Nuvalent Appoints Ron Squarer to Board of Directors

CAMBRIDGE, Mass. , Dec. 10, 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 appointment of Ron Squarer to its Board of Directors.

PRNewsWire • Dec 10, 2025

Nuvalent to Participate in the Piper Sandler 37th Annual Healthcare Conference

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.

PRNewsWire • Nov 26, 2025

Nuvalent Announces Closing of Public Offering of Common Stock and Full Exercise by Underwriters of Option to Purchase Additional Shares from Selling Stockholders

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.

PRNewsWire • Nov 24, 2025

Biotech Stock Gets Booted in Latest Fund Update

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

The Motley Fool • Nov 19, 2025

Nuvalent Announces FDA Acceptance of New Drug Application for Zidesamtinib for the Treatment of TKI Pre-treated Patients with Advanced ROS1-positive NSCLC

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).

PRNewsWire • Nov 19, 2025

Nuvalent Announces Pricing of Public Offering of Common Stock

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.

PRNewsWire • Nov 19, 2025

Nuvalent Unveils A New Promise For Hard-To-Treat Lung Cancer

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

Investors Business Daily • Nov 17, 2025

Nuvalent Reports 31% Response Rate In Patients With Advanced Form Of Lung Cancer

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

Benzinga • Nov 17, 2025

Nuvalent, Inc. (NUVL) Discusses Topline Pivotal Data From ALKOVE-1 Trial of Neladalkib in ALK-Positive Non-Small Cell Lung Cancer Transcript

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.

Seeking Alpha • Nov 17, 2025

Nuvalent Announces Positive Topline Pivotal Data from ALKOVE-1 Clinical Trial of Neladalkib for TKI Pre-treated Patients with Advanced ALK-positive NSCLC

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.

PRNewsWire • Nov 17, 2025