Topline pivotal data expected in 2025 for both TKI pre-treated ROS1-positive and TKI pre-treated ALK-positive NSCLC populationsFirst NDA submission planned for mid-year 2025 towards potential first approval in 2026 for zidesamtinib in TKI pre-treated ROS1-positive NSCLC populationDevelopment strategies in place for TKI-naïve populations, including planned initiation of ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC in first half of 2025Implemented global Expande ...

Strategy prioritizes most accelerated path to first potential approval  Initial NDA submission expected by mid-year for zidesamtinib in TKI pre-treated ROS1-positive NSCLC population, with topline pivotal data anticipated in the first half of 2025 Topline pivotal data for neladalkib (NVL-655) in TKI pre-treated ALK-positive NSCLC population anticipated by year-end 2025 Company to present at 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14th at 9:00 a.m. PT CAMBRIDGE, Mass., Jan. 13, 2025 ...

Investment Opportunities - Nuvalent's ALK-selective inhibitor, NVL-655, has been granted Breakthrough Therapy Designation (BTD) by the FDA, indicating its potential as a blockbuster therapy [2] - The company focuses on innovative therapies and pharmaceuticals with catalysts for potential acquisitions, particularly in the biotech and life-saving therapies sector [2] Analyst's Position - The analyst holds a beneficial long position in Nuvalent (NUVL) and several other pharmaceutical companies, including Pfizer (PFE), Eli Lilly (LLY), AstraZeneca (AZN), Takeda (TAK), Merck (MRK), Roche (RHHBY), Johnson & Johnson (JNJ), Amgen (AMGN), and Bristol-Myers Squibb (BMY) [3] Disclosure - The article is written by the analyst and reflects their personal opinions, with no compensation received other than from Seeking Alpha [3] - Seeking Alpha clarifies that its analysts are third-party authors, including both professional and individual investors, and the platform is not a licensed securities dealer, broker, or investment adviser [4]

CAMBRIDGE, Mass., Dec. 19, 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 James Porter, Ph.D., Chief Executive Officer, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2025, at 9:00 a.m. PT in San Francisco.  A live webcast will be available in the Investors section of the company's website at www.nuval ...

CAMBRIDGE, Mass, Nov. 26, 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 James Porter, Ph.D., Chief Executive Officer, and Alexandra Balcom, Chief Financial Officer, will participate in a fireside chat during the Piper Sandler 36th Annual Healthcare Conference on Tuesday, December 3, 2024, at 3:30 p.m. ET in NYC.A live webcast will be available ...

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. ...