURRENT Diagnosis & Treatment: Rheumatology (3rd ed.). McGraw-Hill. https://accessmedicine.mhmedical.com/content.aspx?aid=57272268
5. Izmirly, PM. et al. (2021) Prevalence of systemic lupus erythematosus in the United States: estimates from a meta-analysis of the Centers for Disease Control and Prevention National Lupus Registries. Arthritis Rheumatol, 73(6), 991-996. https://doi.org/10.1002/art.41632
6. Pons-Estel, GJ. et al. (2010) Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthritis Rheum, 39(4), 257-268. https://doi.org/10.1016/j.semarthrit.2008.10.007
7. Morand, EF. et al. (2023). Advances in the management of systemic lupus erythematosus. BMJ, 383, e073980. https://doi.org/10.1136/bmj-2022-073980
8. Jourde-Chiche, N. et al. (2024) An era of immunosuppressant withdrawal in systemic lupus erythematosus: winning through weaning. Lancet, 6(3), E133-E134. https://doi.org/10.1016/S2665-9913(24)00001-8
9. Athanassiou, P., & Athanassiou, L. (2023). Current Treatment Approach, Emerging Therapies and New Horizons in Systemic Lupus Erythematosus. Life, 13(7), 1496. https://doi.org/10.3390/life13071496

100% (6 of 6) of dermatomyositis patients maintained immunomodulator-free, moderate-to-major TIS responses through one year, with most patients also free of steroids 

100% (5 of 5) of lupus nephritis patients with follow-up from six months to two years achieved immunomodulator-free DORIS remission and evidence of little-to-no disease activity based on repeat kidney biopsies

71% (5 of 7) of systemic sclerosis patients achieved immunomodulator-free rCRISS-50 and the five patients with interstitial lung disease achieved 9% mean FVC improvement, both at one year

71-patient clinical experience with rese-cel following preconditioning reinforces favorable benefit-risk profile across myositis, systemic sclerosis, lupus, and myasthenia gravis

PHILADELPHIA, Nov. 08, 2026 (GLOBE NEWSWIRE) — Cabaletta Bio, Inc. (Nasdaq: CABA), a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced new Phase 1/2 clinical data on resecabtagene autoleucel (rese-cel) to be presented in one oral and two poster presentations at the American College of Rheumatology (ACR) Convergence 2026 annual meeting in Orlando, FL. In addition, Cabaletta will host an industry-supported Innovation Theater symposium highlighting rese-cel as a potential treatment for autoimmune diseases and insights from the RESET™ clinical development program.

“In three different autoimmune diseases where patients are at risk of severe disability, end-organ damage, and increased risk of death despite current therapies, a single weight-based dose of rese-cel delivered immunomodulator-free clinical improvements that were durable through at least one year with a favorable benefit-risk profile,” said David J. Chang, M.D., Chief Medical Officer of Cabaletta. “We believe these emerging data reinforce the potential of rese-cel to deliver an immune reset that leads to durable efficacy with a favorable benefit-risk profile for autoimmune disease patients.”

Cabaletta’s presentations highlight follow-up from Phase 1/2 patients treated in open-label, single-arm studies with a single, weight-based infusion of rese-cel following preconditioning as of September 4, 2026, the data cut-off date. Nearly all patients discontinued all immunomodulators and required no or only low-dose steroids while achieving durable improvement in disease activity.

All Six Dermatomyositis Patients Achieved Immunomodulator-Free, Moderate-to-Major TIS Responses At One Year

• 100% (6/6) of patients maintained an immunomodulator-free, moderate-to-major Total Improvement Score (TIS) response through one year, with 83% (5/6) achieving that level as early as Week 16, the timepoint corresponding to the primary endpoint of the ongoing registrational dermatomyositis (DM) and antisynthetase syndrome (ASyS) cohort. Most of these patients were also free of steroids at Week 52.
• Improvements were also seen in disease activity, including muscle strength (MMT-8) and skin manifestations (CDASI-A), as well as in patient-reported outcomes on physical function and fatigue.

These data will be presented in an oral presentation (Abstract 0902) at 1:00 p.m. ET on Sunday, November 8. Cabaletta anticipates reporting topline results from the registrational adult DM/ASyS cohort in the second half of 2027 and submitting a Biologics License Application (BLA) for rese-cel in myositis, including adult DM and all available juvenile DM Phase 1/2 clinical data, in the first quarter of 2028.

All Five Lupus Nephritis Patients With Repeat Kidney Biopsy Achieved Immunomodulator-Free DORIS Remission and Histologic Response or Remission

• 100% (5/5) of patients who underwent an optional repeat kidney biopsy after rese-cel infusion achieved the definition of remission in systemic lupus erythematosus (DORIS) off all immunomodulators and on no or low-dose steroids.
• 100% (5/5) of biopsied patients demonstrated histologic response or remission.

These data will be presented in a poster presentation (Abstract 1222) from 10:30 a.m. – 12:30 p.m. ET on Monday, November 9. Cabaletta believes these data provide important insights for assessing clinical responses in lupus nephritis patients who demonstrate histologic response or remission without meeting criteria for complete renal response (CRR), where persistent proteinuria is consistent with structural kidney damage predating treatment rather than ongoing disease activity.

Systemic Sclerosis Patients Sustained Immunomodulator-Free Improvement Across Multiple Measures Through One Year, Including Improved Lung Function

• 71% (5/7) of patients achieved rCRISS-50 at one year, with 86% (6/7) of patients achieving rCRISS-25 at the same timepoint.
• 9% improvement in mean percent-predicted forced vital capacity (FVC) was observed at one year among the five patients with interstitial lung disease.
• Patients also demonstrated improvement as measured by the modified Rodnan Skin Score at one year.

Additional perspective on these patients and on the broader RESET clinical development program will be shared during Cabaletta’s Innovation Theater, “Designed for Autoimmunity: Rese-cel and the RESET™ Clinical Program,” from 1:30 p.m. – 2:15 p.m. ET on Tuesday, November 10. Given the high unmet need in systemic sclerosis, with one of the highest mortality rates among rheumatological conditions, Cabaletta is enrolling a registrational systemic sclerosis cohort with a focus on interstitial lung disease.

Favorable Benefit-Risk Profile Observed to Date Across 71 Patients Spanning Four Autoimmune Diseases

• 94% (67/71) of patients experienced no or Grade 1 cytokine release syndrome (CRS). Grade 2 CRS was reported in 6% (4/71).
• 96% (68/71) of patients experienced no immune effector cell-associated neurotoxicity syndrome (ICANS).
• No immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) was reported.

These data will be presented in a poster presentation (Abstract 1673) from 10:30 a.m. – 12:30 p.m. ET on Monday, November 9. Cabaletta believes the reported benefit-risk profile of rese-cel is reflective of its specific combination of construct and production elements designed to prioritize patient safety, including a fully-human CD19 binder, weight-based dosing, and a standard, well-characterized nine-day manufacturing process.

Additional information can be accessed on the website of the ACR Convergence 2026 annual meeting. Presentation materials can be accessed on the Posters & Publications section of the Company’s website.

About resecabtagene autoleucel (rese-cel) for autoimmune diseases
Rese-cel is an investigational chimeric antigen receptor (CAR) T cell therapy designed to achieve a potential immune reset in patients living with autoimmune diseases. Following a single, weight-based intravenous infusion after discontinuation of immunomodulators, rese-cel has shown the ability to deliver an immune reset, leading to clinical responses that have sustained over time. Cabaletta is evaluating rese-cel across the REstoring SElf-Tolerance (RESET™) clinical development program, which includes multiple single-arm, company-sponsored trials in rheumatology, neurology, and dermatology with disease-specific cohorts designed to evolve directly into registrational studies. Cabaletta is also advancing a program of innovations to broaden and deepen the treatment potential of rese-cel across autoimmune diseases.

About Cabaletta Bio
Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases. Cabaletta’s lead product candidate, resecabtagene autoleucel (rese-cel), is an investigational 4-1BB-containing fully human CD19-CAR T cell therapy being advanced across the REstoring SElf-Tolerance (RESET™) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology, and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and connect with us on LinkedIn.

Forward-Looking Statements
This press release contains “forward-looking statements” of Cabaletta Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including without limitation, express or implied statements regarding: Cabaletta’s business plans and objectives as a whole; Cabaletta’s ability to realize its vision of launching curative targeted cell therapies designed specifically for patients with autoimmune diseases; Cabaletta’s ability to successfully complete research and further development and commercialization of its drug candidates in current or future indications, including the timing and results of Cabaletta’s clinical trials and its ability to conduct and complete clinical trials; expectation that clinical results will support rese-cel’s safety and activity profile; Cabaletta’s expectations regarding the timing of topline results from the registrational DM/ASyS cohort in the second half of 2027 and its plans to submit a BLA for rese-cel in myositis, inclusive of adult and juvenile DM data, in 1Q28; Cabaletta’s expectations regarding the inclusion of multi-year Phase 1/2 myositis durability data in its planned BLA submission based on its recent Type B regulatory interaction with the FDA; Cabaletta’s expectations regarding the potential eligibility for a Priority Review Voucher based on a potential pediatric indication for juvenile DM; Cabaletta’s plans and expectations regarding the registrational RESET-SSc cohort in systemic sclerosis-associated interstitial lung disease, including enrollment, trial design, and timing of data read-outs; the potential applicability of Phase 1/2 clinical data to registrational cohorts; Cabaletta’s interpretation of clinical data, including lupus nephritis kidney biopsy findings and the characterization of persistent proteinuria as reflective of structural damage predating treatment; statements regarding the mechanistic basis of activity and favorable benefit-risk profile of rese-cel, including conclusions drawn from pharmacokinetic, pharmacodynamic and cytokine data described in a publication; the significance of the clinical data read-out at upcoming scientific meetings and timing thereof; and Cabaletta’s expectations around the potential success and therapeutic benefits of rese-cel, including the durability of clinical responses, its benefit-risk profile and its potential as a one-time infusion.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events 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. These risks and uncertainties include, but are not limited to: risks related to regulatory filings, potential clearance and potential approval; the risk that preclinical or clinical data, including signs of biologic activity or clinical response, may not be predictive of long-term results or translate across programs; the risk that interim data may change as more patient data become available; Cabaletta’s ability to demonstrate sufficient evidence of safety, efficacy and tolerability in its preclinical studies and clinical trials of rese-cel; the risk that the results observed with the similarly-designed construct employed in academic publications, including due to the dosing regimen, are not indicative of the results Cabaletta seeks to achieve with rese-cel; risks that modifications to trial design or approach may not have the intended benefits and that the trial design may need to be further modified; risks related to clinical trial site activation, delays in enrollment generally or enrollment rates that are lower than expected; delays related to assessment of clinical trial results; risks related to unexpected safety or efficacy data observed during clinical studies; risks related to volatile market and economic conditions and public health crises; Cabaletta’s ability to retain and recognize the intended incentives conferred by Orphan Drug Designation, Fast Track Designation, Regenerative Medicine Advanced Therapy Designation or other designations for its product candidates, as applicable; risks related to Cabaletta’s ability to protect and maintain its intellectual property position; risks related to fostering and maintaining successful relationships with Cabaletta’s collaboration and manufacturing partners; uncertainties related to the initiation and conduct of studies and other development requirements for its product candidates; the risk that any one or more of Cabaletta’s product candidates will not be successfully developed and/or commercialized; and the risk that the initial or interim results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Cabaletta’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Cabaletta’s most recent annual report on Form 10-K as well as discussions of potential risks, uncertainties, and other important factors in Cabaletta’s other subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Cabaletta undertakes no duty to update this information unless required by law.

Contacts
Investors: [email protected]
Media: [email protected]

NEW YORK, Nov. 08, 2026 (GLOBE NEWSWIRE) — Lead Plaintiff Deadline: December 15, 2026. Investors who purchased (NASDAQ: QBTS) securities between February 26, 2026 and August 25, 2026 may be eligible to recover losses.

Bronstein, Gewirtz & Grossman, LLC (“BG&G”), a nationally recognized investor-rights law firm, announces that it has filed a securities class action lawsuit against D-Wave Quantum Inc. (NYSE: QBTS) (“D-Wave” or the “Company”) and certain of its officers.

The lawsuit, captioned , Case No. 5:26-cv-11953, was filed on October 15, 2026, in the United States District Court for the Northern District of California. The action seeks to recover damages on behalf of all persons and entities that purchased or otherwise acquired D-Wave securities between February 26, 2026 and August 25, 2026, both dates inclusive (the “Class Period”), for alleged violations of the federal securities laws.

Investors are encouraged to join this case by visiting the firm’s website: https://bgandg.com/cases/d-wave-quantum-inc-qbts-class_action_lawsuit/

D-Wave Case Details

The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and financial prospects. Specifically, the complaint alleges that Defendants made false and/or misleading statements and/or failed to disclose that:

On August 6, 2026, D-Wave reported second-quarter revenue of $3.08 million, falling short of analysts’ expectations of approximately $4.03 million to $4.08 million. On this news, D-Wave’s stock price declined $1.99 per share, or 9.28%, closing at $19.41 per share.

Then, on August 25, 2026, D-Wave announced that Chief Financial Officer John Markovich would retire and resign from his position effective September 2, 2026. On this news, D-Wave’s stock price fell $1.84 per share, or 9.51%, closing at $17.51 per share on August 26, 2026.

What’s Next for D-Wave Investors?

Bronstein, Gewirtz & Grossman, LLC has already filed a class action lawsuit on behalf of D-Wave investors. The action is pending in the United States District Court for the Northern District of California under Case No. 5:26-cv-11953.

If you wish to review a copy of the Complaint, you can visit the firm’s site: bgandg.com/cases/d-wave-quantum-inc-qbts-class_action_lawsuit. or you may contact Peretz Bronstein, Esq. or his Client Relations Manager, Nathan Miller, of Bronstein, Gewirtz & Grossman, LLC at 917-590-0911. If you suffered a loss in D-Wave you have until December 15, 2026, to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn’t require that you serve as lead plaintiff.

No Cost to D-Wave Investors

We, Bronstein, Gewirtz & Grossman LLC, represent investors in class actions on a contingency fee basis. That means we will ask the court to reimburse us for out-of-pocket expenses and attorneys’ fees, usually a percentage of the total recovery, only if we are successful.

Why Bronstein, Gewirtz & Grossman, LLC for D-Wave Securities Class Action?

Bronstein, Gewirtz & Grossman, LLC is a nationally recognized firm that represents investors in securities fraud class actions and shareholder derivative suits. Our firm has recovered hundreds of millions of dollars for investors nationwide. More at www.bgandg.com

“Our practice centers on restoring investor capital and ensuring corporate accountability, which serves to uphold the essential integrity of the marketplace,” said Peretz Bronstein, Founding Partner of Bronstein, Gewirtz & Grossman, LLC.

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Contact Info

Peretz Bronstein, Esq. or Nathan Miller
Bronstein, Gewirtz & Grossman, LLC
917-590-0911 | [email protected]

Attorney advertising.
Prior results do not guarantee similar outcomes.

*Lunar sunset captured by Blue Ghost from the Moon with Earth and Venus on the horizon on March 16, 2025; Credit: Firefly Aerospace

CEDAR PARK, Texas, Nov. 07, 2026 (GLOBE NEWSWIRE) — Firefly Aerospace (Nasdaq: FLY), a market leading space and defense technology company, today announced it was onboarded as a vendor under NASA’s $10 billion Commercial Lunar Payload Services (CLPS) 2 Indefinite Delivery/Indefinite Quantity (IDIQ) contract, positioning the company to compete for and deliver task orders that will advance the Agency’s scientific, exploration, and infrastructure objectives on the lunar surface over a 10-year ordering period.

Designed to increase the cadence of commercial deliveries to the Moon, NASA’s CLPS 2 initiative is leveraging CLPS 1 successes with an emphasis on lander reliability, larger cargo landers, and the delivery of critical infrastructure required to establish and sustain a permanent Moon Base. Firefly’s onboarding to CLPS 2 reflects the company’s established track record in meeting NASA’s program requirements as was demonstrated on Blue Ghost Mission 1 that successfully landed on the Moon and completed all mission objectives in March 2025.

“Blue Ghost Mission 1 proved Firefly can deliver on the Moon, and now CLPS 2 gives us the opportunity to do it again and again at greater scale,” said Jason Kim, CEO of Firefly Aerospace. “Every lesson we learned operating from Earth to the Moon is being folded into how we scale up our landers and deliver repeatable lunar access. As a partner that has already been to the Moon’s surface and knows what it takes to succeed, our customers can count on us to deliver more complex lunar missions while reducing risks along the way.”

Following its successful Moon landing, Firefly has won four additional missions under CLPS 1 as well as a contract to deliver NASA’s MoonFall mission. The company is ramping up production of its Blue Ghost landers and Elytra orbiters in its newly expanded cleanroom that can accommodate up to 12 spacecraft.

Firefly is also scaling up the proven technologies into a larger lander architecture to meet growing demand for small to heavy payload delivery and hosting services on and around the Moon. The larger lander is designed to deliver significantly more lunar cargo, terrain vehicles, infrastructure, and power systems essential to a permanent human and robotic lunar presence. After acquiring SciTec and Space-ng, Firefly is further utilizing its proven AI software to enable advanced autonomous guidance and descent operations, along with enhanced on-orbit data processing for each mission.

About Firefly Aerospace

Firefly Aerospace is a space and defense technology company on a mission to reliably and repeatedly launch, land, and operate space systems from Earth to the Moon and beyond. As the partner of choice for responsive space missions, Firefly is the first commercial company to launch a satellite to orbit with approximately 24-hour notice and the first to achieve a successful Moon landing. Firefly’s launch, lunar, and orbital vehicles paired with its AI software and data processing capabilities support end-to-end missions across cislunar space, including payload delivery and maneuverability, space domain awareness, and missile warning and tracking. Established in 2017, Firefly’s engineering, manufacturing, and test facilities are co-located in central Texas to enable rapid innovation and vertical integration across the company’s product lines. For more information, visit www.fireflyspace.com.

Forward-Looking Statements

This press release contains “forward-looking statements” including, but not limited to, statements regarding the company’s positioning, CLPS 2 objectives, operational ramp-up, market demand, AI capabilities, statements of Firefly’s chief executive officer, and other statements regarding Firefly’s future expectations, beliefs, plans, objectives, financial condition, assumptions, future events, or performance that are not historical facts. In some cases, you can identify forward-looking statements because they contain words such as “enable,” “expand,” “help,” “may,” “pave,” “position,” “will,” “expects,” “plans,” “anticipates,” “could,” “would,” “target”, “set,” “intends,” “support,” and “believes.” There may also be negative words or other similar terms or expressions that concern our expectations, strategy, plans, or intentions. Not all forward-looking statements contain such identifying words. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates, or expectations will be achieved.

Various risks that could cause actual results to differ from those expressed by the forward-looking statements included in this press release include, but are not limited to: our failure to manage our growth effectively, including the increasing technological complexity of our business, and our ability to achieve and maintain profitability; the potential for delayed or failed launches, and any failure of our launch vehicles and spacecraft to operate as intended; our inability to deliver software on time or of a quality that our customers demand; the hazards and operational risks that our products and service offerings are exposed to, including the wide and unique range of risks due to the unpredictability of space; the inability to realize our backlog; the fluctuation of our operating results; adverse publicity stemming from any incident involving us, our competitors, or our customers; the failure to adequately protect our proprietary intellectual property rights; our inability to comply with our contractual obligations; and other risk factors set forth in our filings with the Securities and Exchange Commission. 

Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. These statements are based on management’s current expectations, assumptions, and beliefs concerning future developments, which are inherently subject to uncertainties, risks, and changes in circumstances that are difficult to predict. We cannot assure you that the events reflected in the forward-looking statements will occur; actual events could differ materially from those described in the forward-looking statements. We undertake no intent or obligation to publicly update or revise any of the estimates and other forward-looking statements made in this announcement, whether as a result of new information, future events or otherwise, except as required by law.

Media Contact

[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ef652cee-b2d6-4fb5-88b3-1adfbb3ea154