Gewinn- und Verlust: Nuvalent, Inc.

Nuvalent, Inc. (NASDAQ: NUVL) on Monday reported topline results from its ALKOVE-1 Phase 1/2 trial.

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 subset of 63 TKI pre-treated patients who were lorlatinib-naïve, ORR by BICR was 46% (95% CI: 33, 59), with initial estimated durability of response of 80% and 60% at the 12- and 18-month landmarks, respectively Neladalkib demonstrated intracranial responses, ability to address key drivers of disease progression, and a generally well-tolerated safety profile with low rates of dose discontinuation (5%) and dose reduction (17%) due to TEAEs, consistent with its ALK-selective, TRK-sparing design Company plans to discuss pivotal data for the TKI pre-treated ALK-positive NSCLC population with the FDA at a pre-NDA meeting; detailed study results are planned for presentation at a future medical meeting Company to host a conference call today, November 17 th at 8:00am ET CAMBRIDGE, Mass. , Nov. 17, 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 announced positive topline pivotal data for neladalkib, an investigational ALK-selective inhibitor, in tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ALK-positive non-small cell lung cancer (NSCLC) from the global ALKOVE-1 Phase 1/2 clinical trial.

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 company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that the company will host a webcast and conference call on Monday, November 17, 2025 at 8:00 a.m.

NUVL is approaching the precipice of a first targeted therapy approval in lung cancer. They also have an increasingly deep pipeline of therapies, with an audacious phase 3 trial spinning up in ALK-positive NSCLC. Cash position remains strong as well, but the market is pricing in too much success for me to be comfortable at this time.

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 clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the first presentation of patient-reported outcomes data from the Phase 2 portion of the ARROS-1 Phase 1/2 clinical trial of zidesamtinib, an investigational ROS1 inhibitor, as well as encore pivotal efficacy and safety data from the ARROS-1 trial, during two poster presentations at the 2025 IASLC ASCO North America Conference on Lung Cancer being held December 5-7, 2025 in Chicago.

Cwm LLC boosted its holdings in Nuvalent, Inc. (NASDAQ: NUVL) by 253.8% in the undefined quarter, according to the company in its most recent 13F filing with the Securities and Exchange Commission (SEC). The fund owned 1,486 shares of the company's stock after purchasing an additional 1,066 shares during the quarter. Cwm LLC's

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.

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 tumors beyond NSCLC in a Phase 2 cohort of the ALKOVE-1 trial CAMBRIDGE, Mass. , Oct. 18, 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 announced preliminary data from the ongoing ALKOVE-1 Phase 1/2 clinical trial of neladalkib, an investigational ALK-selective inhibitor, in patients with advanced ALK-positive solid tumors outside of non-small cell lung cancer (NSCLC).

CAMBRIDGE, Mass. , Oct. 13, 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 announced an upcoming poster presentation further characterizing the preclinical intracranial activity of its novel HER2-selective inhibitor, NVL-330, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held October 22-26, 2025 in Boston.

Nuvalent, Inc. (NASDAQ:NUVL ) UBS Virtual Oncology Day October 1, 2025 3:30 PM EDT Company Participants James Porter - CEO, President & Director Alexandra Balcom - CFO & Treasurer Conference Call Participants Xiaochuan Dai - UBS Investment Bank, Research Division Presentation Operator Welcome to the UBS Virtual Event. David Dai, you may begin.