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Scholar Rock Removes Catalent Indiana From Apitegromab BLA After FDA OAI Classification; FDA Review Remains On Track for Sept. 30 PDUFA Using Second Fill-Finish Site

Aug 7, 2026, 8:22 PMBenzinga Newsdesk

Today, August 7, 2026, Scholar Rock received customer notification from Catalent Indiana LLC (part of Novo Nordisk) that FDA classified the April 2026 site inspection of Catalent Indiana fill-finish facility as Official

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benzinga
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Aug 7, 2026, 8:22 PM
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Aug 7, 2026, 8:22 PM
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  1. Aug 21, 2026, 1:11 PMBenzinga 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,

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