Upcoming FDA decision · September 26, 2026
Neladalkib (NVL-655) PDUFA date: FDA decision expected September 26, 2026
3 days to goNuvalent, Inc. (NUVL) →
The FDA is expected to decide on Neladalkib (NVL-655) from Nuvalent, Inc. in Non-small Cell Lung Cancer by the PDUFA target action date of September 26, 2026. For Tyrosine kinase non-small cell lung cancer. NDA filing. Extracted from SEC filing: 8-K
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.
September 26
Target action date
Phase 3
Stage
Detected
Date confidence
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FDA designations