Plus Therapeutics Receives FDA Orphan Drug Designation for REYOBIQ in Pediatric Brain Cancers

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Plus Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to REYOBIQ™ (rhenium Re186 obisbemeda) for the treatment of pediatric malignant gliomas, including the broader scope of progressive pediatric ependymoma. Pediatric malignant gliomas are rare, aggressive brain tumors with poor outcomes, where current treatments often fail to prevent recurrence.

Why it matters

The ODD for REYOBIQ in pediatric malignant gliomas is an important milestone that validates Plus Therapeutics' approach of delivering targeted radiotherapy directly to central nervous system (CNS) tumors. REYOBIQ's ability to precisely deliver high-dose radiation to tumor sites while minimizing exposure to healthy brain tissue has the potential to significantly improve outcomes for this underserved patient population.

The details

REYOBIQ is a novel injectable radiotherapy formulated to deliver targeted high-dose radiation to CNS tumors. The FDA granted the ODD more broadly than originally requested, encompassing both pediatric malignant gliomas and ependymoma. This builds on Plus Therapeutics' recent regulatory progress, including a Type B meeting with the FDA supporting development plans in leptomeningeal metastases and ongoing Phase 1 and 2 studies. The company has also received FDA clearance to evaluate REYOBIQ in pediatric patients with high-grade glioma and ependymoma.

• Plus Therapeutics announced the FDA's ODD grant on April 8, 2026.
• The company recently completed a Type B meeting with the FDA supporting REYOBIQ's development plans in leptomeningeal metastases.

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