Nuvalent

1 products tracked · names used in filings: Nuvalent, Nuvalent, Inc.

Upcoming milestones

No upcoming milestones listed.

Recent milestones

Fri 18 Sep 2026🇺🇸 PDUFA datecompany-announced

zidesamtinib: PDUFA target action date (TKI pre-treated advanced ROS1-positive NSCLC)

Nuvalent, Inc. (NUVL); zidesamtinib; NDA; status: set; "…peline Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2026 Financial Results NDA submitted for neladalkib in TKI pre-treated advanced ALK-positive NSCLC NDA for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC under FDA review with PDUFA target action date of September 18,…"; filed 2026-05-07 · source

Wed 22 Jul 2026🇺🇸 FDA approval

FDA approves Jideytro (zidesamtinib), a new medicine

Nuvalent; NDA220185; New molecular entity; tablet · source

Products

ProductStatusApproved
🇺🇸Jideytro
zidesamtinib		Approved2026-07-22

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.