Windtree Therapeutics, Inc. (NASDAQ:WINT) is a leading Nasdaq-listed stock on Tuesday, gaining ground for the third straight day to near its highest trading levels of 2017 after hitting a 52-week low on Thursday. Today’s movement is underscored by news that an independent Data Safety Monitoring Board completed its second and final interim safety review of a phase 2b study of Windtree’s AEROSURF®, concluding that the trial should continue without modification.
AEROSURF is a novel investigational drug-device combination utilizing Windtree’s proprietary KL4 surfactant and aerosolization technologies. It’s being developed under the premise that it can potentially reduce the need for endotracheal intubation and mechanical ventilation for premature babies with respiratory distress syndrome, a breathing disorder caused by immature lungs.
The phase 2b trial is designed to enroll 240 premature infants to evaluate efficacy, better characterize the safety profile of AEROSURF and define the best dose regimen for a pivotal phase 3 trial. Windtree expects to release top-line results from the trial during the middle of this year.
After closing Monday at $1.24, shares of WINT have traded as high as $1.66 on Tuesday. With about 2-1/2 hours left in the session, shares have pulled back slightly to $1.53, representing a gain of 23.4% on the day.
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