NUVL Stock Recent News

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 14 th at 9:00 a.m.

Nuvalent's NVL-655 and Zidesamtinib show strong potential as first-line therapies for NSCLC, with impressive Phase I/II trial results and FDA designations. Nuvalent's robust financial position and pipeline make it a prime M&A target, with potential suitors like Pfizer, AstraZeneca, and Novartis. Downside risks include regulatory setbacks, commercialization challenges, strong competition, and financial management, but Nuvalent's cash runway is healthy until 2028.

Nuvalent's lead candidates, NVL-520 and NVL-655, show promising efficacy and safety in Phase 1/2 trials. Both drugs have received FDA Breakthrough Therapy and orphan drug designations, with pivotal Phase 2 data expected in 2025 and potential approvals by 2026. The company completed a $500 million secondary offering, reflecting strong investor interest and providing the cash runway through Phase 3.

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 shares, at a price to the public of $100.00 per share.

The upside comes after NUVL reported encouraging data on two experimental lung cancer therapies.

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.

Over the weekend, Nuvalent, Inc. NUVL highlighted the presentation of updated data from Phase 1 dose-escalation 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.

Biotech stocks Nuvalent and Iteos diverged Monday on updates for their lung cancer treatments at the ESMO meeting in Madrid.

Biotech Nuvalent unveiled updates on two experimental cancer medicines over the weekend. Analysts say each could be the best in their category.

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.