Welcome to our dedicated page for Edesa Biotech news (Ticker: EDSA), a resource for investors and traders seeking the latest updates and insights on Edesa Biotech stock.
Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company whose news flow centers on the development of host-directed therapeutics for immuno-inflammatory diseases. Company announcements frequently highlight progress in its two main therapeutic areas, Medical Dermatology and Respiratory, giving investors and observers insight into the status of key clinical programs and funding arrangements.
On this page, readers can follow updates on Edesa’s dermatology pipeline, including news about EB06, an anti-CXCL10 monoclonal antibody candidate being developed as a therapy for vitiligo, and EB01 (1.0% daniluromer cream), a Phase 3-ready asset for moderate-to-severe chronic Allergic Contact Dermatitis. Disclosures often cover manufacturing milestones, regulatory interactions and plans for Phase 2 and Phase 3 clinical studies in these indications.
The news feed also captures developments in Edesa’s respiratory portfolio. This includes clinical data and regulatory context for paridiprubart (EB05), a monoclonal antibody being developed for Acute Respiratory Distress Syndrome (ARDS), as well as information on the U.S. government-funded “Just Breathe” platform study and Canadian government funding from the Strategic Innovation Fund. Announcements may detail Phase 3 study outcomes, safety findings, and the company’s exploration of additional uses for paridiprubart in chronic respiratory diseases and pulmonary fibrosis via EB07.
In addition to clinical and scientific news, Edesa’s releases include financial results, equity financings, at-the-market offering updates, and executive or board changes. Visitors can use this page to monitor how Edesa reports on its operating expenses, government contribution agreements, capital raises and conference participation. For those tracking EDSA, the news section provides a centralized view of the company’s disclosed milestones, strategic priorities and regulatory progress over time.
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.
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.
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