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 reports developments as a clinical-stage biopharmaceutical company developing host-directed therapeutics for immuno-inflammatory diseases. Its recurring news centers on paridiprubart, or EB05, an anti-TLR4 antibody evaluated for Acute Respiratory Distress Syndrome, and EB06, an anti-CXCL10 monoclonal antibody program for moderate-to-severe nonsegmental vitiligo.
Company updates also cover clinical data presentations, manufacturing and regulatory preparation, government-supported research activities, conference participation, operating results, capital-structure matters and shareholder governance. Financial reports generally frame spending around clinical development priorities and the company’s monoclonal antibody pipeline.
Edesa Biotech (Nasdaq: EDSA) will deliver an oral presentation on paridiprubart, a first-in-class anti-TLR4 antibody, at the 63rd European Renal Association Congress in Glasgow, June 3–6, 2026.
The June 5 talk covers exploratory Phase 3 data in acute kidney injury with respiratory distress and additional analyses.
Edesa Biotech (Nasdaq: EDSA) reported fiscal Q2 2026 results and clinical updates. The company advanced preparations for a Phase 2 study of EB06 in vitiligo and reported additional positive Phase 3 data for paridiprubart in ARDS.
Q2 operating expenses were $4.3M, with a net loss of $4.2M ($0.49/share). For the six months, net loss was $6.5M ($0.78/share). Edesa ended March 31, 2026 with $10.0M in cash and $8.2M in working capital.
Edesa Biotech (Nasdaq: EDSA) announced oral and poster presentations of its Phase 3 paridiprubart (EB05) data at ATS 2026 events. Dr. Par Nijhawan will present at the Respiratory Innovation Summit on May 15, 2026, and a full oral presentation occurs on May 20, 2026.
Two Phase 3 data sets were described: an initial 104-patient IMV cohort and expanded 278-patient results including IMV and non-IMV patients, with reported statistically significant mortality reductions for ARDS patients.
Edesa Biotech (Nasdaq:EDSA) updated progress on its Phase 2 study of EB06 for moderate-to-severe nonsegmental vitiligo and reaffirmed a mid-2026 timeline for site activations and patient recruitment.
The company selected JSS Medical Research as CRO, began outreach to sites and investigators, and noted its Canadian clinical trial application was approved, with enrollment to start first in Canada pending any required administrative protocol filings.
Edesa Biotech (Nasdaq:EDSA) reported positive additional Phase 3 results for paridiprubart in 278 randomized ARDS patients. Adjusted 28-day mortality fell to 24% versus 33% with placebo (27% relative reduction, p<0.001). Non-IMV patients saw mortality drop to 15% from 23% (35% relative reduction, p<0.05).
Exploratory subgroup reductions included acute kidney injury, sepsis and pneumonia; safety was similar between arms. Edesa filed provisional US patent applications for these indications and plans regulatory discussions, manufacturing scale-up and strategic collaborations.
Edesa Biotech (Nasdaq:EDSA) reported Q1 FY2026 results for the three months ended December 31, 2025, and program updates.
The company advanced manufacturing of EB06 and placebo for a planned Phase 2 vitiligo study with recruitment anticipated mid‑2026, reported positive Phase 3 results for paridiprubart in ARDS and is evaluating subgroup efficacy signals.
Financials: Operating expenses $2.3M, net loss $2.2M ($0.28/sh), cash and equivalents $12.1M, working capital $12.0M.
Edesa Biotech (Nasdaq:EDSA) reported fiscal year 2025 results for the year ended September 30, 2025, highlighting clinical and financial updates. The company said a Phase 3 study of paridiprubart (EB05) met primary and secondary endpoints with statistical significance and that manufacturing activities began for a Phase 2 study of EB06 (anti-CXCL10) in vitiligo with recruitment anticipated by mid‑2026, subject to manufacturing and approvals. Financials showed total operating expenses $7.9M (up $0.9M), R&D $3.7M (up $0.8M), net loss $7.2M or $1.27 per share, cash and equivalents $10.8M, and working capital $10.4M. The company received $3.4M net proceeds from an at‑the‑market offering after year‑end and extended Canadian government funding to support programs.
Edesa Biotech (Nasdaq: EDSA) announced management and business development participation at two upcoming industry conferences in Europe: BIO-Europe in Vienna, Austria on November 3-5, 2025, and LSX Investival Showcase Europe in London, UK on November 17, 2025 (presentation at 3:45 pm GMT). To schedule meetings during these events, investors should contact conference organizers or email investors@edesabiotech.com.
Edesa Biotech (Nasdaq: EDSA) reported positive Phase 3 results for paridiprubart (EB05) in Acute Respiratory Distress Syndrome (ARDS) on Oct 28, 2025. In the ITT population (n=104) paridiprubart plus standard of care reduced 28‑day mortality to 39% vs 52% for placebo (absolute improvement 13%, relative risk reduction 25%, p<0.001). At 60 days mortality was 46% vs 59% (absolute improvement 13%, relative reduction 22%, p=0.003). Paridiprubart also produced a 41% higher relative rate of clinical improvement at Day 28. Safety in a population >275 subjects was reported as generally well tolerated.
Edesa Biotech (Nasdaq:EDSA) reported its fiscal Q3 2025 results and provided updates on its drug development programs. The company is advancing manufacturing activities for EB06, an anti-CXCL10 monoclonal antibody for moderate-to-severe nonsegmental vitiligo, with FDA submission planned by end of 2025.
Financial highlights include: Q3 net loss of $1.7 million ($0.25 per share), unchanged from last year, with operating expenses stable at $1.9 million. The company maintains a strong financial position with $12.4 million in cash and $12.1 million in working capital. The company's EB05 program continues through a fully funded U.S. government "Just Breathe" study for ARDS patients.