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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 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.
Edesa Biotech (NASDAQ:EDSA) announced the closing of a $3.0 million private placement priced at-the-market. The offering included 2,691,337 common shares, alongside 12-month and 3-year warrants for an additional 1,345,665 shares each. The common shares were sold at $1.125 each. Proceeds will support clinical programs, including a Phase 2b study for allergic contact dermatitis. Notably, officers and directors invested approximately $0.5 million in this offering. This transaction is registered under Section 4(a)(2) of the Securities Act.
Edesa Biotech reported favorable final results from the Phase 2 study of its monoclonal antibody candidate EB05 for treating Covid-19 induced ARDS. The study demonstrated an 84% reduction in mortality risk at 28 days for critically ill patients receiving EB05 compared to placebo (7.7% vs. 40%, p=0.04). A Clinical Study Report has been submitted to the FDA, and the company is advancing to Phase 3 trials.
EB05 may address significant unmet needs in ARDS treatment caused by various pathogens. The study was partially funded by a C$14 million government grant.
Edesa Biotech (NASDAQ:EDSA) announced that CEO Par Nijhawan will present at the H.C. Wainwright Global Investment Conference in New York from September 12-14, 2022. The presentation is scheduled for September 12 at 10:00 am Eastern Time, and slides will be available on the Edesa website. Edesa is focused on developing treatments for inflammatory diseases, with key products, EB05 for ARDS and EB01 for chronic allergic contact dermatitis, in late-stage studies.
Edesa Biotech (NASDAQ:EDSA) has completed patient recruitment for its Phase 2b clinical study of EB01, a non-steroidal anti-inflammatory drug candidate for moderate-to-severe chronic Allergic Contact Dermatitis. The primary endpoint is expected to be reached within 30 days, with topline data anticipated by year-end. The company is exploring out-licensing opportunities outside North America and prioritizing future clinical studies for EB01. Interim results show promising efficacy, with significant differences reported in key endpoints compared to placebo, and no serious adverse events were recorded.
Edesa Biotech (NASDAQ:EDSA) reported financial results for Q3 and nine months ended June 30, 2022. The company expanded its Phase 3 drug study for Covid-19 patients and confirmed robust recruitment for its Phase 2b dermatology study. Q3 operational expenses decreased to $5.80 million, while net loss was $5.79 million. For the nine months, total operating expenses dropped to $15.53 million, with a net loss of $14.74 million. Edesa holds $12.81 million in cash, with plans to participate in the H.C. Wainwright Global Investment Conference in September 2022.
Edesa Biotech (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, will partake in the BTIG Biotechnology Conference in New York on August 8-9, 2022. This hybrid event allows for both virtual and in-person attendance. Interested parties can connect with Edesa through BTIG representatives or via email at investors@edesabiotech.com. Edesa is advancing two critical product candidates, EB05, targeting Acute Respiratory Distress Syndrome, and EB01, for chronic allergic contact dermatitis.
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