Neladalkib
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Nuvalent Announces Pricing of Public Offering of Common Stock
Prnewswire· 2025-11-19 04:50
Core Viewpoint - Nuvalent, Inc. has announced a public offering of Class A common stock priced at $101.00 per share, aiming to raise approximately $500 million before expenses [1][2]. Group 1: Offering Details - The company is selling 4,950,496 shares in the offering, with the expected closing date on November 20, 2025, pending customary closing conditions [1]. - Selling stockholders have granted underwriters a 30-day option to purchase an additional 742,574 shares at the public offering price [2]. - J.P. Morgan, Jefferies, TD Cowen, and Cantor are acting as joint book-running managers for the offering [3]. Group 2: Regulatory Information - The shares are being offered under an automatically effective shelf registration statement filed with the SEC on March 16, 2023 [4]. - A preliminary prospectus supplement has been filed with the SEC, and a final prospectus will also be filed [4]. Group 3: Company Overview - Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on developing targeted therapies for cancer, particularly for kinase targets [6]. - The company aims to create innovative small molecules that can overcome resistance and minimize adverse events, with a pipeline targeting ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer [6].
Nuvalent, Inc. (NUVL) Discusses Topline Pivotal Data From ALKOVE-1 Trial of Neladalkib in ALK-Positive Non-Small Cell Lung Cancer Transcript
Seeking Alpha· 2025-11-17 20:47
Group 1 - The article does not provide any specific content or key points related to a company or industry [1]
Nuvalent Announces Timing of Topline Pivotal Data for TKI Pre-treated Patients with Advanced ALK-positive NSCLC from ALKOVE-1 Clinical Trial of Neladalkib
Prnewswire· 2025-11-14 21:01
Core Insights - Nuvalent, Inc. is set to host a webcast and conference call on November 17, 2025, to discuss pivotal data for neladalkib, an investigational ALK-selective inhibitor for advanced ALK-positive non-small cell lung cancer [1][2] Company Overview - Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on developing targeted therapies for cancer, specifically designed to overcome limitations of existing treatments for kinase targets [5] - The company is advancing a robust pipeline that includes investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, along with multiple discovery-stage research programs [5] Product Information - Neladalkib is designed to be a brain-penetrant ALK-selective inhibitor, aimed at overcoming resistance seen with current ALK inhibitors and improving treatment options for patients with brain metastases [3] - The drug has received FDA breakthrough therapy designation for patients with locally advanced or metastatic ALK-positive non-small cell lung cancer who have been previously treated with two or more ALK tyrosine kinase inhibitors [3] Clinical Trial Details - The ALKOVE-1 trial is a first-in-human Phase 1/2 clinical trial for patients with advanced ALK-positive non-small cell lung cancer and other solid tumors, focusing on safety, tolerability, and preliminary anti-tumor activity [4] - The Phase 1 portion of the trial has been completed, and the ongoing Phase 2 portion is designed with registrational intent for TKI pre-treated patients [4]