Scholar Rock Holding Corporation (SRRK)
Scholar Rock: Reiterating 'Strong Buy' On FDA Approval SMA And Expansions Now In Play
Scholar Rock Holding Corporation maintains a "Strong Buy" rating following FDA approval of ISEMBYLD [apitegromab] for SMA in patients ≥2 years old. SRRK targets a $2B+ market opportunity in SMA, with expansion potential into younger populations, subcutaneous formulations, and new indications like FSHD. Regulatory catalysts include planned MAA resubmission in Europe and anticipated JNDA filing in Japan by year-end 2026, leveraging a validated manufacturing facility.
US FDA approves Scholar Rock's muscle weakness drug
The U.S. Food and Drug Administration on Friday approved Scholar Rock's therapy to treat a rare genetic condition that causes muscle weakness.
Scholar Rock Holding Corporation (SRRK) Presents at Citigroup's Biopharma Back to School Summit 2026 Transcript
Scholar Rock Holding Corporation (SRRK) Presents at Citigroup's Biopharma Back to School Summit 2026 Transcript
Scholar Rock Eyes Sept. 30 FDA Decision for SMA Drug Apitegromab
Scholar Rock NASDAQ: SRRK CEO David Hallal said the company is preparing for a September 30 FDA decision date for apitegromab, its investigational treatment for spinal muscular atrophy, or SMA, following a resubmitted biologics license application supported by an alternate fill-finish manufacturing facility.
Scholar Rock Q2 Earnings Call Highlights
Scholar Rock NASDAQ: SRRK said its resubmitted biologics license application for apitegromab remains on track for a U.S. Food and Drug Administration decision by its Sept. 30 PDUFA date, as the company prepares for a potential launch of the muscle-targeted treatment for spinal muscular atrophy, or SMA.
Scholar Rock Holding Corporation (SRRK) Q2 2026 Earnings Call Transcript
Scholar Rock Holding Corporation (SRRK) Q2 2026 Earnings Call Transcript
Scholar Rock Holding Corporation (SRRK) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript
Scholar Rock Holding Corporation (SRRK) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript
Scholar Rock Holding Corporation (SRRK) Presents at Bank of America Global Healthcare Conference 2026 Transcript
Scholar Rock Holding Corporation (SRRK) Presents at Bank of America Global Healthcare Conference 2026 Transcript
Scholar Rock Q1 Earnings Call Highlights
Scholar Rock NASDAQ: SRRK said the U.S. Food and Drug Administration has accepted for review its resubmitted Biologics License Application for apitegromab, the company's investigational treatment for children and adults with spinal muscular atrophy, and set a PDUFA action date of Sept. 30, 2026.
Scholar Rock Holding Corporation (SRRK) Q1 2026 Earnings Call Transcript
Scholar Rock Holding Corporation (SRRK) Q1 2026 Earnings Call Transcript
SRRK Stock Jumps on Resubmission of FDA Filing for SMA Drug
Scholar Rock stock jumps 14% after it resubmits its FDA filing for SMA drug apitegromab, revives approval hopes and sets up a potential September 2026 decision.
Scholar Rock Holding Corporation (SRRK) Discusses BLA Resubmission for Apitegromab in Spinal Muscular Atrophy and Regulatory Progress Transcript
Scholar Rock Holding Corporation (SRRK) Discusses BLA Resubmission for Apitegromab in Spinal Muscular Atrophy and Regulatory Progress Transcript
