Scholar Rock withdraws Europe filing for muscle weakness drug, plans resubmission

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 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.

Scholar Rock Holding (NASDAQ:SRRK) said the FDA review of its apitegromab BLA for spinal muscular atrophy will proceed using only its secondary fill-finish facility after an OAI tied to Catalent Indiana. The company withdrew the Catalent site from the submission. The PDUFA action date remains Sept. 30. Shares were down 3.14% to $51.26.

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.

Scholar Rock Holding Corp (SRRK) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Scholar Rock Reports Second Quarter 2026 Financial Results and Recent Business Highlights • Apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA) review by FDA continues to advance with two fill-finish facilities, representing two independ