On February 26, 2026 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline progress, reiterated key anticipated milestones, and announced fourth quarter and full year 2025 financial results.

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"As we advance toward the culmination of our OnTarget 2026 operating plan with a first potential FDA approval targeted for later this year, our focus remains on applying the disciplined, patient-centric approach that has enabled rapid progress in discovery and development across our pipeline towards building the capabilities needed to effectively deliver new medicines to patients," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We are executing against our initial registration paths for zidesamtinib and neladalkib in TKI pre-treated patients and are well underway with launch readiness efforts to ensure we have the commercial infrastructure in place to deliver these medicines to patients, if approved. In parallel, we continue to pursue label expansion opportunities for TKI-naïve patients towards our goal of bringing new therapies to all patients with ROS1-positive or ALK-positive NSCLC, and advance our earlier-stage and discovery programs. With a steady cadence of anticipated milestones across our pipeline in 2026 and a strong balance sheet, we believe we are positioned to become an enduring leader in precision oncology across the full continuum of discovery, development, and delivery, built to serve patients for years to come."

Recent Pipeline Achievements and Anticipated 2026 Milestones

ROS1 Program

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The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for zidesamtinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least 1 prior ROS1 tyrosine kinase inhibitor (TKI), and assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026. Pending FDA review, Nuvalent anticipates U.S. commercial launch of zidesamtinib in 2026.
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Nuvalent plans to submit data to the FDA to support a potential label expansion of zidesamtinib in TKI-naïve patients with advanced ROS1-positive NSCLC in the second half of 2026.

ALK Program

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Nuvalent completed its pre-NDA meeting with the FDA and aligned on a submission strategy for neladalkib in TKI pre-treated ALK-positive NSCLC. The company plans to move forward with an NDA submission of the data for TKI pre-treated patients with advanced ALK-positive NSCLC from the ALKOVE-1 study of neladalkib in the first half of 2026.
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Enrollment is ongoing in ALKAZAR, the company’s global Phase 3 randomized, controlled trial designed to evaluate neladalkib for the treatment of TKI-naïve patients with advanced ALK-positive NSCLC. Patients are randomized 1:1 to receive neladalkib or alectinib, a front-line standard of care, reflecting input from collaborating physician-scientists and alignment with global regulatory agencies. The company expects to continue to progress the ALKAZAR trial throughout 2026.

HER2 Program

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Enrollment is ongoing in the HEROEX-1 Phase 1a/1b clinical trial evaluating the overall safety and tolerability of NVL-330 for pre-treated patients with HER2-altered NSCLC. Additional objectives include determination of the recommended Phase 2 dose, characterization of NVL-330’s pharmacokinetic profile, and preliminary evaluation of anti-tumor activity. The company expects to continue to progress the HEROEX-1 trial throughout 2026.

Discovery Research Programs

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Nuvalent continues to advance its discovery research programs and expects to disclose a new development candidate by year-end 2026.

Business Highlights

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Completed Successful Public Offering of Common Stock Raising $500.0 Million in Gross Proceeds: On November 20, 2025, Nuvalent closed an underwritten public offering of 4,950,496 shares of Class A common stock at a price to the public of $101.00 per share. The gross proceeds to Nuvalent from the offering were approximately $500.0 million, before deducting underwriting discounts and commissions and other offering expenses.
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Ron Squarer Appointed to Board of Directors: Nuvalent appointed Ron Squarer to its board of directors in December 2025. Mr. Squarer brings more than 30 years of proven leadership in oncology drug development and commercialization to the Nuvalent Board.

Upcoming Events

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TD Cowen 46thAnnual Health Care Conference in Boston: Management will be participating in a fireside chat on Wednesday, March 4, 2026, at 9:45 a.m. ET.
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Leerink Global Healthcare Conference 2026 in Miami: Management will be participating in a fireside chat on Monday, March 9, 2026, at 2:20 p.m. ET.
Live webcasts of the fireside chats will be available in the Investors section of Nuvalent’s website at www.nuvalent.com, and will be archived for 30 days following each conference.

Fourth Quarter and Full Year 2025 Financial Results

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Cash Position: Cash, cash equivalents and marketable securities were $1.4 billion as of December 31, 2025. Nuvalent continues to believe that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations into 2029.
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R&D Expenses: Research and development (R&D) expenses were $67.8 million for the fourth quarter of 2025 and $307.0 million for the year ended December 31, 2025.
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G&A Expenses: General and administrative (G&A) expenses were $34.4 million for the fourth quarter of 2025 and $107.3 million for the year ended December 31, 2025.
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Net Loss: Net loss was $118.7 million for the fourth quarter of 2025 and $425.4 million for the year ended December 31, 2025.

(Press release, Nuvalent, FEB 26, 2026, View Source [SID1234663083])