Edesa Biotech Inc Stock Price, News & Analysis

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.

Edesa Biotech (NASDAQ:EDSA) announced the approval from Health Canada for a Phase 2 clinical study of its monoclonal antibody candidate, EB06, targeting vitiligo, a widespread autoimmune condition affecting 1% of the global population. The study aims to evaluate the safety and efficacy of EB06 versus placebo in approximately 120 adults with moderate to severe non-segmental vitiligo. EB06 works by binding to chemokine ligand 10 (CXCL10), which is associated with the disease's progression. This approval marks a significant milestone for Edesa, potentially enhancing partnerships and advancing its development pipeline.

Edesa Biotech announced promising topline results from a Phase 2b clinical trial evaluating the 1.0% EB01 cream for moderate-to-severe allergic contact dermatitis (ACD). The trial, involving 200 subjects, showed that the 1.0% formulation achieved a statistically significant 60% average improvement in symptoms compared to 39% for the placebo (p=0.02) at day 29. Additionally, 53% of patients treated with EB01 reached 'clear' or 'almost clear' skin, versus 29% in the placebo group (p=0.04). No serious treatment-related adverse events were reported. Edesa plans to meet with the FDA for an End of Phase 2 discussion following a complete analysis expected mid-2023.

Edesa Biotech (Nasdaq:EDSA) has received Fast Track designation from the FDA for its monoclonal antibody candidate EB05, aimed at treating Acute Respiratory Distress Syndrome (ARDS)84% reduction in mortality risk for patients receiving EB05 compared to a placebo. The Fast Track program aims to address serious diseases and unmet medical needs.

Edesa Biotech, Inc. (NASDAQ:EDSA) reported its financial results for the fiscal year ending September 30, 2022. The company achieved an 84% reduction in the risk of death for critically ill COVID-19 patients receiving its monoclonal antibody, EB05. Total operating expenses fell over 20% to $18.37 million, with a net loss of $17.55 million for the year. Edesa reported cash and cash equivalents of $7.09 million as of September 30. The company has ongoing Phase 3 clinical protocol reviews and anticipates significant progress in 2023.

Edesa Biotech (NASDAQ:EDSA), a clinical-stage biopharmaceutical firm, announced Dr. Par Nijhawan's participation in the panel discussion at the Cantor Fitzgerald Medical Dermatology, Ophthalmology & Medtech Conference on December 8, 2022, at 10:00 am ET. Meetings can be arranged through Cantor representatives or directly at investors@edesabiotech.com. Edesa is focused on treatments for immune-related diseases, with lead candidates EB01 (Phase 2b) for allergic contact dermatitis and EB05 (Phase 3) for Acute Respiratory Distress Syndrome.