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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, a clinical-stage biopharmaceutical company (NASDAQ:EDSA), will participate in the Swiss Biotech Day on April 24-25, 2023, in Basel, Switzerland. This event will feature a delegation of Canadian officials and industry leaders. Interested parties can schedule meetings using the conference system or contact Edesa directly via email.
Edesa focuses on innovative treatments for inflammatory and immune-related diseases. Their leading candidate, EB05 (Paridiprubart), is in a Phase 3 study for Acute Respiratory Distress Syndrome (ARDS). Additionally, Edesa is developing an sPLA2 inhibitor, EB01, for chronic Allergic Contact Dermatitis and plans to conduct a Phase 2 trial of EB06 for vitiligo. The company emphasizes the importance of regulatory approvals and the inherent risks associated with clinical trials.
Edesa Biotech, Inc. (NASDAQ:EDSA) has announced that the World Health Organization (WHO) has adopted the international nonproprietary name "paridiprubart" for its monoclonal antibody candidate, EB05. This drug is currently in a Phase 3 study targeting hospitalized Covid-19 patients suffering from Acute Respiratory Distress Syndrome (ARDS). The drug exhibited an 84% reduction in mortality risk compared to a placebo during Phase 2 trials. The assignment of a generic name is seen as a vital step for Edesa's future marketing and regulatory filings, as paridiprubart is one of the first drugs to utilize WHO's new nomenclature system for monoclonal antibodies.
Edesa Biotech (NASDAQ:EDSA) announced participation in the H.C. Wainwright Autoimmune & Inflammatory Disease Virtual Conference on March 30, 2023. The event will feature a Fireside Chat with CEO Par Nijhawan, available to registered attendees at around 7:00 am ET. Edesa is a clinical-stage biopharmaceutical company focused on innovative treatments for inflammatory and immune-related diseases. Key developments include the Phase 3 study of monoclonal antibody EB05 for Acute Respiratory Distress Syndrome, and a Phase 2 trial for EB06 targeting vitiligo. For meeting arrangements, participants can contact their H.C. Wainwright representative or Edesa directly at investors@edesabiotech.com.
Edesa Biotech has been selected to present key clinical trial data for its EB01 drug candidate at the American Academy of Dermatology Association annual meeting from March 17-21, 2023. The presentation will occur on March 18, 2023, at 2:50 PM CT, showcasing significant results from a Phase 2B study involving 1.0% EB01 cream for treating moderate-to-severe chronic allergic contact dermatitis (ACD). The EB01 candidate, which targets sPLA2 pro-inflammatory enzymes, has previously shown efficacy in treating ACD. The meeting will also make presentation slides available shortly after the event.
Edesa Biotech (NASDAQ:EDSA) announced an agreement with the FDA on the primary endpoint for a pivotal Phase 3 study evaluating its monoclonal antibody candidate, EB05, in hospitalized patients with severe Acute Respiratory Distress Syndrome (ARDS) related to Covid-19. The FDA granted Fast Track designation for the program. The study will focus on the 28-day mortality rate among approximately 600 patients on invasive mechanical ventilation. A previous Phase 2 trial indicated an 84% reduction in mortality among critically ill Covid-19 patients receiving EB05 compared to placebo. Edesa is also exploring EB05 for broader ARDS applications.
Edesa Biotech, Inc. (NASDAQ:EDSA) reported its financial results for Q1 2023, ending December 31, 2022. The U.S. FDA granted Fast Track designation for its drug candidate, EB05, aimed at Acute Respiratory Distress Syndrome (ARDS), following favorable Phase 2 results. Edesa achieved positive topline results from a Phase 2b study of EB01 for Allergic Contact Dermatitis, showing significant efficacy. Additionally, Canadian regulators authorized a Phase 2 study for EB06, targeting vitiligo. The company reduced operating expenses by over 50% year-over-year to $2.38 million. Edesa reported a net loss of $2.33 million or $0.13 per share, an improvement from the previous year's loss.
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