Upcoming FDA decision · November 27, 2026
Neladalkib (NVL-655) PDUFA date: FDA decision expected November 27, 2026
42 days to goGSK plc (GSK) →
The FDA is expected to decide on Neladalkib (NVL-655) from GSK plc in TKI pre-treated advanced ALK-positive NSCLC by the PDUFA target action date of November 27, 2026. For TKI pre-treated advanced ALK-positive NSCLC. NDA, Priority Review. Verified against the company announcement on 2026-10-16.
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: investors.nuvalent.com · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
November 27
Target action date
Phase 3
Stage
Verified
Date confidence
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FDA designations
Questions about this FDA decision
- When is the PDUFA date for Neladalkib (NVL-655)?
- The FDA's PDUFA target action date for Neladalkib (NVL-655) is November 27, 2026. The FDA can act before that date, and the review can be extended.
- What is Neladalkib (NVL-655) being reviewed for?
- The application under FDA review covers TKI pre-treated advanced ALK-positive NSCLC.
- Which company is developing Neladalkib (NVL-655)?
- GSK plc (GSK).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).