Welcome to our dedicated page for Nuvalent news (Ticker: NUVL), a resource for investors and traders seeking the latest updates and insights on Nuvalent stock.
Nuvalent, Inc. develops precisely targeted small-molecule therapies for clinically proven kinase targets in cancer. Its news centers on investigational programs including zidesamtinib for ROS1-positive NSCLC, neladalkib for ALK-positive NSCLC, and HER2-altered NSCLC research, with updates on clinical data from ARROS-1 and ALKOVE-1, FDA submission activity, companion-diagnostic collaborations, and discovery-stage programs.
Company updates also cover quarterly financial results, research and development spending, cash resources, commercial-readiness activities for potential oncology launches, medical-meeting presentations, and leadership or governance developments tied to its clinical-stage biopharmaceutical model.
Nuvalent (Nasdaq: NUVL) will present pivotal neladalkib data and preliminary zidesamtinib data at the 2026 ASCO Annual Meeting in Chicago (May 29–June 2, 2026).
Neladalkib ALKOVE-1 data in TKI pre-treated advanced ALK-positive NSCLC supported a recent FDA NDA and ongoing Phase 3 ALKAZAR. Zidesamtinib ARROS-1 data in 15 ROS1-positive solid tumor patients (non-NSCLC) showed a 40% objective response rate and a generally well-tolerated safety profile.
Nuvalent (Nasdaq: NUVL) reported Q1 2026 results and pipeline progress on May 7, 2026. Key items: zidesamtinib NDA under FDA review with a PDUFA date of September 18, 2026; neladalkib NDA submitted for TKI‑pretreated ALK NSCLC; planned zidesamtinib label expansion submission in H2 2026. Cash, cash equivalents and marketable securities totaled $1.3 billion as of March 31, 2026, expected to fund operations into 2029. Q1 expenses: R&D $83.6M, G&A $35.8M; net loss $109.3M. Leadership promotions announced; ongoing Phase 3 ALKAZAR enrollment and ASCO presentations planned.
Guardant Health (Nasdaq: GH) announced a multi-year global collaboration with Nuvalent (Nasdaq: NUVL) to use Guardant’s tissue and liquid biopsy portfolio, including the Guardant Infinity™ platform, to support Nuvalent clinical studies and evaluate companion diagnostic (CDx) development and potential joint commercialization.
The partnership will: use Guardant tissue and liquid tests in certain Nuvalent global trials; assess Guardant assays as potential CDx for Nuvalent investigational candidates; and collaborate on global commercialization of Nuvalent therapies and Guardant CDx if approvals occur.
Nuvalent (Nasdaq: NUVL) will present pivotal Phase 1/2 ALKOVE-1 data for neladalkib in TKI pre-treated advanced ALK-positive NSCLC and preliminary TKI-naïve data during an oral session at ASCO 2026 on May 29, 2026. The company will also present ARROS-1 poster data for zidesamtinib in ROS1-positive non-NSCLC tumors on May 30, 2026.
Oral presentation details: Abstract 8503, May 29, 1:00 PM–4:00 PM CDT, Hall D2. Poster details: Abstract 3108/Board 2451, May 30, 1:30 PM–4:30 PM CDT, Hall A.
Nuvalent (Nasdaq: NUVL) presented clinical and preclinical data for investigational zidesamtinib at AACR 2026 showing activity in heavily pretreated ROS1+ NSCLC, including patients previously treated with repotrectinib or taletrectinib.
Key points: FDA accepted the NDA with a PDUFA date of Sept 18, 2026; ARROS-1 subgroup ORR was 41% after repotrectinib and 47% after taletrectinib; intracranial responses and activity versus ROS1 G2032R were reported; preclinical data showed higher brain penetrance versus comparator TKIs.
Nuvalent (Nasdaq: NUVL) submitted a New Drug Application to the FDA on April 7, 2026 for neladalkib, an investigational ALK-selective inhibitor for TKI pre-treated advanced ALK-positive NSCLC.
The NDA is supported by data from the global, registration-directed ALKOVE-1 Phase 1/2 trial showing overall activity, intracranial responses and a generally well-tolerated safety profile. Neladalkib holds Breakthrough Therapy and Orphan Drug designations from the FDA; detailed efficacy and safety results will be shared at a future medical meeting.
Nuvalent (Nasdaq: NUVL) will present new preclinical and clinical data for zidesamtinib, an investigational ROS1-selective inhibitor, at the AACR Annual Meeting 2026 in San Diego on April 21, 2026.
Two poster sessions report clinical data from TKI pre-treated ROS1+ NSCLC patients in the ARROS-1 Phase 1/2 trial and preclinical brain penetrance and intracranial activity comparisons versus other ROS1 inhibitors.
Poster details include authors Geoffrey Liu, M.D. and Anupong Tangpeerachaikul, Ph.D., abstract numbers CT248 and LB366, and poster locations and times for April 21, 2:00-5:00 p.m. PT.
Nuvalent (Nasdaq: NUVL) reported pipeline progress and 2025 results. Key items: FDA accepted an NDA for zidesamtinib with a PDUFA date of Sept 18, 2026; an NDA for neladalkib in pre-treated ALK-positive NSCLC is planned H1 2026. The company raised $500.0M in Nov 2025 and held $1.4B cash as of Dec 31, 2025, providing runway into 2029.
Ongoing trials include ALKAZAR (Phase 3), HEROEX-1 (Phase 1a/1b), and a planned label expansion submission for zidesamtinib in H2 2026.
Nuvalent (Nasdaq: NUVL) announced that CEO James Porter, Ph.D., and CFO Alexandra Balcom will take part in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit 2026 on Thursday, February 12, 2026 at 1:30 p.m. ET in New York City.
A live webcast will be available in the Investors section of Nuvalent's website and archived for 30 days after the presentation.
Nuvalent (Nasdaq: NUVL) reported progress under its OnTarget 2026 plan and outlined anticipated 2026 milestones, including FDA acceptance of the zidesamtinib NDA for TKI pre-treated ROS1-positive NSCLC with a PDUFA date of Sept 18, 2026.
The company plans an NDA submission for neladalkib in TKI pre-treated ALK-positive NSCLC in H1 2026, a potential zidesamtinib expansion filing in TKI-naïve ROS1-positive NSCLC in H2 2026, continued Phase 3 and Phase 1 trial progress, disclosure of a new development candidate by year-end 2026, and a commercial launch in the U.S. if approved.
Nuvalent ended 2025 with approximately $1.4 billion in cash, cash equivalents and marketable securities, which it says is expected to fund operations into 2029.