NUVL
Neladalkib (NVL-655)
FDA PDUFA Target Action Date · Nuvalent, Inc.
Friday, November 27, 2026
142 days away
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
- SEC CIK
- 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
Track All FDA Decisions
View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.
View FDA Calendar →Data sourced from SEC EDGAR filings. Last updated: 2026-06-30. Report an issue