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. 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 that Founder, President and CEO David Hung and CFO Philippe Sauvage will join a fireside chat at the Jefferies Global Healthcare Conference on June 3, 2026, at 9:55 a.m. ET in New York.
A live webcast and 90-day archive will be available on the company’s investor relations website.
Nuvation Bio (NYSE: NUVB) reported new patient-reported outcomes from the Phase 2 TRUST-II study of IBTROZI (taletrectinib) in advanced ROS1-positive NSCLC. Among 69 patients, 88% showed improved or stable global quality-of-life at first assessment, with cognitive function and key symptoms like cough and shortness of breath generally improving or remaining stable over time.
IBTROZI is FDA-approved in the US for locally advanced or metastatic ROS1+ NSCLC, approved in Japan and China, has a US sNDA under review with a target action date of January 4, 2027, and an EMA MAA validated in Europe. Results will be presented at ASCO 2026.
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.