NEW YORK, NY — Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for safusidenib, the company’s investigational, oral, brain-penetrant selective inhibitor of mutant IDH1.
“People with IDH1-mutant glioma urgently need additional treatment options. We were eager to pursue Fast Track Designation for safusidenib to hopefully reach these patients on an expedited timeline,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “We look forward to working with the FDA as we advance our mission to provide an effective therapy to nearly every patient whose life is impacted by this disease.”
FDA Fast Track Designation is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and address unmet medical need. The designation provides for more frequent interactions with the FDA throughout a drug’s development. If relevant criteria are met, the designation may allow for rolling review of a marketing application, permitting completed sections to be submitted for FDA review as they become available, rather than waiting for the entire application to be complete. These benefits have the potential to shorten the time it takes to bring safusidenib to patients.
The designation was granted based on favorable data from the safusidenib clinical program to date. Most recently, Nuvation Bio announced updated data from the Phase 2 J201 study demonstrating durable responses and a favorable risk-benefit profile over long-term follow-up. Specifically, at a median follow-up of 38.8 months in the J201 study, treatment with safusidenib showed a confirmed objective response rate (cORR) of 51.9%, with median progression-free survival (PFS) not yet reached and a 36-month PFS rate of 79.1%, and only one patient who had previously responded experienced subsequent disease progression. No new safety signals have been identified with longer-term follow-up. These results build upon findings previously published in Neuro-Oncology.
About IDH1-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 IDH-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 an investigational, oral, brain-penetrant, selective inhibitor of mutant IDH1. It is being studied in patient populations with significant unmet medical need, including settings where there are limited or no approved targeted treatment options. In Phase 1 and Phase 2 clinical studies, safusidenib demonstrated encouraging clinical activity, including delayed disease progression and durable responses across a range of tumor grades and risk groups, with a favorable risk-benefit profile. These early findings support further investigation of safusidenib in the currently enrolling Phase 3 SIGMA study, as well as in the Phase 3 G307 study outside the U.S. where vorasidenib is not yet approved or accessible and the Phase 2 G209 study in a post-vorasidenib setting.
In August 2026, the FDA granted Fast Track Designation to safusidenib in IDH1-mutant glioma.
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.
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.
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).
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