Investing.com -- Veradermics Inc (NYSE:MANE) shares rose 6.7% in premarket trading Monday after the company announced its oral hair loss drug VDPHL01 met all primary and secondary endpoints in a Phase 3 clinical trial.
The registration-directed Phase 3 trial, Study '304', enrolled 536 male participants with mild-to-moderate pattern hair loss who received either VDPHL01 8.5mg once daily, VDPHL01 8.5mg twice daily, or placebo. VDPHL01 demonstrated increases in target area hair count of 28.6 hairs/cm² for once-daily dosing and 36.4 hairs/cm² for twice-daily dosing, compared to 6.6 hairs/cm² for placebo, with high statistical significance.
Approximately 78.8% of once-daily participants and 85.0% of twice-daily participants reported visible improvement in patient-reported outcomes versus 35.3% of placebo participants. Additionally, 55.7% of once-daily participants and 68.7% of twice-daily participants reported improved or much improved hair coverage on the Androgenetic Alopecia Impact Rating Scale, compared to 15.0% of placebo participants.
The drug demonstrated a favorable safety profile across more than 1,000 participants in two registration-directed studies with no treatment-related serious adverse events and no adverse events of cardiac origin. Treatment-emergent adverse events included peripheral edema in 2.8% of once-daily participants and 4.5% of twice-daily participants, compared to 0.6% for placebo.
These results, combined with previously reported positive findings from the Phase 2/3 trial Study '302' in April 2026, support VDPHL01's potential to become the first FDA-approved non-hormonal oral treatment for pattern hair loss in nearly 30 years. Veradermics anticipates reporting longer-term data from Study '302' later this year and topline data from its female pattern hair loss trial, Study '306', in the first half of 2027.
Original Article
Veradermics stock surges as hair loss drug meets Phase 3 goals
