On December 12, 2025, Edesa Biotech, Inc. (EDSA) announced financial results for fiscal year 2025 that ended September 30, 2025 and provided a business update. The company is continuing activities in preparation for an Investigational New Drug (IND) application submission with the U.S. FDA in order to initiate a Phase 2 trial of EB06 in vitiligo. We anticipate patient enrollment initiating in mid-2026, contingent on the company completing manufacturing and regulatory activities. In October 2025, Edesa announced positive results from a Phase 3 clinical trial evaluating paridiprubart (EB05) as a treatment for Acute Respiratory Distress Syndrome (ARDS). EB05 met both the primary and secondary endpoints of the study, which included a statistically significant and clinically meaningful 25% relative risk reduction in the risk of death compared to placebo (P<0.001). The company plans to submit data to regulatory agencies to determine the next steps for the program.
