EYLEA HD® (aflibercept) Injection 8 mg Applications for Expanded U.S. Label and Prefilled Syringe Receive FDA Review Period Extension
TARRYTOWN, N.Y., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has extended the target action dates to the fourth quarter of 2025 for two EYLEA HD® (aflibercept) Injection 8 mg regulatory submissions. This includes a Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the EYLEA HD prefilled syringe and a supplemental Biologics License Application (sBLA) seeking approval for both the treatment of macular edema following retinal vein occlusion (RVO) and the broadening of the dosing schedule to include every 4-week (monthly) dosing across approved indications.
Related Questions
How will the FDA review extension and delayed Q4‑2025 target affect Regeneron's near‑term revenue forecasts and earnings guidance?
What is the market potential of the expanded EYLEA HD label and prefilled syringe, and how does it compare to competitors like Lucentis and Beovu?
What are the risks of additional regulatory setbacks or a potential rejection, and how might they influence Regeneron's stock volatility and valuation?