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.
China's NMPA approves Innovent's taletrectinib for NSCLC treatment
China's NMPA approved Innovent Biologics’ DOVBLERON for ROS1-positive NSCLC, following positive Phase II TRUST-I trial results. The therapy showed high efficacy, especially against intracranial lesions. Innovent aims to enhance NSCLC treatment options, with DOVBLERON now part of its commercial lineup.
Innovent Announces Second New Drug Application of DOVBLERON® (Taletrectinib)
Innovent Biologics announced China's NMPA approved DOVBLERON® for ROS1-positive NSCLC, based on TRUST-I trial results showing high efficacy. DOVBLERON® is Innovent's 13th product, offering a new treatment option for lung cancer patients. Innovent aims to enhance patient care with innovative medicines.
Innovent Announces Second New Drug Application of DOVBLERON ® (Taletrectinib)
Innovent Biologics announced China's NMPA approved DOVBLERON® (taletrectinib) for ROS1-positive NSCLC, based on TRUST-I trial results showing high efficacy. DOVBLERON® is Innovent's 13th product, enhancing treatment options for NSCLC patients. Innovent aims to advance innovative medicines, improving patient quality of life.
Innovent's DOVBLERON Scores 91% Response Rate in Lung Cancer, Wins China Approval
Innovent Biologics announced China's NMPA approved DOVBLERON® for ROS1-positive NSCLC, based on TRUST-I trial results showing high efficacy and safety. DOVBLERON® offers a new treatment option for lung cancer patients.
FDA Grants Taletrectinib Priority Review in ROS1+ Advanced NSCLC
The FDA granted priority review to taletrectinib's NDA for ROS1-positive advanced NSCLC, supported by phase 2 trials TRUST-1 and TRUST-II. Taletrectinib showed an 88.8% ORR in treatment-naive patients and 55.8% in previously treated patients. A target decision date is set for June 23, 2025.
FDA Grants Taletrectinib Priority Review for Advanced ROS1+ NSCLC
Taletrectinib, a next-gen ROS1 TKI, showed favorable efficacy and tolerability in TRUST-I and TRUST-II trials for advanced ROS1-positive NSCLC. The FDA granted priority review for its NDA, with a Prescription Drug User Fee Act date set for June 23, 2025. Pooled data from over 300 patients demonstrated taletrectinib's potential for durable benefits, with cORR of 88.8% in TKI-naive and 55.8% in TKI-pretreated patients. Common TEAEs included increased liver enzymes and diarrhea.
FDA Grants Priority Review to Taletrectinib in ROS1+ Advanced NSCLC
The FDA granted priority review to taletrectinib for ROS1-positive advanced NSCLC, supported by phase 2 TRUST trials showing ORR of 88.8% in TKI-naive patients and 55.8% in previously treated patients. The FDA target action date is June 23, 2025.
U.S. Food and Drug Administration Accepts for Priority Review Nuvation Bio's New
Nuvation Bio's NDA for taletrectinib, a next-gen ROS1 TKI for advanced ROS1+ NSCLC, has been accepted by the FDA with a PDUFA goal date of June 23, 2025. Taletrectinib, supported by Phase 2 TRUST studies, shows potential as a best-in-class treatment with durable responses and prolonged PFS.
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