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.
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.
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
Investment Themes
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 | ||||
|---|---|---|---|---|---|
Jul 27, 2026 9w ago | 15-12G | — | awaiting T+5 | — | — |
Jul 15, 2026 11w ago | 25-NSE | $123.96 $123.96 | · 0.00% | ▲ +0.98% | — |
Jul 15, 2026 11w ago | 8-K | $123.96 $123.96 | · 0.00% | ▲ +0.98% | — |
Jul 8, 2026 12w ago | Insider Cluster | $123.80 $123.96 | ▲ +0.13% | ▼ −0.73% | — |
Jul 6, 2026 12w ago | Insider Cluster | $123.72 $123.90 | ▲ +0.15% | ▼ −0.34% | — |
Jun 11, 2026 16w ago | Insider Cluster | $123.25 $123.43 | ▲ +0.15% | ▼ −0.53% | — |
Jun 10, 2026 16w ago | Insider Cluster | $123.45 $123.36 | ▼ −0.07% | ▼ −0.51% | — |
Jun 9, 2026 16w ago | 8-K | $123.25 $123.35 | ▲ +0.08% | ▼ −2.33% | — |
May 7, 2026 21w ago | 8-K | $102.40 $105.22 | ▲ +2.75% | ▲ +1.25% | — |
Apr 29, 2026 22w ago | Insider Cluster | $99.10 $101.47 | ▲ +2.39% | ▼ −0.72% | — |
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