NEW YORK, December 30, 2025, 15:25 ET — Regular session
- Scholar Rock shares fell about 3% in afternoon trade, reversing early gains.
- The stock underperformed a broader biotech pullback, with major biotech ETFs down.
- Investors remain focused on year-end manufacturing reinspection timing tied to apitegromab’s FDA path.
Scholar Rock Holding Corp (SRRK) slid 3.2% to $43.76 in afternoon trading on Tuesday after opening at $45.18. The stock traded between $45.95 and $43.74.
The move matters because Scholar Rock’s near-term valuation still hinges on regulatory timing for apitegromab, its lead drug candidate. he company said in an October update that the FDA classified a third-party manufacturing site in Bloomington, Indiana (formerly Catalent Indiana LLC, now fully owned and operated by Novo Nordisk) as “official action indicated” and that it requested a Type A meeting to discuss resubmitting its biologics license application. Scholar Rock
A biologics license application, or BLA, is the dossier required to win U.S. marketing approval for a biologic medicine. A Type A meeting is an FDA mechanism used to resolve a stalled review or major dispute.
A Nov. 14 community update posted by patient group Cure SMA said Scholar Rock held that Type A meeting with the FDA on Nov. 12 and that the facility expected to be ready for reinspection by the end of 2025. “We are unwavering in our commitment to bring apitegromab to children and adults living with SMA,” Chairman and Chief Executive David L. Hallal said. Cure SMA
The Cure SMA update said Scholar Rock anticipates resubmitting the BLA in 2026 and has lined up a second U.S. fill-finish facility, with commercial capacity expected to begin in early 2026. Fill-finish sites handle sterile filling and final packaging — a chokepoint regulators must clear before a launch. Cure SMA
Scholar Rock’s drop came as biotech stocks broadly weakened. The SPDR S&P Biotech ETF was down 1.6% and the iShares Nasdaq Biotechnology ETF fell 1.2%, while the S&P 500 was off less than 0.1%.
No fresh company announcement was immediately available on Tuesday, leaving the stock to trade on sentiment and year-end positioning. Thin liquidity into year-end can amplify moves in smaller biotech names.
In September, the U.S. FDA declined to approve apitegromab and issued a complete response letter — a formal rejection that lays out what must be fixed — Reuters reported. The FDA cited issues found during an inspection at Catalent’s Indiana fill-finish plant, and Scholar Rock said the observations were not specific to the drug; Reuters also noted that delays tied to the same facility had affected some Regeneron drug applications and that analysts had estimated apitegromab could generate nearly $2 billion in revenue by the early 2030s. Reuters
Investors are now watching for any signal that the Indiana site completes remediation and is reinspected on schedule, and for a clearer resubmission timeline. Any guidance that narrows the window for a refiling would likely move expectations for when Scholar Rock can start selling apitegromab in the United States.
On the chart, Tuesday’s low near $43.74 is the first level traders are watching after the slide. A move back above $45.95 would reclaim the session high.
Trading volume was about 452,000 shares by mid-afternoon, suggesting Tuesday’s move was driven more by positioning than a new company catalyst. The stock has tended to remain headline-sensitive when regulatory timelines are the main variable.
