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Upcoming FDA decision · October 1, 2026

NUV-868 PDUFA date: FDA decision expected October 1, 2026

The FDA is expected to decide on NUV-868 from Nuvation Bio Inc. in prostate cancer by the PDUFA target action date of October 1, 2026. For prostate 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.

October 1
Target action date
NDA
Stage
Detected
Date confidence
FDA designations