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Plus Therapeutics Granted U.S. FDA Orphan Drug Designation to REYOBIQ™ in Pediatric Malignant Gliomas
HOUSTON, April 08, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing
About this update from Plus Therapeutics, Inc.
[{"type":"text","content":"HOUSTON, April 08, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today 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. Pediatric malignant gliomas are rare, aggressive brain tumors with limited treatment options and poor outcomes, where current standards of care—including surgery and radiation—often fail to prevent recurrence. Notably, the FDA granted orphan designation for malignant glioma more broadly than originally requested, encompassing pediatric ependymoma. “Receiving orphan drug designation for REYOBIQ in pediatric malignant gliomas, including the broader scope for progressive pediatric ependymoma, is an important milestone and further validates our approach to delivering targeted radiotherapy directly to CNS tumors,” said Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. “We believe REYOBIQ’s ability to deliver high-dose radiation precisely to tumor sites while minimizing exposure to healthy brain tissue has the potential to meaningfully improve outcomes in this underserved patient population. This orphan designation reinforces the potential applicability of REYOBIQ across a wider range of CNS tumor indications and our continued advancement of REYOBIQ across multiple CNS cancer indications.” Orphan Drug Designation is granted by the FDA to investigational therapies intended to treat rare diseases affecting fewer than 200,000 people in the United States. The designation provides several potential benefits, including seven years of market exclusivity upon approval, tax credits for qualified clinical trial expenses, and exemptions from certain regulatory fees. The ODD for pediatric malignant gliomas builds on recent regulatory and clinical progress for REYOBIQ, including completion of a Type B meeting with the FDA supporting development plans in leptomeningeal metastases (LM), encouraging clinical data from the ReSPECT-LM trial, and ongoing advancement of Phase 1 and Phase 2 studies. In addition, the Company has received FDA clearance of its Investigational New Drug ...