Nuvalent, Inc. (NUVL) catalysts

Upcoming FDA decisions and readouts we track for Nuvalent, Inc., each with the filing that announced it.

Listed on — Nasdaq Catalysts tracked — 1 Rows last checked — 14 Sep 2026

FreeBioList has 1 catalyst on record for Nuvalent, Inc. (NUVL, listed on Nasdaq), all now decided. It concerns Zidesamtinib (ROS1-positive non-small cell lung cancer (TKI pre-treated)).

Decided and on record:

Zidesamtinib, PDUFA date: Approved 22 July 2026, almost two months ahead of the PDUFA date.

Each outcome links to the filing or notice that reported it in the table below.

The row links to an FDA notice. It has been verified by a person reading the filing itself, most recently on 14 Sep 2026. The methodology page explains each status.

Background reading: What a PDUFA date is, and why the FDA doesn't publish them.

Ticker: NUVL
Next catalyst: —
Type: —
Listed options: Yes

Company ▾	Drug ▾	Effect / indication	Next catalyst ▾	Phase / type ▾	Status ▾	Source	Options
Nuvalent, Inc. NUVL · Nasdaq	Zidesamtinib	ROS1-positive non-small cell lung cancer (TKI pre-treated)	18 Sep 2026 19d ago	PDUFA date	Verified	FDA approval notice ↗	Yes
Notes — FDA approval notice: zidesamtinib (Jideytro, Nuvalent) approved for adults with locally advanced or metastatic ROS1-positive NSCLC who received at least one prior ROS1 TKI — well ahead of the September 18, 2026 PDUFA target action date. Outcome — Approved 22 July 2026, almost two months ahead of the PDUFA date — FDA approved zidesamtinib (Jideytro) for adults with ROS1-positive NSCLC previously treated with a ROS1 TKI. Source: FDA approval notice, filed 22 Jul 2026 · verified 14 Sep 2026

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