Articles from Nuvation Bio Inc.

Nuvation Bio Inc. (NYSENUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced that China’s National Medical Products Administration (NMPA) has approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) who either have or have not been previously treated with ROS1 tyrosine kinase inhibitors (TKI). As part of an exclusive license agreement, Innovent Biologics will commercialize taletrectinib in China under the brand name DOVBLERON®. The product was officially launched in the territory in January 2025. Taletrectinib was previously granted Breakthrough Therapy Designation and Priority Review by China’s NMPA.

Nuvation Bio Inc. (NYSENUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced that the U.S. FDA has accepted the company’s NDA for taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor (TKI), for the treatment of advanced ROS1+ NSCLC (line agnostic). The U.S. FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025. Priority Review designation underscores the significant advancement taletrectinib may offer patients with ROS1+ NSCLC, for which there remains a high unmet need for new treatment options. Taletrectinib previously received Orphan Drug Designation and is the only ROS1 TKI currently in development that has received Breakthrough Therapy Designation from the U.S. FDA for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs.

Nuvation Bio Inc. (NYSENUVB), 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 4, 2024, at 9:10 a.m. ET.

Nuvation Bio Inc. (NYSENUVB), 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.

Nuvation Bio Inc. (NYSENUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today reported financial results for the third quarter ended September 30, 2024, and provided a business update.

Nuvation Bio Inc. (NYSENUVB), 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 Officer (CFO).

Nuvation Bio Inc. (NYSENUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced positive pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies evaluating taletrectinib, an investigational next-generation ROS1 TKI. The findings will be highlighted in a poster presentation on September 14, 2024, at the European Society of Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain.

Nuvation Bio Inc. (NYSENUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today reported financial results for the second quarter ended June 30, 2024, and provided a business update.

Nuvation Bio Inc. (NYSENUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced multiple updates for its taletrectinib program. Data from the global, pivotal Phase 2 TRUST-II study has been accepted for an oral presentation at WCLC 2024 taking place September 7-10 in San Diego, California. Pooled data from both pivotal Phase 2 studies, TRUST-I and TRUST-II, has been accepted for a poster presentation at ESMO 2024 taking place September 13-17, in Barcelona, Spain. The pooled data presented at ESMO will support the Company’s NDA in the United States. Additionally, the U.S. FDA has granted Orphan Drug Designation to taletrectinib for the treatment of multiple NSCLC indications, including ROS1-positive NSCLC.

Nuvation Bio Inc. (NYSENUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, announced that results from the pivotal Phase 2 TRUST-I study conducted in China evaluating taletrectinib, its investigational next-generation ROS1 tyrosine kinase inhibitor (TKI), were published today in the Journal of Clinical Oncology (JCO) and will be highlighted in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, Illinois.

Nuvation Bio Inc. (NYSENUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, announced today that David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, will participate in a hybrid presentation at the Jefferies Global Healthcare Conference in New York, NY on Wednesday, June 5, 2024, at 1:30 p.m. ET.

Nuvation Bio Inc. (NYSENUVB), a late-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported financial results for the first quarter ended March 31, 2024, and provided a business update.

Nuvation Bio Inc. (NYSENUVB), 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) will be reported in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31-June 4, 2024 in Chicago, Illinois.

Nuvation Bio Inc. (NYSENUVB), a late-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced the completion of the acquisition of AnHeart Therapeutics Ltd. (AnHeart), a late-stage, global biopharmaceutical company developing novel precision therapies for people with cancer. With the acquisition’s completion, AnHeart is now a wholly-owned subsidiary of Nuvation Bio.

Nuvation Bio Inc. (NYSENUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced the appointment of Colleen Sjogren as Chief Commercial Officer. Ms. Sjogren will lead the Company’s commercial strategy and operations, including marketing, sales, and market access.

Nuvation Bio Inc. (NYSENUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, and AnHeart Therapeutics Ltd. (AnHeart), a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer, today announced that the companies have entered into a definitive agreement for Nuvation Bio to acquire AnHeart in an all-stock transaction (the Acquisition). Immediately following the closing of the Acquisition, the former shareholders of AnHeart will own approximately 33% and the current stockholders of Nuvation Bio will own approximately 67% of Nuvation Bio on a fully diluted basis. The Acquisition, which has been approved by the board of directors of each company and is subject to approval by AnHeart’s shareholders and other customary closing conditions, will position Nuvation Bio as a late-stage global oncology company with multiple programs in clinical development. The Acquisition is expected to close in the second quarter of 2024.

Nuvation Bio Inc. (NYSENUVB), 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 clinic.

Nuvation Bio Inc. (NYSENUVB), 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, 2023, and provided a business update.

Nuvation Bio Inc. (NYSENUVB), 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.

Nuvation Bio Inc. (NYSENUVB), 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. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-1511, the first clinical candidate from the company’s novel drug-drug conjugate (DDC) platform.

Nuvation Bio Inc. (NYSENUVB) (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 leadership and its financial state. Ms. Fox submitted her resignation on November 9, 2023 with an effective date of November 27, 2023. Members of the executive management team and the Company’s finance team will assume the duties and responsibilities of the CFO office.

Nuvation Bio Inc. (NYSENUVB), 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 third quarter ended September 30, 2023, and provided a business update.

Nuvation Bio Inc. (NYSENUVB), 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, 2023, and provided a business update.

Nuvation Bio Inc. (NYSENUVB), 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 work alongside the Nuvation Bio management team to advance its pipeline of therapeutic candidates for some of the most difficult-to-treat cancers.

Nuvation Bio Inc. (NYSENUVB), 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, 2023, and provided a business update.

Nuvation Bio Inc. (NYSENUVB), 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.

Nuvation Bio Inc. (NYSENUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced it has dosed the first patient in a Phase 1b study of its BD2-selective BET inhibitor, NUV-868, in combination with olaparib.

Nuvation Bio Inc. (NYSENUVB), 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 third quarter ended September 30, 2022, and provided a business update.

Nuvation Bio Inc. (NYSENUVB), 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.

Nuvation Bio Inc. (NYSENUVB), 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.

Nuvation Bio Inc. (NYSENUVB), 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 strategic direction for the Company’s research and drug development programs. Ms. Wentworth will oversee regulatory and quality affairs across the Company’s pipeline.

Nuvation Bio Inc. (NYSENUVB), 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 castration resistant prostate cancer. The Company’s Phase 1 trial began enrolling patients 19 months ago in December 2020 and, in recent months, was exploring higher doses to define a maximum tolerated dose. Following the emergence of uveitis, a form of inflammation in the eye, in certain patients receiving NUV-422, the Company proactively paused enrollment of new patients in order to further assess these adverse events with investigators and uveitis experts, and also reached out to the FDA for guidance around an appropriate path forward. While the partial hold is in place, no new patients will be enrolled in the NUV-422 program, although current study participants may continue to be treated in the Phase 1 study.

Nuvation Bio Inc. (NYSENUVB), 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.