Nuvalent's Lung Cancer Drug Gets FDA Green Light—Stock Pops Then Fades

Nuvalent (NUVL) just landed a major win: the FDA accepted its NDA for zidesamtinib, a ROS1-targeted therapy for patients with advanced lung cancer who’ve already tried other TKI treatments. The drug targets a specific genetic mutation (ROS1-positive NSCLC) that affects a slice of non-small cell lung cancer patients.

The timeline: The FDA assigned a PDUFA target date of September 18, 2026—roughly 18 months to make a decision. The submission is backed by Phase 1/2 data from the ARROS-1 trial, which enrolled TKI pre-treated patients globally.

Market reaction was mixed: Stock jumped $2.89 (+2.77%) during regular trading, closing at $107.13. But after-hours? It gave back $2.13 (-1.99%), suggesting some profit-taking or investor caution about the long timeline ahead.

Why it matters: ROS1-positive NSCLC is a niche indication, but precision oncology keeps expanding. If approved, zidesamtinib could fill a gap for patients resistant to earlier TKI generations. The 18-month wait means NUVL won’t see revenue impact until 2026—plenty of time for clinical and competitive dynamics to shift.