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. (NUVL) is a clinical-stage biopharmaceutical company pioneering targeted therapies for cancer treatment resistance and brain metastases. This page serves as the definitive source for Nuvalent-related news, offering investors and researchers centralized access to essential updates.
Find timely press releases covering clinical trial progress, regulatory milestones, and strategic collaborations. Our curated collection includes updates on ROS1, ALK, and HER2 inhibitor development programs alongside scientific presentations and partnership announcements.
Key content categories include:
- Clinical trial results for novel small molecule therapies
- Regulatory filings and FDA communications
- Research publications demonstrating therapeutic mechanisms
- Corporate partnerships advancing oncology innovation
Bookmark this page for streamlined tracking of Nuvalent's progress in developing precision oncology treatments. Check regularly for authoritative updates directly from company filings and verified sources.
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.
Nuvalent (NASDAQ: NUVL) has initiated ALKAZAR, a global Phase 3 randomized controlled trial evaluating neladalkib for treatment-naive patients with advanced ALK-positive non-small cell lung cancer (NSCLC). The study will compare neladalkib against ALECENSA® (alectinib), a current front-line standard treatment.
The trial will enroll approximately 450 TKI-naïve patients, randomized 1:1 to receive either neladalkib or alectinib monotherapy. The primary endpoint is progression-free survival (PFS), with multiple secondary endpoints including overall survival and intracranial response measures.
Neladalkib is also being evaluated in the ALKOVE-1 Phase 1/2 trial, where Phase 1 data showed durable clinical responses in heavily pre-treated patients, including those with brain metastases and resistance mutations. Topline pivotal data from ALKOVE-1's Phase 2 portion is expected by year-end 2025.
Nuvalent (NASDAQ:NUVL) announced positive pivotal data from the ARROS-1 clinical trial of zidesamtinib for ROS1-positive NSCLC patients. The drug showed an overall response rate (ORR) of 44% in 117 TKI pre-treated patients, with 78% durability at 12 months. In patients treated with one prior ROS1 TKI, the ORR increased to 51% with 93% durability at both 12 and 18 months.
The company has aligned with FDA on NDA submission strategy and plans to initiate a rolling NDA submission in July 2025, targeting completion in Q3 2025. Zidesamtinib demonstrated strong intracranial responses, effectiveness against ROS1 G2032R resistance mutation, and a well-tolerated safety profile with only 10% dose reduction and 2% discontinuation rates.
Nuvalent (NASDAQ: NUVL) has announced it will host a webcast and conference call on June 24, 2025, at 8:00 AM ET to present pivotal data from their ARROS-1 Phase 1/2 clinical trial. The presentation will focus on zidesamtinib, their novel ROS1-selective inhibitor, specifically its performance in TKI pre-treated patients with advanced ROS1-positive non-small cell lung cancer.
The event will be accessible via phone and live video webcast through the company's investor relations website, with presentation slides available. A replay will be archived for 30 days following the presentation.
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