Note: FDA accepted the NDA for filing with Priority Review; PDUFA target action date Nov 27, 2026 (announced 2026-05-27). Investigational ALK-selective, brain-penetrant inhibitor; submission based on the global registration-directed ALKOVE-1 Phase 1/2 trial in TKI pre-treated advanced ALK-positive NSCLC. Shares the 2026-11-27 date with BridgeBio's BBP-418 (different company/drug — not a duplicate). [UPDATE 2026-10-06: GSK completed its acquisition of Nuvalent (about 2026-07-15) and is now the sponsor; GSK release of 2026-07-22 restates the 27 November 2026 target decision date. Source: https://www.gsk.com/en-gb/media/press-releases/jideytro-zidesamtinib-approved-in-the-us-for-previously-treated-ros1-positive-non-small-cell-lung-cancer/]
Drug Information
- Drug Name
- Neladalkib (NVL-655) (CT.gov)
- Application Type
- NDA
- FDA Designations
- Priority Review
- Indication
- TKI pre-treated advanced ALK-positive non-small cell lung cancer (NSCLC)
Filing Details
- Company
- Nuvalent, Inc. →
- Stock Ticker
- NUVL
- Source
- company-press-release →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Explore Nuvalent, Inc.
View Nuvalent, Inc.'s full pipeline, approved drugs, and clinical trials.
Data sourced from SEC EDGAR filings. Last updated: 2026-06-30. Report an issue