Regeneron’s linvoseltamab receives FDA approval for multiple myeloma

NEW YORK - The U.S. Food and Drug Administration has granted accelerated approval to Regeneron Pharmaceuticals’ (NASDAQ:REGN) Lynozyfic (linvoseltamab-gcpt) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, the company announced Wednesday. The biotech giant, with a market capitalization of $57.55 billion and maintaining a "GREAT" financial health score according to InvestingPro, continues to strengthen its position in the oncology market.

The approval is based on results from the Phase 1/2 LINKER-MM1 trial, where the treatment demonstrated a 70% objective response rate among 80 patients, with 45% achieving a complete response or better. The median time to first response was 0.95 months, while the median duration of response had not been reached at the time of assessment.

Lynozyfic is the first FDA-approved BCMAxCD3 bispecific antibody that can be dosed every two weeks starting at week 14, and potentially every four weeks if patients achieve a very good partial response or better after completing at least 24 weeks of therapy.

The treatment requires hospitalization for safety monitoring during the step-up dosing period, with 24-hour observation periods after the first and second step-up doses.

The prescribing information includes a Boxed Warning for cytokine release syndrome and neurologic toxicity. Common adverse reactions included musculoskeletal pain, cytokine release syndrome, cough, and upper respiratory tract infection.

Multiple myeloma is the second most common blood cancer, with over 36,000 new cases expected in the U.S. in 2025. Approximately 4,000 patients have disease that has progressed after four or more therapies. Regeneron, currently trading at an attractive P/E ratio of 12.91 and generating annual revenue of $14.09 billion, appears well-positioned to capture this market opportunity. InvestingPro analysis suggests the stock is currently undervalued, presenting a potential opportunity for investors.

Lynozyfic is available only through a restricted program called the Lynozyfic Risk Evaluation and Mitigation Strategy. The company has launched Lynozyfic Surround to provide financial and educational resources for patients.

The information in this article is based on a press release statement from Regeneron Pharmaceuticals. For deeper insights into Regeneron’s financial health, growth prospects, and detailed valuation metrics, access the comprehensive Pro Research Report available exclusively on InvestingPro, along with 8 additional ProTips and over 30 financial metrics that help paint a complete picture of this prominent biotech player.

In other recent news, Sanofi and Regeneron Pharmaceuticals received FDA approval for Dupixent as a treatment for bullous pemphigoid, marking the eighth indication for this drug in the U.S. The approval was based on a pivotal study showing significant improvements in disease remission and itch reduction compared to a placebo. Dupixent generated over €13 billion in sales last year, highlighting its financial significance. Meanwhile, JPMorgan adjusted its price target for Regeneron to $800 from $950 due to a setback in the IL-33 program, though it maintained an Overweight rating, citing strong support from existing assets like Dupixent and Eylea.

RBC Capital also reaffirmed its Sector Perform rating with a $662 price target, following challenges with the itepekimab program. RBC’s investor survey indicated a desire for strategic changes, such as mergers and acquisitions, to enhance Regeneron’s market position. UBS maintained its Neutral rating and $633 price target, noting a licensing agreement for a Phase 3 obesity treatment. This agreement involves an $80 million upfront payment and could complement Regeneron’s existing therapies. These developments underscore Regeneron’s ongoing efforts to adapt and strengthen its pipeline amid recent challenges.

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