Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan
Scholar Rock announced it has removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from its apitegromab Biologics License Application (BLA) for treating spinal muscular atrophy (SMA), as part of an update on global regulatory progress across the U.S., Europe, and Japan.
Why it matters — SRRK watchers would care because this regulatory update affects the company's apitegromab BLA filing and its global commercialization plans for treating SMA.