FDA Delays Approval of Regeneron's Eylea HD and Odronextamab Due to Manufacturing Issues

Regeneron Pharmaceuticals has faced setbacks for its Eylea HD eye drug and lymphoma drug due to issues at a contract manufacturer, Catalent. The FDA inspection of the Catalent plant in Indiana has delayed the expanded approval of Eylea HD and rejected the application for odronextamab. The company expects a resolution to the filling issues for Eylea HD and is working with Novo Nordisk to address the FDA's observations.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) recently announced its second-quarter 2025 financial results, showcasing growth in key areas but also revealing setbacks related to regulatory approvals and manufacturing issues. The company reported revenues of $3.68 billion, a 4% increase from the same period last year [1].

One notable challenge is the FDA inspection of the Catalent plant in Indiana, which has delayed the expanded approval of Eylea HD and led to the rejection of the application for odronextamab. Eylea HD, a treatment for age-related macular degeneration and diabetic macular edema, saw its net sales in the U.S. increase by 29% to $393 million, but the company expects regulatory approvals to be delayed due to the inspection findings [1].

Regeneron has been working with Novo Nordisk to address the FDA's observations and anticipates an expeditious resolution of the filling issues for Eylea HD. The company also announced interim 26-week results from the Phase 2 COURAGE trial investigating combinations of semaglutide and trevogrumab for obesity treatment, demonstrating significant weight loss and fat mass reduction [1].

The FDA granted accelerated approval for Lynozyfic (linvoseltamab) to treat adults with relapsed or refractory multiple myeloma, and the EC granted conditional marketing approval for the same indication. However, the FDA rejected the application for odronextamab due to issues related to the Catalent plant inspection [1].

Despite these challenges, Regeneron continues to focus on its diverse pipeline and long-term value creation. The company returned over $2.3 billion of capital to shareholders through share repurchases and dividends and committed over $7 billion to U.S. manufacturing investments, capital expenditures, and business development since the start of 2025 [1].

References:
[1] https://www.manilatimes.net/2025/08/01/tmt-newswire/globenewswire/regeneron-reports-second-quarter-2025-financial-and-operating-results/2160685