Nuvation Bio Inc. reports news as a global oncology company developing and commercializing targeted cancer therapies. Its updates center on IBTROZI® (taletrectinib), an oral, CNS-active, selective next-generation ROS1 inhibitor approved for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer, as well as regulatory submissions, clinical data from TRUST studies, guideline inclusion, and commercialization activity.
Company news also covers safusidenib, a brain-penetrant IDH1 inhibitor for IDH1-mutant glioma, and Nuvation Bio's drug-drug conjugate program. Recurring corporate items include licensing and collaboration arrangements, product-rights updates, investor conference participation, operating results, financial results, capital-structure disclosures, and governance matters.
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.
Nuvation Bio (NYSE: NUVB) reported preliminary commercial and financial metrics ahead of its January 13, 2026 J.P. Morgan presentation. Key 4Q25/launch figures: 216 new patient starts in 4Q25 and 432 total since launch in H2 June 2025; preliminary IBTROZI net product revenue of $15.7M in 4Q25 and $24.7M since launch. The company reported a $25M milestone from Nippon Kayaku and preliminary cash, cash equivalents and marketable securities of approximately $529.2M as of December 31, 2025. On January 11, 2026 Nuvation entered an exclusive license and collaboration with Eisai for taletrectinib in multiple international territories. The company plans continued commercial growth, a phase 3 safusidenib trial, and will webcast its J.P. Morgan presentation.