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Nuvation Bio Inc. (symbol: NUVB) is a biopharmaceutical company pioneering the development of innovative therapies to treat various forms of cancer. Founded in 2018 by industry veteran David Hung, M.D., who previously established Medivation, Inc., the company has quickly positioned itself as a leader in oncology therapeutics. Nuvation Bio operates out of New York and San Francisco, focusing on unmet medical needs in the cancer treatment landscape.
The company's core business revolves around its proprietary portfolio of six novel oncology therapeutic product candidates. These therapies are mechanistically distinct and aim to tackle some of the hardest-to-treat cancers. Among its product pipeline, the flagship clinical-stage candidate is NUV-868, an oral small molecule BET inhibitor that selectively targets BD2. This inhibitor disrupts the BRD4 protein, a crucial member of the BET family involved in tumor growth regulation. NUV-868's mechanism of action includes the inhibition of oncogenes such as c-myc, which are often altered in human cancers.
Nuvation Bio is also breaking new ground with its small molecule Drug-Drug Conjugate (DDC) platform. This approach is a novel category within anti-cancer therapies, closely related to Antibody-Drug Conjugates (ADCs). The DDC platform aims to deliver targeted therapy with improved efficacy and reduced side effects compared to traditional chemotherapy.
In addition to its robust product pipeline, Nuvation Bio has formed strategic partnerships and collaborations to enhance its research and development capabilities. These alliances are key to accelerating the development and commercialization of its therapeutic candidates, ensuring that new treatments can reach patients who need them the most.
Financially, Nuvation Bio is well-positioned, leveraging its strong foundation and innovative pipeline to attract investor interest and funding. The company's commitment to revolutionizing cancer treatment is evident in its continuous pursuit of groundbreaking therapies and clinical trials that aim to provide better outcomes for cancer patients.
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.
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.
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