Nuvation Bio
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- -
- Employees
- 51
- Market Cap
- $767.6M
- Introduction
Nuvation Bio, Inc. is a biopharmaceutical company tackling some of the unmet needs in oncology by developing differentiated and novel therapeutic candidates. Its proprietary portfolio includes six novel and mechanistically distinct oncology therapeutic product candidates, each targeting some of the most difficult-to-treat types of cancer. The company was founded by David Hung on March 20, 2018 and is headquartered in New York, NY.
Nuvation Bio's Lung Cancer Drug DOVBLERON Wins China Approval, FDA Decision Coming June
Nuvation Bio's taletrectinib, for advanced ROS1+ NSCLC, approved by China's NMPA, marketed as DOVBLERON® by Innovent Biologics. Based on Phase 2 TRUST-I study, showing efficacy. U.S. FDA granted Priority Review, PDUFA date June 23, 2025.
Nuvation Bio Receives Approval from China's National Medical Products Administration for Taletrectinib
Taletrectinib, approved by China’s NMPA for ROS1+ NSCLC treatment, will be marketed in China by Innovent Biologics as DOVBLERON®. Based on Phase 2 TRUST-I study data, it shows durable responses and prolonged progression-free survival. Nuvation Bio aims for U.S. FDA approval by mid-2025.
Nuvation Bio's Taletrectinib Approved By NMPA For ROS1-Positive NSCLC
Nuvation Bio Inc. (NUVB) received NMPA approval in China for taletrectinib, a ROS1 inhibitor for advanced ROS1+ non-small cell lung cancer, based on Phase 2 TRUST-I study results. Marketed by Innovent Biologics as Dovbleron, it launched in January 2025. Also under U.S. FDA Priority Review, with a goal date of June 23, 2025.
Nuvation Bio Receives Approval from China's National Medical Products Administration for Taletrectinib in ROS1+ NSCLC Treatment
Taletrectinib, approved by China’s NMPA for ROS1+ NSCLC treatment, will be marketed by Innovent Biologics as DOVBLERON®. Based on Phase 2 TRUST-I study results, it shows durable responses and prolonged progression-free survival. Nuvation Bio anticipates U.S. FDA approval by mid-2025.
Nuvation Bio Receives Approval from China's National Medical Products Administration
Nuvation Bio's taletrectinib approved by China’s NMPA for treating adult patients with locally advanced or metastatic ROS1-positive NSCLC, regardless of prior ROS1 TKI treatment.
China NMPA approves Innovent Biologics' Dovbleron to treat ROS1-positive non-small cell lung cancer
Innovent Biologics' Dovbleron, a next-gen ROS1 TKI, approved by China's NMPA for treating ROS1-positive NSCLC, shows high efficacy in TRUST-I trial. It offers a new, effective treatment option, demonstrating superior response rates and prolonged PFS, especially in TKI-naïve patients.
FDA Accepts New Drug Application For Taletrectinib in ROS1+ NSCLC
FDA grants priority review to taletrectinib for ROS1+ NSCLC, with a PDUFA action date of June 23, 2025. Based on TRUST-I and TRUST-II trials, taletrectinib showed tumor shrinkage in 89% of TKI-naive and 56% of TKI-pretreated patients, with durable responses and prolonged PFS.
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