Nuvalent

NUVL

Market cap $8.15B

CAMBRIDGE, Mass. , Nov. 26, 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 James Porter, Ph.D.

CAMBRIDGE, Mass. , Nov. 24, 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 closing of its previously announced underwritten public offering of 4,950,496 shares of Class A common stock at a price to the public of $101.00 per share.

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: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for zidesamtinib, an investigational ROS1-selective inhibitor, 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).

Sold 1,447,267 shares, a net position change of $110.43 million Post-trade stake: 0 shares, $0 value The position was previously 13.8% of the fund's AUM as of the prior quarter, marking a significant portfolio shift

CAMBRIDGE, Mass. , Nov. 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 the pricing of an underwritten public offering of shares of Class A common stock at a price to the public of $101.00 per share.

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 that it has commenced an underwritten public offering of shares of Class A common stock.

Nuvalent, Inc. ( NUVL ) Discusses Topline Pivotal Data From ALKOVE-1 Trial of Neladalkib in ALK-Positive Non-Small Cell Lung Cancer November 17, 2025 8:00 AM EST Company Participants Chelcie Lister James Porter - CEO, President & Director Christopher Turner - Chief Medical Officer Alexandra Balcom - CFO & Treasurer Darlene Noci - Chief Development Officer Conference Call Participants Bradley Canino - Guggenheim Securities, LLC, Research Division Marc Frahm - TD Cowen, Research Division Laura Prendergast - Stifel, Nicolaus & Company, Incorporated, Research Division Anupam Rama - JPMorgan Chase & Co, Research Division Andrew Berens - Leerink Partners LLC, Research Division Yue-Wen Zhu - LifeSci Capital, LLC, Research Division Joshua Schimmer - Cantor Fitzgerald & Co., Research Division Jin Law - Goldman Sachs Group, Inc., Research Division Kelsey Goodwin - Piper Sandler & Co., Research Division Samuel Alexander Leach - Raymond James & Associates, Inc., Research Division Etzer Darout - Barclays Bank PLC, Research Division Swayampakula Ramakanth - H.C. Wainwright & Co, LLC, Research Division Xiaochuan Dai - UBS Investment Bank, Research Division Colleen Hanley - Robert W.

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

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

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.