REGN PDUFA Date: Cemdisiran Page updated September 18, 2026 · next FDA decision on the calendar · Data as of Oct 11, 2026 9:31 PM ET FDA decision (PDUFA) target Nov 2026 · Regeneron · Generalized myasthenia gravis (gMG)
Key facts FDA PDUFA target date Nov 2026
Drug / candidate Cemdisiran
Indication Generalized myasthenia gravis (gMG)
Company Regeneron
Market-cap tier Large
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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 expected in November 2026 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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