Mim8 (denecimig) is a Novo Nordisk A/S program in Hemophilia A prophylaxis, with or without inhibitors. Its PDUFA date is Sep 30, 2026, the FDA's goal date to complete review of the application. Every date links its source.
Indication under review: Hemophilia A prophylaxis, with or without inhibitors. Sponsor: Novo Nordisk A/S (NVO). Market-cap tier at the time we tracked it: Large. We track 1 catalyst event for this program: 1 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 Mim8 (denecimig)'s next FDA decision or readout?
Mim8 (denecimig)'s PDUFA date is Sep 30, 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 Mim8 (denecimig)'s most recent FDA decision?
No FDA decision for Mim8 (denecimig) is in our archive yet.
What is Mim8 (denecimig) used for?
In our records Mim8 (denecimig) is under review or in development for Hemophilia A prophylaxis, with or without inhibitors.
Who makes Mim8 (denecimig)?
Novo Nordisk A/S (NVO).
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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