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Regeneron Stock Plunges 22.6% YTD: Should You Buy, Sell or Hold?
ZACKS· 2025-07-18 14:56
Key Takeaways REGN shares are down 22.8% YTD due to weak Eylea sales and pipeline disappointments. Eylea faces intense competition from Vabysmo and biosimilars, with HD version uptake still ramping up. Dupixent and new oncology approvals offer some support, but setbacks in COPD and lymphoma drugs persist. Shares of Regeneron Pharmaceuticals, Inc. (REGN) have lost 22.6% year to date against the industry’s growth of 0.6%. The stock has underperformed the medical sector and S&P 500 Index in this timeframe.A ...
FDA Grants Accelerated Approval to Regeneron's Blood Cancer Drug
ZACKS· 2025-07-03 14:20
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]