Safusidenib - (J201) - (SIGMA)

November 2, 2026: Nuvation Bio (NYSE: NUVB) said it will present four safusidenib posters at the Society for Neuro-Oncology Annual Meeting on November 12–15, 2026, including updated long-term Phase 2 J201 data in IDH1-mutant glioma and three ongoing-study overviews.

Safusidenib / J201: Updated efficacy and safety results will be presented November 13, 2026 for safusidenib in chemotherapy- and radiotherapy-naïve Grade 2 IDH1-mutant glioma. The company said the poster will include additional data beyond positive topline Phase 2 results announced in July 2026.

SIGMA (G203): Trial-in-progress poster for the pivotal Phase 3 study of maintenance safusidenib versus placebo after radiotherapy or chemoradiotherapy plus adjuvant temozolomide in patients with IDH1-mutant astrocytoma with high-risk features. The pivotal study is planned to enroll about 300 patients.

Grade 3 oligodendroglioma cohort: Trial-in-progress poster for an open-label, single-arm exploratory cohort of safusidenib in chemotherapy- and radiotherapy-naïve Grade 3 IDH1-mutant oligodendroglioma; primary endpoint is objective response rate and expected enrollment is about 40 patients.

G209: Trial-in-progress poster for a Phase 2 study of safusidenib in Grade 2 or 3 IDH1-mutant glioma after progression on vorasidenib.

The release also states FDA granted Fast Track designation to safusidenib for IDH1-mutant glioma in August 2026.