Achievement of all anticipated 2024 milestones and accelerated development timelines reinforce progress on OnTarget 2026 operating plan towards first approved product in 2026Leading medical oncologist Alice Shaw, M.D., Ph.D. appointed to Scientific Advisory BoardStrong cash position of $1.2 billion, including proceeds from upsized $575 million public offering, expected to extend operating runway into 2028CAMBRIDGE, Mass., Nov. 12, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharm ...

Analyst's Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. Although there are no personal account positions, SOME STOCKS MENTIONED CAN ALREADY BE PART OF THE PO ...

CAMBRIDGE, Mass., Sept. 18, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the closing of its previously announced upsized underwritten public offering of 5,750,000 shares of Class A common stock, which includes 750,000 shares of Class A common stock sold pursuant to the exercise in full by the underwriters of their option to purchase additional sha ...

Shares of Nuvalent (NUVL) have soared nearly 20% in the past week owing to encouraging updates on its two investigational therapies. Both therapies target previously treated non-small cell lung cancer (NSCLC) patients but focus on different genetic mutations. These updates were announced earlier this weekend at the European Society for Medical Oncology (ESMO) Congress 2024 meeting held in Spain. NUVL Boasts Encouraging Pipeline Potential in NSCLC Space Management presented updated data from the early-stage ...

This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33. ...

CAMBRIDGE, Mass., Sept. 16, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the pricing of an upsized underwritten public offering of 5,000,000 shares of Class A common stock at a price to the public of $100.00 per share. All shares are being offered by Nuvalent. The gross proceeds to Nuvalent from the offering, before deducting underwriting discount ...

Over the weekend, Nuvalent, Inc. NUVL highlighted the presentation of updated data from Phase 1 doseescalation portions of the ongoing ARROS-1 Phase 1/2 trial of zidesamtinib and ALKOVE-1 Phase 1/2 trial of NVL-655, at the European Society for Medical Oncology (ESMO) Congress 2024. In total, 227 patients were enrolled in the Phase 2 portion of the ARROS-1 trial of zidesamtinib for TKI-naïve and TKI-pretreated patients with advanced ROS1-positive NSCLC and other solid tumors. The company expects to report pi ...

CAMBRIDGE, Mass., Sept. 16, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that it has commenced an underwritten public offering of $350.0 million of its shares of Class A common stock. All shares are being offered by Nuvalent. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering ma ...

Core Insights - Updated Phase 1 dose-escalation data from ARROS-1 and ALKOVE-1 clinical trials support potential best-in-class profiles for zidesamtinib and NVL-655 [1][2] - Rapid enrollment in Phase 2 portions of the ARROS-1 and ALKOVE-1 clinical trials; pivotal data from both ROS1 and ALK programs anticipated in 2025 [1][2] - Initiation of ALKAZAR Phase 3 randomized, controlled trial of NVL-655 for treatment-naïve patients with advanced ALK-positive NSCLC expected in the first half of 2025 [1][2] Company Updates - Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on creating targeted therapies for kinase targets in cancer [31] - The company has achieved all supporting milestones for 2024 and is on track to share pivotal datasets from both parallel-lead programs in 2025 [4] - The company plans to host a conference call to discuss these updates [24] Clinical Trial Progress - The Phase 2 portion of the ARROS-1 trial has enrolled 227 patients from September 2023 to September 1, 2024, with pivotal data expected in 2025 [2] - The Phase 2 portion of the ALKOVE-1 trial has enrolled 229 patients from February 2024 to September 1, 2024, also with pivotal data expected in 2025 [2] - The ALKAZAR trial is designed to enroll approximately 450 patients with TKI-naïve ALK-positive NSCLC, with primary and secondary endpoints defined [4] Drug Profiles - Zidesamtinib is a novel ROS1-selective inhibitor designed to overcome limitations of existing therapies and has received FDA breakthrough therapy designation [8][26] - NVL-655 is a novel ALK-selective inhibitor with similar design goals and has also received FDA breakthrough therapy designation [18][29] - Both drugs are designed for CNS penetrance and aim to avoid TRK-related adverse events [26][29] Safety and Efficacy Data - Zidesamtinib demonstrated an overall response rate (ORR) of 44% in response-evaluable patients with ROS1-positive NSCLC [9] - NVL-655 showed an ORR of 38% in response-evaluable patients with ALK-positive NSCLC [17] - Both drugs exhibited favorable safety profiles, with no discontinuations due to treatment-related adverse events [11][20]

Publication provides comprehensive assessment of NVL-655's preclinical activity and includes preliminary clinical case studies CAMBRIDGE, Mass., Sept. 13, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the publication of a manuscript in Cancer Discovery, a journal of the American Association for Cancer Research, which describes the design and charac ...