Nuvalent (NUVL) Stock News

Nuvalent (Nasdaq: NUVL) appointed Ron Squarer to its Board of Directors effective Dec. 10, 2025. Squarer brings 30+ years in oncology drug development and commercialization, including leadership at Array Biopharma (acquired by Pfizer in 2019) and Board Chair at Deciphera (acquired by Ono Pharmaceuticals in 2024).

The company said his commercial and R&D experience will support pre-launch preparation as Nuvalent advances toward a potential first approval and launch of zidesamtinib for TKI pre-treated ROS1-positive NSCLC in 2026.

Nuvalent (Nasdaq: NUVL) said CEO James Porter, Ph.D., and CFO Alexandra Balcom will take part in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Thursday, December 4, 2025 at 8:30 a.m. ET. A live webcast will be available in the Investors section of the company's website and will be archived for 30 days after the presentation.

Nuvalent (Nasdaq: NUVL) closed an underwritten public offering of 4,950,496 shares of Class A common stock at $101.00 per share, with the offering closing on November 20, 2025.

Gross proceeds to Nuvalent were approximately $500.0 million before underwriting discounts, commissions and expenses. On November 20, 2025 underwriters fully exercised an option to buy an additional 742,574 shares from Deerfield Healthcare Innovations Fund and Deerfield Private Design Fund IV; the sale of those Additional Shares closed on November 24, 2025 and Nuvalent received no proceeds from that secondary sale. J.P. Morgan, Jefferies, TD Cowen and Cantor served as joint book-running managers.

Nuvalent (Nasdaq: NUVL) announced the U.S. FDA has accepted for filing its New Drug Application for zidesamtinib, an investigational ROS1-selective inhibitor, for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who received ≥1 prior ROS1 TKI.

The NDA is based on data from the global ARROS-1 Phase 1/2 trial (TKI pre-treated cohort) and carries a PDUFA target action date of September 18, 2026. ARROS-1 data and preliminary TKI-naïve cohort results were presented at the Presidential Symposium at the IASLC 2025 World Conference on Lung Cancer in September 2025.

Nuvalent (Nasdaq: NUVL) priced an underwritten public offering of 4,950,496 shares of Class A common stock at $101.00 per share, with gross proceeds to Nuvalent of approximately $500.0 million before underwriting discounts, commissions and expenses.

The offering is expected to close on November 20, 2025, subject to customary closing conditions. Selling stockholders granted a 30-day option for up to 742,574 additional shares; Nuvalent will not receive proceeds from shares sold by those selling stockholders.

Nuvalent (Nasdaq: NUVL) announced on November 17, 2025 that it has commenced an underwritten public offering of Class A common stock seeking to raise $500.0 million. The offering is subject to market and other conditions and may change in size or terms.

Deerfield Healthcare Innovations Fund and Deerfield Private Design Fund IV (the selling stockholders) expect to grant underwriters a 30‑day option to purchase up to an additional 15% of the shares at the public offering price less underwriting discounts and commissions. Nuvalent will not receive proceeds from any shares sold by the selling stockholders. J.P. Morgan, Jefferies, TD Cowen and Cantor are joint book‑running managers. The shares are offered under a shelf registration effective March 16, 2023.

Nuvalent (Nasdaq: NUVL) reported positive topline pivotal data from the ALKOVE-1 Phase 1/2 trial for neladalkib in TKI pre-treated patients with advanced ALK-positive NSCLC (data cut-off Aug 29, 2025; primary cohort n=253).

Key efficacy: ORR 31% by BICR in the TKI pre-treated cohort and 46% in the lorlatinib‑naïve subset (n=63). Durability: estimated DOR ≥12 months of 64% overall and 80% in lorlatinib‑naïve patients; DOR ≥18 months of 53% and 60%, respectively. Intracranial activity and responses in ALK G1202R patients were reported. Safety: low discontinuation rate 5% and dose reductions 17%, with transaminase elevations noted.

Company plans a pre‑NDA meeting with FDA and will present detailed results at a future medical meeting.

Nuvalent (Nasdaq: NUVL) will host a webcast and conference call on Monday, November 17, 2025 at 8:00 a.m. ET to discuss topline pivotal data for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated patients with advanced ALK-positive non-small cell lung cancer from the global ALKOVE-1 Phase 1/2 trial.

Live audio, accompanying slides and a video webcast will be available in the Investors section of Nuvalent's website at https://investors.nuvalent.com/events. Dial-in access is +1 (800) 836-8184 (US) or +1 (646) 357-8785 (international). A replay and slides will be archived on the site for 30 days.

Nuvalent (Nasdaq: NUVL) will present patient-reported outcomes from the Phase 2 portion of the ARROS-1 trial of zidesamtinib, a ROS1-selective investigational inhibitor, plus encore pivotal efficacy and safety data from ARROS-1.

Two poster presentations are scheduled at the 2025 IASLC ASCO North America Conference on Lung Cancer in Chicago (Dec 5-7, 2025): Abstract PP01.41 (PROs and health-related quality of life) and Abstract PP01.32 (pivotal efficacy and safety). Both posters are on Saturday, December 6, 2025, 4:00-5:30 p.m. ET, presented by Melissa Laurie, Pharm.D., M.S., M.B.A., and Stephen V. Liu, M.D.