NUVB · Nuvation Bio Inc. · Investor Relations

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"), a human-centered global leading research-based pharmaceutical company working in the neurology and oncology therapeutic areas, and Nuvation Bio Inc. (NYSE: NUVB, Corporate Headquarters: New York, NY, CEO: David Hung, M.D., "Nuvation Bio"), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The filing will follow a standard review timeline. Taletrectinib (marketed as IBTROZI ® in the U.S. and Japan) is a highly selective, next-generation oral treatment for patients living with advanced ROS1+ NSCLC. In January 2026, Eisai and Nuvation Bio announced they had entered into an exclusive licensing and collaboration agreement in Europe and additional countries*

Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that new data will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2026 taking place April 17–22, 2026, in San Diego, California. These data include updated results from the TRUST-I and TRUST-II clinical studies highlighting the efficacy and safety of IBTROZI ® (taletrectinib) for the treatment of ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) in both tyrosine kinase inhibitor (TKI)-naïve and TKI-pretreated patients with ROS1+ NSCLC. The data to be presented represent nearly an additional year of follow-up from the data that supported IBTROZI's line-agnostic FDA approval in June 2025. "We're excited to present even longer-term follow-up data from our pivotal trials for IBTROZI, which further reinforce the depth and durability of responses in patients with advanced ROS1+ NSCLC across

Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. "We ended our transformational 2025 with a strong fourth quarter that underscored IBTROZI's rapid adoption, and we believe our medicine is becoming the new standard of care for people living with advanced ROS1+ NSCLC across treatment lines. In 2026, we look forward to further building upon our successful U.S. launch, and partnering closely with Eisai to bring IBTROZI to more patients around the globe," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We are also excited and eager to progress our promising pipeline, with safusidenib now being studied in the pivotal Phase 3 SIGMA trial across those living with high-risk and high-grade IDH1 -mutant glioma where significant needs exist for these