Scholar Rock Resubmits FDA Biologics License Application For Apitegromab For Spinal Muscular Atrophy, PDUFA Action Date Expected In Late September 2026
SCHOLAR ROCK HOLDING CORP
SCHOLAR ROCK HOLDING CORP SRRK | 0.00 |
- Apitegromab BLA resubmission includes Catalent Indiana LLC (part of Novo Nordisk) and second U.S.-based fill-finish facility, aligned with FDA guidance from March 3, 2026 Type C meeting
- FDA and Novo Nordisk Q1 2026 interactions resulted in Scholar Rock's alignment with FDA to resubmit apitegromab BLA prior to FDA reinspection of Catalent Indiana facility
- FDA and Scholar Rock Q1 2026 interactions regarding accelerated progress in qualifying a second fill-finish facility resulted in alignment with FDA to include facility in BLA resubmission
- Company anticipates FDA acceptance of BLA within 30 days and a review period of up to 6 months from date of resubmission, with PDUFA action date expected in late September 2026