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Scholar Rock Overcomes Manufacturing Hurdle to Keep Lead Drug FDA Review on Schedule

BenzingaAug 10, 2026, 4:03 PMVandana Singh

Scholar Rock shifts its FDA review for SMA treatment apitegromab to a secondary facility, keeping the September 30 approval date on schedule.

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benzinga
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Aug 10, 2026, 4:03 PM
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Aug 10, 2026, 4:03 PM
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Captured once, then retained as an archive reference
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Keep reading

  1. BenzingaAug 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,

    Read original at benzinga