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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular diseases by applying its leading platform in myostatin biology, today announced that the FDA has approved ISEMBYLD (apitegromab-mstn) for the treatment of spinal muscular atrophy (SMA) in adults and children two years of age and older who are currently receiving a survival motor neuron 2 (SMN2)-targeted.
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 is positioned to launch apitegromab as the first muscle-targeted therapy for SMA, pending FDA approval by September 30, 2026. Manufacturing setbacks were production-based, not due to drug efficacy or safety; the alternate fill-finish facility mitigates approval risk but does not eliminate it. SAPPHIRE trial data support apitegromab's add-on value in SMA, showing statistically significant motor function gains over placebo for nonambulatory patients.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular diseases by applying its world-leading platform in myostatin biology, today announced that the FDA has granted Fast Track and Orphan Drug designations to apitegromab for the treatment of people living with FSHD. In addition, the Company announced that participant dosing is underway in the Phase 2 FORGE c.
Beaconlight Capital LLC purchased a new stake in shares of Scholar Rock Holding Corporation (NASDAQ: SRRK) during the second quarter, according to its most recent Form 13F filing with the Securities and Exchange Commission. The firm purchased 87,893 shares of the company's stock, valued at approximately $4,834,000. Scholar Rock makes up about 1.7%
BlackRock Inc. acquired a new position in shares of Scholar Rock Holding Corporation (NASDAQ: SRRK) in the undefined quarter, according to its most recent filing with the SEC. The fund acquired 9,494,084 shares of the company's stock, valued at approximately $522,175,000. BlackRock Inc. owned approximately 7.92% of Scholar Rock at the end of
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular diseases by applying its world-leading platform in myostatin biology, today announced it has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from its apitegromab Biologics License Application (BLA) for the treatment of spinal muscular atrophy (SMA) in.