Nuvalent reported a Q4 net loss of USD 118.7 million and a FY 2025 net loss of USD 425.4 million. Q4 R&D expenses were USD 67.8 million and Q4 G&A expenses were USD 34.4 million, while FY 2025 R&D expenses were USD 307.0 million and FY 2025 G&A expenses were USD 107.3 million. Cash, cash equivalents and marketable securities totaled USD 1.4 billion as of Dec. 31, 2025, and Nuvalent said its operating runway is anticipated into 2029. On the pipeline, Nuvalent said the FDA accepted the NDA for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC and assigned a PDUFA target action date of Sept. 18, 2026, with commercial preparations underway for a potential U.S. launch in 2026 pending FDA review. The company also said an NDA submission for neladalkib in TKI pre-treated advanced ALK-positive NSCLC is planned for H1 2026, and it plans to submit data to support a potential label expansion for zidesamtinib in TKI-naïve advanced ROS1-positive NSCLC in H2 2026. Nuvalent highlighted a USD 500.0 million gross proceeds public offering completed in November 2025 and the appointment of Ron Squarer to its board in December 2025.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Nuvalent Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: 202602260630PR_NEWS_USPR_____NE96065) on February 26, 2026, and is solely responsible for the information contained therein.