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), a global oncology company, has scheduled its first quarter 2025 earnings release and business update for May 7, 2025. The company will host a conference call at 4:30 p.m. ET, where executives will discuss their programs, financial results, and outline the commercial strategy for taletrectinib.
Notably, the FDA has assigned a PDUFA date of June 23, 2025 for taletrectinib's New Drug Application. The presentation will be accessible via webcast at the company's investor relations website, with related materials available before the call and a replay option afterward.
Nuvation Bio (NYSE: NUVB), a global biopharmaceutical company focused on oncology, has announced its upcoming participation in the Jones Healthcare and Technology Innovation Conference.
The company's leadership, including Founder, President, and CEO David Hung, M.D., and CFO Philippe Sauvage, will engage in a fireside chat scheduled for April 9, 2025, at 10:00 a.m. PT/1:00 p.m. ET in Las Vegas.
An audio recording of the presentation will be accessible on the company's investor relations website at investors.nuvationbio.com/investors/ and will remain available for 90 days after the event.
Nuvation Bio (NYSE: NUVB) has announced it will present new nonclinical data for taletrectinib in ROS1-positive non-small cell lung cancer (NSCLC) at the upcoming American Association for Cancer Research (AACR) Annual Meeting in Chicago (April 25-30, 2025).
The presentation will focus on taletrectinib's role as a next-generation selective ROS1 inhibitor and its effectiveness in inhibiting growth of ROS1 wild-type and ROS1-G2032R xenografts. Dr. Hitisha Patel, Director of Research at Nuvation Bio, will present the findings on April 29, 2025, during the Kinase and Phosphatase Inhibitors 3 session.
Nuvation Bio (NYSE: NUVB) has announced an upcoming presentation of new comparative data for taletrectinib versus crizotinib in treating ROS1-positive non-small cell lung cancer (NSCLC) at the European Lung Cancer Congress 2025 in Paris.
The research, featuring a matching-adjusted indirect comparison study, will be presented by Dr. Misako Nagasaka, Associate Professor at UCI School of Medicine's Division of Hematology and Oncology. The mini oral presentation, numbered LBA2, is scheduled for March 27, 2025, from 4:00 p.m. to 5:05 p.m. CET (11:00 a.m. to 12:05 p.m. ET).
The presentation materials will be subsequently available in the Publications section of Nuvation Bio's website.
Nuvation Bio (NYSE: NUVB) reported significant developments in Q4 and full year 2024. The FDA granted Priority Review to taletrectinib for advanced ROS1-positive non-small cell lung cancer, with a PDUFA date of June 23, 2025. The drug received approval in China and is under review in Japan.
The company's financial position remains strong with $502.7 million in cash and equivalents as of December 31, 2024, further bolstered by securing up to $250 million in non-dilutive financing from Sagard Healthcare Partners in March 2025.
Q4 2024 financial results showed increased expenses, with R&D costs rising to $29.3 million from $15.4 million year-over-year, and SG&A expenses increasing to $26.1 million from $5.5 million. The company reported a net loss of $49.4 million, or $(0.15) per share, compared to $13.8 million loss in Q4 2023.
Nuvation Bio (NYSE: NUVB) has secured up to $250 million in non-dilutive financing from Sagard Healthcare Partners, comprising a $150 million royalty interest financing and up to $100 million in senior term loans. The financing is contingent on FDA approval of taletrectinib by September 30, 2025.
Upon FDA approval, Sagard will provide $150 million upfront in exchange for tiered royalties on U.S. taletrectinib sales: 5.5% for annual sales up to $600 million and 3.0% for sales between $600 million and $1 billion. Nuvation Bio retains all sales above $1 billion. The royalty agreement terminates when payments reach 1.6-2.0 times Sagard's investment.
The term loan includes $50 million available upon FDA approval and an additional $50 million option until June 30, 2026, following first U.S. commercial sale. The loan carries SOFR + 6.00% interest with a 4.00% floor and matures in 5 years.
Nuvation Bio (NYSE: NUVB), a global biopharmaceutical company focused on oncology, has announced its upcoming participation at the TD Cowen 45th Annual Health Care Conference. David Hung, M.D., who serves as the company's Founder, President, and Chief Executive Officer, will deliver a presentation on Monday, March 3, 2025, at 3:10 p.m. ET in Boston, MA.
The presentation will be accessible through a live webcast on the company's investor relations website. For those unable to attend live, an archived recording will remain available for 90 days following the event on the Nuvation Bio investor website.
Nuvation Bio (NYSE: NUVB) has launched an Expanded Access Program (EAP) in the United States for taletrectinib, targeting patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) who lack alternative treatment options. The EAP, authorized by the FDA, enables patients with serious or life-threatening ROS1+ NSCLC to access taletrectinib outside the ongoing Phase 2 TRUST-II study.
This initiative follows the FDA's acceptance of Nuvation Bio's New Drug Application (NDA) for taletrectinib in December 2024. The application received Priority Review status with a PDUFA goal date of June 23, 2025. The NDA is supported by combined results from the Phase 2 TRUST-I and TRUST-II studies, which were presented at the ESMO Congress in September 2024.
Nuvation Bio (NYSE: NUVB), a global biopharmaceutical company focused on oncology, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. David Hung, M.D., who serves as the company's Founder, President, and Chief Executive Officer, will deliver a presentation on Monday, January 13, 2025, at 9:00 a.m. PT in San Francisco, California.
The presentation will be accessible through a live webcast on the company's investor relations website. For those unable to attend live, an archived recording will remain available for 30 days after the event.
Nuvation Bio (NYSE: NUVB) announced the approval of taletrectinib by China's National Medical Products Administration (NMPA) for treating adult patients with advanced ROS1-positive non-small cell lung cancer (NSCLC). The drug, to be marketed as DOVBLERON® by Innovent Biologics in China, was launched in January 2025.
The approval was based on the Phase 2 TRUST-I study results, which demonstrated the drug's efficacy in patients who have or haven't been previously treated with ROS1 tyrosine kinase inhibitors. The drug previously received Breakthrough Therapy Designation and Priority Review in China.
Additionally, the U.S. FDA has accepted Nuvation Bio's New Drug Application for taletrectinib with Priority Review, setting a PDUFA date of June 23, 2025. The U.S. application is supported by pooled results from the TRUST-I and TRUST-II studies presented at ESMO Congress in September 2024.
