Plus Therapeutics Soars 122.46% on FDA Clearance for Pediatric Brain Cancer Trial

On June 25, 2025, Plus Therapeutics experienced a remarkable surge of 122.46% in pre-market trading, marking a significant milestone for the company.

Plus Therapeutics recently announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for REYOBIQ, a novel radiotherapeutic designed to treat pediatric patients with high-grade glioma and ependymoma. This clearance paves the way for the ReSPECT-PBC trial, which is funded by a $3.0 million grant from the U.S. Department of Defense. The trial aims to evaluate the safety, tolerability, and efficacy of REYOBIQ in pediatric patients aged 6 to 21 years, with a focus on delivering high doses of beta radiation directly to brain tumors while minimizing damage to surrounding healthy tissue.

Dr. Ashley S. Plant, the Principal Investigator for the trial, expressed enthusiasm about the potential of REYOBIQ to improve outcomes for pediatric brain cancer patients. The trial design includes a Phase 1a/b dose escalation phase and a Phase 2a efficacy assessment phase, with a total enrollment of approximately 56 patients. This development is particularly significant given the aggressive nature of pediatric high-grade glioma and ependymoma, which have limited treatment options and poor prognosis.

Marc Hedrick, President and Chief Executive Officer of Plus Therapeutics, highlighted the company's successful track record in adult patients and expressed hope that REYOBIQ will offer much-needed hope to children with aggressive brain cancers. The clearance of the IND application for REYOBIQ in the pediatric setting builds on the promising preclinical data and clinical results observed in adult patients with more common central nervous system cancers.