Nuvalent, Inc.
NUVLDrugs in Pipeline
3
Phase 3 Programs
1
Upcoming Catalysts
1
Next Catalyst
Nov 27, 2026
9wMarket Overview
Stock performance and key metrics
2 upcoming, 2 past
FDA PDUFA Date NUV-1034 (standard)
For Tyrosine kinase non-small cell lung cancer. NDA filing. Extracted from SEC filing: 8-K
Fast-detected from FDA RSS: FDA approves Nuvalent's cancer drug, a week after GSK closed $10.6B buyout
Source1 more catalyst beyond 14 days
Start a 48-hour free trial to see all upcoming catalysts
How NUVL's past catalysts played out
Neladalkib (NVL-655)
Non-small Cell Lung Cancer
Zidesamtinib (NVL-520)
Locally Advanced Solid Tumor
Midazolam
Locally Advanced Solid Tumor
| Drug Name | Phase | Indication | Designations | Patent |
|---|---|---|---|---|
Neladalkib (NVL-655) | Phase 3 | Non-small Cell Lung Cancer | - | - |
Zidesamtinib (NVL-520) | Phase 2 | Locally Advanced Solid Tumor | - | - |
Midazolam | Phase 2 | Locally Advanced Solid Tumor | - | - |
Full breakdown — the signals behind the verdict
Frequently asked questions
What is in Nuvalent, Inc.'s drug pipeline?→
CatalystAlert tracks 3 drug candidates in Nuvalent, Inc.'s (NUVL) pipeline across Phase 3, Phase 2. Its lead program is Neladalkib (NVL-655) (Phase 3). Each drug's phase, indication and upcoming catalysts are listed on this page.
When is Nuvalent, Inc.'s next FDA catalyst?→
Nuvalent, Inc.'s (NUVL) next tracked catalyst is a NDA Filing expected September 18, 2026. See the catalyst timeline on this page for the full schedule of PDUFA dates, trial readouts and FDA events.
How do I track NUVL biotech catalysts?→
Add NUVL to your CatalystAlert watchlist for alerts ahead of each catalyst, and follow Nuvalent, Inc.'s live catalyst calendar, drug pipeline and clinical-trial timeline on this page — sourced from ClinicalTrials.gov, FDA and SEC filings.