Nuvalent, Inc. Stock Price, News & Analysis

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.

Nuvalent (NUVL) has provided updates on its pipeline progress and financial results for Q4 and full year 2024. The company expects to report topline pivotal data in 2025 for both ROS1-positive and ALK-positive NSCLC populations. Their first NDA submission is planned for mid-2025 for zidesamtinib.

Key developments include:

• 430 patients enrolled in ARROS-1 Phase 1/2 trial for zidesamtinib
• 596 patients enrolled in ALKOVE-1 Phase 1/2 trial for neladalkib
• Implementation of global Expanded Access Programs for both therapies
• Planned initiation of ALKAZAR Phase 3 trial in first half 2025

Financial highlights: Cash position of $1.1 billion as of December 31, 2024, expected to fund operations into 2028. R&D expenses were $217.8 million and G&A expenses $62.6 million for 2024, with a net loss of $260.8 million for the year.

Nuvalent (NUVL) has outlined its 'OnTarget 2026' plan, targeting its first potential FDA approval in 2026. Key 2025 milestones include: reporting pivotal data for zidesamtinib in ROS1-positive NSCLC patients in H1 2025, submitting an NDA by mid-2025, and reporting pivotal data for neladalkib in ALK-positive NSCLC patients by year-end 2025.

The company has shown strong enrollment progress, with 430 patients enrolled in the ARROS-1 trial for zidesamtinib and 596 patients in the ALKOVE-1 trial for neladalkib as of December 31, 2024. The company plans to initiate the ALKAZAR Phase 3 trial for neladalkib in H1 2025 and continues to progress its HEROEX-1 trial for NVL-330.

Nuvalent reports having sufficient cash runway into 2028 to support clinical programs and commercial infrastructure development.

Nuvalent (Nasdaq: NUVL), a clinical-stage biopharmaceutical company developing targeted cancer therapies, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. James Porter, Ph.D., the company's Chief Executive Officer, will deliver a presentation on Tuesday, January 14, 2025, at 9:00 a.m. PT in San Francisco. The presentation will be accessible via live webcast through the Investors section of Nuvalent's website and will remain available for 30 days afterward.

Nuvalent (NUVL) has appointed Grant Bogle to its Board of Directors, bringing nearly four decades of biotechnology leadership experience. Bogle's previous roles include CEO of Epizyme and Chief Commercial Officer at TESARO, both of which were successfully acquired by larger pharmaceutical companies.

The appointment comes as Nuvalent prepares for potential pivotal data readouts in 2025 from two parallel-lead programs: the ARROS-1 trial of zidesamtinib (ROS1-selective inhibitor) and the ALKOVE-1 trial of NVL-655 (ALK-selective inhibitor). The company anticipates its first pipeline approval in 2026 and plans to initiate the Phase 3 ALKAZAR trial in early 2025, comparing NVL-655 to ALECENSA for ALK-positive NSCLC treatment.