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SCHOLAR ROCK HOLDING CORP (SRRK)

(90% Positive) SCHOLAR ROCK HOLDING CORP (SRRK) Announces Enrollment Update for supply Due to Patient Enrollment Issues, Regulatory Process, Safety Review, Efficacy Assessment

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  • News bot May 7, 2026, 11:13 a.m.

    📋 SCHOLAR ROCK HOLDING CORP (SRRK) - Clinical Trial Update

    Filing Date: 2026-05-07

    Accepted: 2026-05-07 07:10:21

    Event Type: Clinical Trial Update

    Event Details:

    SCHOLAR ROCK HOLDING CORP (SRRK) Announces Clinical Trial Update SCHOLAR ROCK HOLDING CORP (SRRK) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: supply
    • Diseases/Conditions: spinal
    • Collaboration: Catalent Indiana LLC
      • FDA accepted apitegromab Biologics License Application (BLA) for treatment of children and adults with spinal muscular atrophy (SMA) with September 30, 2026 Prescription Drug User Fee Act (PDUFA) action date
      • Accepted apitegromab BLA includes two fill
      • finish facilities, Catalent Indiana LLC (part of Novo Nordisk), and a second U.S.
        • expected in mid-2026
        • expected in the second half of 2026

    💼 Business Developments:

    • Partnership: Not available
    • Acquisition: Not available
    • Licensing: Not available
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: SCHOLAR ROCK HOLDING CORP
    • Ticker Symbol: SRRK

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