On August 11, 2025, Edesa Biotech, Inc. (EDSA) announced financial results for the third quarter of fiscal year 2025 that ended June 30, 2025 and provided a business update. During the quarter, the company advanced manufacturing activities to support U.S. regulatory approval for a Phase 2 study of EB06 in the treatment of vitiligo. Based on current availability of manufacturing slots at third-party vendors, we estimate that drug manufacturing data for EB06 is likely to be submitted to the U.S. Food and Drug Administration (FDA) before the end of calendar 2025. Once cleared by the FDA, topline results from the Phase 2 study of EB06 in vitiligo could be available in approximately 12-18 months.
