News · 26 weeks74+22%
2025-10-262026-04-19
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25 items- PRNuvalent 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 MeetingCompany 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
- PRNew Clinical and Preclinical Data for Investigational Candidate Zidesamtinib Presented at AACR Annual Meeting 2026Zidesamtinib 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 mutationsPreclinical data support differentiated brain penetrance and intracranial activity as compared to repotrectinib and taletrectinibCAMBRIDGE, 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-selectiv
- INSIDERSEC Form 4 filed by Pelish Henry E.4 - Nuvalent, Inc. (0001861560) (Issuer)
- INSIDERSEC Form 4 filed by Porter James Richard4 - Nuvalent, Inc. (0001861560) (Issuer)
- SECNuvalent Inc. filed SEC Form 8-K: Other Events8-K - Nuvalent, Inc. (0001861560) (Filer)
- PRNuvalent Announces Submission of New Drug Application to FDA for Neladalkib in TKI Pre-treated Advanced ALK-positive NSCLCNew Drug Application (NDA) based on data in TKI pre-treated patients from the global ALKOVE-1 Phase 1/2 clinical trialCAMBRIDGE, 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. "The advancement of neladalkib from first
- INSIDERSEC Form 4 filed by Balcom Alexandra4 - Nuvalent, Inc. (0001861560) (Issuer)
- INSIDERSEC Form 4 filed by Lane Benjamin4 - Nuvalent, Inc. (0001861560) (Issuer)
- INSIDERSEC Form 4 filed by Noci Darlene4 - Nuvalent, Inc. (0001861560) (Issuer)
- INSIDERSEC Form 4 filed by Miller Deborah Ann4 - Nuvalent, Inc. (0001861560) (Issuer)
- ANALYSTWells Fargo initiated coverage on Nuvalent with a new price targetWells Fargo initiated coverage of Nuvalent with a rating of Overweight and set a new price target of $116.00
- SECAmendment: SEC Form SCHEDULE 13G/A filed by Nuvalent Inc.SCHEDULE 13G/A - Nuvalent, Inc. (0001861560) (Subject)
- INSIDERSEC Form 4 filed by Balcom Alexandra4 - Nuvalent, Inc. (0001861560) (Issuer)
- INSIDERSEC Form 3 filed by new insider Lane Benjamin3 - Nuvalent, Inc. (0001861560) (Issuer)
- PRNuvalent to Present New Preclinical and Clinical Data for Zidesamtinib, an Investigational ROS1-Selective Inhibitor, at AACR Annual Meeting 2026CAMBRIDGE, 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. The posters will highlight clinical data from a subset of TKI pre-treated patients with ROS1-positive NSCLC treated in the ARROS-1 Phase 1/2 clinical trial and preclinical data further characterizing zidesamtinib's brain penetra
- INSIDERChief Scientific Officer Pelish Henry E. exercised 17,320 shares at a strike of $31.52 and sold $3,442,856 worth of shares (35,104 units at $98.08), decreasing direct ownership by 21% to 65,604 units (SEC Form 4)4 - Nuvalent, Inc. (0001861560) (Issuer)
- INSIDERPresident and CEO Porter James Richard exercised 30,000 shares at a strike of $27.85 and sold $2,969,550 worth of shares (30,000 units at $98.99) (SEC Form 4)4 - Nuvalent, Inc. (0001861560) (Issuer)
- SECSEC Form 144 filed by Nuvalent Inc.144 - Nuvalent, Inc. (0001861560) (Subject)
- INSIDERChief Development Officer Noci Darlene exercised 5,500 shares at a strike of $27.85 and sold $566,682 worth of shares (5,500 units at $103.03) (SEC Form 4)4 - Nuvalent, Inc. (0001861560) (Issuer)
- INSIDERChief Legal Officer Miller Deborah Ann exercised 5,500 shares at a strike of $6.89 and sold $566,788 worth of shares (5,500 units at $103.05) (SEC Form 4)4 - Nuvalent, Inc. (0001861560) (Issuer)
- SECSEC Form S-8 filed by Nuvalent Inc.S-8 - Nuvalent, Inc. (0001861560) (Filer)
- SECSEC Form 10-K filed by Nuvalent Inc.10-K - Nuvalent, Inc. (0001861560) (Filer)
- SECNuvalent Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits8-K - Nuvalent, Inc. (0001861560) (Filer)
- PRNuvalent Outlines Recent Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports Fourth Quarter and Full Year 2025 Financial ResultsCommercial 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, 2026NDA submission for neladalkib in TKI pre-treated advanced ALK-positive NSCLC population planned for the first half of 2026Submission for potential label expansion of zidesamtinib in TKI-naïve advanced ROS1-positive NSCLC population planned for the second half of 2026Strong financial position with operating runway anticipated into 2029CAMBRIDGE, Mass., Feb. 26, 2026 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely
- SECAmendment: SEC Form SCHEDULE 13G/A filed by Nuvalent Inc.SCHEDULE 13G/A - Nuvalent, Inc. (0001861560) (Subject)