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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

ReutersSep 23, 2025 11:03 AM
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- 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

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