Nuvalent Highlights Recent Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2026 Financial Results

NDA submitted for neladalkib in TKI pre-treated advanced ALK-positive NSCLC NDA for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC under FDA review with PDUFA target action date of September 18, 2026 Submission for potential label expansion of zidesamtinib in TKI-naïve advanced ROS1-positive NSCLC planned for the second half of 2026 Strengthened leadership team with key internal promotions CAMBRIDGE, Mass., May 7, 2026 /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 first quarter 2026 financial results.

PRNewsWire • May 7, 2026

Nuvalent: A Precision Oncology Platform With Two Near-Term Shots On Goal

Nuvalent is positioned as a high-quality late-stage biotech with two near-commercial precision oncology assets, not a traditional value play. NUVL's robust $1.37B cash position and recent $500M raise provide operational runway through 2029, supporting commercialization and expansion without near-term financing risk. Zidesamtinib's NDA for ROS1-positive NSCLC is accepted with a PDUFA date of September 2026; neladalkib NDA submission is planned for 1H 2026, targeting major unmet needs.

Seeking Alpha • Apr 30, 2026

Guardant Health Announces Multi-Year Strategic Collaboration with Nuvalent to Develop Companion Diagnostics and Support Potential Commercialization of Targeted Cancer Therapies Using the Guardant Infinity™ Platform

PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced a multi-year strategic collaboration with Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, to support the development and potential commercialization of Nuvalent's oncology pipeline using the tissue and liquid offerings of the Guardant Infinity™ platf.

Business Wire • Apr 30, 2026

Nuvalent to Present Pivotal Data from ALKOVE-1 Trial of Neladalkib in TKI Pre-treated Advanced ALK-positive NSCLC at the 2026 American Society of Clinical Oncology Annual Meeting

Company to also present preliminary data for zidesamtinib in advanced ROS1-positive solid tumors outside of NSCLC from the global ARROS-1 trial CAMBRIDGE, Mass., April 21, 2026 /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 pivotal data for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated patients with advanced ALK-positive non-small cell lung cancer (NSCLC) from the global ALKOVE-1 Phase 1/2 clinical trial, in addition to preliminary data for TKI-naïve patients, will be presented during an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting from May 29 – June 2, 2026, in Chicago.

PRNewsWire • Apr 21, 2026

New Clinical and Preclinical Data for Investigational Candidate Zidesamtinib Presented at AACR Annual Meeting 2026

Zidesamtinib demonstrated meaningful clinical activity in subset of TKI pre-treated ROS1-positive NSCLC patients from ARROS-1 trial previously treated with repotrectinib or taletrectinib, including in those with CNS disease or ROS1 resistance mutations Preclinical data support differentiated brain penetrance and intracranial activity as compared to repotrectinib and taletrectinib CAMBRIDGE, Mass., April 17, 2026 /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 new clinical and preclinical data for zidesamtinib, an investigational ROS1-selective inhibitor, to be presented during poster sessions at the American Association for Cancer Research (AACR) Annual Meeting 2026 being held April 17-22 in San Diego.

PRNewsWire • Apr 17, 2026

Nuvalent Announces Submission of New Drug Application to FDA for Neladalkib in TKI Pre-treated Advanced ALK-positive NSCLC

New Drug Application (NDA) based on data in TKI pre-treated patients from the global ALKOVE-1 Phase 1/2 clinical trial CAMBRIDGE, Mass., April 7, 2026 /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 submission to the U.S. Food and Drug Administration (FDA) of the Company's NDA for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated advanced ALK-positive NSCLC.

PRNewsWire • Apr 7, 2026

Nuvalent to Present New Preclinical and Clinical Data for Zidesamtinib, an Investigational ROS1-Selective Inhibitor, at AACR Annual Meeting 2026

CAMBRIDGE, Mass., March 17, 2026 /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 presentation of new data for zidesamtinib, an investigational ROS1-selective inhibitor, during two poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2026, being held April 17-22 in San Diego.

PRNewsWire • Mar 17, 2026

This Investor Sold $104 Million of Nuvalent Stock Amid Cancer Drug Developer's Nearly 30% Rally

Vestal Point Capital sold 1,054,000 Nuvalent shares in the fourth quarter, an estimated $103.93 million trade based on quarterly average pricing. The fund's quarter-end Nuvalent position value declined by $90.50 million, reflecting both trading activity and stock price movement.

The Motley Fool • Mar 17, 2026

Does Nuvalent (NUVL) Have the Potential to Rally 37.26% as Wall Street Analysts Expect?

The average of price targets set by Wall Street analysts indicates a potential upside of 37.3% in Nuvalent (NUVL). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.

Zacks Investment Research • Feb 27, 2026

Nuvalent Outlines Recent Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports Fourth Quarter and Full Year 2025 Financial Results

Commercial preparations well underway to support potential U.S. launch of zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC population, pending FDA review; 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 label expansion of zidesamtinib in TKI-naïve advanced ROS1-positive NSCLC population planned for the second half of 2026 Strong financial position with operating runway anticipated into 2029 CAMBRIDGE, Mass., Feb. 26, 2026 /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 fourth quarter and full year 2025 financial results.

PRNewsWire • Feb 26, 2026