SRRK PDUFA Date: Apitegromab Updated September 6, 2026 ยท next FDA decision on the calendar FDA decision (PDUFA) target Sep 30, 2026 · Scholar Rock Holding Corporation · Spinal muscular atrophy (SMA), children and adults (BLA)
Key facts FDA PDUFA target date 2026-09-30
Drug / candidate Apitegromab
Indication Spinal muscular atrophy (SMA), children and adults (BLA)
Company Scholar Rock Holding Corporation
New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs .
See the full 2026 PDUFA calendar → All September 2026 PDUFA dates → FAQ When is the SRRK PDUFA date? The FDA PDUFA target date for SRRK (Scholar Rock Holding Corporation) is 2026-09-30 for Apitegromab. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is SRRK's drug Apitegromab? Apitegromab is Scholar Rock Holding Corporation's candidate under FDA review for Spinal muscular atrophy (SMA), children and adults (BLA).
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