Edesa Biotech, Inc. (EDSA): Entry into a Material Definitive Agreement

Edesa Biotech (EDSA) received FDA clearance to expand its Phase 2 trial of EB06 for vitiligo into the U.S. The double-blind, placebo-controlled study will enroll up to 80 adults. Edesa expects topline data in Q4 2027. The company reported a net loss of $5.4M for Q3 2026 and has $10.3M in cash. EDSA stock is up 0.57% to $2.66.

Edesa Biotech (EDSA) received FDA clearance to expand its Phase 2 vitiligo study to the U.S., with topline data expected in Q4 2027. The study evaluates EB06, a monoclonal antibody targeting CXCL10, in 80 adults with moderate-to-severe vitiligo. Patient recruitment is already underway in Canada, and U.S. sites are expected to begin enrolling next quarter.

Edesa Biotech (EDSA) received FDA clearance for a Phase 2 trial of EB06 in vitiligo, enabling U.S. patient recruitment. The study will enroll 80 adults, with topline data expected in Q4 2027. The primary endpoint is the mean percent change in facial VASI at Week 28.

Edesa Biotech (NASDAQ:EDSA) received FDA clearance to expand its Phase 2 clinical study of EB06 for vitiligo into the U.S. The study, currently recruiting in Canada, aims to enroll up to 80 adults with moderate-to-severe vitiligo. Topline data is expected in Q4 2027. EB06 is a monoclonal antibody targeting CXCL10, with no approved systemic drug therapies for vitiligo in the U.S. according to the company.

Edesa Biotech, Inc. (EDSA) filed an SEC Form 8-K — Other Events. Item 8.01. Other Events. On October 15, 2026, Edesa Biotech, Inc. (the “Company”) reported that the U.S. Food and Drug Administration (“FDA”) has cleared the Company's Investigational New Drug (“IND”) application for its Phase 2 clinical study of EB06 in vitiligo, enabling the Co

Edesa Biotech (EDSA) received FDA clearance to expand its Phase 2 trial of EB06 for vitiligo to the U.S. Enrollment will begin next quarter, with Canadian recruitment already underway. Topline data is expected in Q4 2027, according to the company.