WALTHAM, Mass., Dec. 07, 2025 (GLOBE NEWSWIRE) — Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today announced that it plans to announce topline clinical results from the Registrational Expansion Cohort (REC) of the Phase 1/2 DELIVER trial of zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251) on December 8, 2025, and to host a webcast at 8:00 a.m. ET. The company intends to issue a press release prior to the start of the event. Investor Conference Call and WebcastThe webcast will be available on the Events & Presentations page of the Investors & Media section of Dyne’s website, and a replay will be accessible for 90 days following the presentation. An accompanying slide presentation...

HERZLIYA, Israel, Dec. 07, 2025 (GLOBE NEWSWIRE) — Nayax Ltd. (Nasdaq: NYAX; TASE: NYAX) (the “Company”), a global commerce payments and loyalty platform designed to help merchants scale their business, announced today that it is considering an offering by way of an expansion of its existing Series A Notes and Series 1 Warrants, with such offering to be made to the public in Israel only. The offering will be conducted as a uniform offering through a public tender for a single unit price, with each unit consisting of NIS 1,000 par value of Series A Notes and three Series 1 Warrants, with each such warrant exercisable into one ordinary share of the Company. The offering will be conducted in Israel only, pursuant to a shelf offering report that would be published pursuant to the Company’s shelf prospectus dated August 23, 2023. The...

– Combination of evorpacept plus rituximab and lenalidomide (R2) generated complete responses (CR) in 92% of patients with untreated indolent non-Hodgkin lymphoma (iNHL) comparing favorably to an approximate 50% historical CR rate for R2 alone – Data indicates combination of evorpacept plus R2 was well-tolerated and provides impressive anti-tumor activity in frontline treatment setting – While longer follow up matures, minimal residual disease (MRD) eradication rate with this novel regimen will be evaluated SOUTH SAN FRANCISCO, Calif., Dec. 07, 2025 (GLOBE NEWSWIRE) — ALX Oncology Holdings Inc., (“ALX Oncology” or the “Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced that positive data...

CAMBRIDGE, Mass., Dec. 07, 2025 (GLOBE NEWSWIRE) — Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today announced the publication of Phase 1/2 clinical data with PM359, the Company’s investigational autologous hematopoietic stem cell product for p47phox chronic granulomatous disease (CGD) in the New England Journal of Medicine (NEJM). The data will also be presented in a poster session at the 67th American Society of Hematology (ASH) Annual Meeting, December 6-9, 2025 in Orlando, Florida. The publication, titled “Prime Editing for p47-phox Chronic Granulomatous Disease,” reports initial data for two patients treated in the Phase 1/2 trial of PM359, which was designed to assess safety, biological activity and preliminary efficacy...

Media Release COPENHAGEN, Denmark; December 7, 2025Trial demonstrated treatment with fixed duration EPKINLY plus rituximab and lenalidomide (EPKINLY+ R2) resulted in statistically significant and clinically meaningful reduction in the risk of disease progression or death and overall response compared to R2 alone EPKINLY + R2 was recently approved by the U.S. Food and Drug Administration as the first and only bispecific-based therapy for follicular lymphoma in the second-line setting Results of EPCORE FL-1 simultaneously published in The LancetGenmab A/S (Nasdaq: GMAB) today announced primary data from the pivotal Phase 3 EPCORE® FL-1 study evaluating fixed duration EPKINLY® (epcoritamab-bysp) in combination with rituximab and lenalidomide (EPKINLY + R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The...

Poster outlines clinical benefit with acceptable safety profile across 9 tested dosing regimensAccelerated step-up dosing and higher dosing frequency is feasible and results in increased exposureSix of eight responders presented with low bone marrow blast counts at baseline, supporting further investigation in this patient population most likely to benefit from MP0533ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., Dec. 07, 2025 (GLOBE NEWSWIRE) — Ad hoc announcement pursuant to Art. 53 LR Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics (“Molecular Partners” or the “Company”), has today announced it will present updated data from a Phase 1/2a trial of the multispecific T-cell engager MP0533 in patients with...

― Clear dose-response observed, with a robust and clinically meaningful fetal hemoglobin (HbF) induction at the Week 6 timepoint (n=12): mean absolute HbF in the 20 mg cohort increased by 9.9% at Week 6 (vs. 5.6% at Week 6 in the 12 mg cohort); 7 of 12 patients in the 20 mg cohort (58%) achieved absolute HbF levels ≥20% ― ― >3.75-fold mean induction of HbF at Week 12 in the 20 mg cohort among patients who reached the Week 12 visit as of November 11, 2025 data cutoff (n=6), compared to a 2.4-fold induction at Week 12 in the 12 mg cohort ― ― Consistent early evidence of pan-cellular HbF induction, improvements in markers of hemolysis and anemia, and encouraging trends in vaso-occlusive crisis (VOC) reduction ― ― Pociredir continued to be generally well-tolerated, with no treatment-related serious adverse events (SAEs) ― ― Fulcrum to host...

Treatment arm continues to demonstrate favorable relapse-free survival (HR=0.50; p=0.23) and overall survival (HR=0.61; p=0.52) 3/3 (100%) of TSC-101-treated patients who reached two-year follow-up remained relapse-free vs. 1/4 (25%) in the control arm TSC-101 was well-tolerated with no dose-limiting toxicities observed Company to host virtual KOL event featuring Ran Reshef, M.D., M.Sc. on Monday, December 8, at 8:00 a.m. ET WALTHAM, Mass., Dec. 06, 2025 (GLOBE NEWSWIRE) — TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, today announced updated results from the ongoing ALLOHA™ Phase 1 trial (NCT05473910) of TSC-101 in patients with heme malignancies undergoing allogeneic...

Selective Treg modulator gotistobart (BNT316/ONC-392) showed a reduction in the risk of death by more than half compared to standard of care chemotherapy and a manageable safety profile in the first of two stages of the global Phase 3 trial PRESERVE-003 in patients with squamous non-small cell lung cancer (“sqNSCLC”) who have progressed on prior immunotherapy plus chemotherapy Median OS with gotistobart has not been reached at almost 15 months of follow-up, compared to a median OS of 10 months observed with chemotherapy As a chemotherapy-free monotherapy, gotistobart has the potential to become an alternative to traditional cytotoxic treatment for a patient population with high unmet medical need Gotistobart was granted Fast Track Designation by the U.S. Food and Drug Administration (“FDA”) for the treatment of patients with metastatic...

Triple-class exposed patients with three prior lines of therapy in CARTITUDE-1 and CARTITUDE-4 achieved a median PFS of 50.4 months after a single infusion of CARVYKTI®Translational analyses show stronger immune fitness and a more immunocompetent TME when CARVYKTI® is used earlier in the treatment journeyEighty percent of as-treated patients in CARTITUDE-4 with standard-risk cytogenetics remained progression-free and off treatment at 30 months after a single infusion of CARVYKTI®Promising first-in-human results from allogeneic CAR-T candidate LUCAR-G39D demonstrate encouraging safety and efficacy in B-cell non-Hodgkin lymphomaSOMERSET, N.J., Dec. 06, 2025 (GLOBE NEWSWIRE) — Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced new long-term clinical and translational...