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
Rhea-AI Summary
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.
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News Market Reaction – NUVL
In the Apr 21 session, NUVL declined 1.03%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Apr 07 | NDA submission | Positive | -1.4% | Filed FDA NDA for neladalkib in TKI pre-treated ALK-positive NSCLC. |
| Mar 17 | Clinical data update | Positive | -1.6% | Announced new preclinical and ARROS-1 clinical data for zidesamtinib at AACR. |
| Feb 26 | Earnings and pipeline | Positive | -0.6% | Reported 2025 results, FDA acceptance of zidesamtinib NDA, strong cash and runway. |
| Feb 05 | Conference participation | Positive | -3.9% | Announced executive participation in Guggenheim biotech summit fireside chat. |
| Jan 12 | Milestone outlook | Positive | -5.6% | Outlined OnTarget 2026 plan, key NDA and trial milestones, and cash runway. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent Nuvalent news, often positive on pipeline and milestones, has been followed by short-term share declines.
Over the last few months, Nuvalent has transitioned its lead assets from late-stage development toward regulatory review. On Apr 7, 2026, it submitted an NDA for neladalkib in TKI pre-treated ALK-positive NSCLC, backed by ALKOVE-1 data. Earlier, it highlighted new zidesamtinib data at AACR and reported strong cash of $1.4B and financing of $500.0M for runway into 2029. Despite these constructive updates, shares frequently traded down after prior announcements, framing today’s ASCO presentation news against a backdrop of cautious short-term reactions.
Key Terms
non-small cell lung cancer medical
nsclc medical
alk-positive medical
alk-selective inhibitor medical
ros1-positive medical
ros1-selective inhibitor medical
phase 1/2 clinical trial medical
oral presentation technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Company to also present preliminary data for zidesamtinib in advanced ROS1-positive solid tumors outside of NSCLC from the global ARROS-1 trial
Additionally, preliminary data in patients with advanced ROS1-positive solid tumors outside of NSCLC from the global ARROS-1 Phase 1/2 clinical trial of zidesamtinib, an investigational ROS1-selective inhibitor, will be presented during a poster session.
Details of the presentations are as follows:
Title: ALKOVE-1: Efficacy and safety of neladalkib in patients with advanced ALK+ NSCLC
Presenting Author: Jessica J. Lin, M.D.1
Abstract Number: 8503
Oral Session Title: Lung Cancer—Non-Small Cell Metastatic
Presentation Date and Time: May 29, 2026, 1:00 PM-4:00 PM CDT
Location: Hall D2
Title: Zidesamtinib efficacy and safety in patients with advanced ROS1-positive solid tumors other than NSCLC in the ARROS-1 study
Presenting Author: Benjamin Solomon, M.D., Ph.D.2
Abstract Number: 3108
Poster Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT
Location: Hall A
Poster Board Number: 245
1 Mass General Brigham Cancer Institute,
About Neladalkib
Neladalkib is an investigational, brain-penetrant, ALK-selective inhibitor created with the aim to overcome limitations observed with currently available ALK inhibitors. Neladalkib is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with single or compound treatment-emergent ALK mutations such as G1202R. In addition, neladalkib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and to drive deep, durable responses for patients across all lines of therapy. Neladalkib has received breakthrough therapy designation from the
About Zidesamtinib
Zidesamtinib is an investigational, brain-penetrant, ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy.
Based on results for tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) enrolled in the global registrational ARROS-1 Phase 1/2 clinical trial, the
About Nuvalent
Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses. Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Nuvalent's strategy, business plans, and focus; the expected timing of data announcements; the clinical development programs for zidesamtinib and neladalkib; the potential benefits and effects of Nuvalent's product development candidates; the design of Nuvalent's clinical trials, including for the ARROS-1 trial its intended pivotal registration-directed design; the potential of Nuvalent's pipeline programs, including zidesamtinib and neladalkib; Nuvalent's research and development programs for the treatment of cancer; and risks and uncertainties associated with drug development. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "aim," "goal," "intend," "believe," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target" or the negative of these terms and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. You should not place undue reliance on these statements or the scientific data presented.
Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation: unexpected concerns that may arise from additional data, analysis, or results obtained during preclinical studies and clinical trials; the risk that results of earlier clinical trials may not be predictive of the results of later-stage clinical trials; the risk that data from our clinical trials may not be sufficient to support registration and that Nuvalent may be required to conduct one or more additional studies or trials prior to seeking registration of our zidesamtinib product candidate; the occurrence of adverse safety events; risks that the FDA may not approve our potential products on the timelines we expect, or at all; risks of unexpected costs, delays, or other unexpected hurdles; risks that Nuvalent may not be able to nominate drug candidates from its discovery programs; the direct or indirect impact of public health emergencies or global geopolitical circumstances on the timing and anticipated timing and results of Nuvalent's clinical trials, strategy, and future operations; the timing and outcome of Nuvalent's planned interactions with regulatory authorities; and risks related to obtaining, maintaining, and protecting Nuvalent's intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Nuvalent's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as well as any prior and subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Nuvalent's views only as of today and should not be relied upon as representing its views as of any subsequent date. Nuvalent explicitly disclaims any obligation to update any forward-looking statements.
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