Key insights
- Veradermics Inc. (MANE) stock surged after its oral hair loss drug, VDPHL01, met all primary and secondary endpoints in a Phase 3 clinical trial. The drug demonstrated statistically significant increases in hair count and patient-reported improvements in hair coverage, with a favorable safety profile. These results support its potential as the first FDA-approved non-hormonal oral treatment for pattern hair loss in decades.
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.
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