Plus Therapeutics' REYOBIQ gets FDA Orphan Drug Designation for pediatric malignant gliomas

PLUS THERAPEUTICS, INC.

ODD covers pediatric malignant gliomas including ependymoma, broader than originally requested.
Designation provides 7 years of market exclusivity upon approval, tax credits, and fee exemptions.
Follows FDA Type B meeting supporting development in leptomeningeal metastases and IND clearance for pediatric high-grade glioma and ependymoma.
REYOBIQ delivers targeted radiotherapy to CNS tumors while minimizing healthy brain exposure.

item 8.01 item 9.01

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