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Nuvalent Reports Q4 and Full Year 2025 Financial Results and Provides Pipeline Updates
NUVL
Earnings
Product Launch
New Projects/Investments
- Nuvalent reported a net loss of $118.7 million for the fourth quarter of 2025 and $425.4 million for the full year 2025.
- The company's cash, cash equivalents, and marketable securities totaled $1.4 billion as of December 31, 2025, with an anticipated operating runway into 2029. This includes approximately $500.0 million in gross proceeds from a public offering completed on November 20, 2025.
- The FDA accepted the New Drug Application (NDA) for zidesamtinib for TKI pre-treated ROS1-positive NSCLC, assigning a PDUFA target action date of September 18, 2026, with a potential U.S. commercial launch anticipated in 2026.
- An NDA submission for neladalkib in TKI pre-treated ALK-positive NSCLC is planned for the first half of 2026, and a submission for potential label expansion of zidesamtinib in TKI-naïve patients is planned for the second half of 2026.
2 days ago
Nuvalent Reports Q4 and Full Year 2025 Financial Results and Provides Pipeline Update
NUVL
Earnings
Guidance Update
New Projects/Investments
- Nuvalent reported cash, cash equivalents and marketable securities of $1.4 billion as of December 31, 2025, and anticipates its operating runway to extend into 2029.
- The company's net loss for Q4 2025 was $118.7 million and for the full year 2025 was $425.4 million.
- The FDA accepted the New Drug Application (NDA) for zidesamtinib with a PDUFA target action date of September 18, 2026, and Nuvalent plans to submit an NDA for neladalkib in the first half of 2026.
- In November 2025, Nuvalent completed a public offering of common stock, raising approximately $500.0 million in gross proceeds.
| Metric | Q4 2025 | FY 2025 |
|---|---|---|
| R&D Expenses ($USD Thousands) | $67,796 | $306,970 |
| G&A Expenses ($USD Thousands) | $34,432 | $107,337 |
| Net Loss ($USD Thousands) | ($118,705) | ($425,377) |
2 days ago
Nuvalent Provides Regulatory and Commercial Strategy Updates for Lead Programs and Pipeline
NUVL
Product Launch
Guidance Update
New Projects/Investments
- Nuvalent is advancing its lead programs, with the FDA accepting the NDA for zidesamtinib (ROS1) for TKI-pretreated patients, setting a PDUFA date of September 18, and planning to submit data for TKI-naive ROS1 in the second half of the year. The company is also on track to submit the NDA for neladalkib (ALK) in TKI-pretreated patients in the first half of the year.
- The company is pursuing an ex-US "go it alone" commercialization strategy, aiming to build a global biotech company, leveraging global studies and established markets.
- Nuvalent ended the past year with approximately $1.4 billion in cash, providing an operating runway into 2029, which supports its global expansion plans.
- The company estimates the ROS1 market could grow to over $2 billion, similar to the current ALK market, and the ALK market, already over $2 billion, could expand to 2-3 times that, comparable to today's EGFR market.
- Beyond its lead programs, Nuvalent is continuing to advance its HEROEX phase 1b/2 study in HER2-altered non-small cell lung cancer and plans to disclose a new development candidate by year-end.
Feb 12, 2026, 6:30 PM
Nuvalent Provides Regulatory and Commercial Strategy Update for Lead Programs
NUVL
Product Launch
New Projects/Investments
Guidance Update
- Nuvalent anticipates a PDUFA date of September 18 for its zidesamtinib (ROS1 inhibitor) in TKI-pretreated ROS1-positive non-small cell lung cancer, with commercial launch preparations underway for later this year. The company also plans to submit an NDA for NVL-655 (ALK inhibitor) in TKI-pretreated ALK-positive non-small cell lung cancer in the first half of the year.
- The company is pursuing a "go it alone" strategy for ex-US commercialization of its lead programs, aiming to build internal capabilities to maximize product ownership and flexibility. Global registration strategies are in place for both zidesamtinib and NVL-655.
- Nuvalent reported $1.4 billion in cash at the end of last year, providing an operating runway into 2029. This financial strength supports its global expansion and pipeline, which includes a HER2 exon 20 phase 1b/2 study and a planned disclosure of a new development candidate by year-end.
Feb 12, 2026, 6:30 PM
Nuvalent Provides Regulatory Updates for ROS1 and ALK Programs, Details Financial Position and Global Commercial Strategy
NUVL
Product Launch
Guidance Update
New Projects/Investments
- Nuvalent's zidesamtinib for ROS1-positive non-small cell lung cancer has an FDA PDUFA date of September 18, with commercial readiness underway for a potential US launch later this year. The company also plans to submit data for TKI-naive ROS1 indication expansion in the second half of the year.
- The company is on track to submit an NDA for its ALK program, neladalkib, in TKI-pretreated ALK-positive non-small cell lung cancer in the first half of this year.
- Nuvalent reported approximately $1.4 billion in cash at the end of last year, providing an operating runway into 2029.
- The company is pursuing an independent ex-US commercialization strategy, building internal capabilities and actively recruiting for a head of international.
- Nuvalent projects the ROS1 market could grow to over $2 billion, similar to the current ALK market, and the existing ALK market (also over $2 billion) could expand to 2-3 times that size.
Feb 12, 2026, 6:30 PM
Nuvalent Provides OnTarget 2026 Operating Plan Update and 2025 Year-End Cash Estimate
NUVL
Guidance Update
New Projects/Investments
- The FDA accepted Nuvalent's New Drug Application (NDA) for zidesamtinib for TKI pre-treated patients with advanced ROS1-positive NSCLC, with a PDUFA target action date of September 18, 2026.
- Nuvalent plans to submit an NDA for neladalkib in TKI pre-treated advanced ALK-positive NSCLC in the first half of 2026 and a submission for potential indication expansion of zidesamtinib in TKI-naïve advanced ROS1-positive NSCLC in the second half of 2026.
- The company reported an unaudited estimate of approximately $1.4 billion in cash, cash equivalents, and marketable securities as of December 31, 2025, which is anticipated to fund operations into 2029.
Jan 14, 2026, 11:30 AM
Nuvalent Provides Regulatory and Pipeline Updates at J.P. Morgan Healthcare Conference
NUVL
Product Launch
New Projects/Investments
Guidance Update
- Nuvalent announced that the NDA for Zidesamtinib for ROS1 non-small cell lung cancer has been accepted by the FDA with an expected PDUFA date of September 2026.
- The company plans to submit the NDA for NVL-655 for previously treated ALK non-small cell lung cancer patients in the first half of 2026.
- Nuvalent is well-capitalized with a financial runway into 2029 and is building its U.S. commercial infrastructure for potential drug launches in 2026.
- The company also expects to submit TKI-naive data for Zidesamtinib to the FDA in the second half of 2026 and for a fourth development candidate to emerge from its discovery portfolio in 2026.
Jan 13, 2026, 5:00 PM
Nuvalent provides updates on oncology pipeline and commercialization strategy
NUVL
Product Launch
New Projects/Investments
Guidance Update
- Nuvalent's zidesamtinib for ROS1 non-small cell lung cancer has an accepted NDA with an expected PDUFA date of September 2026, and TKI-naive data will be submitted in the second half of 2026 for a potential line-agnostic indication.
- The company plans to submit an NDA for NVL-655 for previously treated ALK-positive non-small cell lung cancer in the first half of 2026 and is progressing an ongoing Phase 3 study for TKI-naive patients.
- Nuvalent is well-capitalized with a runway into 2029 and is building its U.S. commercial infrastructure to launch these drugs, with the potential to grow the ROS1 market to $1.5 billion-$2 billion and the ALK market beyond $2 billion.
- The company is also progressing its NVL-330 program for HER2 lung cancer and expects a fourth development candidate to emerge from its discovery portfolio in 2026.
Jan 13, 2026, 5:00 PM
Nuvalent Provides Updates on Zidesamtinib and NVL-655 Regulatory Filings and 2026 Milestones
NUVL
Product Launch
New Projects/Investments
Guidance Update
- Nuvalent's Zidesamtinib for ROS1 non-small cell lung cancer (NSCLC) has an accepted NDA with an expected PDUFA date of September 2026, and the company plans to submit an NDA for NVL-655 for ALK-positive NSCLC in the first half of 2026.
- The company is well-capitalized with a financial runway into 2029 and is actively building its U.S. commercial infrastructure to support potential drug launches.
- Nuvalent also expects to submit TKI-naive ROS1 data to the FDA in the second half of 2026 and anticipates a new development candidate from its discovery portfolio in 2026.
Jan 13, 2026, 5:00 PM
Nuvalent Outlines Key 2026 Milestones and Financial Position
NUVL
Product Launch
New Projects/Investments
Guidance Update
- The FDA accepted Nuvalent's New Drug Application (NDA) for zidesamtinib for TKI pre-treated ROS1-positive NSCLC, with a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026.
- Nuvalent plans to submit an NDA for neladalkib in TKI pre-treated ALK-positive NSCLC in the first half of 2026 and a submission for potential indication expansion of zidesamtinib in TKI-naïve ROS1-positive NSCLC in the second half of 2026.
- The company reported approximately $1.4 billion in unaudited cash, cash equivalents, and marketable securities at the end of 2025, which is expected to fund operations into 2029.
Jan 12, 2026, 11:30 AM
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