Scholar Rock updates apitegromab regulatory status in U.S., Europe, Japan
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Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan
August 21, 2026 9:06 AM EDTUnder FDA guidance, Scholar Rock has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA); FDA review of BLA progressing well with Scholar Rocks alternate fill-finish facility Company is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026 Prescription Drug User Fee Act (PDUFA) date; robust supply of apitegromab commercial vials from alternate fill-finish facility available upon FDA... More
