Nuvation Bio to Expand Pivotal Phase 3 SIGMA Study of Safusidenib for IDH1-Mutant Glioma to Six European Countries
PR Newswire•29/10/2026•08:00 ET
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Key Highlights
- ➤SIGMA Phase 3 expands to sites across six European countries
- ➤Pivotal SIGMA portion plans to enroll approximately 300 patients
- ➤Exploratory cohort will evaluate approximately 40 chemotherapy- and radiotherapy-naïve patients
- ➤FDA granted safusidenib Fast Track Designation in August 2026
Expert Statements
David Hung, Founder, President and Chief Executive Officer of Nuvation Bio
“Our goal is to develop therapies that create a profound, positive impact on patients' lives, and for safusidenib that means building a broad development program that has the potential to reach more people with IDH1-mutant glioma in need of treatment options around the world.”
David Hung, Founder, President and Chief Executive Officer of Nuvation Bio
“Expanding SIGMA to sites across six European countries is an important step for patients, and we have been encouraged by the strong interest in the study from physicians and the glioma community in Europe. We sincerely thank the investigators, site teams, patient advocates and patients who will help make this study possible.”
Nuvation Bio to Expand Pivotal Phase 3 SIGMA Study of Safusidenib for IDH1-Mutant Glioma to Six European Countries PR Newswire
New sites in the UK, France, Sweden, Germany, Italy and Spain will add to the global footprint of the pivotal SIGMA study
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