Nuvation Bio Expands Phase 3 SIGMA Trial of Safusidenib to Six European Countries

Nuvation Bio Inc. (NUVB) said its pivotal Phase 3 SIGMA study of safusidenib in IDH1-mutant glioma will add clinical trial sites in the United Kingdom, France, Sweden, Germany, Italy and Spain, extending the program beyond the U.S., Australia, China, Canada and Japan. Shares were trading at $4.71, up 2.61%. SIGMA is a randomized, placebo-controlled study evaluating the oral, brain-penetrant mutant IDH1 inhibitor as maintenance therapy in patients with high-risk IDH1-mutant astrocytoma following radiotherapy or chemoradiotherapy and adjuvant temozolomide. The pivotal portion is planned to enroll approximately 300 patients, with progression-free survival by blinded independent central review as the primary endpoint. A separate exploratory cohort will test safusidenib in about 40 patients with grade 3 IDH1-mutant oligodendroglioma who have not received prior chemotherapy or radiotherapy, using objective response rate as the primary endpoint. The FDA granted Fast Track Designation to safusidenib in August 2026.