SRRK
Scholar Rock Holding Corp.
September 11, 2026 · after-hours
- Rarity
- 3.95
- Peak move
- +23.47%
- Float cap
- $4.7B
Scholar Rock is a global biopharmaceutical company dedicated to improving the lives of children and adults with spinal muscular atrophy and additional rare, severe, and debilitating neuromuscular diseases. It develops monoclonal antibodies that selectively target latent forms of growth factors, including apitegromab for SMA and facioscapulohumeral muscular dystrophy, and SRK-439 for rare neuromuscular diseases.
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What we found
7 events · 1 from SEC or newswire · 1 timed with the move- Key eventTimed with the move
regulatory_approvalThe FDA approved Scholar Rock's ISEMBYLD (apitegromab-mstn) for spinal muscular atrophy in adults and children 2 years and older receiving an SMN2-targeted treatment, based on the Phase 3 SAPPHIRE trial, earlier than the Sept 30, 2026 PDUFA date; the approval carries a Rare Pediatric Disease Priority Review Voucher and U.S. launch is underway with product shipping in coming days.
trading_haltTrading in Scholar Rock shares was halted in aftermarket trading on Sept 11, 2026 for pending news ahead of the FDA approval of ISEMBYLD for spinal muscular atrophy.
- Key event
analyst_ratingBMO Capital Markets reiterated its Outperform rating and $76.00 price target on Scholar Rock on September 10, 2026, citing a survey of 15 neurologists in which 62% of SMN-treated patients were deemed apitegromab candidates and 73% of physicians planned to prescribe within six months of approval.
- Key event
executive_appointmentScholar Rock named Akshay Vaishnaw, formerly Alnylam's head of R&D, as president of research and development, and said SRK-439 initial data is expected by year-end 2026 or January 2027.
executive_remarkAt investor conferences, Scholar Rock CEO David Hallal outlined the pipeline and launch plans, including the FDA PDUFA decision on apitegromab for SMA about 20-21 days from September 30, 2026, an alternate fill-finish site replacing Catalent Indiana as the commercial path, a planned Japan PMDA filing by year-end, and launch readiness with 140 U.S. treatment centers and a 10,000-nurse home-infusion network.
regulatory_approvalScholar Rock received FDA Fast Track and Orphan Drug designations for apitegromab in facioscapulohumeral muscular dystrophy and confirmed dosing has begun in the Phase 2 FORGE study of about 60 patients.
analyst_ratingHC Wainwright reaffirmed its Buy rating on Scholar Rock with a $65 price target on September 8, 2026, implying about 17.5% upside.