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Regeneron rises after FDA's extended decision date for eye drug comes ahead of expectations

ReutersAug 20, 2025 5:10 PM

** Shares of drugmaker Regeneron REGN.O rise 3.5% to $591.78

** U.S. FDA has extended the target action dates for two applications of the high-dose version of REGN's eye disease drug, Eylea, to the fourth quarter

** Earlier this month, REGN said it expected a delay due to an inspection at contract manufacturer Catalent's site, which was acquired by Danish drugmaker Novo Nordisk NOVOb.CO

** This outcome is an improvement on expectations, with investors likely anticipating longer timelines for regulatory decisions - BMO Capital Markets

** This development is also positive for Scholar Rock SRRK.O, which produces its drug for a rare neuromuscular disease at the affected facilities - BMO

** Shares of SRRK, which is expecting FDA's decision on the experimental drug for spinal muscular atrophy by September 22, gain 12.90% to $34.01

** REGN shares down 17%, while SRRK stock fell 21%, YTD

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