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Scholar Rock Holding Corporation
Video analysis: SRRK
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News: SRRK
Scholar Rock Announces FDA Approval of ISEMBYLD™ (apitegromab-mstn), the First and Only Muscle-Targeted Treatment for Children and Adults with Spinal Muscular Atrophy (SMA)
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.
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: Manufacturing Noise Obscures A Muscle-Targeted Franchise
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.
Scholar Rock Receives FDA Fast Track Designation for Apitegromab Facioscapulohumeral Muscular Dystrophy (FSHD) Program as Participant Dosing Commences in Phase 2 FORGE Trial
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 Makes New Investment in Scholar Rock Holding Corporation $SRRK
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%
9,494,084 Shares in Scholar Rock Holding Corporation $SRRK Purchased by BlackRock Inc.
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
Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan
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.
