Latest news with #NuvationBio
Business Wire
21-05-2025
- Business
- Business Wire
Nuvation Bio To Present New Data from Pivotal Clinical Studies of Taletrectinib in Advanced ROS1-Positive Non-Small Cell Lung Cancer at ASCO 2025 Annual Meeting
NEW YORK--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that additional results from TRUST-I and TRUST-II, its pivotal Phase 2 clinical studies on the efficacy and safety of taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC), will be presented at the upcoming American Society of Clinical Oncology (ASCO) 2025 Annual Meeting taking place May 30–June 3, 2025, in Chicago, Illinois. 'Taletrectinib is a highly selective, next-generation oral tyrosine kinase inhibitor, with the potential to expand what's possible for patients with ROS1-positive non-small cell lung cancer,' saidDavid Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. 'We look forward to presenting data from our pivotal TRUST-I and TRUST-II clinical studies, which further demonstrate the potential efficacy and safety of taletrectinib in patients across ethnicities and regions of the world. With a PDUFA date and potential approval by the U.S. FDA in just over a month, we are looking forward to hopefully bringing a truly meaningful new option to patients living with this disease.' Presentation Overview: Title: Presenter: Maurice Perol, Department of Medical Oncology, Léon Bérard Cancer Center, Lyon, France Date: Session Time: 1:30-4:30 p.m. CT Abstract Number: #8643 Location: Poster #123 The materials will be made available in the Publications section of Nuvation Bio's website after the session. To learn more about Nuvation Bio, visit Booth #28031 at the ASCO Annual Meeting. About Taletrectinib Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study. Based on results of the TRUST-I and TRUST-II clinical studies, the U.S. FDA has accepted and granted Priority Review to Nuvation Bio's NDA for taletrectinib for advanced ROS1+ NSCLC (line agnostic, full approval) and assigned a PDUFA goal date of June 23, 2025. The U.S. FDA previously granted taletrectinib Breakthrough Therapy Designation for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs, and Orphan Drug Designation for the treatment of patients with ROS1+ NSCLC and other NSCLC indications. In January 2025, China's NMPA approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. About Nuvation Bio Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment by developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes taletrectinib, a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; NUV-1511, an innovative drug-drug conjugate (DDC) designed for targeted cancer treatment; and NUV-868, a BD2-selective BET inhibitor. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, visit or follow the company on LinkedIn and X (@nuvationbioinc). Forward Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as 'believe,' 'may,' 'will,' 'estimate,' 'continue,' 'anticipate,' 'intend,' 'expect,' 'should,' 'would,' 'plan,' 'predict,' 'potential,' 'seem,' 'seek,' 'future,' 'outlook' and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, our expectations regarding U.S. FDA approval and timing thereof, and taletrectinib's therapeutic potential in advanced ROS1+ NSCLC. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to the challenges associated with conducting drug discovery and initiating or conducting clinical studies due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on May 7, 2025 under the heading 'Risk Factors,' and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.
National Post
13-05-2025
- Business
- National Post
Nuvation Bio to Present Matching-adjusted Indirect Comparison Data for Taletrectinib vs. Entrectinib at ISPOR 2025
Article content NEW YORK — Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that new data from a matching-adjusted indirect comparison study evaluating taletrectinib versus entrectinib in ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) will be presented in a poster session at ISPOR 2025, the Professional Society for Health Economics and Outcomes Research's annual conference, taking place May 13-16, 2025 in Montreal, QC, Canada. Article content Article content Presentation Overview: Article content Title: Taletrectinib vs Entrectinib in ROS1-Positive (ROS1+) Non-Small Cell Lung Cancer (NSCLC): A Matching-Adjusted Indirect Comparison (MAIC) Presenter: Misako Nagasaka, M.D., Ph.D., Associate Professor – Division of Hematology and Oncology, UCI School of Medicine Date: Wednesday, May 14 Session Time: 10:30 a.m. – 1:30 p.m. ET Session: Poster Session 1 Presentation Number: CO151 Article content The materials will be made available in the Publications section of Nuvation Bio's website after the presentation. Article content About Taletrectinib Article content Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study. Article content Based on results of the TRUST-I and TRUST-II clinical studies, the U.S. FDA has accepted and granted Priority Review to Nuvation Bio's NDA for taletrectinib for advanced ROS1+ NSCLC (line agnostic, full approval) and assigned a PDUFA goal date of June 23, 2025. The U.S. FDA previously granted taletrectinib Breakthrough Therapy Designation for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs, and Orphan Drug Designation for the treatment of patients with ROS1+ NSCLC and other NSCLC indications. In January 2025, China's NMPA approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Article content About Nuvation Bio Article content Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment by developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes taletrectinib, a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor for glioma; NUV-1511, an innovative drug-drug conjugate (DDC) designed for targeted cancer treatment; and NUV-868, a BD2-selective BET inhibitor. Article content Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, visit or follow the company on LinkedIn and X (@nuvationbioinc). Article content Article content Article content Contacts Article content Article content
Yahoo
12-05-2025
- Business
- Yahoo
Nuvation Bio to Participate in Upcoming Investor Conferences
NEW YORK, May 12, 2025--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global oncology company tackling some of the toughest challenges in cancer treatment, today announced that David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, and Philippe Sauvage, Chief Financial Officer of Nuvation Bio, will participate in fireside chats at three upcoming investor conferences: H.C. Wainwright 3rd Annual BioConnect Investor Conference at NASDAQ on Tuesday, May 20, 2025, at 3:00 p.m. ET in New York, NY 2025 RBC Capital Markets Global Healthcare Conference on Wednesday, May 21, 2025, at 1:35 p.m. ET in New York, NY TD Cowen 6th Annual Oncology Innovation Summit: Insights for ASCO & EHA on Wednesday, May 28, 2025, at 3:30 p.m. ET (virtual) Live webcasts of each presentation will be available on the Nuvation Bio website at An archived recording will be available for 90 days following each event. About Nuvation Bio Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment by developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes taletrectinib, a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; NUV-1511, an innovative drug-drug conjugate (DDC) designed for targeted cancer treatment; and NUV-868, a BD2-selective BET inhibitor. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, visit or follow the company on LinkedIn and X (@nuvationbioinc). View source version on Contacts Nuvation Bio Investor Contact: ir@ Nuvation Bio Media Contact: media@ Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
09-05-2025
- Business
- Yahoo
Nuvation Bio Inc. (NUVB): Among Billionaire David Abrams' Stock Picks with Huge Upside Potential
We recently published a list of Billionaire David Abrams' 10 Stock Picks with Huge Upside Potential. In this article, we are going to take a look at where Nuvation Bio Inc. (NYSE:NUVB) stands against other stock picks with huge upside potential. David Abrams founded Abrams Capital Management in 1999. Before forming the Boston-based investment firm, Abrams worked at Seth Klarman's Baupost Group for 10 years. He graduated from the University of Pennsylvania with a BA degree in History, where he also served on the Board of Advisors of the College of Arts and Sciences. Abrams didn't have a finance background when he got his first job in New York in the early 1980s. He learned all about investing under Seth Klarman before setting out independently after a decade. He is a value investor, and in the ~12 years of his fund, he has achieved an annualized return of around 20%. His firm is like a one-man shop, which employs a small staff. Abrams Capital has 9 clients and discretionary assets under management (AUM) of $10.05 billion, as reported in the firm's Form ADV dated 13 January 2025. The last reported 13F filing for Q4 2024 included $6.22 billion in managed 13F securities and a top 10 holdings concentration of 98.7%. Abrams is known for maintaining a low public profile, but in a conversation on Columbia Business School's 'Value Investing with Legends' Podcast series, he discussed the surface of his foundational principles when it comes to his investment philosophy. He starts by looking at the risks first and foremost, without any consideration of prospective gains. This is a reminder that the future remains unpredictable, which Abrams puts in the following words: 'When you look back, there's one path that happened, but that doesn't mean that going forward there's only one path. In the future, there's multiple paths.' Abrams' portfolio reflects a balanced approach with exposure to growth sectors like Industrials and Consumer Cyclical, while also maintaining moderate allocations in established industries such as Communication Services. He also believes that declining industries can present stability because they attract limited new entrants. This also implies that high-growth sectors are, on the contrary, characterized by intense competition, which necessitates a more detailed analysis of potential competitive threats. Here's what Abrams had to say about this: 'If you have a shrinking industry and it's dying, it's like, people are not dying to get into that.' Abrams serves as a director of several private companies. He is currently on the board of MITMCO, which manages the MIT endowment. Previously, he was a trustee of Berklee College of Music for 15 years, where he chaired the investment committee. He was also the trustee of Milton Academy. To compile the list of billionaire David Abrams' 10 stock picks with huge upside potential, we sifted through Q4 2024 13F filings of Abrams Capital Management from Insider Monkey. From these filings, we checked each stock's upside potential from CNN and ranked the stocks in ascending order of this upside potential. We have also added Abrams Capital Management's stake in each stock as well as the broader hedge fund sentiment for it. Note: All data was sourced on May 8. Why are we interested in the stocks that hedge funds pile into? The reason is simple: our research has shown that we can outperform the market by imitating the top stock picks of the best hedge funds. Our quarterly newsletter's strategy selects 14 small-cap and large-cap stocks every quarter and has returned 373.4% since May 2014, beating its benchmark by 218 percentage points (see more details here). A close-up of researchers, carefully studying a biopharmaceutical compound in a laboratory. Abrams Capital Management's Stake: $10.14 million Number of Hedge Fund Holders: 34 Average Upside Potential as of May 8: 194.12% Nuvation Bio Inc. (NYSE:NUVB) is a clinical-stage biopharmaceutical company that focuses on unmet needs in oncology by developing differentiated and novel therapeutic candidates. Its lead product candidate is taletrectinib, which is a next-generation ROS1 inhibitor for advanced ROS1+ non-small cell lung cancer (NSCLC). The FDA granted Priority Review to taletrectinib's NDA with a PDUFA goal date of 23 June 2025, which indicates a potential US launch in mid-2025. Taletrectinib is already approved in China and is being commercialized by Innovent Biologics. A Marketing Authorization Application has been submitted in Japan by Nippon Kayaku as well. Nuvation also launched a US Expanded Access Program in February 2025 for eligible patients. The upcoming FDA decision on taletrectinib will unlock funding and establish taletrectinib as Nuvation's first commercial product in the US. On March 12, analyst Soumit Roy of JonesTrading initiated coverage of the stock with a Buy rating and a price target of $10. Roy mentioned that Nuvation Bio Inc. (NYSE:NUVB) is poised to transition to a commercial-stage company by mid-2025. As of December 31, 2024, the company held $502.7 million in cash and marketable securities. Overall, NUVB ranks 1st on our list of billionaire David Abrams' stock picks with huge upside potential. While we acknowledge the potential of NUVB as an investment, our conviction lies in the belief that AI stocks hold great promise for delivering high returns and doing so within a shorter time frame. There is an AI stock that went up since the beginning of 2025, while popular AI stocks lost around 25%. If you are looking for an AI stock that is more promising than NUVB but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
22-04-2025
- Business
- Business Wire
Nuvation Bio to Report Results for First Quarter 2025 and Provide Business Update on May 7, 2025
NEW YORK--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on solving some of the toughest challenges in cancer treatment, will announce results for the first quarter of 2025 on Wednesday, May 7, 2025. Company executives will provide an overview of its programs, summarize its commercial strategy for taletrectinib, and review financial results beginning at 4:30 p.m. ET. The U.S. Food and Drug Administration assigned taletrectinib's New Drug Application with a Prescription Drug User Fee Act goal date of June 23, 2025. Investors and the general public are invited to listen to a live webcast of the call at Materials related to the call will be available prior to the start of the conference call. A replay of the webcast will be available after the conference call concludes. About Nuvation Bio Nuvation Bio is a global oncology company focused on solving some of the toughest challenges in cancer treatment by developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes taletrectinib, a third-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; NUV-1511, an innovative drug-drug conjugate (DDC) designed for targeted cancer treatment; and NUV-868, a BD2-selective BET inhibitor. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, visit or follow the company on LinkedIn and X (@nuvationbioinc).
