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. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company developing precisely targeted kinase inhibitors for oncogene-driven cancers, with a focus on non-small cell lung cancer (NSCLC). The NUVL news feed on Stock Titan aggregates company announcements, press releases, and related coverage so readers can follow how its pipeline and regulatory interactions progress over time.
According to Nuvalent’s disclosures, its lead investigational programs include zidesamtinib, a ROS1-selective inhibitor for ROS1-positive NSCLC, and neladalkib, an ALK-selective inhibitor for ALK-positive NSCLC. News items often highlight pivotal and preliminary data from the ARROS-1 and ALKOVE-1 Phase 1/2 trials, updates on the ALKAZAR Phase 3 trial in TKI-naïve ALK-positive NSCLC, and information about design features such as brain penetrance and activity against resistance mutations.
Investors and observers can also find coverage of Nuvalent’s regulatory milestones, including FDA breakthrough therapy and orphan drug designations, New Drug Application (NDA) submissions and acceptances, and PDUFA target action dates. Corporate developments such as public equity offerings, cash runway guidance, royalty arrangements on future net sales of zidesamtinib and neladalkib, and board appointments are regularly disclosed through press releases and Form 8-K filings and are reflected in the news flow.
For those tracking NUVL, this news stream provides a centralized view of clinical trial readouts, conference presentations, financing activities, and strategic updates that shape the company’s outlook in targeted oncology. Bookmarking the NUVL news page on Stock Titan can help readers quickly review new disclosures and place them in the context of Nuvalent’s broader development strategy.
Nuvalent (Nasdaq: NUVL) will host a webcast and conference call on Monday, November 17, 2025 at 8:00 a.m. ET to discuss topline pivotal data for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated patients with advanced ALK-positive non-small cell lung cancer from the global ALKOVE-1 Phase 1/2 trial.
Live audio, accompanying slides and a video webcast will be available in the Investors section of Nuvalent's website at https://investors.nuvalent.com/events. Dial-in access is +1 (800) 836-8184 (US) or +1 (646) 357-8785 (international). A replay and slides will be archived on the site for 30 days.
Nuvalent (Nasdaq: NUVL) will present patient-reported outcomes from the Phase 2 portion of the ARROS-1 trial of zidesamtinib, a ROS1-selective investigational inhibitor, plus encore pivotal efficacy and safety data from ARROS-1.
Two poster presentations are scheduled at the 2025 IASLC ASCO North America Conference on Lung Cancer in Chicago (Dec 5-7, 2025): Abstract PP01.41 (PROs and health-related quality of life) and Abstract PP01.32 (pivotal efficacy and safety). Both posters are on Saturday, December 6, 2025, 4:00-5:30 p.m. ET, presented by Melissa Laurie, Pharm.D., M.S., M.B.A., and Stephen V. Liu, M.D.
Nuvalent (Nasdaq: NUVL) reported third quarter 2025 results and pipeline progress, including completion of a rolling NDA submission for zidesamtinib in TKI pre-treated ROS1-positive NSCLC and an on‑track timeline to report topline pivotal data for neladalkib in TKI pre-treated ALK-positive NSCLC by year-end 2025.
The company highlighted preliminary neladalkib activity in ALK-positive solid tumors, new preclinical NVL-330 data showing brain penetration and intracranial regressions, ongoing Phase 3 ALKAZAR and Phase 1 HEROEX-1 trials, and a cash position of $943.1M supporting runway into 2028. Q3 expenses: R&D $83.8M, G&A $28.9M; net loss $122.4M.
Nuvalent (NASDAQ: NUVL) reported preliminary ALKOVE-1 data for neladalkib in advanced ALK-positive solid tumors beyond NSCLC with a data cutoff of August 7, 2025. Among 34 response-evaluable patients across 14 tumor types, overall objective response rate was 44% (15/34), including 9/13 ALK TKI‑naïve and 6/21 TKI‑pretreated patients. Most patients (32/34) received the recommended Phase 2 dose of 150 mg once daily.
Responses included durable case-study responses ongoing ~10–16 months and one confirmed intracranial complete response. Safety was described as generally well-tolerated with 8.8% dose reductions and no treatment-related discontinuations as of cutoff. Global Phase 2 enrollment continues; topline pivotal NSCLC data expected by end of 2025.
Nuvalent (Nasdaq: NUVL) will present new preclinical data for its HER2-selective inhibitor NVL-330 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, held October 22–26, 2025 in Boston.
The poster, titled “Preclinical intracranial activity of NVL-330, a selective HER2 tyrosine kinase inhibitor” (Abstract No. B057), is authored by Yuting Sun and colleagues and will be presented during Poster Session B on Friday, October 24, 2025, 12:30–4:00 p.m. ET in Exhibit Hall D. Yuting Sun is listed as presenter and corresponding author.
Nuvalent (Nasdaq: NUVL), a clinical-stage biopharmaceutical company developing targeted cancer therapies, has announced its participation in the upcoming UBS 2025 Virtual Oncology Day. The company's CEO James Porter, Ph.D., and CFO Alexandra Balcom will engage in a fireside chat on October 1, 2025, at 3:30 p.m. ET.
Investors can access the live webcast through Nuvalent's website investor section, where it will remain available for 30 days after the presentation.
Nuvalent (Nasdaq: NUVL) presented pivotal data for zidesamtinib, its novel ROS1-selective inhibitor, for treating TKI pre-treated patients with advanced ROS1-positive NSCLC at WCLC 2025. The data, initially announced in June 2025, supports the company's ongoing rolling NDA submission to the FDA.
The FDA has accepted the NDA for the Real-Time Oncology Review (RTOR) program, enabling earlier submission of efficacy and safety results. Nuvalent expects to complete the rolling NDA submission in Q3 2025 and is exploring potential line-agnostic expansion opportunities with the FDA.
The drug aims to address unmet needs in ROS1-positive NSCLC patients, particularly those intolerant to current TKIs or experiencing disease progression with brain metastases or resistance mutations.
Nuvalent (Nasdaq: NUVL), a clinical-stage biopharmaceutical company developing targeted cancer therapies, has announced its participation in the upcoming Cantor Global Healthcare Conference 2025. The company's leadership, including CEO James Porter, Ph.D., and CFO Alexandra Balcom, will engage in a fireside chat on September 4, 2025, at 9:45 a.m. ET in New York City.
Investors can access a live webcast of the presentation through Nuvalent's website, where it will remain available for 30 days after the event.
Nuvalent (Nasdaq: NUVL) announced that pivotal data from their ARROS-1 Phase 1/2 clinical trial for zidesamtinib, their novel ROS1-selective inhibitor, will be presented at the WCLC 2025 Presidential Symposium in Barcelona. The presentation will showcase results for both TKI pre-treated and TKI-naïve patients with advanced ROS1-positive non-small cell lung cancer (NSCLC).
The company has initiated a rolling NDA submission for zidesamtinib in TKI pre-treated patients, with FDA accepting it under the Real-Time Oncology Review (RTOR) pilot program. Nuvalent targets completion of the NDA submission in Q3 2025 and is exploring potential line-agnostic expansion opportunities with the FDA.
Nuvalent (Nasdaq: NUVL) reported significant pipeline progress and Q2 2025 financial results. The company initiated a rolling NDA submission for zidesamtinib for ROS1-positive NSCLC treatment, targeting completion in Q3 2025. They also launched the ALKAZAR Phase 3 trial of neladalkib for front-line ALK-positive NSCLC.
Key developments include the promotion of Jason Waters to SVP, Commercial and appointment of Christy Oliger to the board. The company maintains a strong financial position with $1.0 billion in cash as of June 30, 2025, expected to fund operations into 2028. Q2 2025 financial results showed R&D expenses of $80.9M, G&A expenses of $23.7M, and a net loss of $99.7M.
Upcoming milestones include topline pivotal data for neladalkib in ALK-positive NSCLC by year-end 2025 and preliminary data presentation at ESMO Congress 2025 for ALK-positive solid tumors beyond NSCLC.