- Completed constructive and collaborative in-person Type A meeting with U.S. Food and Drug Administration (FDA) on November 12th for apitegromab biologics license application (BLA) for the treatment of children and adults with spinal muscular atrophy (SMA)
- Catalent Indiana, LLC (part of Novo Nordisk) participated in the Type A meeting in person and presented the progress made in implementing the remediation plan; confirmed to FDA that the site is on-track to be reinspection ready by the end of this year
- Resubmission of BLA and U.S. launch following approval of apitegromab for children and adults with SMA anticipated in 2026
- Timelines accelerated with additional apitegromab U.S. fill-finish facility; tech transfer underway with commercial capacity reserved beginning in Q1 2026
- Dosing underway in Phase 2 OPAL study evaluating apitegromab in infants and toddlers
Scholar Rock Reports Third Quarter 2025 Financial Results and Recent Business Highlights
Watch Scholar Rock explain itScholar Rock Holding (NASDAQ:SRRK) Q3 2025 Earnings Call · Replay · Nov 14, 2025 · From 18:45 · Financial Results and Capital Allocation
Scholar Rock's next earnings callScholar Rock Holding (NASDAQ:SRRK) Q3 2026 Earnings Call · Nov 10, 2026 at 8:00 AM ESTRegister
Scholar Rock Holding Corporation on 6ix
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Earlier from Scholar Rock
- Scholar Rock to Present at the 2025 Jefferies Global Healthcare Conference
- Scholar Rock to Report Third Quarter 2025 Financial Results on November 14, 2025
- FDA Issues Complete Response Letter (CRL) for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA) Solely Related to Observations Identified at Catalent Indiana LLC Fill-Finish Facility
- Pivotal SAPPHIRE Trial Data Published in The Lancet Neurology: Apitegromab Demonstrated Significant Motor Function Gains for Children and Adults with SMA on SMN-Targeted Treatment
- Scholar Rock Reports Second Quarter 2025 Financial Results and Highlights Business Progress
Later from Scholar Rock
- Scholar Rock to Present at Upcoming Investor Conferences
- Scholar Rock to Present at the 44th Annual J.P. Morgan Healthcare Conference
- Scholar Rock Highlights 2026 Strategic Priorities
- Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
- Scholar Rock to Report Fourth Quarter and Full Year 2025 Financial Results on March 3, 2026
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