Welcome to our dedicated page for Nuvation Bio news (Ticker: NUVB), a resource for investors and traders seeking the latest updates and insights on Nuvation Bio stock.
Nuvation Bio Inc (NUVB) is a clinical-stage biopharmaceutical company pioneering novel therapies for challenging cancers through innovative platforms like BD2-selective BET inhibitors and Drug-Drug Conjugate technology. This page serves as the definitive source for tracking the company’s progress in oncology research and corporate developments.
Investors and industry observers will find timely updates on clinical trial milestones, regulatory filings, and strategic partnerships. All press releases and news articles are organized to provide clear insights into Nuvation Bio’s work targeting epigenetic regulators and advanced drug delivery systems.
Key content includes updates on lead candidate NUV-868, financial results, and scientific presentations. The page is regularly updated to reflect the most current information about the company’s efforts to develop precision oncology treatments.
Bookmark this page to stay informed about Nuvation Bio’s advancements in creating therapies for tumors resistant to conventional treatments. Check back frequently for verified updates directly from corporate communications and trusted industry sources.
Nuvation Bio (NYSE: NUVB) announced that the FDA has accepted their New Drug Application (NDA) for taletrectinib, granting it Priority Review status for treating advanced ROS1-positive non-small cell lung cancer (NSCLC). The FDA has set a target action date of June 23, 2025.
The NDA is supported by pooled data from the Phase 2 TRUST-I and TRUST-II studies, representing the largest ROS1-positive NSCLC dataset for an original NDA, with over 300 patients. Taletrectinib, a next-generation ROS1 tyrosine kinase inhibitor, has already received Orphan Drug Designation and is the only ROS1 TKI in development with Breakthrough Therapy Designation for both TKI-naive and previously treated patients.
Innovent Biologics (HKEX: 01801) has received NMPA approval for DOVBLERON® (taletrectinib adipate capsule), a next-generation ROS1 tyrosine kinase inhibitor, for treating adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs.
The approval is based on the Phase 2 TRUST-I trial results, which demonstrated significant therapeutic effects on brain lesions and efficacy in crizotinib-resistant patients. DOVBLERON® becomes Innovent's 13th commercial product, addressing a critical need as approximately 2.6% of NSCLC patients in China are ROS1-positive, with up to 55% developing brain metastases after initial treatment.
A second NDA for DOVBLERON® was accepted and granted Priority Review Designation in March 2024 for first-line treatment of ROS1-positive NSCLC patients.
Nuvation Bio (NYSE: NUVB), a late clinical-stage biopharmaceutical company focused on oncology, announced its upcoming participation in the 7th Annual Evercore ISI HealthCONx Conference. David Hung, M.D., the company's Founder, President, and CEO, will engage in a fireside chat at the conference in Coral Gables, Florida, on December 4, 2024, at 9:10 a.m. ET. The presentation will be accessible via live webcast on the company's investor website, with a recording available for 90 days afterward.
Nuvation Bio (NYSE: NUVB), a late clinical-stage biopharmaceutical company focused on oncology, has announced its participation in the Jefferies London Healthcare Conference. David Hung, M.D., the company's Founder, President, and Chief Executive Officer, will deliver a presentation on Tuesday, November 19, 2024, at 3:30 a.m. ET/8:30 a.m. GMT in London, U.K. The presentation will be accessible via live webcast on the company's investor website, with a recording available for 90 days after the event.
Nuvation Bio (NYSE: NUVB) reported Q3 2024 financial results and business updates. Key highlights include the submission of a New Drug Application for taletrectinib to the FDA for ROS1-positive NSCLC treatment, with potential commercialization by mid-2025. The company presented positive pooled data showing 89% response rate in TKI-naïve patients. Financial results show cash position of $549.1 million, with increased R&D expenses of $27.7 million and G&A expenses of $19.6 million. The quarter ended with a net loss of $41.2 million, or ($0.15) per share, compared to $19.6 million loss in Q3 2023.
Nuvation Bio Inc. (NYSE: NUVB) has appointed Philippe Sauvage as Chief Financial Officer. With over 20 years of global leadership experience in finance, operations, and commercialization within healthcare and biopharmaceutical organizations, Sauvage joins Nuvation Bio as the company prepares to transition into a commercial-stage organization.
Sauvage's most recent role was Global Head of Operations and Access at Sanofi, where he oversaw strategic segments including commercial systems, multichannel strategy, and market access. He previously served as CFO for Sanofi-Genzyme and Sanofi North America, managing a $14 billion region. His experience also includes roles as CFO in Sanofi's JPAC region and Japan, as well as leadership positions in the French public health sector and Ministry of Health.
David Hung, M.D., Founder, President, and CEO of Nuvation Bio, expressed excitement about Sauvage joining the company, highlighting his broad skillset and strategic vision as invaluable for Nuvation Bio's transition to a commercial-stage organization in 2025.
Nuvation Bio (NYSE: NUVB) announced positive pooled data from TRUST-I and TRUST-II studies evaluating taletrectinib, a next-generation ROS1 TKI for advanced ROS1-positive NSCLC. Key findings include:
- 89% tumor shrinkage in TKI-naïve patients
- 56% tumor shrinkage in TKI-pretreated patients
- Median DOR of 44 months and PFS of 46 months in TKI-naïve patients
- 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. The data support taletrectinib's potential as a best-in-class treatment for ROS1-positive NSCLC.
Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage biopharmaceutical company focusing on oncology, has announced its participation in the Cantor Global Healthcare Conference. The event is scheduled for Thursday, September 19, 2024, at 9:45 a.m. E.T. in New York, NY.
Dr. David Hung, the Founder, President, and Chief Executive Officer of Nuvation Bio, will be presenting at the conference. Interested parties can access a live webcast of the presentation through the company's investor relations website. For those unable to attend live, an archived recording will be available for 90 days following the event.
Nuvation Bio (NYSE: NUVB) reported Q2 2024 financial results and provided a business update. Key highlights include:
- Efficacy and safety data from the Phase 2 TRUST-I study of taletrectinib published in the Journal of Clinical Oncology and presented at ASCO 2024
- Pooled data from TRUST-I and TRUST-II studies to be presented at ESMO 2024, supporting planned NDA filing
- Taletrectinib granted Orphan Drug Designation by FDA for ROS1-positive NSCLC
- Strong balance sheet with $577.2 million in cash and equivalents as of June 30, 2024
- Q2 2024 net loss of $462.5 million, or $(1.89) per share, compared to $20.6 million in Q2 2023
- R&D expenses increased to $29.2 million, up from $18.6 million in Q2 2023
Nuvation Bio (NYSE: NUVB) announced updates for its taletrectinib program, a ROS1 inhibitor for non-small cell lung cancer (NSCLC). Key highlights include:
- Presentation of pooled data from pivotal Phase 2 TRUST-I and TRUST-II studies at ESMO Congress 2024, supporting the New Drug Application (NDA) in the US
- Presentation of global Phase 2 TRUST-II study data at WCLC 2024
- FDA granted Orphan Drug Designation for taletrectinib in ROS1-positive NSCLC and other NSCLC indications
The company aims to commercialize taletrectinib in 2025. The Orphan Drug Designation provides development incentives, including tax credits and potential market exclusivity. Taletrectinib is being evaluated in two pivotal Phase 2 studies for ROS1-positive NSCLC patients.
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