Nuvation Bio Inc. Awaits FDA Decision on Taletrectinib with PDUFA Date Set for June 23, 2025

Reuters

05-22

Nuvation Bio Inc. Awaits FDA Decision on Taletrectinib with PDUFA Date Set for June 23, 2025

Nuvation Bio Inc., a global oncology company, has announced that its innovative cancer treatment, taletrectinib, is currently under Priority Review by the U.S. Food and Drug Administration (FDA). This review is part of the ongoing regulatory process, with a Prescription Drug User Fee Act (PDUFA) date set for June 23, 2025. The drug, aimed at treating advanced ROS1-positive non-small cell lung cancer, has shown promising results in pivotal Phase 2 clinical studies, which will be presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting. Nuvation Bio is hopeful for a positive outcome, potentially providing a new, meaningful treatment option for patients affected by this disease.

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. Nuvation Bio Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250521881222) on May 21, 2025, and is solely responsible for the information contained therein.

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