$SRRK

Scholar Rock Holding Corp (SRRK) hit a 52-week high of $58.52, up 59% over the past year. The company reported a narrower-than-expected Q2 loss and confirmed its lead drug is on track for a U.S. regulatory decision by September 30. Analysts BMO Capital and H.C. Wainwright maintained positive ratings with price targets of $76.00 and $65.00, respectively.

Scholar Rock has withdrawn its European filing for its muscle weakness drug and plans to resubmit it. The company aims to address feedback from regulators to advance the drug's approval process.

Scholar Rock (SRRK) updated its regulatory progress for apitegromab, a treatment for spinal muscular atrophy (SMA). The FDA review is ongoing with an alternate fill-finish facility, and approval is expected by September 30, 2026. The company withdrew its European application and plans to resubmit with the alternate facility. Scholar Rock also aims to submit a Japanese application by year-end 2026, as no additional clinical studies are required. The company is prepared for a U.S. launch upon FDA

Scholar Rock (NASDAQ:SRRK) said the FDA’s prior complete response letter for its SMA drug apitegromab was linked to good manufacturing practice issues at Catalent Indiana’s fill-finish site, not clinical data. The company resubmitted its BLA on Mar. 30, 2026, with two manufacturing paths, and FDA is reviewing an agreed data package. It also discussed Phase III and a new Phase II FSHD study.

Scholar Rock Holding (SRRK) reported Q2 2026 net loss of $109.9M, slightly better than a year earlier, and a wider six-month net loss of $215.41M. The company said its apitegromab SMA biologics license application remains under active FDA review, with two independent fill-finish facilities ready for a potential U.S. launch. PDUFA is late September 2026.

Insider Monkey compares Scholar Rock (SRRK) and Novo Nordisk (NVO) amid FDA manufacturing scrutiny. Scholar Rock said it will remove the Catalent Indiana fill-finish site from its apitegromab BLA after OAI status, keeping its Sept. 30, 2026 PDUFA on track. SRRK reported Q2 net loss of $0.84/share and $492M cash, while NVO’s Q2 included impairment charges and a lowered Citi target.

Scholar Rock Holding Corp. disclosed an amended Schedule 13G showing Invus Public Equities, L.P. and affiliates beneficially own 9,575,013 shares, or 8.0% of Scholar Rock’s common stock, based on 119,828,338 shares outstanding as of May 4, 2026. The filing states the stake is passive and not intended to change or influence control.

Scholar Rock removed Novo Nordisk’s ex-Catalent Indiana manufacturing site from its FDA submission for apitegromab after an FDA inspection classified the plant as “Official Action Indicated.” Scholar Rock will rely on an alternative U.S. fill-finish facility; the PDUFA action date remains Sept. 30, 2026. The Catalent site also affected Incyte’s Zynyz FDA bid.

According to the FDA, it issued Warning Letter 320-26-20 to Catalent Indiana, LLC after a June 23 to July 14, 2025 inspection of its Bloomington, Indiana sterile drug facility resulted in an Official Action Indicated classification. Scholar Rock removed the facility from its apitegromab BLA refiling, with a Sept. 30, 2026 PDUFA date, and the FDA accepted the refile.

Scholar Rock (SRRK) said it has addressed a manufacturing hurdle for its lead SMA drug by withdrawing a Catalent manufacturing site from its FDA submission and proceeding with an alternative U.S. site. The company said the FDA PDUFA action date remains Sept. 30. It is also updating EMA discussions and expects a revised CHMP opinion schedule.