Nuvalent (NUVL)
Developer of selective kinase inhibitors targeting ROS1 and ALK resistance in lung cancer.
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Nuvalent is a clinical-stage biotech developing selective, brain-penetrant kinase inhibitors for ROS1- and ALK-positive non-small cell lung cancer. Its lead asset zidesamtinib is under FDA review with a 2026 PDUFA date; neladalkib is completing pivotal trials. The company has no approved products or commercial revenue.
Nuvalent is a clinical-stage precision-oncology company founded in Cambridge, Massachusetts in 2017 from the structure-based drug-design research of Harvard chemist Matthew Shair. Its two internally discovered programs — zidesamtinib (ROS1-selective) and neladalkib (ALK-selective) — target non-small cell lung cancer subsets where first- and second-generation tyrosine kinase inhibitors fail through acquired resistance mutations or inadequate brain penetration.
Both candidates were designed from first principles to maintain potency against the full spectrum of clinically observed resistance mutations, including compound mutations, while minimizing off-target kinase activity to reduce toxicity. Zidesamtinib's NDA was accepted by the FDA in November 2025 under Real-Time Oncology Review, with a PDUFA target action date of September 18, 2026; a neladalkib NDA submission is planned for the first half of 2026. The business depends on FDA approval timelines and has no approved products or revenue.
Company facts
No analyst consensus on record.
EPSReportedEstimate
RevenueReportedEstimate
Balance sheet, Mar 31, 2026Cash & short-term investments $1.29B · Total debt $0 · Total assets $1.33B · Shareholders' equity $1.17B
- Revenue
- $0
- Operating income
- −$119.4M
- Net income
- −$109.3M
No dividends on record.
| Insiders | 28.51% | 22.52M shares | |
|---|---|---|---|
| 5 holders · as of Jul 17, 2026 | |||
| Strategic holders | 15.94% | 12.59M shares | |
| 2 holders · as of May 6, 2026 | |||
| Other | 55.55% | 43.89M shares | |
| remainder | |||
79.00M company shares as of Sep 23, 2026 · holders as of their latest filing
This company has 2 share classes; every stake here is a share of the whole company.
Top shareholders13F · 13D/G · Form 4
| Holder | Stake | Shares | Date |
|---|---|---|---|
James E. Flynn1Insiderdirector, 10 percent owner, other: Director by Deputization | 24.66% | 22.85M COMPANY | filed Jul 17, 2026 |
FMR LLCStrategic | 11.71% | 9.25M | filed May 6, 2026 |
BlackRock, Inc.Strategic | 4.23% | 3.34M | filed Jul 17, 2025 |
Matthew ShairInsiderdirector | 2.00% | 1.58M A | filed Nov 26, 2025 |
Andrew A. F. HackInsiderdirector | 1.83% | 1.45M A | filed Dec 13, 2024 |
- James E. Flynn's transaction reports restate only vehicles that traded; the 2026 ownership statement (22.85M) less the 3.37M net shares sold since is used instead.
Insider tradesForm 4
| Date | Insider | Role | Shares | Avg price |
|---|---|---|---|---|
| Jul 9, 2026 | Henry E. Pelish | officer: Chief Scientific Officer | −2,111 | $123.81 |
| Jul 6, 2026 | James Richard Porter | director, officer: President and CEO | −30,000 | $123.72 |
| Jul 1, 2026 | Alexandra Balcom | officer: Chief Financial Officer | −11,430 | $123.58 |
| Jul 1, 2026 | Darlene Noci | officer: Chief Development Officer | −23,000 | $123.59 |
| Jun 29, 2026 | Darlene Noci | officer: Chief Development Officer | −5,500 | $123.51 |
- Bristol-Myers Squibb
Augtyro (repotrectinib) competes directly in ROS1+ NSCLC across treatment lines.
- Nuvation Bio
IBTROZI (taletrectinib) is the newest commercial ROS1 rival, NCCN Preferred.
- Pfizer
Lorbrena sets the first-line ALK+ benchmark; Xalkori covers first-gen ROS1/ALK.
- Takeda (ADR)
Alunbrig holds second ALK+ market share; its progressors feed neladalkib's pool.
Compare
| Company | Price | Change | |||||
|---|---|---|---|---|---|---|---|
| Nuvalent | $123.96 | 0.00% | $9.13B | — | — | — | — |
| Bristol-Myers Squibb | $61.32 | +0.29% | $127.16B | 13.7 | 9.6 | 2.6 | +5.7% |
| Nuvation Bio | $5.79 | +1.67% | $2.12B | — | — | 12.5 | +555.6% |
| Pfizer | $28.16 | −0.02% | $159.19B | 36.9 | 10.1 | 2.5 | +2.6% |
| Takeda (ADR) | $18.81 | −0.05% | $60.30B | 52.9 | 59.9 | 2.0 | +4.2% |
| Median | 36.9 | 10.1 | 2.5 | +5.0% |