Edesa Biotech Inc Stock Price, News & Analysis

Edesa Biotech (NASDAQ:EDSA) announced promising results from its Phase 2 study of monoclonal antibody EB05 for hospitalized COVID-19 patients. The Data and Safety Monitoring Board revealed a 68.5% decrease in mortality risk for critically ill patients treated with EB05 compared to placebo. Additional efficacy signals were found, including an 8.2% mortality rate for patients on supplemental oxygen in the EB05 group. The company plans to focus on this critically ill population in Phase 3 and may expedite regulatory filings due to the significant clinical outcomes observed.

Edesa Biotech (NASDAQ:EDSA) announced promising results from the Phase 2 segment of its ongoing Phase 2/3 study for EB05, a monoclonal antibody aimed at treating hospitalized COVID-19 patients. An independent Data Safety Monitoring Board noted a significant efficacy signal, leading to the study's unblinding. Critically ill patients showed a 68.5% reduction in 28-day mortality with EB05 treatment compared to standard care. The DSMB recommended continuing to the Phase 3 study, which is set to focus on segments with the strongest efficacy signals.

Edesa Biotech (NASDAQ:EDSA) will be presenting at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. Dr. Par Nijhawan, CEO, will discuss the company's corporate strategy and business overview. An on-demand presentation will be available starting September 13, 2021, at 7:00 am ET. Attendees can also schedule one-on-one meetings with company management. Edesa is focused on developing treatments for inflammatory and immune-related diseases, with products in clinical stages for conditions like ARDS and chronic allergic contact dermatitis.

Edesa Biotech (NASDAQ:EDSA) announced significant progress in its Phase 2/3 clinical study for a monoclonal antibody (EB05) targeting hospitalized COVID-19 patients. As of August 25, 2021, over 525 patients have been enrolled, with an upcoming blinded interim analysis expected soon, covering approximately 316 subjects. The Delta variant has accelerated patient enrollment, particularly in regions heavily impacted by the virus. Funded partly by a C$14 million grant from the Canadian Government, Edesa has established 46 clinical sites across Canada, Colombia, and the U.S. for this crucial therapeutic development.

Edesa Biotech (NASDAQ:EDSA) reported its financial results for Q3 and the nine months ending June 30, 2021. The company achieved key milestones in clinical programs EB05 and EB01, with recommendations to advance both to final enrollment stages. R&D expenditures increased to $4.46 million, reflecting enhanced clinical study activities. Edesa recorded no revenues for the quarter, leading to a net loss of $4.76 million ($0.36 per share). For the nine-month period, total operating expenses rose to $18.20 million amid no revenues, resulting in a net loss of $9.66 million ($0.83 per share).

Edesa Biotech (NASDAQ:EDSA) has expanded patient enrollment for its Phase 2b study of EB01 in Canada, targeting chronic Allergic Contact Dermatitis (ACD). This decision comes after positive interim results from the U.S. segment of the study. ECD affects around 20% of occupational dermatitis cases, leading to significant work-related challenges. Edesa aims to enroll at least 120 additional subjects, providing varying concentrations of EB01 or a placebo. The primary outcome will measure symptom improvement by day 29. The study's acceleration in Canada is expected to enhance enrollment efforts.

Edesa Biotech, Inc. (NASDAQ:EDSA) announced the appointment of Rajan Puri as Senior Vice President of Manufacturing to enhance its manufacturing operations. Puri, an expert in Chemistry, Manufacturing, and Controls (CMC), brings over 20 years of experience from previous roles at CMAB Biopharma and Therapure Biopharma. His expertise is expected to be crucial for advancing Edesa's clinical and commercialization plans, particularly in inflammatory and immune-related diseases. The company is focusing on drugs like EB05 for Acute Respiratory Distress Syndrome and EB01 for chronic allergic contact dermatitis.

Edesa Biotech, Inc. (NASDAQ:EDSA) announced that an independent Data and Safety Monitoring Board (DSMB) has recommended the continuation of its Phase 2/3 study of EB05, a monoclonal antibody treatment for hospitalized COVID-19 patients. Following an interim review, the DSMB assessed safety and efficacy data, concluding that enrollment may proceed. More than 370 patients have been enrolled to date, with plans for further analysis of 316 evaluable subjects. The company is also seeking to streamline its U.S. protocol to potentially expedite results.

Edesa Biotech, Inc. (NASDAQ:EDSA) announced its participation in the 2021 BIO Digital Conference from June 14-18, 2021, focusing on advancements in inflammatory and immune-related diseases. Interested participants can arrange meetings via the BIO One-on-One Partnering system or contact the company directly. Edesa is developing two primary product candidates: EB05 for Acute Respiratory Distress Syndrome and EB01 for allergic contact dermatitis. For more details, please visit Edesa's website.