REGN PDUFA Date: Cemdisiran Updated August 19, 2026 ยท next FDA decision on the calendar FDA decision (PDUFA) target Nov 30, 2026 · Regeneron · Generalized myasthenia gravis (gMG)
Key facts FDA PDUFA target date 2026-11-30
Drug / candidate Cemdisiran
Indication Generalized myasthenia gravis (gMG)
Company Regeneron
Market-cap tier Large
New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs .
See the full 2026 PDUFA calendar → All November 2026 PDUFA dates → FAQ When is the REGN PDUFA date? The FDA PDUFA target date for REGN (Regeneron) is 2026-11-30 for Cemdisiran. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is REGN's drug Cemdisiran? Cemdisiran is Regeneron's candidate under FDA review for Generalized myasthenia gravis (gMG).
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