Core Insights - Regeneron Pharmaceuticals, Inc. (REGN) received FDA approval for linvoseltamab-gcpt, branded as Lynozyfic, for treating relapsed or refractory multiple myeloma (MM) after at least four prior therapies [1][6][7] - Lynozyfic is a bispecific antibody that connects B-cell maturation antigen (BCMA) on MM cells with CD3-expressing T cells, leading to T-cell activation and cancer cell destruction [2][5] - The approval was based on the LINKER-MM1 trial, which showed a 70% objective response rate and a 45% complete response rate, marking it as one of the most effective bispecific antibodies for this patient group [4][7] Regulatory Approval - Lynozyfic is the first FDA-approved BCMAxCD3 bispecific antibody with a dosing schedule of every two weeks starting at week 14, and every four weeks if a very good partial response is achieved after 24 weeks of therapy [5][7] - The approval addresses a significant unmet need for patients with late-stage MM, who have limited treatment options [6] Market Context - MM is the second most common blood cancer, with over 36,000 new cases expected in the US by 2025 [5] - REGN's shares have declined by 22.9% year-to-date, contrasting with a 0.6% decline in the industry [2] Oncology Portfolio Development - The approval of Lynozyfic enhances REGN's oncology portfolio, which includes Libtayo for various cancers [9] - REGN is also pursuing the approval of odronextamab for treating relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma, with a target action date for resubmission set for July 30, 2025 [10][11] Competitive Landscape - REGN faces challenges with its lead drug Eylea, which is experiencing declining sales due to competition from Roche's Vabysmo, impacting its market share [11][12]

Regeneron Pharmaceuticals has won Food and Drug Administration accelerated approval of its Lynozyfic treatment for certain patients with the blood cancer multiple myeloma https://t.co/uOJuKJ92zD ...

TARRYTOWN, N.Y., July 02, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody. Lynozyfic was granted accelerated approval bas ...

Regeneron Pharmaceuticals, Inc. (REGN) and partner Sanofi (SNY) announced mixed results from two late-stage studies, AERIFY-1 and AERIFY-2, on itepekimab for the treatment of chronic obstructive pulmonary disease (COPD).The candidate is being jointly developed by Regeneron and Sanofi. It is currently in clinical development programs for chronic rhinosinusitis with nasal polyps (phase III), non-cystic fibrosis bronchiectasis (phase II) and chronic rhinosinusitis without nasal polyps (phase II).Year to date, ...

Core Insights - The European Commission has granted conditional marketing approval for Lynozyfic (linvoseltamab) to treat adults with relapsed and refractory multiple myeloma, specifically for those who have undergone at least three prior therapies [1][3][5] - Lynozyfic is a bispecific antibody that targets B-cell maturation antigen (BCMA) on multiple myeloma cells and CD3 on T cells, facilitating T-cell activation and cancer cell killing [1][3] - The approval is based on the LINKER-MM1 trial, which showed a 71% objective response rate and a 50% complete response rate among patients treated with Lynozyfic [3][4] Company Overview - Regeneron Pharmaceuticals is a leading biotechnology company focused on developing innovative medicines for serious diseases, including blood cancers [17][18] - The company has a strong commitment to transforming cancer care, as evidenced by the approval of Lynozyfic as its second bispecific antibody [5][12] - Regeneron utilizes proprietary technologies, such as VelociSuite, to develop optimized fully human antibodies and bispecific antibodies [15][18] Clinical Development - Lynozyfic is currently being investigated in a broad clinical development program, including monotherapy and combination regimens across different lines of therapy for multiple myeloma [11][12] - The ongoing LINKER-MM1 trial has enrolled over 300 patients, assessing safety, tolerability, and anti-tumor activity [9][10] - The regimen for Lynozyfic includes an initial step-up dosing followed by a response-adapted schedule, allowing for convenient administration every four weeks for eligible patients [2][10] Market Context - Multiple myeloma is the second most common blood cancer, with over 35,000 new cases diagnosed annually in Europe and 187,000 globally [6][7] - Despite treatment advances, multiple myeloma remains incurable, and patients often experience relapses and require new therapies [7][8] - The introduction of Lynozyfic provides a new treatment option with a different mechanism of action, addressing the need for innovative therapies in this patient population [3][5]