NUVL Nuvalent, Inc.
Price Chart
Executive Summary
Nuvalent reported Q1 2026 results with a net loss of $109.3M ($1.39/share), wider than the $84.6M loss in Q1 2025, as R&D spending increased to $83.6M. The clinical-stage biotech reiterated key PDUFA milestones (zidesamtinib September 18, 2026) and submitted its NDA for neladalkib, but with no revenue and rising operating expenses, the quarter itself was a routine cash-burn update with no fundamental catalyst.
Actionable Insight
No revenue or guidance to trade on. The stock will move on binary PDUFA events (Sept 18 for zidesamtinib) and ASCO data presentations (May 29-June 2). Monitor for any FDA advisory committee announcements or clinical hold signals ahead of the PDUFA date.
Key Facts
- Net loss of $109.3M for Q1 2026, vs $84.6M in Q1 2025
- Cash, cash equivalents and marketable securities of $1.3B as of March 31, 2026, down from $1.4B at year-end 2025
- R&D expenses of $83.6M in Q1 2026, up from $74.4M in Q1 2025
- G&A expenses of $35.8M in Q1 2026, up from $20.4M in Q1 2025
- NDA for neladalkib in TKI pre-treated ALK-positive NSCLC submitted to FDA
- Zidesamtinib NDA under FDA review with PDUFA target action date of September 18, 2026
- Cash runway anticipated into 2029
- Leadership promotions: Benjamin Lane to Chief Technology Operations Officer, Kirsten Duncan to VP Medical Affairs
Financial Impact
Net loss widened by $24.7M YoY to $109.3M; cash burn of ~$84.5M in Q1 2026 (from $1.37B to $1.29B)
Risk Factors
- FDA non-approval or delay for zidesamtinib (PDUFA Sept 18, 2026)
- Neladalkib NDA could face regulatory setbacks or require additional trials
- Cash burn rate increasing as commercial infrastructure is built pre-revenue
- Clinical trial enrollment or data readout risks for ALKAZAR and HEROEX-1
Market Snapshot
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001861560-26-000020 |
| Document: nuvl-20260507.htm | 0001861560-26-000020 |
| Document: 0001861560-26-000020-index-headers.html | 0001861560-26-000020 |
| Document: 0001861560-26-000020-index.html | 0001861560-26-000020 |
| Document: 0001861560-26-000020.txt | 0001861560-26-000020 |
| 8-K Data (Synthetic) | 0001861560-26-000020 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
|
Jun 9, 2026
today
|
8-K
| $122.92 awaiting T+20 | awaiting T+20 | — | $88.49 (−28.01%) |
|
May 7, 2026
4w ago
|
8-K
| $102.40 $90.18 | ▼ −11.93% | ▼ −15.07% | $88.49 (−13.58%) |
|
Apr 29, 2026
6w ago
|
Insider Cluster
| $99.10 $107.38 | ▲ +8.36% | ▲ +2.90% | $88.49 (−10.71%) |
|
Apr 7, 2026
9w ago
|
8-K
| $102.25 $102.62 | ▲ +0.36% | ▼ −9.42% | $88.49 (−13.46%) |
|
Apr 6, 2026
9w ago
|
Insider Cluster
| $103.71 $102.62 | ▲ +1.05% | ▲ +10.03% | $88.49 (+14.68%) |
|
Mar 30, 2026
10w ago
|
Insider Cluster
| $96.72 $101.94 | ▼ −5.40% | ▲ +7.20% | $88.49 (+8.51%) |
|
Mar 26, 2026
10w ago
|
Insider Cluster
| $98.06 $104.50 | ▲ +6.57% | ▼ −4.10% | $88.49 (−9.76%) |
|
Mar 25, 2026
11w ago
|
Insider Cluster
| $98.00 $108.02 | ▼ −10.22% | ▼ −2.36% | $88.49 (+9.70%) |
|
Mar 25, 2026
11w ago
|
Insider Cluster
| $98.00 $100.49 | ▼ −2.54% | ▲ +5.32% | $88.49 (+9.70%) |
|
Mar 6, 2026
13w ago
|
Insider Cluster
| $99.41 $103.71 | ▲ +4.33% | ▲ +6.37% | $88.49 (−10.98%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Try SecBot Free Coming soon: SecBot Pro with alerts, watchlists, and API access