Scholar Rock removes Novo Nordisk's Catalent plant from FDA filing for SMA drug apitegromab

Scholar Rock announced it will no longer list Novo Nordisk’s legacy Catalent facility as a contract manufacturer in its FDA resubmission for apitegromab, its spinal muscular atrophy (SMA) candidate.

The change follows two FDA inspections of the Bloomington, Indiana fill‑finish plant that resulted in a Form 483 in July 2025 and a warning letter in November, and a second Form 483 after an April 2026 inspection.

In the March 2026 refiling, Scholar Rock had named the Catalent site and another U.S. fill‑finish facility, but the latest filing removes the Catalent location while keeping the alternate manufacturer.

CEO David Hallal told investors the company still expects the FDA’s target decision date of September 30, emphasizing that the drug’s development timeline remains on track despite the manufacturing shift.