JIDEYTRO (zidesamtinib), a ROS1-selective TKI, approved on July 22, 2026 for previously treated ROS1-positive NSCLC - 58 days ahead of its September 18 PDUFA goal date.
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (1/27/26) through T+0. Run-up high $123.96 on 7/14/26, low $88.49 on 6/8/26 (T-120 to T-1). FDA decision 7/22/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-07-22
OutcomeApproved
Drug / candidateJIDEYTRO (zidesamtinib)
IndicationLocally advanced or metastatic ROS1-positive non-small cell lung cancer in adults who have received at least one prior ROS1 tyrosine kinase inhibitor
CompanyNuvalent, Inc.
Market-cap tierMid
120-day run-up (T-120→T-1)+16.4%
Cohort decision-day move (history)±2% median
The PDUFA target action date was September 18, 2026; the FDA approved zidesamtinib on July 22, nearly two months early. Efficacy came from ARROS-1, a multicenter, single-arm, open-label, multi-cohort trial in 117 patients: 59 who had received one prior ROS1 TKI and 58 who had received two or more, including lorlatinib, repotrectinib and/or taletrectinib. Zidesamtinib held Breakthrough Therapy and Orphan Drug designations. Nuvalent is partnered with GSK, which announced the approval alongside the FDA notice.
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.
Yes. The FDA approved the application for JIDEYTRO (zidesamtinib) on July 22, 2026. The primary source is linked on this page.
Which company is behind JIDEYTRO (zidesamtinib)?
JIDEYTRO (zidesamtinib) is a Nuvalent, Inc. (NUVL) program. The FDA decision came on July 22, 2026; the company's own announcement is linked on this page.
How did NUVL stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), NUVL moved +16.4%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.
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