Regeneron Stock Rises 1.21% on $610M Volume (127th Rank) as FDA Delays Eylea HD Review and Q2 Sales Grow 29%

Regeneron Pharmaceuticals (REGN) rose 1.21% on August 21, 2025, with a trading volume of $0.61 billion, marking a 20.84% decline from the previous day’s volume and ranking 127th in market activity. The stock has fallen 17% year-to-date, underperforming the broader healthcare sector. Key developments include the FDA extending review timelines for Eylea HD, a higher-dose version of its flagship product Eylea, which remains available in the U.S. via vial administration. The delay stems from an FDA inspection of a third-party manufacturer, though Regeneron emphasized Eylea HD’s ongoing commercial availability as a mitigating factor.

The extended review period affects two submissions for Eylea HD: a prior-approval supplement for a prefilled syringe and a supplemental application for expanded indications, including monthly dosing for retinal vein occlusion. Regeneron and Bayer AG co-develop and co-market Eylea HD, sharing global profits. Meanwhile, Eylea sales continue to decline due to competition from Vabysmo, though Eylea HD’s U.S. sales grew 29% in Q2 2025, driven by higher demand.

Regeneron’s oncology pipeline saw a recent boost with FDA accelerated approval of Lynozyfic for relapsed multiple myeloma. The bispecific antibody demonstrated high response rates in trials and offers a patient-centric dosing regimen. This approval strengthens Regeneron’s diversification strategy amid Eylea-related challenges. Additionally, Dupixent, co-developed with Sanofi, continues to expand its label, including recent approval for bullous pemphigoid, supporting long-term revenue growth.

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