BUZZ-Scholar Rock up after refiling FDA application for genetic disorder drug

Reuters03-31
BUZZ-<a href="https://laohu8.com/S/SRRK">Scholar Rock</a> up after refiling FDA application for genetic disorder drug

** Shares of drug developer Scholar Rock SRRK.O rise 11.84% to $48.18 premarket

** Co says it has resubmitted its marketing application to the U.S. FDA for its drug apitegromab to treat children and adults with spinal muscular atrophy, a genetic disease that damages nerve cells controlling movement

** Co says the FDA rejected its earlier application in September 2025 over inspection findings at a third-party Catalent manufacturing site, owned by Novo Nordisk NOVOb.CO, but the issues were not specific to apitegromab

** Brokerage Truist views SRRK shares as de-risked, citing a strong data package and no near-term competition in the space after Roche ROPC.S discontinued development of its drug for the disease

** Says the new filing includes Catalent Indiana and a second U.S. manufacturing site; expects the FDA to accept the filing within 30 days, with a decision due in late September 2026

** SRRK shares were up ~2% in 2025

(Reporting by Kunal Das in Bengaluru)

((Kunal.Das2@thomsonreuters.com;))

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