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) 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.
Innovent Biologics (HKEX: 01801) has received approval from China's NMPA for the second New Drug Application of DOVBLERON® (taletrectinib adipate capsule), a next-generation ROS1 tyrosine kinase inhibitor. This approval is for treating adult patients with locally advanced or metastatic ROS1-positive NSCLC.
The approval is based on the Phase 2 TRUST-I trial results, which showed impressive efficacy: 91% confirmed objective response rate in ROS1 TKI-naïve patients and 88% intracranial response rate. After a median follow-up of 23.5 months, the median duration of response and progression-free survival were not reached.
This follows DOVBLERON®'s first approval in December 2024 for previously treated ROS1-positive NSCLC patients. It becomes Innovent's 13th commercial product, strengthening their TKI franchise alongside RETSEMOV®, PEMAZYRE®, and DUPERT®.
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.
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