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.
FDA sets review date for Nuvation Bio's cancer drug
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.
Innovent Receives Approval of DOVBLERON® (Taletrectinib Adipate Capsule, ROS1 ...)
Innovent Biologics announced China's NMPA approval of DOVBLERON®, a next-gen ROS1 TKI for previously treated ROS1-positive NSCLC. DOVBLERON®, Innovent's 13th commercial product, addresses unmet needs, especially for patients with brain metastases and resistance to prior ROS1 TKIs. A second NDA for DOVBLERON® was accepted for ROS1-positive NSCLC patients without prior ROS1 TKI treatment.
Innovent Receives Approval of DOVBLERON® (Taletrectinib Adipate Capsule, ROS1 Inhibitor) by China's National Medical Products Administration
Innovent Biologics announced NMPA approval for DOVBLERON®, a ROS1 TKI for treating advanced ROS1-positive NSCLC, especially for patients with brain metastases or resistance to prior therapies. Based on TRUST-I trial results, DOVBLERON® offers a new treatment option, showcasing Innovent's leadership in precision oncology.
Nuvation Bio Announces Positive Pooled Data from the Pivotal Phase 2 TRUST-I
Nuvation Bio announced positive pooled data from Phase 2 TRUST-I and TRUST-II studies on taletrectinib, a next-gen ROS1 TKI, to be presented at ESMO 2024. The analysis highlights taletrectinib's efficacy and safety, with median duration of response at 44 months and progression-free survival at 46 months in TKI-naive patients. The data supports Nuvation Bio's planned NDA submission in the U.S., with taletrectinib granted Orphan Drug and Breakthrough Therapy Designations by the U.S. FDA and China's NMPA for ROS1+ NSCLC treatment.
Positive Pooled Data from Nuvation Bio's TRUST-I and TRUST-II Studies Highlight
Nuvation Bio announced positive pooled data from TRUST-I and TRUST-II studies evaluating taletrectinib, a next-generation ROS1 TKI for advanced ROS1-positive NSCLC, showing 89% tumor shrinkage in TKI-naïve patients and 56% in TKI-pretreated patients, with a median DOR of 44 months and PFS of 46 months in TKI-naïve patients. The drug also demonstrated a favorable safety profile with low neurologic TEAEs. Nuvation Bio plans to submit an NDA to the FDA in Q4 2024, aiming for a U.S. launch in 2025.
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