Brief: FDA Issues Complete Response Letter (CRL) for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA) Solely Related to Observations Identified at Catalent Indiana LLC Fill-Finish Facility
23/09/2025 12:03
Sept 23 (Reuters) - Scholar Rock Holding Corp SRRK.O: FDA ISSUES COMPLETE RESPONSE LETTER (CRL) FOR APITEGROMAB AS A TREATMENT FOR PATIENTS WITH SPINAL MUSCULAR ATROPHY (SMA) SOLELY RELATED TO OBSERVATIONS IDENTIFIED AT CATALENT INDIANA LLC FILL-FINISH FACILITY SCHOLAR ROCK HOLDING CORP - NO OTHER APPROVABILITY ISSUES CITED IN CRL SCHOLAR ROCK HOLDING CORP - INTENDS TO RESUBMIT APITEGROMAB BLA AFTER CATALENT ISSUES SCHOLAR ROCK: OUTSIDE U.S., APITEGROMAB MAA UNDER REVIEW BY EMA, DECISION EXPECTED NEAR MID-2026 Source text: ID:nBw8yYcSsa Further company coverage: SRRK.O ((Reuters.Briefs@thomsonreuters.com;))
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