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Day: December 7, 2025

Lynozyfic™ (linvoseltamab) Monotherapy in Newly Diagnosed Multiple Myeloma (NDMM) Shows Impressive Responses, Supporting Rationale as a Potential Foundation in Frontline Treatment

All three dose groups (50 mg, 100 mg and 200 mg) showed impressive monotherapy efficacy, with VGPR+ (very good partial response or better) of ≥70% despite limited follow-up; evidence shows that these responses are expected to deepen over time Across all dose groups, 95% (19 of 20 patients) of all evaluable VGPR+ patients achieved minimal residual disease negative status Data featured in an ASH oral presentation; LINKER-MM4 is the first clinical trial to evaluate a BCMAxCD3 bispecific monotherapy in NDMM and is part of a broad clinical development program evaluating Lynozyfic-based regimens in earlier lines of treatment Regeneron to host virtual ‘Regeneron Roundtable’ investor event to discuss its multiple myeloma development program on Wednesday, December 10 at 8:30 a.m. ET  TARRYTOWN, N.Y., Dec. 07, 2025 (GLOBE NEWSWIRE) — Regeneron...

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Lyell Immunopharma Presents New Clinical Data from Ongoing Trial of Ronde-Cel Showing High Rates of Durable Complete Responses in Patients with Large B-cell Lymphoma at the 67th ASH Annual Meeting and Exposition

93% overall response and 76% complete response rates with median progression-free survival of 18 months in patients with large B-cell lymphoma in the 3L+ setting 83% overall response and 61% complete response rates in cohort comprised predominantly of patients with primary refractory large B-cell lymphoma in the 2L setting Manageable safety profile appropriate for outpatient administration; no high-grade CRS and ≤ 5% of patients with Grade ≥ 3 ICANS following dexamethasone prophylaxis Lyell management will host an investor webcast with presenting author and ronde-cel investigator Sarah M. Larson, MD, Associate Professor at the David Geffen School of Medicine, University of California, Los Angeles, at 8:30 AM ET on Monday, December 8thSOUTH SAN FRANCISCO, Calif., Dec. 07, 2025 (GLOBE NEWSWIRE) — Lyell Immunopharma, Inc. (Nasdaq:...

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Wave Life Sciences to Announce Interim Data from the Phase 1 INLIGHT Trial of WVE-007 (INHBE) for Obesity on Monday, December 8, 2025

CAMBRIDGE, Mass., Dec. 07, 2025 (GLOBE NEWSWIRE) — Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health, will announce interim data from the ongoing Phase 1 INLIGHT clinical trial evaluating WVE-007, an investigational INHBE GalNAc-siRNA using Wave’s proprietary SpiNA design, for the treatment of obesity on Monday, December 8, 2025. A press release announcing the interim data will be issued at 7:30 a.m. ET, followed by an investor conference call and webcast at 8:30 a.m. ET. A webcast of the conference call can be accessed by visiting “Investor Events” on the investor relations section of the Wave Life Sciences website: https://ir.wavelifesciences.com/events-publications/events. Following the live event, an archived version...

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Dyne Therapeutics to Host Investor Conference Call and Webcast to Review Topline Results from Registrational Expansion Cohort (REC) of DELIVER Clinical Trial of Z-Rostudirsen (DYNE-251) in Duchenne Muscular Dystrophy; Tomorrow, December 8 at 8:00 a.m. ET

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...

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Nayax Considering an Offering of Notes and Warrants in Israel

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...

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ALX Oncology Announces Positive Results from Ongoing Investigator-Sponsored Phase 2 Trial Evaluating Evorpacept in Combination with Standard-of-Care Treatment in Patients with Indolent B-cell Non-Hodgkin Lymphoma, at ASH Annual Meeting

– 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...

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Prime Medicine Announces The New England Journal of Medicine Publication of PM359 Clinical Data for the Treatment of Chronic Granulomatous Disease

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...

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Genmab Presents Pivotal Phase 3 Data from EPCORE® FL-1 Trial Demonstrating Clinical Benefit of EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide (R2) in Patients with Relapsed or Refractory Follicular Lymphoma

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...

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Molecular Partners Presents Updated Data from Ongoing Phase 1/2a Trial of MP0533 in AML at ASH Annual Meeting

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...

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