Nuvation Bio Acquires Japan Rights to Safusidenib from Daiichi Sankyo

Agreement provides Nuvation Bio global development and commercialization rights for investigational IDH1 inhibitor

Apr. 2, 2026 at 5:33am by Ben Kaplan

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Nuvation Bio Inc. has amended its exclusive license agreement with Daiichi Sankyo to include Japan rights for safusidenib, a novel, oral, potent, brain-penetrant, selective inhibitor of mutant IDH1. This agreement gives Nuvation Bio exclusive global development and commercialization rights for the investigational medicine, enabling the company to expand its ongoing pivotal SIGMA study into Japan and access all previously generated and future data to support further publication of safusidenib results in IDH1-mutant glioma.

Why it matters

Safusidenib has shown promising efficacy signals across all IDH1-mutant glioma grades and treatment lines in early clinical studies, including durable responses and prolonged progression-free survival. Securing global rights will allow Nuvation Bio to fully explore the potential of this investigational therapy for patients with these devastating brain tumors, for whom there are limited targeted treatment options.

The details

Under the amended agreement, Nuvation Bio now has exclusive global development and commercialization rights for safusidenib, including the ability to expand the ongoing pivotal SIGMA Phase 3 study into Japan. The SIGMA study is evaluating safusidenib as a maintenance therapy after standard-of-care in IDH1-mutant astrocytoma with high-risk features. Nuvation Bio also plans to present longer-term data from a previous Phase 2 study of safusidenib in Japan at a future medical meeting.

  • Nuvation Bio plans to present longer-term data from the Phase 2 study of safusidenib at a future medical meeting.
  • Data from the pivotal Phase 3 SIGMA study is anticipated to be available in 2029.
  • Data from the exploratory, non-pivotal cohort of the SIGMA study evaluating safusidenib in grade 3 IDH1-mutant oligodendroglioma is anticipated to be available in 2027.

The players

Nuvation Bio Inc.

A global oncology company focused on developing therapies to address challenging cancer treatment needs, founded by biopharma industry veteran David Hung, M.D.

Daiichi Sankyo

A Japanese pharmaceutical company that previously held the rights to safusidenib and has now granted Nuvation Bio the exclusive global development and commercialization rights for the investigational IDH1 inhibitor.

David Hung, M.D.

The founder, president, and CEO of Nuvation Bio, who previously founded Medivation, Inc. and brought a leading prostate cancer medicine to patients.

Yuki Abe, Ph.D.

The head of R&D Division in Japan and head of research at Daiichi Sankyo.

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What they’re saying

“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.”

— David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio

“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. 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.”

— Yuki Abe, Ph.D., Head of R&D Division in Japan and Head of Research, Daiichi Sankyo

What’s next

Nuvation Bio plans to expand the pivotal Phase 3 SIGMA study of safusidenib into Japan and continue to advance the global development of the investigational IDH1 inhibitor.

The takeaway

This agreement gives Nuvation Bio full control over the global clinical development and commercialization of safusidenib, a promising investigational therapy for patients with IDH1-mutant gliomas, a devastating type of brain cancer with limited targeted treatment options. Securing these global rights positions Nuvation Bio to maximize the potential of safusidenib and bring it to patients in need.