NUVB · Nuvation Bio Inc.

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

Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, and Philippe Sauvage, Chief Financial Officer of Nuvation Bio, will participate in four upcoming investor conferences, including fireside chats at two conferences. The management team will participate in fireside chats and one-on-one meetings at the following conferences: TD Cowen 46 th Annual Health Care Conference – fireside chat on Wednesday, March 4, 2026, at 10:30 a.m. ET in Boston, MA The Citizens Life Sciences Conference – fireside chat on Wednesday, March 11, 2026, at 8:25 a.m. ET in Miami, FL The management team will participate in one-on-one meetings only at the following conferences: UBS Biotech Summit Miami: Catalyst for Change on Monday, March 9, 2026, in Miami, FL Jefferies Biotech on the Beach Summit on Tuesday,

Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced it will host a conference call and webcast on Monday, March 2, 2026, at 4:30 p.m. ET to discuss its financial results and business updates for the fourth quarter and full year of 2025. Investors and the general public are invited to listen to the live webcast and may register on the Investor Relations section of the Nuvation Bio website. To access the live conference call, participants can dial +1 833-470-1428 (U.S. toll-free) and enter access code 833155. An archived recording will be available on Nuvation Bio's website for 90 days following the event. About Nuvation Bio Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment with the goal of developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes taletrectinib (IBTROZI ®

Protocol amendment to change SIGMA from a Phase 2 to a Phase 3 study now complete The currently enrolling SIGMA trial will now include patients with grade 2 astrocytoma with high-risk features in the maintenance setting, in addition to previously eligible patients with high-grade astrocytoma A new exploratory cohort has also been added for patients with grade 3 oligodendroglioma in the post-surgical setting Broad patient population in SIGMA represents most forms of IDH1 -mutant glioma that do not have an FDA-approved targeted treatment option Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced finalization of a protocol amendment to the ongoing global SIGMA study (also known as G203; NCT05303519 ) of safusidenib that expands it to a Phase 3 trial. SIGMA is evaluating the efficacy and safety of safusidenib versus placebo for the maintenance treatment of patients with high-risk or high-grade