GSK plc (LSE/NYSE: GSK) today announced that it has entered an agreement to acquire Nuvalent, Inc. (“Nuvalent”) (NASDAQ: NUVL) a Boston-based clinical-stage biopharmaceutical company focused...

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....