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
FDA approval tracked on pdufa.bio: ROS1-positive non-small cell lung cancer (approved Sep 16, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: Nuvation Bio Inc. (NUVB). Approval record: 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 2 catalyst events for this program: 0 upcoming and 2 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.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| Redmile Group | 3,031,009 | $17.2 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
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 FDA-approved for ROS1-positive non-small cell lung cancer (approved Sep 16, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
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.