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.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.