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Upcoming FDA decision · January 4, 2027

Taletrectinib PDUFA date: FDA decision expected January 4, 2027

The FDA is expected to decide on Taletrectinib from Nuvation Bio Inc. in Non Small Cell Lung Cancer by the PDUFA target action date of January 4, 2027. SNDA filing. Extracted from: Nuvation Bio Announces FDA Acceptance of Supplemental New Drug Application for IBTROZI® (taletrectinib) with Updated Duration of Response in Advanced ROS1-Positive Non-Small Cell Lung Cancer

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.

January 4
Target action date
Phase 3
Stage
Verified
Date confidence
FDA designations