The clinical-stage biopharmaceutical company Edesa Biotech, Inc. (EDSA) has lost -14.71% to $6.38 in the early hours of the trading. The investors today are seemed to be profit taking as the stock surged +35.26% to $7.48 in Tuesday session, helped by an FDA approval for its investigational drug around Acute Respiratory Distress Syndrome (ARDS).
So what’s just happening?
A sub-study to EDSA’s ongoing Phase 2/Phase 3 clinical study of its investigational drug, EB05, was approved by the U.S. Food and Drug Administration (FDA) as well as Health Canada. ADRS, the leading cause of death among patients with COVID-19, will be treated with the new drug. The sub-study will evaluate the drug for critically severe COVID-19 cases as a potential rescue therapy.
The focus of the company was to develop innovative treatments for inflammatory and immune-related diseases with clear medical needs that were not met. In later stage clinical studies, the company’s two lead product candidates, EB05 and EB01, are. EB05 is a monoclonal antibody therapy developed by the company as a treatment for ARDS in patients with COVID-19, which is a life-threatening form of respiratory failure and the leading cause of death among patients with COVID-19. As a topical treatment for chronic allergic contact dermatitis (ACD), a common, potentially debilitating condition and occupational disease, Edesa is also developing a sPLA2 inhibitor, designated as EB01.
The company’s Chief Executive Officer, Dr. Par Nijhawan, said that COVID-19 patients identified by physicians involved in Edesa’s ARDS study were too ill to be considered for the main study, but could benefit from the experimental treatment.
Nijhawan said the EB05 would be applied to critically ill patients with deep, medically irreversible respiratory failure caused by COVID-19 in this sub-study.
The Edesa sub-study will include up to 100 patients with severe COVID-19 symptoms, including those who received extracorporeal membrane oxygenation (ECMO) for five or more days.
The success of Edesa Biotech, Inc.’s (EDSA) that study could be a driving force for growth as the Covid-19 or related issues are likely to be remain for some more time. But, the profit taking is just happening causing the stock to lose a larger portion of the yesterday’s gain.