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Edesa Biotech, Inc. (NASDAQ: EDSA) is a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for inflammatory and immune-related diseases. Founded in 2015, Edesa is focused on dermatological and anorectal conditions, particularly those with limited treatment options. The company's experienced team has licensed global rights to several clinical-stage assets targeting these conditions.
Edesa operates in a single segment: the research, development, manufacturing, and commercialization of pharmaceutical products. Its leading product candidates include EB01, a non-steroidal, anti-inflammatory treatment for chronic Allergic Contact Dermatitis (ACD), and EB05, a monoclonal antibody therapy for hospitalized COVID-19 patients. The company's focus on alternatives to topical steroids, which often have side effects, positions it uniquely in the dermatology market.
In the latest developments, Edesa announced its intention to effect a one-for-seven reverse share split of its common shares, which began trading on a post-reverse split basis on October 11, 2023. Additionally, the company secured a commitment of up to C$23 million from the Government of Canada for a pivotal Phase 3 clinical study of EB05. This support underscores the potential of Edesa's therapies to modulate the body's immune response in critical conditions like Acute Respiratory Distress Syndrome (ARDS).
Another significant milestone was the favorable final results from a Phase 2b study of EB01, demonstrating its efficacy in treating moderate-to-severe chronic ACD. The company also received Health Canada approval to harmonize clinical trial designs in the U.S. and Canada for its ongoing Phase 3 study of EB05. Further, a $10 million revolving credit facility agreement with the company's CEO enhances its financial flexibility for future developments.
Edesa's pipeline includes candidates like EB06, for the treatment of vitiligo, and plans to file an investigational new drug application for a future Phase 2 study of paridiprubart for systemic sclerosis. The company's ongoing efforts in research and strategic partnerships continue to pave the way for innovative solutions in the biopharmaceutical landscape.
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.
Edesa Biotech (NASDAQ:EDSA) announced a definitive license agreement to acquire global rights to a non-steroidal anti-inflammatory technology related to its EB01 and EB02 drug candidates. This agreement enhances Edesa's intellectual property portfolio and allows for broader development and commercialization across various fields, following an earlier licensing from Hebrew University. CEO Par Nijhawan emphasized the importance of this agreement in strengthening Edesa's strategic position. The company has also completed patient enrollment for a Phase 2b trial of EB01 aimed at treating chronic Allergic Contact Dermatitis.
Edesa Biotech (NASDAQ:EDSA) announced the completion of over 50% patient enrollment for the Phase 2 portion of its Phase 2/Phase 3 clinical study of EB05, aimed at treating hospitalized COVID-19 patients at risk of developing Acute Respiratory Distress Syndrome (ARDS). Over 160 out of 316 planned subjects have been randomized. The company is accelerating the process by activating approximately 20 more hospital sites. Dr. Par Nijhawan highlighted the unmet medical need for ARDS treatment, emphasizing the importance of this milestone in their efforts to address severe cases of COVID-19.
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