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NUVB expands SIGMA trial to six European countries, potential enrollment catalyst

Oct 29, 2026, 8:16 AM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

Expanded European sites increase enrollment flexibility, potentially shortening timelines and increasing likelihood of earlier readouts; Fast Track designation adds optionality for expedited development, though ultimate trial success remains uncertain.

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NUVB announced expansion of the SIGMA Phase 3 trial of safusidenib to the UK, France, Sweden, Germany, Italy and Spain, extending beyond the US, Australia, China, Canada and Japan. The pivotal portion targets about 300 patients, with an exploratory cohort of roughly 40 oligodendroglioma patients. The move could accelerate enrollment and broaden global data for IDH1-mutant glioma, potentially impacting timing of future readouts.

NUVB expands SIGMA Phase 3 to UK, France, Sweden, Germany, Italy, Spain. Broadens global trial footprint.
SIGMA evaluates safusidenib for IDH1-mutant glioma; pivotal ~300 patients, exploratory ~40.
FDA Fast Track designation awarded to safusidenib in August 2026, supporting development.
Enrollment target and endpoints: primary endpoint progression-free survival; trial locations updated on ClinicalTrials.gov.
New European sites may accelerate enrollment and enable broader global data for IDH1-mutant glioma.

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