Nuvalent, Inc. Stock Price, News & Analysis

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.

Nuvalent (NUVL) has appointed Christy Oliger to its Board of Directors, strengthening its leadership team as the company approaches potential commercialization. Oliger brings over 30 years of pharmaceutical and biotech industry experience, most notably serving as Senior Vice President of the Oncology Business Unit at Genentech. During her 20-year tenure at Genentech, she held various senior leadership roles across multiple therapeutic areas including oncology, neurology, rare disease, and immunology. The appointment comes as Nuvalent prepares for a potential first approval from its pipeline of novel kinase inhibitors in 2026. The company, focused on developing targeted cancer therapies, aims to leverage Oliger's commercial expertise in delivering new treatments to patients.

Nuvalent (NUVL) reported Q1 2025 progress and financials, highlighting key milestones for its cancer therapeutics pipeline. The company expects pivotal data for zidesamtinib in ROS1-positive NSCLC in H1 2025, with plans for its first NDA submission by mid-2025. The ALKAZAR Phase 3 trial for neladalkib in front-line ALK-positive NSCLC is planned for H1 2025, with pivotal data expected by year-end. Financially, Nuvalent maintains a strong position with $1.1 billion in cash, sufficient to fund operations into 2028. Q1 2025 results showed R&D expenses of $74.4M, G&A expenses of $20.4M, and a net loss of $84.6M. The company strengthened its leadership team with key promotions and continues advancing its HER2 program through the HEROEX-1 trial.

Nuvalent announced the publication of research in Molecular Cancer Therapeutics supporting their novel cancer drug zidesamtinib. The drug is being tested in the ARROS-1 Phase 1/2 trial for patients with ROS1-positive non-small cell lung cancer and other solid tumors.

Key highlights:

• First-ever crystal structure of ROS1 G2032R mutation revealed
• Drug shows promising activity against resistance mutations
• Demonstrates effective inhibition of brain tumors compared to other treatments
• Designed to avoid TRK inhibition in the central nervous system

The company plans to report pivotal clinical data for TKI pre-treated patients in the first half of 2025, with a New Drug Application submission expected by mid-2025. The initial target indication focuses on TKI pre-treated patients with advanced ROS1-positive NSCLC.