FDA sets review date for Nuvation Bio's cancer drug - Investing.com

Nuvation Bio Inc. announced the FDA accepted its NDA for taletrectinib, a ROS1 TKI for advanced ROS1+ NSCLC, with a PDUFA goal date of June 23, 2025. The NDA is supported by TRUST-I and TRUST-II Phase 2 studies data, showing durable responses and prolonged PFS. The company's stock has returned 79.87% over the past year, and it maintains strong financial health with a current ratio of 9.57. Taletrectinib has Breakthrough Therapy Designation and Orphan Drug Designation.


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FDA sets review date for Nuvation Bio's cancer drug - Investing.com

Nuvation Bio Inc. announced the FDA accepted its NDA for taletrectinib, a ROS1 TKI for advanced ROS1+ NSCLC, with a PDUFA goal date of June 23, 2025. The NDA is supported by TRUST-I and TRUST-II Phase 2 studies data, showing durable responses and prolonged PFS. The company's stock has returned 79.87% over the past year, and it maintains strong financial health with a current ratio of 9.57. Taletrectinib has Breakthrough Therapy Designation and Orphan Drug Designation.

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