New Drug Application for neladalkib in TKI pre-treated advanced ALK-positive NSCLC accepted for filing with Priority Review by the FDA with PDUFA target action date of November 27, 2026 Veteran...

Presentation of pivotal data for neladalkib in TKI pre-treated patients with advanced ALK-positive NSCLC from ALKOVE-1 trial TKI pre-treated data from ALKOVE-1 trial of neladalkib support recent...

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...

Company to also present preliminary data for zidesamtinib in advanced ROS1-positive solid tumors outside of NSCLC from the global ARROS-1 trial CAMBRIDGE, Mass., April 21, 2026 /PRNewswire/ --...

Zidesamtinib demonstrated meaningful clinical activity in subset of TKI pre-treated ROS1-positive NSCLC patients from ARROS-1 trial previously treated with repotrectinib or taletrectinib,...

New Drug Application (NDA) based on data in TKI pre-treated patients from the global ALKOVE-1 Phase 1/2 clinical trial CAMBRIDGE, Mass., April 7, 2026 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq:...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the...

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...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

FDA accepted NDA for zidesamtinib for the treatment of TKI pre-treated patients with advanced ROS1-positive NSCLC; PDUFA target action date of September 18, 2026 NDA submission for neladalkib in...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the...

NDA based on data from global ARROS-1 Phase 1/2 clinical trial FDA assigns PDUFA target action date of September 18, 2026 CAMBRIDGE, Mass., Nov. 19, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq:...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that it...

In 253 ALK TKI pre-treated patients, ORR by BICR was 31% (95% CI: 26, 37), with initial estimated durability of response of 64% and 53% at the 12-month and 18-month landmarks, respectively In the...

Company to host webcast and conference call on November 17, 2025 at 8:00am ET CAMBRIDGE, Mass., Nov. 14, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical...

Encore pivotal efficacy and safety data from the ARROS-1 trial also to be presented during poster session CAMBRIDGE, Mass., Nov. 4, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a...

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...

Encouraging preliminary activity observed across diverse set of advanced ALK-positive solid tumors Global enrollment ongoing for adult and adolescent patients with advanced ALK-positive solid...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced an...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today presented pivotal...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

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...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that the...

Aligned with FDA on NDA submission strategy for TKI pre-treated patients with advanced ROS1-positive NSCLC and participation in Real-Time Oncology Review; the company plans to initiate a rolling...

Company to host webcast and conference call on June 24, 2025 at 8:00am ET CAMBRIDGE, Mass., June 23, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the...

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...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced two...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced upcoming...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Topline pivotal data expected in 2025 for both TKI pre-treated ROS1-positive and TKI pre-treated ALK-positive NSCLC populations First NDA submission planned for mid-year 2025 towards potential...

Strategy prioritizes most accelerated path to first potential approval Initial NDA submission expected by mid-year for zidesamtinib in TKI pre-treated ROS1-positive NSCLC population, with topline...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Achievement of all anticipated 2024 milestones and accelerated development timelines reinforce progress on OnTarget 2026 operating plan towards first approved product in 2026 Leading medical...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that it...

Updated Phase 1 dose-escalation data from ARROS-1 and ALKOVE-1 clinical trials continue to support potential best-in-class profiles for zidesamtinib and NVL-655 Rapid enrollment in Phase 2...

Publication provides comprehensive assessment of NVL-655's preclinical activity and includes preliminary clinical case studies CAMBRIDGE, Mass., Sept. 13, 2024 /PRNewswire/ -- Nuvalent, Inc....

Updated Phase 1 data from ALKOVE-1 and ARROS-1 clinical trials to be presented at the ESMO Congress 2024 Durable activity of NVL-655 and zidesamtinib in heavily pre-treated patient populations...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Company plans to host a conference call in conjunction with oral presentations at ESMO on September 14, 2024, at 8:30 a.m. ET/2:30 p.m. CEST $658.0 million in cash, cash equivalents and marketable...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that the...

Updates from the ongoing Phase 1/2 ARROS-1 and ALKOVE-1 clinical trials expected at a medical meeting in the second half of 2024 Strong financial position with operating runway anticipated into...

Preclinical data continue to support NVL-330's broad activity against HER2 oncogenic alterations, selectivity over wild-type EGFR, and differentiated brain-penetrant profile Zidesamtinib shown to...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced upcoming...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today highlighted...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that the...

Alignment with US Food and Drug Administration on a Recommended Phase 2 Dose for NVL-655 of 150 mg once daily Phase 2 Designed with Registrational Intent for TKI Pre-Treated Patients with...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Targeting first approved product in 2026 towards realizing mission of bringing new, potential best-in-class treatments to patients with cancer Well-capitalized to support OnTarget 2026 initiatives...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Presented preliminary Phase 1 clinical data from ALKOVE-1 trial of NVL-655, initiated Phase 2 portion of ARROS-1 trial of NVL-520, and continued advancement of NVL-330 toward clinical development...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that it...

Encouraging preliminary signs of activity observed in heavily pre-treated patients with ALK-positive NSCLC, including in subgroups of patients who have previously received a 2nd generation ALK TKI...

Updated preliminary data to be presented at the 35th AACR-NCI-EORTC Symposium Company plans to host a conference call on October 13, 2023 at 8:00am EDT CAMBRIDGE, Mass., Oct. 4, 2023 /PRNewswire/...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced it will...

Alignment with US Food and Drug Administration on a Recommended Phase 2 Dose for NVL-520 of 100 mg daily CAMBRIDGE, Mass., Sept. 5, 2023 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Continued execution across pipeline with clinical trials ongoing for NVL-520 and NVL-655, and advancement of NVL-330 toward clinical development Preliminary dose-escalation data anticipated from...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced plans to...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced an...

Significant progress made across pipeline of novel kinase inhibitors with parallel-lead programs in ongoing Phase 1 clinical trials and a third program advancing toward clinical development...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced an...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Nuvalent, Inc., (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Publication provides comprehensive assessment of NVL-520's activity spanning preclinical characterization and preliminary clinical case studies CAMBRIDGE, Mass., Dec. 13, 2022 /PRNewswire/ --...

Preliminary Phase 1 clinical data from ARROS-1 Study presented at the 2022 EORTC-NCI-AACR Symposium supports best-in-class potential of NVL-520 for patients with ROS1-positive NSCLC Enrollment...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that it...

Favorable preliminary safety profile of NVL-520 suggests potential for a highly ROS1-selective, TRK sparing design, with no dose-limiting toxicities, treatment-related serious adverse events,...

Preclinical data demonstrated that NVL-330 inhibits HER2 exon 20 insertion mutations, is selective for HER2 versus wild-type EGFR, and is brain-penetrant NVL-655 preclinical data further support...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the...

Preliminary Dose Escalation Data on ROS1-selective Inhibitor NVL-520 to be Presented in the "New Drugs on the Horizon" Oral Plenary Session New Preclinical Data to be Presented on Parallel-lead,...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...

Preliminary dose escalation data expected in second half of 2022 from the ARROS-1 study of NVL-520 for advanced ROS1 positive NSCLC and other solid tumors Rapid advancement of pipeline with...

Trial in progress poster also to be presented for Phase 1/2 ARROS-1 study of ROS1-selective inhibitor NVL-520 CAMBRIDGE, Mass., Aug. 5, 2022 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a...

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that...