Nuvalent

NUVL

Market cap $8.1B

Nuvalent, Inc. (NUVL) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript

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 TKI pre-treated advanced ALK-positive NSCLC population planned for the first half of 2026 Submission for potential indication expansion of zidesamtinib in TKI-naïve advanced ROS1-positive NSCLC population planned for the second half of 2026 Well capitalized with operating runway anticipated into 2029 Company to present at 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13th at 9:00 a.m.

Biotech's 2025 rebound sets the stage for Denali Therapeutics and two peers, with key FDA decisions and pipeline catalysts lined up for 2026.

CAMBRIDGE, Mass. , Dec. 22, 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. , 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.

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.