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.
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (3/25/26) through T+4. Run-up high $7.26 on 8/19/26, low $4.05 on 3/30/26 (T-120 to T-1). FDA decision 9/16/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-09-16
OutcomeApproved
Drug / candidateIBTROZI (taletrectinib) - sNDA S-004 label update
IndicationROS1-positive non-small cell lung cancer: label updated with longer-term TRUST-I / TRUST-II response and duration-of-response data
CompanyNuvation Bio Inc.
Market-cap tierSmall
120-day run-up (T-120→T-1)+32.4%
Cohort decision-day move (history)3.6% median (n=280)
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.
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