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Nuvation Bio Granted FDA Fast-Track Designation for Glioma Treatment

Provided by Dow Jones Aug 20, 2026, 5:53:00 PM

By Dean Seal

Nuvation Bio said regulators have granted their fast-track designation to its treatment for IDH1-mutant glioma, a type of brain tumor.

The oncology company said the U.S. Food and Drug Administration has granted the designation to safusidenib, an investigational, oral and brain-penetrant selective inhibitor of mutant IDH1.

The FDA's fast-track designation facilitates development and expedites the review of drugs that treat serious or life-threatening conditions and have the potential to fill unmet medical needs.

The designation was based on favorable data from the clinical program for safusidenib so far, Nuvation said.

The company recently announced updated data from a phase 2 study showing durable responses and a favorable risk-benefit profile.

Write to Dean Seal at dean.seal@wsj.com

(END) Dow Jones Newswires

August 20, 2026 08:53 ET (12:53 GMT)

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