Approval follows Priority Review and is supported by the robust TRUST clinical program, in which IBTROZI treatment demonstrated high, durable response rates and brain-penetrant efficacy across different lines of therapy The safety and tolerability of IBTROZI have been well established in the pivotal program, with one of the largest safety datasets in ROS1+ NSCLC showing a favorable and consistent profile Company to host... Read More

Presentation will highlight the comparable efficacy and safety of taletrectinib across pivotal studies and different ethnicities and world regions The drug is under Priority Review by the U.S. Food and Drug Administration (FDA) and has a Prescription Drug User Fee Act (PDUFA) date of June 23, 2025 NEW YORK / May 21, 2025 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of... Read More

NEW YORK / May 13, 2025 / 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 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... Read More

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 3 rd... Read More

New Drug Application (NDA) for taletrectinib for advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) under U.S. Food and Drug Administration (FDA) Priority Review; Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025 Published pooled results from pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib in Journal of Clinical Oncology demonstrating high response rates, durable responses, and a... Read More

NEW YORK / May 01, 2025 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a global oncology company tackling some of the toughest challenges in cancer treatment, today announced that Philippe Sauvage, Chief Financial Officer of Nuvation Bio, will participate in a fireside chat at The Citizens Life Sciences Conference on Thursday, May 8, 2025, at 10:00 a.m. ET in New York, NY. A live webcast of the presentation will be... Read More

NEW YORK / Apr 22, 2025 / 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... Read More

NEW YORK / Apr 02, 2025 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, 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 a fireside chat at the Jones Healthcare and Technology Innovation Conference... Read More

NEW YORK / Mar 25, 2025 / Business Wire / Nuvation Bio Inc . (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced that new nonclinical data for taletrectinib in ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) will be presented at the American Association for Cancer Research (AACR) Annual Meeting taking place April 25–30, 2025 in Chicago, Illinois.... Read More

NEW YORK / Mar 25, 2025 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced that new data from a matching-adjusted indirect comparison study evaluating taletrectinib versus crizotinib in ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) will be reported in a mini oral presentation at the European Lung Cancer... Read More

U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to the New Drug Application (NDA) for taletrectinib for advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC); Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025 Innovent Biologics’ commercialization of taletrectinib underway in China after recent line agnostic approval for advanced ROS1+ NSCLC; Nippon Kayaku completed... Read More

Nuvation Bio to receive $150 million in royalty interest financing and $50 million in debt upon U.S. FDA approval of taletrectinib, with access to additional $50 million in debt at the Company’s option Proceeds from the royalty interest financing expected to fully fund U.S. commercial launch of taletrectinib Pro forma cash balance expected to fully fund development of current clinical-stage pipeline and create a path to... Read More

NEW YORK / Feb 24, 2025 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced that David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, will present at the TD Cowen 45th Annual Health Care Conference on Monday, March 3, 2025, at 3:10 p.m. ET in Boston, MA. A live webcast of the presentation will... Read More

NEW YORK / Feb 03, 2025 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced it has initiated an Expanded Access Program (EAP) for taletrectinib in the U.S. for the treatment of patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) when no comparable or satisfactory... Read More

Taletrectinib will be marketed in China by Innovent Biologics Approval is based on the pivotal Phase 2 TRUST-I study, demonstrating taletrectinib's durable responses and prolonged progression-free survival NEW YORK--( BUSINESS WIRE )-- Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced that China’s National Medical Products Administration... Read More

New Drug Application (NDA) is based on pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib that demonstrated durable responses and prolonged progression-free survival in patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) If approved, taletrectinib represents a potential best-in-class treatment option for patients with advanced ROS1+ NSCLC U.S. Food and Drug... Read More

SAN FRANCISCO and SUZHOU, China , Dec. 20, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, today announced that China's National Medical Products Administration (NMPA) has... Read More

NEW YORK / Nov 26, 2024 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced that David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, will participate in a fireside chat at the 7th Annual Evercore ISI HealthCONx Conference in Coral Gables, Florida, on Wednesday, December... Read More

NEW YORK / Nov 12, 2024 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced that David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, will present at the Jefferies London Healthcare Conference in London, U.K., on Tuesday, November 19, 2024, at 3:30 a.m. ET/8:30 a.m. GMT. A... Read More

Submitted New Drug Application (NDA) for taletrectinib to the U.S. Food and Drug Administration (FDA) in October for the treatment of patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC), positioning Company to commercialize taletrectinib, if approved, as early as mid-2025 Presented positive pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib in patients with advanced... Read More

Global leader with proven financial, operational, and commercial expertise joins Nuvation Bio as the company prepares to transition into a commercial-stage organization NEW YORK / Oct 07, 2024 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced the appointment of Philippe Sauvage as Chief Financial... Read More

Tumors shrank in 89% of taletrectinib-treated patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) who were tyrosine kinase inhibitor (TKI)-naïve and 56% of those who were TKI-pretreated in the study Taletrectinib demonstrated durable responses and prolonged progression-free survival (PFS) with long-term follow up; median duration of response (DOR) and median PFS in TKI-naïve patients were 44... Read More

NEW YORK / Sep 09, 2024 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced that David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, will present at the Cantor Global Healthcare Conference in New York, NY on Thursday, September 19, 2024, at 9:45 a.m. E.T. A live webcast... Read More

Efficacy and safety data from the pivotal Phase 2 TRUST-I clinical study of taletrectinib, a ROS1 inhibitor, published in the Journal of Clinical Oncology and presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting Company to present pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies at the European Society of Medical Oncology (ESMO) Congress 2024, which will support Nuvation Bio’s... Read More

Company to present pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies at the European Society of Medical Oncology (ESMO) Congress 2024, which will support Nuvation Bio’s New Drug Application (NDA) in the United States Company to present data from the global, pivotal Phase 2 TRUST-II study at the 2024 World Conference on Lung Cancer (WCLC) Taletrectinib granted Orphan Drug Designation by the U.S. Food and Drug... Read More

Tumors shrank in 91% of taletrectinib-treated patients with advanced ROS1-positive NSCLC who were ROS1 TKI-naïve and 52% of those who were ROS1 TKI-pretreated in the study Responses were durable with long-term follow-up; 71% of TKI-naïve patients were still progression-free at two years TRUST-I is one of two registrational Phase 2 studies evaluating taletrectinib for the treatment of patients with advanced ROS1-positive... Read More

Acquisition of AnHeart Therapeutics transformed Nuvation Bio into a late-stage, global oncology company with potential to become a commercial organization by the end of 2025 Updated data from the pivotal Phase 2 TRUST-I clinical study of taletrectinib, a ROS1 inhibitor, to be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting First patient treated in a Phase 1/2 study of NUV-1511, the company’s... Read More

NEW YORK / Apr 24, 2024 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a late-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that updated data from the Phase 2 TRUST-I clinical study (NCT04395677) evaluating taletrectinib in patients in China with ROS1-positive non-small cell lung cancer (NSCLC)... Read More

Transforms Nuvation Bio into late-stage global oncology company with potential to become a commercial organization by the end of 2025 Shareholders of Nuvation Bio and AnHeart Therapeutics immediately prior to close now own approximately 67% and 33%, respectively, of Nuvation Bio on a fully diluted basis NEW YORK / Apr 10, 2024 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a late-stage, global biopharmaceutical company... Read More

Ms. Sjogren brings nearly 30 years of biopharmaceutical experience building commercial organizations and leading successful oncology launches Pending acquisition of AnHeart Therapeutics and expanded leadership strongly positions Nuvation Bio to potentially become a commercial organization by the end of 2025 NEW YORK / Mar 28, 2024 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of... Read More

Acquisition transforms Nuvation Bio into late-stage global oncology company with potential to become a commercial organization by the end of 2025 Acquisition adds taletrectinib, a next-generation, potentially best-in-class ROS1 inhibitor with Breakthrough Therapy Designations currently completing two pivotal studies for the treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC) Acquisition also adds... Read More

NUV-1511 is the Company’s first drug-drug conjugate (DDC) to enter the clinic NEW YORK / Mar 14, 2024 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the first patient has been dosed in a Phase 1/2 study of NUV-1511, the Company’s first DDC to enter the... Read More

Determined maximum tolerated dose (MTD) in Phase 1 monotherapy study of NUV-868; Phase 1b studies of NUV-868 in combination with olaparib or enzalutamide remain ongoing Received U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug (IND) application for NUV-1511, the first clinical candidate from our novel drug-drug conjugate (DDC) platform Strong balance sheet with cash, cash equivalents and... Read More

NEW YORK / Jan 08, 2024 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced the appointment of Robert Mashal, M.D. to its Board of Directors. “We are delighted to have Dr. Mashal join our Board of Directors,” said David Hung, M.D., Founder, President, and Chief... Read More

NUV-1511 is the first clinical candidate from the company’s novel drug-drug conjugate platform Company anticipates initiating a Phase 1/2 clinical study of NUV-1511 in 1H 2024 NEW YORK / Jan 08, 2024 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, announced today that the U.S.... Read More

NEW YORK / Nov 13, 2023 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB) (the “Company”) announced today that Jennifer Fox will be stepping down from her role as Chief Financial Officer to pursue a new opportunity. Ms. Fox has advised the Company that she is seeking later stage development and commercial launch experience as part of her career development and that she is leaving with a high regard for the Company, its... Read More

Phase 1 monotherapy study of NUV-868 and Phase 1b study of NUV-868 in combination with olaparib or enzalutamide are ongoing Expect to submit an IND for first Drug-Drug Conjugate (DDC) clinical candidate by year end 2023 Strong balance sheet with cash, cash equivalents, and marketable securities of $619.3 million as of September 30, 2023 NEW YORK / Nov 02, 2023 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a... Read More

Enrollment ongoing in the Phase 1b study of NUV-868 in combination with olaparib or enzalutamide Enrollment ongoing in the Phase 1 monotherapy study of NUV-868 Expect to submit an IND for first Drug-Drug Conjugate (DDC) clinical candidate by year end 2023 Announced formation of oncology-focused Scientific Advisory Board Strong balance sheet with cash, cash equivalents and marketable securities of $630.9 million as of June... Read More

Scientific Advisory Board members bring significant global expertise in oncology drug and clinical development NEW YORK / Jun 01, 2023 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced the formation of a Scientific Advisory Board. The Scientific Advisory Board will... Read More

Enrollment ongoing in the Phase 1b study of NUV-868 in combination with olaparib or enzalutamide Enrollment ongoing in the Phase 1 monotherapy study of NUV-868 Expect to submit an IND for first Drug-Drug Conjugate (DDC) clinical candidate by year end 2023 Strong balance sheet with cash, cash equivalents and marketable securities of $646.6 million as of March 31, 2023 NEW YORK / May 04, 2023 / Business Wire / Nuvation Bio... Read More

NEW YORK / Mar 15, 2023 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update. “In the fourth quarter, we dosed the first patient in both dosing regimens of our... Read More

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported its financial results for the second quarter ended June 30, 2022, and provided a business update. “We are committed to advancing innovative therapies as quickly and safely as possible for people with cancers that do not currently have... Read More

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that it will prioritize NUV-868 and development of its novel small molecule DDC platform and discontinue clinical development of NUV-422. The decision to discontinue clinical development of NUV-422 is the result of an internal... Read More

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced the appointment of David Liu, M.D., Ph.D., as Chief Medical Officer and Kerry Wentworth as Chief Regulatory Officer. Dr. Liu will lead Nuvation Bio’s clinical development team and collaborate with the executive committee to provide... Read More

Nuvation Bio Inc . (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced the Food and Drug Administration (FDA) has placed a partial clinical hold on the Company’s Phase 1 dose escalation study of NUV-422 in solid tumors, including high grade glioma, HR+/HER2- advanced breast cancer and metastatic... Read More

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported its financial results for the first quarter ended March 31, 2022, and provided a business update. “We are encouraged by the important progress we have made so far this year across our pipeline of novel oncology therapeutic candidates... Read More

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported financial results for the fourth quarter and full year ended December 31, 2021, and provided a business update. “In 2021, the Nuvation Bio team made significant progress for our lead cyclin-dependent kinase 2/4/6 inhibitor program in... Read More

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-868, a... Read More

David Hung , M.D., founder, president, and chief executive officer, to present virtually at the 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022 at 7:30 a.m. ET Multiple trials anticipated to initiate in 2022 as well as additional IND filings - • Phase 2 monotherapy cohorts and Phase 1b combination studies for... Read More

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to NUV-422, a cyclin-dependent kinase (CDK) 2/4/6... Read More

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-422, a... Read More

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-422, a... Read More

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported financial results for the third quarter ended September 30, 2021 , and provided a business update. "In the third quarter, Nuvation Bio... Read More

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported financial results for the second quarter ended June 30, 2021 , and provided a business update. "The second quarter of 2021 marked... Read More

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced the appointment of David C. Hanley , Ph.D., as Chief Technical Operations Officer, joining the Company's executive management team. In... Read More

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that David Hung , M.D., founder and chief executive officer of Nuvation Bio, will participate in a fireside chat at the Jefferies... Read More

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported its financial results for the first quarter ended March 31, 2021 , and provided a business update. "Nuvation Bio continues to make... Read More

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported its financial results for the year ended December 31, 2020 and provided a business update. "Nuvation Bio began a new chapter as a public... Read More

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NUV-422, a cyclin-dependent kinase (CDK) 2/4/6... Read More