FDA Clears IND for Plus Therapeutics’ REYOBIQ™ in Pediatric Brain Cancer Trial

Plus Therapeutics is pleased to announce that the U.S. Food and Drug Administration (FDA) has officially cleared its Investigational New Drug (IND) application for REYOBIQ™, a targeted radiotherapeutic designed for the treatment of pediatric patients with supratentorial recurrent, refractory, or progressive high-grade glioma (HGG) and ependymoma.

This significant regulatory milestone paves the way for the initiation of the ReSPECT-PBC trial, a new clinical study that will evaluate REYOBIQ™ in children with these aggressive and difficult-to-treat brain tumors.

About the ReSPECT-PBC Trial

The ReSPECT-PBC trial is supported by a $3.0 million research grant from the U.S. Department of Defense, underscoring the urgent need for innovative treatments in pediatric neuro-oncology. The study will focus on assessing the safety, dosage, and potential efficacy of REYOBIQ™ in children who have few remaining therapeutic options.

Read the full press release here: Plus Therapeutics Announcement

This is a major step forward in our mission to bring life-extending, targeted radiation therapies to underserved cancer populations—including children with recurrent pediatric brain cancer.

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