Ifinatamab deruxtecan (I-DXd) is a Merck & Co., Inc. program in Extensive-stage small cell lung cancer. Its PDUFA date is Oct 10, 2026, the FDA's goal date to complete review of the application. Every date links its source.
Indication under review: Extensive-stage small cell lung cancer. Sponsor: Merck & Co., Inc. (MRK). 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 Ifinatamab deruxtecan (I-DXd)'s next FDA decision or readout?
Ifinatamab deruxtecan (I-DXd)'s PDUFA date is Oct 10, 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 Ifinatamab deruxtecan (I-DXd)'s most recent FDA decision?
No FDA decision for Ifinatamab deruxtecan (I-DXd) is in our archive yet.
What is Ifinatamab deruxtecan (I-DXd) used for?
In our records Ifinatamab deruxtecan (I-DXd) is under review or in development for Extensive-stage small cell lung cancer.
Who makes Ifinatamab deruxtecan (I-DXd)?
Merck & Co., Inc. (MRK).
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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