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Scholar Rock Announces European Medicines Agency Reviewing Apitegromab Marketing Authorisation Application To Treat Spinal Muscular Atrophy; Committee For Medicinal Products For Human Use Anticipated Later This Year If FDA Reclassifies Catalent Indiana

Jul 20, 2026, 12:08 PMBenzinga 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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benzinga
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Jul 20, 2026, 12:08 PM
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Jul 20, 2026, 12:08 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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