Edesa Biotech Inc - EDSA STOCK NEWS

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.

Edesa Biotech, Inc. (NASDAQ:EDSA) announced that its drug candidate EB01 has achieved key interim study milestones in its Phase 2b trial for moderate to severe chronic Allergic Contact Dermatitis (ACD). The study's Data and Safety Monitoring Board reported a significant efficacy difference between treatment arms with 1.7-fold improvement on the Contact Dermatitis Severity Index. No serious adverse events were noted. Edesa will proceed to the next patient cohort, aiming to validate EB01's effectiveness as a non-steroidal anti-inflammatory treatment for ACD, a condition affecting millions and costing the U.S. economy billions annually.

Edesa Biotech (NASDAQ:EDSA) announced that CEO Dr. Par Nijhawan will participate in a virtual panel hosted by the Ontario Bioscience Innovation Organization on June 1, 2021, at 12:00 PM ET. The discussion will center on the topic "Health Science IPOs: Will We Continue To Break Records?" Edesa is a biopharmaceutical company focused on developing therapies for inflammatory diseases, with two lead candidates: EB05 for Acute Respiratory Distress Syndrome and EB01 for chronic allergic contact dermatitis.

Edesa Biotech, Inc. (NASDAQ:EDSA) will host a KOL webinar on its lead asset, EB05, for treating Acute Respiratory Distress Syndrome (ARDS) on April 29, 2021 at 1:00 pm ET. KOL Dr. Ted Steiner from the University of British Columbia will discuss the treatment landscape for COVID-19 induced ARDS and answer questions after his presentation. Edesa's Phase 2/3 study aims to evaluate the safety and efficacy of EB05, with enrollment of up to 316 adult COVID-19 patients. An update on patient enrollment will be provided during the event.