Nuvalent, Inc. Stock Price, News & Analysis

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.

Nuvalent (Nasdaq: NUVL) has announced two 'Trial in Progress' poster presentations at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from May 30-June 5, 2025.

The first presentation features the ALKAZAR trial (NCT06765109), a global Phase 3 study comparing neladalkib versus ALECENSA® (alectinib) for TKI-naïve ALK-positive non-small cell lung cancer (NSCLC) patients. The trial, set to begin in first half 2025, will randomize patients 1:1 to receive either treatment as monotherapy.

The second presentation covers the ongoing HEROEX-1 Phase 1a/1b trial (NCT06521554) of NVL-330, evaluating safety and tolerability in pre-treated patients with HER2-altered NSCLC. This study aims to determine the recommended Phase 2 dose, characterize pharmacokinetic profile, and assess preliminary anti-tumor activity.

Nuvalent (Nasdaq: NUVL), a clinical-stage biopharmaceutical company specializing in targeted cancer therapies, has announced its participation in the Stifel 2025 Virtual Targeted Oncology Forum. The company's leadership, including CEO James Porter, Ph.D., and CFO Alexandra Balcom, will engage in a fireside chat scheduled for April 8, 2025, at 2:30 p.m. ET.

The presentation will be accessible through a live webcast on the Investors section of Nuvalent's website (www.nuvalent.com) and will remain available for replay for 30 days after the event.

Nuvalent (NUVL) announced it will present new preclinical data for two of its cancer therapies at the AACR Annual Meeting 2025 in Chicago (April 25-30). The presentations will feature detailed characterization of neladalkib, their ALK-selective inhibitor, and zidesamtinib, their ROS1-selective inhibitor.

The first presentation on April 28 will focus on mutagenesis screens supporting neladalkib's potential best-in-class profile as a brain-penetrant and TRK-sparing ALK inhibitor. The second presentation on April 29 will showcase the crystal structure of drug-resistant ROS1 G2032R in complex with zidesamtinib, highlighting its best-in-class potential as a clinical-stage ROS1 inhibitor.

Nuvalent (Nasdaq: NUVL), a clinical-stage biopharmaceutical company developing targeted cancer therapies, has announced its participation in three major investor conferences this March 2025. CEO James Porter, Ph.D., and CFO Alexandra Balcom will engage in fireside chats at:

• TD Cowen 45th Annual Health Care Conference - March 5, 9:50 a.m. ET (Boston)
• Leerink Global Healthcare Conference 2025 - March 10, 10:40 a.m. ET (Miami)
• Barclays 27th Annual Global Healthcare Conference - March 12, 2:30 p.m. ET (Miami)

Live webcasts will be accessible through Nuvalent's website investor section and remain archived for 30 days post-presentation.