Northwire Canada EditionThursday, October 15, 2026
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M&A / Property

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

4568 · Price

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
Read the original news release →

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