Edesa Biotech, Inc. (NASDAQ: EDSA) witnessed a notable upsurge in its stock performance during the extended trading session on Thursday. The value of Edesa’s stock experienced a remarkable increase of 17.30%, reaching $4.00 in the after-hours trading period.
Prior to this, during the standard trading session, EDSA’s stock had already displayed a substantial rise of 6.56%, culminating at $3.41. This surge in EDSA’s stock price was instigated by the company’s active participation and presentation at a prestigious dermatology drug development summit.
The occasion which marked Edesa’s presence was the 7th Annual Dermatology Drug Development Summit. The Summit was held in Boston, Massachusetts, from October 31 to November 2, 2023. The keynote address was delivered by Dr. Par Nijhawan, Edesa’s Chief Executive Officer, who, among other salient topics, provided an insightful case study on the regulatory pathway pertaining to Edesa’s investigational drug EB06. This particular drug has shown promise as a potential remedy for individuals suffering from moderate to severe nonsegmental vitiligo.
Of note, Health Canada has granted approval to Edesa’s proposal to align the clinical trial designs between the United States and Canada for an ongoing Phase 3 study of EB05, also known as paridiprubart. Edesa’s monoclonal antibody is currently under evaluation as a prospective treatment for Acute Respiratory Distress Syndrome (ARDS).
The harmonized protocol for this study outlines the treatment of approximately 600 ARDS patients who are hospitalized and afflicted with SARS-CoV2 infections. These individuals are under invasive machine-assisted breathing, with or without supplementary help for their organs, like extracorporeal membrane oxygenation (ECMO).
The main concern of this research is the evaluation of death rates after 28 days. This modified research layout replaces the earlier plan, which aimed at a larger group of over 800 participants, with two distinct groups and specific goals for each group.
Earlier this year, Edesa made an agreement with the U.S. Food and Drug Administration to create a more streamlined approach, concentrating on a smaller population for the Phase 3 research. Edesa CEO mentioned that the adoption of a uniform and standardized plan in both the United States and Canada is expected to simplify the procedures for enrolling patients, managing trials, and analyzing data.
