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) 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.
Nuvation Bio (NYSE:NUVB) signed an exclusive licensing and collaboration agreement with Eisai granting Eisai development, registration and commercialization rights for taletrectinib in Europe and multiple other territories outside the U.S., China and Japan.
Nuvation Bio will receive €50 million upfront, up to €145 million in regulatory and commercial milestones, and double-digit tiered royalties up to the high-teens; total upfront and milestones may reach €195 million (≈USD $230M). An EU Marketing Authorization Application is expected H1 2026. Taletrectinib is already approved in the U.S., China and Japan for advanced ROS1+ non-small cell lung cancer.
Nuvation Bio (NYSE: NUVB) announced that David Hung, M.D., Founder, President, and CEO, will present at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026 at 3:45 p.m. PT (6:45 p.m. ET) in San Francisco.
A live webcast will be available on the company Investor Relations website and an archived recording will be available for 30 days after the event.
Innovent (NUVB) announced that seven of its innovative medicines were included in China’s updated 2025 National Reimbursement Drug List (NRDL), effective January 1, 2026. The inclusions cover oncology, cardiovascular/metabolic, autoimmune and ophthalmology indications, and include a new TYVYT indication (sintilimab plus fruquintinib for advanced pMMR endometrial cancer) and first-time listing of SYCUME (teprotumumab) for moderate-to-severe thyroid eye disease. Other newly listed medicines include limertinib, fulzerasib (Dupert), taletrectinib (DOVBLERON), selpercatinib (Retsevmo) and pirtobrutinib (Jaypirca).
The company says NRDL inclusion will expand patient access and improve affordability across multiple high-need disease areas in China.
Nuvation Bio (NYSE:NUVB) published positive Phase 2 results for safusidenib in chemotherapy- and radiotherapy‑naïve grade 2 IDH1‑mutant glioma.
Key results: ORR 44.4%, median follow-up 28 months, median PFS not reached, and 87.9% progression‑free at 24 months. Adverse events were mostly mild; grade ≥3 treatment‑related events occurred in 18.5% and 11.1% discontinued due to TEAEs. A GCP noncompliance in AE collection led to a re‑investigation and re‑collection of safety data.
The company said G203 will be amended to a global Phase 3 with PFS by blinded independent central review as the primary endpoint, and the FDA agreed that PFS by BICR could support full approval.
Nuvation Bio (NYSE: NUVB) announced that CEO David Hung, M.D., and CFO Philippe Sauvage will take part in fireside chats at two investor conferences in Miami on Dec 2–3, 2025. The events are the 8th Annual Evercore Healthcare Conference (Dec 2 at 9:35 a.m. ET) and the Citi 2025 Global Healthcare Conference (Dec 3 at 9:00 a.m. ET).
Live webcasts will be available on Nuvation Bio's Investor Relations website, and archived recordings will be accessible for 90 days after each event.
Nuvation Bio (NYSE:NUVB) reported Q3 2025 results and operational milestones on November 3, 2025. Key commercial and clinical updates include 204 new patients started on IBTROZI in Q3, updated pooled TRUST-I/II median Duration of Response 50 months (Aug 2025 cut-off), first-patient enrollment in TRUST-IV adjuvant IBTROZI study and in the global safusidenib G203 registrational study, and partner Nippon Kayaku’s approval in Japan with a $25.0M milestone expected upon reimbursement price establishment.
Financials: $549.0M cash and marketable securities, $7.7M Q3 net product revenue, collaboration revenue $5.4M, and net loss $55.8M for Q3 2025.
Nuvation Bio (NYSE: NUVB) announced that CEO David Hung, M.D., and CFO Philippe Sauvage will participate in three investor conferences in November–December 2025.
- Jefferies Global Healthcare Conference: Wednesday, November 19, 2025 at 10:00 a.m. ET / 3:00 p.m. GMT in London (fireside chat)
- Truist Securities BioPharma Symposium: Thursday, November 6, 2025 in New York (one-on-one meetings)
- 8th Annual Evercore Healthcare Conference: Tuesday, December 2, 2025 at 9:35 a.m. ET in Miami (fireside chat)
Live webcasts of the two fireside chats will be available on the company's Investor Relations website, with archived recordings accessible for 90 days after each event.