Plus Therapeutics Receives FDA Orphan Drug Designation for REYOBIQ Targeting Pediatric Malignant Gliomas

Plus Therapeutics has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its investigational drug, REYOBIQ, targeting pediatric malignant gliomas. This designation is intended to encourage the development of treatments for rare diseases or conditions affecting fewer than 200,000 individuals in the United States. Pediatric malignant gliomas are aggressive brain tumors that primarily affect children and currently have limited treatment options.

The FDA’s Orphan Drug Designation provides certain benefits to drug developers, including tax credits for clinical trial costs, exemption from certain FDA fees, and potential market exclusivity upon approval for seven years. Plus Therapeutics is developing REYOBIQ as part of its broader focus on innovative therapies for rare cancers. The company aims to address unmet medical needs in this area by advancing research and development efforts under the framework provided by this designation.

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Date: April 8, 2026

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