Biotech News

Scholar Rock Receives FDA Fast Track Designation for Apitegromab Facioscapulohumeral Muscular Dystrophy (FSHD) Program as Participant Dosing Commences in Phase 2 FORGE Trial

Scholar Rock (SRRK)Scholar Rock2026-09-02 12:00 ESTFDA / regulatory

Apitegromab for FSHD granted Fast Track and Orphan Drug designations by FDA Dosing underway in Phase 2 FORGE trial; FSHD program expands Scholar Rock’s global leadership in myostatin biology across rare neuromuscular diseases FORGE builds on clinically validated mechanism of apitegromab, the first

Scholar Rock

Myostatin Biology Scholar Rock develops therapies that selectively modulate growth factors in their latent forms. Its lead work targets myostatin to improve muscle function while preserving related signaling pathways. Apitegromab Apitegromab is a selective inhibitor of latent myostatin under FDA review for children and adults with spinal...

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SRRKScholar Rock2026-09-11 22:25 EST

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)

SRRKScholar Rock2026-09-02 12:00 EST