Cemdisiran (C5 RNAi) is a Regeneron Pharmaceuticals Inc. program in Generalized myasthenia gravis (gMG), anti-AChR antibody-positive. Its PDUFA date is Nov 2026, the FDA's goal date to complete review of the application. Every date links its source.
Indication under review: Generalized myasthenia gravis (gMG), anti-AChR antibody-positive. Sponsor: Regeneron Pharmaceuticals Inc. (REGN). Market-cap tier at the time we tracked it: Large. We track 2 catalyst events for this program: 2 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
When is Cemdisiran (C5 RNAi)'s next FDA decision or readout?
Cemdisiran (C5 RNAi)'s PDUFA date is Nov 2026. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
What happened at Cemdisiran (C5 RNAi)'s most recent FDA decision?
No FDA decision for Cemdisiran (C5 RNAi) is in our archive yet.
What is Cemdisiran (C5 RNAi) used for?
In our records Cemdisiran (C5 RNAi) is under review or in development for Generalized myasthenia gravis (gMG), anti-AChR antibody-positive.
Who makes Cemdisiran (C5 RNAi)?
Regeneron Pharmaceuticals Inc. (REGN).
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
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