IBTROZI (taletrectinib) is a Nuvation Bio Inc. program in ROS1-positive non-small cell lung cancer. The FDA approved it on Sep 16, 2026. 2 FDA decisions on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Indication under review: ROS1-positive non-small cell lung cancer. Sponsor: Nuvation Bio Inc. (NUVB). Review status: Supplemental NDA (S-004, submitted March 4, 2026) approved September 16, 2026, 110 days before the January 4, 2027 goal date. Label update only: the TRUST-I TKI-naive median duration of response (49.7 months) and longer follow-up from TRUST-I and TRUST-II enter the label; the indication and the safety sections are unchanged. Market-cap tier at the time we tracked it: Mid. We track 3 catalyst events for this program: 0 upcoming and 3 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
No upcoming catalyst is on our calendar for IBTROZI (taletrectinib); 2 FDA decisions are on record below.
On Sep 16, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records IBTROZI (taletrectinib) is under review or in development for ROS1-positive non-small cell lung cancer.
Nuvation Bio Inc. (NUVB).
Yes. The FDA approved an application for IBTROZI (taletrectinib) on Sep 16, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.