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. (NYSE: NUVB) is a global oncology company whose news flow is driven by the development, approval and commercialization of targeted cancer therapies. Investors following NUVB news can track updates on taletrectinib (marketed as IBTROZI in the U.S. and Japan and as DOVBLERON in China), a next-generation ROS1 inhibitor for ROS1-positive non-small cell lung cancer, as well as safusidenib, a brain-penetrant IDH1 inhibitor for IDH1-mutant gliomas, and other pipeline programs.
News about Nuvation Bio frequently covers regulatory milestones, clinical trial progress and commercial performance. Recent announcements have included U.S. FDA approval and commercial launch of IBTROZI for locally advanced or metastatic ROS1+ NSCLC, adoption trends in this rare disease setting, and long-term clinical data from the TRUST-I and TRUST-II registrational studies. The company also reports on global expansion activities, such as its exclusive license and collaboration agreement with Eisai Co., Ltd. granting Eisai development and commercialization rights for taletrectinib in Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand and several Asian markets, and on regional commercialization through partners in China and Japan.
Nuvation Bio’s news feed also highlights progress in its safusidenib program, including publication of Phase 2 results in IDH1-mutant grade 2 glioma and the advancement of the G203 global randomized study in high-grade IDH1-mutant astrocytoma with a protocol aligned with the U.S. FDA. Additional items may include decisions about pipeline prioritization, such as discontinuation of NUV-1511 while continuing the drug-drug conjugate platform, participation in major healthcare and investor conferences, and preliminary financial updates related to product revenue and collaboration agreements.
By monitoring NUVB news, readers can follow how Nuvation Bio executes on its oncology strategy, from pivotal trials and regulatory interactions to licensing deals and commercial performance of IBTROZI and other assets. This page aggregates company press releases and related coverage so that investors and observers can review key developments in one place.
Nuvation Bio (NYSE: NUVB) announced enrollment of the first patient in part 2 of G203 (NCT05303519), a global, randomized study of safusidenib versus placebo as maintenance therapy for newly diagnosed high-grade IDH1-mutant astrocytoma following surgery, radiation/chemoradiation, and adjuvant temozolomide.
A protocol amendment aligned with the FDA converts G203 part 2 to a planned Phase 3 study enrolling ~300 patients in the U.S., Australia, and China. Patients will be randomized 1:1 to 250 mg safusidenib or placebo twice daily. The primary endpoint is progression-free survival (PFS) by BICR per RANO 2.0, which FDA agreed could support full approval; secondary endpoints include overall survival and objective response rate. Nuvation will provide program updates on its Nov 3, 2025 earnings call.
Nuvation Bio (NYSE: NUVB) will report third quarter 2025 financial results and provide a business update on Monday, November 3, 2025 at 4:30 p.m. ET. The company will host a live conference call and webcast; investors may register via the company's Investor Relations website. To join the call by phone dial +1 833-470-1428 (U.S. toll-free) and enter access code 405112. An archived recording will be available on Nuvation Bio's website for 90 days after the event.
Nuvation Bio (NYSE:NUVB) has enrolled its first patient in the TRUST-IV Phase 3 study evaluating IBTROZI™ (taletrectinib) for adjuvant treatment of ROS1-positive early-stage non-small cell lung cancer (NSCLC). The trial follows IBTROZI's recent approval for advanced ROS1-positive NSCLC.
The study will enroll approximately 180 patients across multiple countries, randomized 2:1 to receive either taletrectinib or placebo. The trial targets patients with ROS1+ stage IB, II or IIIA NSCLC who have undergone surgery. The primary endpoint is disease-free survival, with completion expected in 2033.
Nuvation Bio (NYSE:NUVB) has received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for IBTROZI™ (taletrectinib) to treat adult patients with ROS1-positive unresectable, advanced and/or recurrent non-small cell lung cancer (NSCLC). The approval is based on the pivotal Phase 2 TRUST clinical program data.
This marks the third major regulatory approval for IBTROZI, following U.S. FDA approval in June 2025 and China's NMPA approval in January 2025. Nippon Kayaku will commercialize the drug in Japan under an exclusive license agreement. The MHLW also approved the AmoyDx® PLC Panel as a companion diagnostic.
Nuvation Bio expects to receive a $25 million milestone payment upon establishing reimbursement pricing in Japan, anticipated in Q4 2025. The drug has been designated as a Preferred Agent in the NCCN Guidelines® for both first-line and subsequent therapy for ROS1+ NSCLC.
Nuvation Bio (NYSE:NUVB) has presented new data from its pivotal TRUST-I and TRUST-II clinical studies of IBTROZI™ (taletrectinib) for ROS1-positive non-small cell lung cancer (NSCLC) at the 2025 World Conference on Lung Cancer.
In the TRUST-II study, TKI-naïve patients showed a confirmed objective response rate (cORR) of 85.2% at 20.5 months median follow-up, with median progression-free survival (PFS) not yet reached. For TRUST-I, TKI-naïve patients demonstrated a cORR of 90.3% with an impressive median PFS of 44.6 months.
The integrated safety analysis across trials (N=337) revealed a favorable profile with manageable adverse events. Notable intracranial responses were observed in patients with brain metastases: 66.7% in TRUST-II and 87.5% in TRUST-I for TKI-naïve patients.
Nuvation Bio (NYSE: NUVB), a global oncology company, announced its management team's participation in three upcoming investor conferences in September 2025. CEO David Hung, M.D. and CFO Philippe Sauvage will engage in fireside chats at the Cantor Global Healthcare Conference on September 4 and the H.C. Wainwright Global Investment Conference on September 9. The team will also conduct one-on-one meetings at the Citi BioPharma Back to School Conference on September 3.
Live webcasts of the fireside chats will be accessible through Nuvation Bio's Investor Relations website, with recordings available for 90 days after each event.
Nuvation Bio (NYSE: NUVB) reported significant milestones in Q2 2025, highlighted by the FDA approval of IBTROZI™ (taletrectinib) for advanced ROS1-positive non-small cell lung cancer on June 11, 2025. The company successfully initiated 70 patients on IBTROZI within seven weeks of approval, generating initial product revenue of $1.2 million in just 13 business days.
Financial highlights include a strong balance sheet with $607.7 million in cash and equivalents, and secured $200 million in non-dilutive financing from Sagard Healthcare Partners. The company reported a net loss of $59.0 million ($0.17 per share) for Q2 2025, with research and development expenses of $27.4 million and selling, general, and administrative expenses of $38.5 million.
Nuvation Bio (NYSE:NUVB) announced upcoming presentations of new data for its FDA-approved drug IBTROZI™ (taletrectinib) at two major conferences: the IASLC 2025 World Conference on Lung Cancer (WCLC) and the European Society of Medical Oncology Congress Meeting (ESMO).
The presentations will showcase updated results from the pivotal Phase 2 TRUST-I and TRUST-II studies evaluating IBTROZI's efficacy and safety in treating adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). The data will be presented across multiple sessions at WCLC (September 6-9, 2025, Barcelona) and ESMO (October 17-21, 2025, Berlin).
Additionally, Nuvation Bio will sponsor a satellite symposium at WCLC titled "Under the Microscope: Focusing on ROS1+ NSCLC" featuring presentations from leading oncology experts.
Nuvation Bio (NYSE: NUVB), a global oncology company, will host a conference call and webcast on Thursday, August 7, 2025, at 8:00 a.m. ET to discuss its second quarter 2025 financial results and provide business updates.
Interested participants can access the live conference call by dialing +1 833-470-1428 (U.S. toll-free) with access code 926066. A webcast will be available through the Investor Relations section of Nuvation Bio's website, with a recording accessible for 90 days after the event.
Nuvation Bio (NYSE:NUVB) announced that its drug taletrectinib (IBTROZI™) has been added as a Preferred Agent in the National Comprehensive Cancer Network® Clinical Practice Guidelines for Non-Small Cell Lung Cancers. The drug, which received FDA approval on June 11, is specifically recommended for ROS1-positive NSCLC patients across all treatment lines.
IBTROZI is designed as a highly selective, next-generation oral ROS1 tyrosine kinase inhibitor targeting a rare form of lung cancer that affects approximately 2% of NSCLC cases, representing about 3,000 new diagnoses annually in the U.S. The guidelines particularly recognize the drug's benefits for patients with brain metastases and those with acquired resistance after first-line therapy.