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NDA submitted for neladalkib in TKI pre-treated advanced ALK-positive NSCLC NDA for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC under FDA review with PDUFA target action date of September 18, 2026 Submission for potential label expansion of zidesamtinib in TKI-naïve advanced ROS1-positive NSCLC planned for the second half of 2026 Strengthened leadership team with key internal promotions CAMBRIDGE, Mass., May 7, 2026 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today outlined pipeline progress, reiterated key anticipated milestones, and reported first quarter 2026 financial results. "The forward momentum continues at Nuvalent, with both of our parallel-lead programs advancing toward key US regulatory milestones and the opportunity to bring our first new medicine to patients this year," said James Porter, Ph.D., Chief Executive Officer of Nuvalent. "We recently submitted our NDA for neladalkib in TKI pre-treated ALK-positive NSCLC and are continuing to build our commercial infrastructure in preparation for a potential US launch of zidesamtinib in TKI pre-treated ROS1-positive NSCLC, if approved." Dr. Porter continued, "Beyond these initial opportunities, we remain focused on progressing our label expansion strategies for ROS1- and ALK-positive NSCLC, as well as our earlier-stage pipeline, with the goal of driving meaningful, long-term impact in NSCLC and beyond. Through these efforts, we believe we are well positioned to realize our vision of becoming a sustainable biotechnology company capable of designing, developing and delivering precisely targeted therapies for patients with cancer." Recent Pipeline Achievements and Anticipated Milestones ROS1 Program The New Drug Application (NDA) for zidesamtinib, an investigational ROS1-selective inhibitor, is under review by the U.S. Food and Drug Administration (FDA) 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) with a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026. Nuvalent continues to advance commercial preparations ahead of an anticipated U.S. commercial launch of zidesamtinib in 2026,...

Commercial preparations well underway to support potential U.S. launch of zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC population, pending FDA review; PDUFA target action date of September 18, 2026 NDA submission for neladalkib in TKI pre-treated advanced ALK-positive NSCLC population planned for the first half of 2026 Submission for potential label expansion of zidesamtinib in TKI-na￯ve advanced ROS1-positive NSCLC population planned for the second half of 2026 Strong financial position with operating runway anticipated into 2029 CAMBRIDGE, Mass., Feb. 26, 2026 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today outlined pipeline progress, reiterated key anticipated milestones, and reported fourth quarter and full year 2025 financial results. "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-na￯ve 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 The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for zidesamtinib for the treatment of adult patients with locally...

Nuvalent said Monday almost a third of patients with a hard-to-treat form of lung cancer responded to its experimental treatment.

Completed rolling NDA submission for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC On track to report topline pivotal data for neladalkib in TKI pre-treated advanced ALK-positive NSCLC by year-end 2025 Strong financial position with operating runway anticipated into 2028 CAMBRIDGE, Mass., Oct. 30, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today outlined pipeline progress, reiterated key anticipated milestones, and reported third quarter 2025 financial results. "The third quarter of 2025 marked the achievement of a significant milestone with the completion of our NDA submission for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC. We look forward to working closely with the FDA throughout the review process, as well as continuing to engage with the agency on potential opportunities for line-agnostic expansion," said Darlene Noci, A.L.M., Chief Development Officer of Nuvalent. "We remain on track to share topline pivotal data this quarter from our ALKOVE-1 trial of neladalkib in TKI pre-treated advanced ALK-positive NSCLC, and continue to progress ALKAZAR, our global Phase 3 randomized, controlled trial of neladalkib for TKI-naïve patients with advanced ALK-positive NSCLC." "Our commercial preparedness activities are well underway as we carry forward the momentum from these exciting development milestones and continue our efforts to transition toward becoming a fully integrated commercial-stage biopharmaceutical company," said Alex Balcom, Chief Financial Officer of Nuvalent. "Combined with a strong financial position with cash runway anticipated into 2028, we believe we are well positioned to achieve our goal of delivering a new and potential best-in-class option for all patients with ROS1 or ALK-positive NSCLC." "We are also pleased to have recently shared the first report of preliminary clinical data demonstrating the potential for neladalkib to address medical needs for patients with ALK-positive solid tumors beyond NSCLC, and new preclinical data further demonstrating the potential for NVL-330 to offer a differentiated profile for HER2-altered NSCLC," said James Porter, Ph.D., Chief Executive Officer of Nuvalent. "With a portfolio anchored by complementary indications in biomarker-...

Initiated rolling NDA submission for zidesamtinib for TKI pre-treated patients with advanced ROS1-positive NSCLC, with target completion in the third quarter of 2025 Initiated ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC Topline pivotal data for neladalkib for TKI pre-treated patients with advanced ALK-positive NSCLC expected by year-end 2025 Preliminary data for neladalkib in patients with ALK-positive solid tumors beyond NSCLC to be presented at the ESMO Congress 2025 Jason Waters, MBA, promoted to Senior Vice President, Commercial CAMBRIDGE, Mass., Aug. 7, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today outlined pipeline and business achievements, reiterated key anticipated milestones, and reported second quarter 2025 financial results. "With the initiation of our rolling NDA submission for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC and the dosing of the first patient in our ALKAZAR Phase 3 trial of neladalkib in TKI-naïve advanced ALK-positive NSCLC, 2025 has been marked by transformative milestones towards our mission to discover, develop, and deliver precisely targeted therapies for patients with cancer," said Alexandra Balcom, Chief Financial Officer of Nuvalent. "We remain focused on continuing to deliver value that is grounded in prioritizing patient impact with topline pivotal data from our ALKOVE-1 trial of neladalkib in TKI pre-treated advanced ALK-positive NSCLC expected by year-end and the first report of preliminary data for other ALK-positive solid tumors at ESMO, continued momentum in our HEROEX-1 trial of NVL-330 for HER2-altered NSCLC, and a robust discovery pipeline." "In parallel to our continued execution against development and regulatory milestones, we are actively building the strong commercial infrastructure needed to achieve our vision of becoming a fully integrated, commercial-stage biopharmaceutical company," said James Porter, Ph.D., Chief Executive Officer of Nuvalent. "Today we are proud to announce the promotion of Jason Waters to Senior Vice President, Commercial, in recognition of his leadership in establishing our commercial strategy and shaping a launch-ready organization that extends from our founding values...

Topline pivotal data expected for zidesamtinib in TKI pre-treated ROS1-positive NSCLC population in the first half of 2025 in support of anticipated first NDA submission by mid-year 2025 Initiation of ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC planned for first half of 2025 Pivotal data for neladalkib in TKI pre-treated ALK-positive NSCLC population anticipated by year-end 2025 Strengthened leadership team with key internal promotions CAMBRIDGE, Mass., May 8, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today outlined pipeline and business progress, reiterated key anticipated milestones, and reported first quarter 2025 financial results. "2025 is a critical year of execution for Nuvalent as we continue to transition toward becoming a fully integrated commercial-stage biopharmaceutical company," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We expect multiple meaningful milestones this year, including pivotal data for TKI pre-treated patients from both of our parallel lead programs, and our first potential NDA submission for zidesamtinib for TKI pre-treated patients with ROS1-positive NSCLC." Dr. Porter continued, "The continued progress across our portfolio is a direct reflection of the strength and dedication of our team—it is their deep expertise, operational excellence, and commitment to patients that drive our ability to execute. In recognition of their significant contributions, we're pleased to announce the leadership promotions of Ruth Adams to Senior Vice President, Clinical Operations; Dr. Joshua Horan to Senior Vice President, Chemistry; and Jessie Lin to Senior Vice President, Corporate Strategy and Portfolio Management. With strong product candidates, a solid financial position, and an experienced team unified by an unwavering commitment to patient impact, we believe we are well-positioned to achieve our goals." Recent Pipeline and Business Highlights ROS1 Program Evaluation of zidesamtinib, the company's novel ROS1-selective inhibitor, is ongoing in the ARROS-1 Phase 1/2 trial for patients with advanced TKI-naïve and TKI pre-treated ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors. The company expects to report...