Nuvation Bio Announces Acquisition of Japan Rights to Safusidenib from Daiichi Sankyo

Executive Summary

• Nuvation Bio amended its exclusive license with Daiichi Sankyo to obtain worldwide development and commercialization rights for safusidenib, including the newly added Japan territory.
• The amendment enables expansion of the pivotal Phase‑3 SIGMA study into Japan and grants Nuvation access to all existing and future data on safusidenib for IDH1‑mutant glioma.
• Safusidenib has shown encouraging efficacy in Phase 1/2 studies, with ongoing long‑term follow‑up; the company plans further data presentations and publications.

Key Details

• Agreement Scope: Amendment to existing exclusive license adds Japan rights, giving Nuvation Bio global development, clinical trial, data, and future commercialization rights for safusidenib.
• Clinical Impact: Allows expansion of the Phase 3 SIGMA (G203) pivotal study into Japan; supports ongoing pivotal enrollment of ~300 patients globally with data expected in 2029.
• Existing Data Highlights:
• Phase 1 Japanese trial (n=47) showed clinical activity in both high‑grade and low‑grade IDH1‑mutant glioma.
• Phase 2 Japanese study (n=27) published Nov 2025; as of Feb 2026, 12 patients remain on treatment with >5‑year median follow‑up.
• Future Plans: Nuvation Bio will present longer‑term Phase 2 data at a future medical meeting and pursue additional publications.
• Quotes:
• David Hung, MD, Founder/President/CEO – emphasized the “immense potential” of safusidenib and the strategic importance of securing global rights.
• Yuki Abe, PhD, Head of R&D Japan, Daiichi Sankyo – expressed confidence in Nuvation Bio’s ability to advance the program.
• Study Details:
• SIGMA Phase 3 study evaluates safusidenib vs placebo as maintenance therapy after standard‑of‑care for IDH1‑mutant astrocytoma with high‑risk features.
• Exploratory non‑pivotal cohort will enroll ~40 patients with grade 3 IDH1‑mutant oligodendroglioma; primary endpoint is objective response rate, data anticipated in 2027.

Notable Quotes

• “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, MD
• “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…” – Yuki Abe, PhD