Nuvalent, Inc. - NUVL STOCK NEWS

Nuvalent, a clinical-stage biotech firm, has promoted Dr. Henry Pelish to Chief Scientific Officer. In this role, Dr. Pelish will continue to oversee discovery and early-stage development initiatives. Dr. Pelish, who joined Nuvalent in 2018, has been instrumental in developing three novel kinase inhibitors, two of which have shown preliminary clinical proof-of-concept. CEO Dr. James Porter praised Pelish's contributions to the company's innovative approach to cancer therapy. Dr. Pelish holds a Ph.D. in chemistry from Harvard and has over 15 years of experience in cancer biology and chemistry. He expressed excitement about advancing Nuvalent's mission to deliver targeted therapies for cancer patients.

Nuvalent, a clinical-stage biopharmaceutical company specializing in targeted cancer therapies, announced its participation in the 2024 Jefferies Global Healthcare Conference. The event will feature a fireside chat with CEO James Porter and CFO Alexandra Balcom on June 5, 2024, at 4:30 p.m. ET. The session will be live-streamed and available on the company's website for 30 days.

Nuvalent announced that the FDA has granted breakthrough therapy designation (BTD) for NVL-655, a novel ALK-selective tyrosine kinase inhibitor (TKI) designed to treat locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) in patients previously treated with two or more ALK TKIs. ALK rearrangements occur in up to 5% of metastatic NSCLCs, with 40% of these patients presenting brain metastases at diagnosis, and 50% developing resistance mutations after treatment. NVL-655 aims to address these challenges with brain-penetrant properties and minimal off-target CNS adverse events. The BTD is based on Phase 1 trial results, with Phase 2 enrollment ongoing. Nuvalent plans an update from the ALKOVE-1 trial in the second half of 2024.

Nuvalent, a clinical-stage biopharmaceutical company, highlighted pipeline progress, reiterated key milestones, and reported strong financial results for the first quarter of 2024. The company is focused on developing novel kinase inhibitors for cancer treatment, with anticipated milestones including updates from ongoing clinical trials and a potential first approval in 2026. Nuvalent's ROS1 and ALK programs are progressing well, with preclinical data demonstrating the effectiveness of their inhibitors. The company also plans to initiate a Phase 1 trial for its HER2 program in 2024. Financially, Nuvalent has a solid cash position expected to fund operations into 2027.

Nuvalent, Inc. presents new preclinical data for NVL-330 and zidesamtinib at AACR Annual Meeting. NVL-330 shows broad activity against HER2 oncogenic alterations and higher CNS penetration. Zidesamtinib demonstrates effectiveness against ROS1 resistance mutations and potential for deep, durable responses. Company plans Phase 1 trials for HER2 program and updates on ARROS-1 trial in 2024.

Nuvalent, Inc. (NUVL) announced preclinical data poster presentations at AACR Annual Meeting 2024 for its novel HER2-selective inhibitor, NVL-330, and ROS1-selective inhibitor, zidesamtinib (NVL-520). The presentations aim to characterize the compounds' profiles in cancer treatment.

Nuvalent, Inc. highlights pipeline progress, key milestones, and financial results for Q4 and full year 2023. The company's well-capitalized position is expected to support operations until 2027. Nuvalent's recent achievements include FDA breakthrough therapy designation for NVL-520, initiation of Phase 2 trials, and leadership promotions. Financially, the company reported a cash position of $719.9 million, with R&D expenses at $35.6 million in Q4 2023.

Nuvalent, Inc. receives FDA breakthrough therapy designation for NVL-520 in treating ROS1-positive metastatic NSCLC. The drug targets patients with resistance mutations after prior treatments, offering hope for a population with limited options. NVL-520 aims to address challenges like treatment resistance, brain metastases, and CNS adverse events, setting it apart from current therapies.

Nuvalent, Inc. initiates Phase 2 of ALKOVE-1 trial for NVL-655 with FDA-recommended dose of 150 mg daily. The Phase 1 portion showed promising results in ALK-positive NSCLC patients, with no maximum tolerated dose reached. The Phase 2 design aims to investigate NVL-655 in pre-treated and TKI-naïve patients globally.