Edesa Biotech receives FDA clearance for vitiligo study expansion

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, 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.

Edesa Biotech (EDSA) received FDA clearance to expand its Phase 2 vitiligo study to U.S. sites, with enrollment expected next quarter. Topline data is anticipated for Q4 2027. The study evaluates EB06, a monoclonal antibody targeting CXCL10, in 80 adults with moderate-to-severe vitiligo. Edesa aims to report results in late 2027, marking a key milestone for its vitiligo program.