FDA Events for Nuvation Bio (NUVB)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Nuvation Bio (NUVB).
Over the past two years, Nuvation Bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Taletrectinib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Taletrectinib (ROS1+ NSCLC) - FDA Regulatory Timeline and Events
Taletrectinib (ROS1+ NSCLC) is a drug developed by Nuvation Bio for the following indication: For Patients with Advanced ROS1-positive NSCLC.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Taletrectinib (ROS1+ NSCLC)
- Announced Date:
- March 6, 2025
- Indication:
- For Patients with Advanced ROS1-positive NSCLC
Announcement
Nuvation Bio Inc provided a business update.
AI Summary
Nuvation Bio Inc. recently provided a business update highlighting a transformative year in 2024. The company acquired AnHeart Therapeutics, reported positive pivotal data for taletrectinib, and submitted the New Drug Application, which was accepted for Priority Review by the FDA. With a PDUFA goal date set for June 23, 2025, taletrectinib is positioned for potential U.S. commercial launch. The company also launched an Expanded Access Program in February 2025 to help patients with advanced ROS1-positive non-small cell lung cancer. Additionally, Nuvation Bio secured up to $250 million in non-dilutive financing from Sagard Healthcare Partners, which is expected to fully fund the U.S. launch of taletrectinib. The management expressed optimism for further updates in 2025 from other pipeline programs such as safusidenib and NUV-1511, reinforcing its commitment to addressing unmet needs in oncology.
Read Announcement- Drug:
- Taletrectinib (ROS1+ NSCLC)
- Announced Date:
- January 6, 2025
- Indication:
- For Patients with Advanced ROS1-positive NSCLC
Announcement
Nuvation Bio Inc announced that China's National Medical Products Administration (NMPA) has approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) who either have or have not been previously treated with ROS1 tyrosine kinase inhibitors (TKI).
AI Summary
Nuvation Bio Inc announced that China's National Medical Products Administration (NMPA) has approved taletrectinib for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). This approval applies to patients who have or have not been previously treated with ROS1 tyrosine kinase inhibitors, offering a new treatment option regardless of past therapies. The decision was supported by data from the pivotal Phase 2 TRUST-I study, which demonstrated durable responses and prolonged progression-free survival in treated patients.
Innovent Biologics will market taletrectinib in China under the brand name DOVBLERON®, with the product officially launching in January 2025. This milestone marks an important step forward in addressing critical treatment needs for patients with ROS1-positive NSCLC, reinforcing taletrectinib’s potential as a best-in-class therapy in oncology.
Read Announcement- Drug:
- Taletrectinib (ROS1+ NSCLC)
- Announced Date:
- September 14, 2024
- Indication:
- For Patients with Advanced ROS1-positive NSCLC
Announcement
Nuvation Bio Inc announced positive pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies evaluating taletrectinib, an investigational next-generation ROS1 TKI.
AI Summary
Nuvation Bio Inc announced positive pooled results from its pivotal Phase 2 TRUST-I and TRUST-II studies on taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) for advanced ROS1-positive non-small cell lung cancer. The data showed significant tumor shrinkage, with 89% of TKI-naïve patients and 56% of TKI-pretreated patients benefiting from the treatment. In TKI-naïve patients, the results were particularly promising with a median duration of response of 44 months and a median progression-free survival of 46 months, indicating durable responses.
The safety profile was favorable, with low rates of treatment-emergent neurologic events and minimal treatment discontinuation. These encouraging findings support Nuvation Bio's planned New Drug Application submission to the FDA in the fourth quarter of 2024, aiming to bring taletrectinib to market by 2025.
Read Announcement- Drug:
- Taletrectinib (ROS1+ NSCLC)
- Announced Date:
- September 14, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 2024
- Indication:
- For Patients with Advanced ROS1-positive NSCLC
Announcement
Nuvation Bio plans to submit a New Drug Application (NDA) for taletrectinib to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2024
AI Summary
Nuvation Bio Inc. announced that it plans to submit a New Drug Application (NDA) for taletrectinib to the U.S. Food and Drug Administration in the fourth quarter of 2024. This next-generation, oral ROS1 tyrosine kinase inhibitor is being developed for patients with advanced ROS1-positive non-small cell lung cancer. The NDA submission is supported by promising results from ongoing Phase 2 studies, which have shown durable responses and prolonged progression-free survival. Taletrectinib’s robust clinical data, including significant tumor shrinkage and a favorable safety profile, have reinforced its potential as an effective treatment option for lung cancer. If the FDA approves the therapy, it is expected that taletrectinib could be launched in the U.S. in 2025, offering a new option for patients in need of improved treatment outcomes.
Read Announcement
Nuvation Bio FDA Events - Frequently Asked Questions
As of now, Nuvation Bio (NUVB) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Nuvation Bio (NUVB) has reported FDA regulatory activity for Taletrectinib (ROS1+ NSCLC).
The most recent FDA-related event for Nuvation Bio occurred on March 6, 2025, involving Taletrectinib (ROS1+ NSCLC). The update was categorized as "Provided Update," with the company reporting: "Nuvation Bio Inc provided a business update."
Currently, Nuvation Bio has one therapy (Taletrectinib (ROS1+ NSCLC)) targeting the following condition: For Patients with Advanced ROS1-positive NSCLC.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NYSE:NUVB) was last updated on 7/13/2025 by MarketBeat.com Staff
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