Veradermics Incorporated (NYSE:MANE) saw its stock rise 17% on Monday after announcing positive topline data from a Phase 2/3 clinical study of its oral hair loss treatment, VDPHL01.
The trial, known as Study ’302’, included 519 participants and successfully met all primary and key secondary endpoints with statistical significance. VDPHL01, an extended-release formulation of minoxidil, delivered a mean increase in non-vellus hair count of 30.3 hairs per cm² with once-daily dosing and 37.7 hairs per cm² with twice-daily dosing, compared with placebo.
Patient-reported outcomes were also strong, with 79.3% of individuals on once-daily treatment and 86.0% on twice-daily dosing reporting improvement, versus 35.6% in the placebo group. In addition, 48.4% of once-daily patients and 58.1% of those on twice-daily treatment described their results as moderate or marked improvements.
The therapy showed measurable benefits as early as Month 2, the first evaluation point in the study. Investigators reported improved hair growth in 72.0% of once-daily patients and 81.7% of twice-daily patients.
VDPHL01 was generally well tolerated through six months of treatment, with adverse event rates broadly in line with placebo. The study reported no serious treatment-related adverse events and no cardiac-related safety concerns. Discontinuation rates were also lower among patients receiving the drug compared with placebo.
If approved, VDPHL01 could become the first non-hormonal oral treatment for pattern hair loss cleared by the U.S. Food and Drug Administration, targeting a market of roughly 80 million men and women in the United States.
The company has also completed enrollment for a second Phase 3 trial, Study ’304’, in February, with topline results expected in the second half of 2026.