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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) announced a collaboration with Thermo Fisher Scientific for U.S.-based manufacturing of IBTROZI (taletrectinib), for advanced or metastatic ROS1-positive non-small cell lung cancer. Process tech transfer, product introduction, and an NDA supplement for the manufacturing transition have been completed to help secure drug supply.
Nuvation Bio (NYSE: NUVB) announced FDA acceptance of a supplemental NDA for IBTROZI (taletrectinib) in advanced ROS1-positive NSCLC, with a target action date of January 4, 2027. The submission adds 10 months of follow-up (August 2025 cutoff) from TRUST-I and TRUST-II.
Key efficacy updates: TRUST-I TKI-naïve mDOR 49.7 months and mPFS 49.6 months; TRUST-II TKI-pretreated mDOR 19.4 months. Safety remained consistent with prior reports.
Nuvation Bio (NYSE: NUVB) announced that CEO David Hung, M.D., and CFO Philippe Sauvage will participate in multiple investor conferences in May 2026, including Bank of America, H.C. Wainwright BioConnect, RBC Capital Markets, and TD Cowen oncology summit.
Live webcasts will be available on the company's Investor Relations website, with archived recordings posted for 90 days after each event.
Nuvation Bio (NYSE: NUVB) reported Q1 2026 results and corporate updates on May 4, 2026. Key points: IBTROZI net product revenue $18.5M, collaboration and license revenue $64.7M, and cash, cash equivalents, and marketable securities of $533.7M as of March 31, 2026. Clinical updates include pooled TRUST-I/II data showing a TKI-naïve cORR 89.8%, mDOR 49.7 months and mPFS 46.1 months; EMA MAA validation in Europe; acquisition of global safusidenib rights; SIGMA Phase 3 ongoing.
Nuvation Bio (NYSE: NUVB) announced that taletrectinib (IBTROZI) was added to the NCCN Clinical Practice Guidelines for Central Nervous System (CNS) cancers on April 24, 2026, as a systemic therapy option for ROS1-positive NSCLC patients with brain metastases. The drug previously was listed as a Preferred Agent in NCCN NSCLC guidelines and is FDA-approved for locally advanced or metastatic ROS1+ NSCLC. Clinical data cited include intracranial overall response rates of 76.5% in TKI-naive patients and 65.6% in TKI-pretreated patients, presented at AACR April 2026.
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.