Neladalkib (NVL-655) is a GSK plc, Nuvalent Inc. program in TKI-pretreated ALK-positive NSCLC. Its PDUFA date is Nov 2026, the FDA's goal date to complete review of the application. Every date links its source.
GSK catalyst hub · NUVL catalyst hub
All upcoming FDA decision dates on the 2026 PDUFA calendar
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.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| Perceptive Advisors | 1,580,505 | $195.2 million | filed August 14, 2026 |
| RA Capital Management | 1,246,456 | $153.9 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Neladalkib (NVL-655)'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.
No FDA decision for Neladalkib (NVL-655) is in our archive yet.
In our records Neladalkib (NVL-655) is under review or in development for TKI-pretreated ALK-positive NSCLC.
GSK plc, Nuvalent Inc. (GSK, NUVL).
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.