NUVL FDA decision: Jul 22, 2026

Zidesamtinib (NVL-520) was approved by the FDA on July 22, 2026 for ROS1 Non-small cell lung cancer (NSCLC), the 27th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.

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)

Key facts

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.

Primary source: FDA approval notice, July 22, 2026

FDA record of the action: the FDA approved on July 22, 2026, per NDA 220185 ORIG-1 (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.

Specialist biotech funds holding NUVL, 13F for the quarter ended June 30, 2026

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