08:06 AM EDT, 06/25/2025 (MT Newswires) -- Plus Therapeutics ( PSTV ) said Wednesday that the US Food and Drug Administration has cleared its investigational new drug application for Reyobiq, paving the way for a phase 1/2a trial targeting pediatric patients with recurrent or progressive high-grade glioma and ependymoma.

The company said the trial, which will assess safety, maximum tolerated dose, and preliminary efficacy in patients aged 6 to 21, will be funded by a $3 million grant from the US Department of Defense.

The phase 1 portion will enroll 24 patients using a dose-escalation approach, while phase 2 will evaluate efficacy in an additional 32 patients, it said.

Shares of the company were rising more than 103% in recent premarket activity.