Neladalkib (NVL-655) is a GSK plc, Nuvalent Inc. program in TKI-pretreated ALK-positive NSCLC. Its PDUFA date is Nov 27, 2026, the FDA's goal date to complete review of the application. Every date links its source.
Indication under review: TKI-pretreated ALK-positive NSCLC. Sponsor: GSK plc, Nuvalent Inc. (GSK, NUVL). Market-cap tier at the time we tracked it: Large. We track 3 catalyst events for this program: 3 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 Neladalkib (NVL-655)'s next FDA decision or readout?
Neladalkib (NVL-655)'s PDUFA date is Nov 27, 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 Neladalkib (NVL-655)'s most recent FDA decision?
No FDA decision for Neladalkib (NVL-655) is in our archive yet.
What is Neladalkib (NVL-655) used for?
In our records Neladalkib (NVL-655) is under review or in development for TKI-pretreated ALK-positive NSCLC.
Who makes Neladalkib (NVL-655)?
GSK plc, Nuvalent Inc. (GSK, NUVL).
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
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