FDA Review of Apitegromab BLA Proceeds with Second Facility After Catalent OAI; Decision by Sept 30
SRRK sits 95% above its 52-week low of $27.07.
Summary
The FDA review of Scholar Rock's apitegromab BLA for SMA will advance using only the second fill-finish facility after Catalent Indiana received an OAI classification from its April 2026 inspection. The company removed Catalent from the application and is progressing with a U.S.-based facility that has a strong compliance record and ready commercial supply. The PDUFA date remains September 30, 2026. This follows the Q2 earnings and ATM upsizing earlier this week, keeping the approval timeline intact despite the manufacturing site setback. The second facility's good standing and the FDA's continued review signal that approval remains on track, a critical catalyst for the company's transition to a commercial-stage biotech. Scholar Rock Holdings also pulled a Novo Nordisk facility from the drug application after an FDA flag.
At the time of this announcement, SRRK was trading at $52.92 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $6.3B. The 52-week trading range was $27.07 to $58.49. This news item was assessed with neutral market sentiment and an importance score of 8 out of 10. Source: BusinessWire.