IBTROZI (taletrectinib) sNDA was approved by the FDA on September 16, 2026 for ROS1-positive non-small cell lung cancer.
Verified against: FDA action day September 16, 2026 (NDA 219713 S-004) · Announcement September 16, 2026 (FDA approval letter NDA 219713/S-004 dated) · Goal date January 4, 2027 (Nuvation Bio Inc. 8-K).
IBTROZI (taletrectinib) sNDA approved: TRUST-I / TRUST-II longer follow-up (TKI-naive median duration of response 49.7 months) added to the U.S. label on September 16, 2026, 110 days before the January 4, 2027 goal date.
The PDUFA goal date was January 4, 2027, sourced to Nuvation Bio's 8-K of August 6, 2026. The FDA's approval letter for NDA 219713/S-004 is dated September 16, 2026 (Drugs@FDA), and Nuvation's release carries the same date, so the FDA action day is documented: 110 days early. This is a supplemental application: the approved indication and the safety sections of the label are unchanged; the label gains updated response-rate and duration-of-response data from an August 2025 data cutoff. The supplement was submitted March 4, 2026 and also fulfils a postmarketing commitment from the June 11, 2025 approval.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: FDA approval letter, NDA 219713/S-004, September 16, 2026
FDA record of the action: the FDA approved on September 16, 2026, per NDA 219713 S-004 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
| 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.
Yes. The FDA approved the application for IBTROZI (taletrectinib) on September 16, 2026, per the FDA's own record. The primary source is linked on this page.
IBTROZI (taletrectinib) is a Nuvation Bio Inc. (NUVB) program. The FDA decision came on September 16, 2026; the FDA's own record of the decision is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), NUVB moved +32.4%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.