With acquisition of Japan rights, Nuvation Bio now has global development and commercialization rights forsafusidenib
Agreement provides Nuvation Bio ownership of global clinical development program, inclusive of clinical trials, past and current data generation, and future publications
NEW YORK, April 1, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced the company has amended its existing exclusive license agreement for safusidenib with Daiichi Sankyo (TSE :4568) to include Japan rights, effectively securing exclusive global development and commercialization rights of the investigational medicine. The agreement, as amended, enables Nuvation Bio to expand its ongoing pivotal SIGMA study of safusidenib into Japan, and provides rights to all previously generated and future data to support further publication of safusidenib results in IDH1-mutant glioma.
Safusidenib is a novel, oral, potent, brain-penetrant, selective inhibitor of mutant IDH1 that is currently being evaluated in the ongoing Phase 3 SIGMA study for the maintenance treatment of patients with IDH1-mutant astrocytoma who have high-risk features following standard-of-care.
In Phase 1 and Phase 2 single arm studies, safusidenib has shown encouraging efficacy signals across all IDH1-mutant glioma grades and treatment lines, including durable responses and prolonged progression-free survival that show tumor shrinkage and disease control. In the Phase 1 study in Japan of 47 participants with recurrent or progressive IDH1-mutant glioma with enhancing (predominantly high-grade) and non-enhancing (predominantly low-grade) tumors, safusidenib showed clinical activity in both populations. Data from a Phase 2 study in Japan of safusidenib in 27 patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant glioma was published online in the November 2025 issue of Neuro-Oncology. The data published reflected a March 10, 2023 data cut-off. As of February 2026, 12 patients in the study remain on treatment with safusidenib with a median follow-up of over 5 years. Nuvation Bio plans to present longer-term data from the Phase 2 study at a future medical meeting.
"We believe safusidenib has immense potential to address significant patient needs in IDH1-mutant glioma, and our current development plan focuses on patient groups with limited or no FDA-approved targeted treatment options. We are thrilled to now have the exclusive global development and commercialization rights to explore this investigational medicine's potential across these devastating brain tumors," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "With this agreement now final, we plan to expand the pivotal Phase 3 SIGMA study into Japan, continue to advance the robust global development of safusidenib, and pursue presentation and publication of longer-term data from the Phase 2 study to ensure the scientific community is up to date on these findings."
"The invention of new medicines is at the core of what we do at Daiichi Sankyo and safusidenib is a strong example of our expertise in science and technology," said Yuki Abe, Ph.D., Head of R&D Division in Japan and Head of Research, Daiichi Sankyo. "We continuously evaluate the best approach to accelerate the delivery of promising medicines to patients and we are confident that Nuvation Bio will carry this program forward, utilizing their strong expertise in clinical development and commercialization to explore the full potential of safusidenib for patients with IDH1-mutant glioma."
AboutIDH1-Mutant Glioma
Gliomas are the most common type of brain cancer in adults worldwide. In the U.S., nearly 2,500 people are diagnosed with IDH1-mutant gliomas each year, of which more than 95% harbor a mutation in the IDH1 gene. Most patients are diagnosed in their 30s and 40s. While patients with IDH1 mutations generally have longer survival times than those with wild-type IDH1, gliomas are not currently curable and prognosis worsens for those with high-risk features, including high grade tumors.
About Safusidenib
Safusidenib is a novel, oral, potent, brain-penetrant, selective inhibitor of mutant IDH1. In Phase 1 and Phase 2 clinical studies, safusidenib delayed disease progression and provided durable responses across grades and risk groups with a favorable risk-benefit profile.
About the SIGMA (G203) Study
SIGMA is a pivotal Phase 3 study that will evaluate safusidenib compared to placebo as a maintenance therapy after standard-of-care in IDH1-mutant astrocytoma with high-risk features. The pivotal portion of the study will enroll approximately 300 patients. Data is anticipated to be available in 2029.
A separate, exploratory, non-pivotal cohort will evaluate safusidenib in participants with grade 3 IDH1-mutant oligodendroglioma who have not yet received chemotherapy or radiotherapy. The primary endpoint is objective response rate. This cohort is expected to enroll approximately 40 patients. Data is anticipated to be available in 2027.
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®), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; and an innovative drug-drug conjugate (DDC) program.
Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, visit www.nuvationbio.com or follow the company on LinkedIn and X (@nuvationbioinc).
Forward-Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding safusidenib's therapeutic potential, development plans, and plans to present new data. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to the challenges associated with conducting drug discovery and commercialization, and initiating or conducting clinical studies due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; physician and patient behavior; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-K filed with the SEC on March 2, 2026 under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.
Media and Investor Contacts
Nuvation Bio Investor Contact
JR DeVita
ir@nuvationbio.com
Nuvation Bio Media Contact
Kaitlyn Nealy
media@nuvationbio.com
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