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Scholar Rock Receives FDA's Fast Track And Orphan Drug Designations For Apitegromab To Treat Facioscapulohumeral Muscular Dystrophy

Benzinga Newsdesk

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

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  1. Benzinga Newsdesk

    Scholar Rock Removes Catalent Indiana As Commercial Fill-Finish Facility From Its Apitegromab BLA For The Treatment Of Spinal Muscular Atrophy Under Guidance From The FDA; Now On Track To Submit Apitegromab Japanese New Drug Application By End-2026

    FDA review of BLA progressing well with Scholar Rock’s alternate fill-finish facilityCompany is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30,

    SRRK