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) reported pooled long-term results from TRUST-I and TRUST-II showing strong efficacy and manageable safety for IBTROZI (taletrectinib) in ROS1+ NSCLC. In TKI-naïve patients cORR was 89.8%, mDOR 49.7 months, and mPFS 46.1 months. Intracranial response was 76.5% in TKI-naïve patients. In TKI-pretreated patients cORR was 55.8% with mPFS 9.7 months and median OS 29.8 months. Safety remained manageable with 8.5% discontinuations and no new safety signals. Company noted FDA approval in June 2025 and EMA MAA validation in March 2026.
Nuvation Bio (NYSE: NUVB) reported pooled long-term data from TRUST-I and TRUST-II showing durable responses with IBTROZI (taletrectinib) in ROS1+ NSCLC. In TKI-naïve patients cORR was 89.8%, median DOR 49.7 months and median PFS 46.1 months. TKI-pretreated patients showed cORR 55.8% and median PFS 9.7 months.
The pooled safety analysis found a manageable profile, low rates of neurologic events, 8.5% discontinuations for TEAEs, strong intracranial activity, and concurrent TRUST-I results published in Journal of Clinical Oncology.
Nuvation Bio (NYSE: NUVB) will report first quarter 2026 financial results and provide a business update on May 4, 2026. The company will host a live conference call and webcast at 4:30 p.m. ET for investors and the public.
Participants can register via the company Investor Relations website, join the call +1 833-461-5787 (U.S. toll-free) with access code 266802059, and review an archived recording for 90 days.
Nuvation Bio (NYSE: NUVB) amended its safusidenib license with Daiichi Sankyo to acquire Japan rights, securing exclusive global development and commercialization rights for the investigational IDH1 inhibitor. The deal enables expansion of the Phase 3 SIGMA study into Japan and grants rights to prior and future clinical data and publications.
Safusidenib is an oral, brain-penetrant mutant IDH1 inhibitor with encouraging Phase 1/2 activity in IDH1-mutant glioma; Phase 2 Japan data include a median follow-up of over five years for 12 patients still on treatment.
Nuvation Bio (NYSE: NUVB) and Eisai announced the European Medicines Agency has validated the Marketing Authorisation Application for taletrectinib to treat advanced ROS1-positive non-small cell lung cancer. The MAA enters a standard review timeline; additional filings are planned for the U.K., Canada and other Eisai territories.
The filing uses pooled Phase 2 TRUST-I and TRUST-II data, with prior approvals in the U.S., China and Japan and a June 2025 U.S. full approval noted.
Nuvation Bio (NYSE: NUVB) will present updated pivotal data for IBTROZI® (taletrectinib) at AACR Annual Meeting 2026 on April 21, 2026.
Updated TRUST-I and TRUST-II results show a median duration of response (DOR) of 50 months in TKI-naïve ROS1+ NSCLC as of the August 2025 cutoff, and new data in TKI-pretreated patients will be reported.
Nuvation Bio (NYSE: NUVB) reported Q4 and full‑year 2025 results and a business update on March 2, 2026. Key items: 216 new patient starts on IBTROZI in Q4 (432 since June 2025 launch), an exclusive license with Eisai (Jan 11, 2026), Phase 2 safusidenib data (ORR 44%; 88% PFS at 24 months), $529.2M cash as of Dec 31, 2025, Q4 net loss $36.6M, FY net loss $204.6M.
Nuvation Bio (NYSE: NUVB) announced that CEO David Hung, M.D., and CFO Philippe Sauvage will attend four investor conferences in March 2026 with fireside chats at TD Cowen and Citizens Life Sciences. Fireside chat dates: March 4 and March 11, 2026. Live webcasts and archived recordings (90 days) will be available on the company Investor Relations website.
Nuvation Bio (NYSE: NUVB) will report fourth quarter and full year 2025 financial results and provide a business update on March 2, 2026 at 4:30 p.m. ET. The company will host a conference call and live webcast; registration and replay will be available on Nuvation Bio's Investor Relations website for 90 days.
Nuvation Bio (NYSE: NUVB) finalized a protocol amendment converting the global SIGMA study (G203; NCT05303519) of safusidenib from Phase 2 to a pivotal Phase 3 trial for IDH1‑mutant astrocytoma and adding an exploratory oligodendroglioma cohort.
The registrational arm expands enrollment from 100 to 300 across the U.S., Australia and China, with primary endpoint progression‑free survival (BICR per RANO 2.0). A non‑pivotal single‑arm oligodendroglioma cohort (~40 patients) will assess objective response rate; initial cohort data expected in 2027.