Nuvalent, Inc.
NASDAQ•NUVL
CEO: Dr. James R. Porter Ph.D.
Sector: Healthcare
Industry: Biotechnology
Listing Date: 2021-07-29
Nuvalent, Inc., a clinical stage biopharmaceutical company, engages in the development of therapies for patients with cancer. Its lead product candidates are NVL-520, a novel ROS1-selective inhibitor to address the clinical challenges of emergent treatment resistance, central nervous system (CNS)-related adverse events, and brain metastases that may limit the use of ROS1 tyrosine kinase inhibitors (TKIs) for patients with ROS proto-oncogene 1 (ROS1)-positive non-small cell lung cancer (NSCLC) which is under the phase 2 portion of the ARROS-1 Phase 1/2 clinical trial; NVL-655, a brain-penetrant ALK-selective inhibitor, to address the clinical challenges of emergent treatment resistance, CNS-related adverse events, and brain metastases that might limit the use of first-, second-, and third-generation ALK inhibitors that is under the phase 2 portion of the ALKOVE-1 Phase 1/2 clinical trial; and NVL-330, a brain-penetrant human epidermal growth factor receptor 2 (HER2)-selective inhibitor designed to treat tumors driven by HER2ex20, brain metastases, and avoiding treatment-limiting adverse events including due to off-target inhibition of wild-type EGFR, which is expected to initiate phase 1 trial. The company was incorporated in 2017 and is headquartered in Cambridge, Massachusetts.
Contact Information
Market Cap
$7.46B
P/E (TTM)
-18.1
19.7
Dividend Yield
--
52W High
$113.02
52W Low
$55.54
52W Range
Rank54Top 78.1%
2.7
F-Score
Modified Piotroski Analysis
Based on 6-year fundamentals
Weak • 2.7 / 9 points
Scoring Range (0-9)
8-9: Excellent Value
6-7: Strong Fundamentals
4-5: Average Quality
0-3: Weak Performance
Data Period: 2020-2025
Financial Dashboard
Q4 2025 Data
Revenue
$0.00+0.00%
4-Quarter Trend
EPS
-$1.58+0.00%
4-Quarter Trend
FCF
-$73.33M+0.00%
4-Quarter Trend
2025 Annual Earnings Highlights
Key Highlights
Net Loss Increased Significantly Net loss reached $425.4M USD in 2025, up $164.8M from $260.8M loss in 2024 due to R&D expansion.
R&D Spending Ramped Up Research and development expenses totaled $307.0M USD in 2025, marking an $89.2M increase over 2024 spending levels.
Zidesamtinib NDA Accepted FDA accepted NDA for zidesamtinib (TKI pre-treated) with PDUFA target action date set for September 18, 2026.
Strong Cash Position Maintained Cash and cash equivalents stood at $261.7M USD as of December 31, 2025, funding operations into 2029.
Risk Factors
Continued Substantial Net Losses Incurred accumulated deficit of $972.4M USD; expects significant net losses for foreseeable future operations.
Product Candidate Development Dependence Business materially harmed if zidesamtinib, neladalkib, or NVL-330 fail development, approval, or commercialization efforts.
Regulatory Approval Uncertainty Remains Cannot assure FDA approval for zidesamtinib NDA by September 2026 PDUFA date, or any future product approvals.
Reliance on Third-Party Manufacturing Heavy reliance on third parties for manufacturing and clinical trials introduces risks of delays, quality issues, and supply disruptions.
Outlook
2026 First Approved Product Goal Anticipates 2026 commercial launch for zidesamtinib (TKI pre-treated) pending FDA review and approval outcome.
Neladalkib NDA Submission Planned Plan to submit NDA for neladalkib (TKI pre-treated) in the first half of 2026, following positive pivotal data.
Advance TKI-Naïve Label Expansion Plan to submit data for zidesamtinib TKI-naïve label expansion to FDA in the second half of 2026.
Continue Pipeline Discovery Efforts Prioritizing research programs, planning to disclose a new development candidate by year-end 2026 timeline.
Peer Comparison
Revenue (TTM)
$4.27B
$1.09B
$638.50M
Gross Margin (Latest Quarter)
100.0%
100.0%
97.9%
Key Metrics
Symbol | Market Cap | P/E (TTM) | ROE (TTM) | Debt to Assets |
|---|---|---|---|---|
| JAZZ | $11.62B | -32.3 | -8.8% | 46.4% |
| ARWR | $9.12B | 45.1 | 36.1% | 19.5% |
| PCVX | $8.63B | -10.7 | -25.9% | 7.5% |
Long-Term Trends
Last 4 Quarters
Revenue
Net Income
Operating Cash Flow
4Q Revenue CAGR
N/M
Revenue Volatile
4Q Net Income CAGR
N/M
Profitability Shift
Cash Flow Stability
0%
Cash Flow Needs Attention
Deep Research
Next earnings:May 7, 2026
EPS:-$1.33
|Revenue:-
Financials
Earnings Calls
Reports
News
Income Statement
Balance Sheet
Cash Flow Statement
Ratios
% Chg.
Income Statement | LTM |
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No Data