Nuvalent, INC 8-K filings

Nuvalent, Inc. has been acquired by GlaxoSmithKline LLC for approximately $10.6 billion in cash, with the merger officially closing on July 15, 2026.

Nuvalent, Inc. held its 2026 Annual Meeting of Stockholders, where directors were elected, executive compensation was approved, and the appointment of KPMG LLP as auditor was ratified.

GSK plc announced an agreement to acquire Nuvalent, Inc. for $10.6 billion, gaining a multi-product oncology portfolio including late-stage NSCLC treatments.

Nuvalent announced first quarter 2026 financial results, highlighting significant progress in its ROS1 and ALK programs with NDAs submitted and under FDA review, alongside reiterating key pipeline milestones and reporting financial performance.

Nuvalent has submitted a New Drug Application to the FDA for neladalkib, targeting advanced ALK-positive non-small cell lung cancer in pre-treated patients.

Nuvalent, Inc. announced significant pipeline advancements, reiterated key anticipated milestones, and reported fourth quarter and full year 2025 financial results, highlighting a robust cash position into 2029.

Nuvalent, Inc. announced significant progress in its oncology pipeline, including FDA acceptance of zidesamtinib's NDA and a strong financial position with cash runway into 2029.

Royalty Pharma has acquired a pre-existing 1.5% royalty interest in Nuvalent's investigational product candidates, neladalkib and zidesamtinib, for up to $315 million.

Nuvalent, Inc. announced a change to its Board of Directors with the resignation of Matthew Shair, Ph.D., and the immediate appointment of Ron Squarer as a new independent director.

Nuvalent, a clinical-stage biopharmaceutical company, announced the pricing of an underwritten public offering of Class A common stock, expecting to raise approximately $471.9 million in net proceeds to fund operations into 2029.

Nuvalent, Inc. announced positive topline pivotal data for its investigational ALK-selective inhibitor, neladalkib, in TKI pre-treated patients with advanced ALK-positive non-small cell lung cancer (NSCLC) from the ALKOVE-1 Phase 1/2 clinical trial.

Nuvalent, Inc. announced the completion of its rolling NDA submission for zidesamtinib and is on track for pivotal data for neladalkib by year-end 2025, alongside reporting third quarter 2025 financial results.

Nuvalent, Inc. announced the completion of its New Drug Application submission to the U.S. Food and Drug Administration for zidesamtinib in TKI pre-treated patients with advanced ROS1-positive NSCLC.

Nuvalent announced significant progress in its oncology pipeline, including an NDA submission for zidesamtinib and initiation of a Phase 3 trial for neladalkib, alongside its second-quarter 2025 financial results.

Nuvalent, Inc. announced the initiation and first patient dosing in its Phase 3 ALKAZAR clinical trial evaluating neladalkib for TKI-naive patients with advanced ALK-positive non-small cell lung cancer.

Nuvalent, Inc. announced positive pivotal data for its ROS1-selective inhibitor, zidesamtinib, in pre-treated advanced ROS1-positive non-small cell lung cancer patients, and outlined progress on its front-line development strategies for zidesamtinib and neladalkib.

Nuvalent, Inc. announced the election of Christy J. Oliger as an independent Class III director and Audit Committee member, alongside the successful ratification of all proposals at its 2025 Annual Meeting of Stockholders, including the election of Class I directors and approval of executive compensation.

Nuvalent, Inc. announced that Emily Conley will resign from its Board of Directors and all committee assignments, effective at the company's 2025 annual meeting of stockholders, with no reported disagreements regarding company operations or policies.

Nuvalent reports pipeline advancements, reiterates key milestones, and announces Q1 2025 financial results, highlighting progress in ROS1, ALK, and HER2 programs.

D. Gary Gilliland, M.D., Ph.D., will resign from Nuvalent's board of directors effective at the 2025 annual meeting, transitioning to a role on the company's scientific advisory board.

Nuvalent reports progress on its pipeline, reiterates key milestones, and announces fourth quarter and full year 2024 financial results, highlighting upcoming pivotal data and NDA submissions.

Nuvalent details its strategy to potentially achieve its first FDA approval in 2026, focusing on zidesamtinib for TKI pre-treated ROS1-positive NSCLC, and highlights key milestones expected in 2025.

Nuvalent, Inc. has appointed Grant Bogle to its Board of Directors and approved a new form of performance-based restricted stock unit agreement.

Nuvalent reports achievement of all 2024 milestones, a strong cash position of $1.2 billion, and progress in its clinical trials for cancer therapies.

Nuvalent, a clinical-stage biopharmaceutical company, has announced the pricing of an upsized public offering of 5,000,000 shares of Class A common stock at $100.00 per share, expected to close on September 18, 2024.

Nuvalent presented updated clinical data at the ESMO Congress 2024, highlighting progress in its ROS1 and ALK inhibitor programs and accelerating development timelines.

Nuvalent announced its second quarter 2024 financial results, highlighted progress in its clinical pipeline, and reiterated its goal of bringing a first product to market by 2026.

Nuvalent, Inc. has commenced its Phase 1a/1b clinical trial, HEROEX-1, evaluating NVL-330, a novel HER2-selective inhibitor, in pre-treated patients with HER2-altered non-small cell lung cancer.

Nuvalent, Inc. successfully held its 2024 Annual Meeting of Stockholders, electing three Class III directors and approving several key proposals.

Nuvalent's NVL-655 has been granted breakthrough therapy designation by the FDA for treating advanced ALK-positive non-small cell lung cancer after multiple prior treatments.