Stock Alert: Pluristem Shares Up 24% In Premarket On FDA Clearance News

(RTTNews) - Shares of Pluristem Therapeutics Inc. (PSTI) are rising over 24% in pre-market today, after the company announced that the U.S. FDA has cleared the company's Investigational New Drug or IND application for a Phase II study of its PLX cells in the treatment of severe COVID-19 cases complicated by Acute Respiratory Distress Syndrome or ARDS.

The study, titled "A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX-PAD for the Treatment of severe COVID-19" would treat 140 adult patients that are intubated and mechanically ventilated and are suffering from respiratory failure and ARDS due to COVID-19.

A Clinical Trial Authorization or CTA has also been filed in Europe for a Phase II COVID-19 trial, with the first European clinical sites planned in Germany and Italy.

The stock has been trading between $2.82 and $13.29 for the past one year, and closed Thursday's trade at $8.49, down 61 cents or 6.70%. PSTI is currently trading at $10.53, up $2.04 or 24.03% in the pre-market session.