Regeneron wins FDA nod for new blood cancer drug, but faces fierce competition

Regeneron Pharmaceuticals (NASDAQ: REGN) secured a regulatory boost on July 2 as the US Food and Drug Administration (FDA) granted accelerated approval to Lynozyfic (linvoseltamab), a treatment for relapsed or refractory multiple myeloma (MM) in patients who have exhausted at least four previous lines of therapy. The approval offers a much-needed win for Regeneron following recent clinical setbacks, including the failure of its chronic obstructive pulmonary disease (COPD) drug Itepekimab in May.

Lynozyfic belongs to a new class of bispecific antibodies that aim to reshape treatment for advanced blood cancers. However, the drug enters a crowded and competitive field dominated by Johnson & Johnson’s (NYSE: JNJ) Tecvayli and Pfizer’s (NYSE: PFE) Elrexfio, both already approved and seen as potential blockbusters.

Based on Visible Alpha consensus, Lynozyfic in MM is expected to generate $36 million in sales this year, rising to $151 million by 2026. Peak global sales could reach $904 million by 2034, assuming expansion into earlier-stage treatment settings and international markets. In comparison, Tecvayli, approved in 2022, is forecast to generate $687 million in global revenue in 2025, with peak sales estimated at $3.7 billion by 2033. Elrexfio, approved in 2023, is expected to post $311 million in sales next year, with a peak forecast of $1.7 billion by 2034.

While Lynozyfic’s commercial prospects appear more modest, the FDA approval has provided a modest lift to Regeneron’s share price, partly offsetting disappointment over the failure of Itepekimab in one of two key late-stage trials in May. Analysts have since significantly lowered their forecasts for Itepekimab following the mixed trial results.