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Recent press releases and 8-K filings for NUVL.
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
Nuvalent Discusses Pipeline Progress and Commercialization Strategy
NUVL
Product Launch
Guidance Update
- Nuvalent is on track with its OnTarget 2026 operating plan, targeting its first potential approval in 2026, and has achieved key 2025 milestones including the NDA acceptance for zidesamtinib (ROS1 program) for TKI pretreated patients.
- The ALK program's NVL-655 has treated over 1,000 patients and shown durable responses, including an 18-month duration of response in third-line patients, which is double lorlatinib's durability, and maintains a clean CNS safety profile. The phase 3 ALCAZAR trial for frontline ALK is enrolling as planned, with estimated data availability in the second half of 2029.
- The company is actively building its commercial presence and aims to become a fully integrated company, possessing the necessary team and capital, while remaining open to strategic partnerships for ex-U.S. markets.
Dec 4, 2025, 1:30 PM
Nuvalent Outlines 2026 Approval Path and Program Milestones
NUVL
Product Launch
New Projects/Investments
Guidance Update
- Nuvalent's OnTarget 2026 operating plan aims for its first potential drug approval in 2026, supported by 2025 milestones including pivotal data sets for ROS1 and ALK programs, and the initiation of the phase 3 ALCAZAR study for frontline ALK.
- The company's New Drug Application (NDA) for zidesamtinib (ROS1 program) for TKI pretreated patients was recently accepted for standard review.
- The ALK program, NVL-655, has shown durable responses in second and third-line settings, with an 18-month duration of response in third-line patients post-lorlatinib, which is double the durability of lorlatinib in that setting.
- The phase 3 ALCAZAR study for frontline ALK is enrolling as planned, with an estimated data availability in the second half of 2029.
- Nuvalent is actively building its commercial presence to become a fully integrated company, possessing the necessary team and capital, while also considering strategic partnerships for ex-U.S. markets.
Dec 4, 2025, 1:30 PM
Nuvalent Prices Public Offering of Common Stock
NUVL
- Nuvalent, Inc. announced the pricing of an underwritten public offering of its Class A common stock at $101.00 per share on November 18, 2025.
- The company is selling 4,950,496 shares, with expected gross proceeds of approximately $500.0 million and estimated net proceeds of approximately $471.9 million.
- Underwriters have been granted a 30-day option to purchase up to an additional 742,574 shares from selling stockholders, from which Nuvalent will not receive any proceeds.
- The offering is expected to close on November 20, 2025.
Nov 20, 2025, 11:01 AM
Nuvalent's NDA for Zidesamtinib Accepted by FDA
NUVL
Product Launch
New Projects/Investments
- Nuvalent, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for zidesamtinib.
- Zidesamtinib is an investigational ROS1-selective inhibitor intended for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have received at least one prior ROS1 tyrosine kinase inhibitor (TKI).
- The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026.
- The NDA submission is based on results from the global registrational ARROS-1 Phase 1/2 clinical trial.
Nov 19, 2025, 9:19 PM
Nuvalent Announces Pricing of Public Offering
NUVL
- Nuvalent, Inc. announced the pricing of an underwritten public offering of 4,950,496 shares of Class A common stock at a price of $101.00 per share.
- The offering is expected to generate approximately $500.0 million in gross proceeds for Nuvalent, before deducting underwriting discounts and other expenses.
- The offering is anticipated to close on November 20, 2025.
- The Selling Stockholders have granted the underwriters a 30-day option to purchase up to an additional 742,574 shares, from which Nuvalent will not receive any proceeds.
Nov 19, 2025, 4:50 AM
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