Nuvalent, Inc. announced that the U.S. Food and Drug Administration has accepted its New Drug Application for zidesamtinib, a brain‑penetrant ROS1‑selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1‑positive non‑small cell lung cancer who have received at least one prior ROS1 tyrosine‑kinase inhibitor.
The acceptance, dated November 19 2025, assigns a Prescription Drug User Fee Act target action date of September 18 2026 and is based on data from the global ARROS‑1 Phase 1/2 clinical trial. In that study, zidesamtinib achieved an objective response rate of 44 % in patients who had progressed on prior ROS1 inhibitors, and the drug has earned both Breakthrough Therapy and Orphan Drug designations, underscoring its potential to address unmet needs in a rare patient population.
Zidesamtinib’s design gives it superior central nervous system penetration, allowing it to treat brain metastases that are common in ROS1‑positive NSCLC, while its selectivity profile reduces the risk of TRK‑related adverse events that have limited earlier agents.
Financially, Nuvalent reported a net loss of $122.44 million for the third quarter of 2025, up from $84.35 million in the same period a year earlier, largely driven by higher research and development expenses. The company’s cash, cash equivalents, and marketable securities position it to fund its operating plan through 2028, providing a runway for continued development and potential commercialization of zidesamtinib.
Chief Development Officer Darlene Noci said the company “looks forward to working closely with the FDA throughout the review process,” while CEO Jim Porter emphasized the importance of continued innovation for patients with ROS1‑positive NSCLC.
The FDA acceptance moves zidesamtinib closer to market approval, expanding Nuvalent’s product portfolio and revenue prospects in the ROS1‑positive NSCLC segment. The milestone also signals investor confidence in the company’s development strategy and its ability to navigate regulatory pathways for a drug that addresses a critical unmet need.
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