Hair loss is a big market with a small number of options, and most of them involve either a hormonal pill or something you rub on your scalp twice a day and hope for the best. On Monday, Veradermics Incorporated (MANE) said it has a third idea, and the data looks decent. The stock jumped more than 10% on the news.
The dermatologist-founded biopharmaceutical firm announced positive topline results from Part A of its registration-directed Phase 3 trial evaluating VDPHL01, a proprietary extended-release oral minoxidil formulation. The study enrolled 536 men with mild-to-moderate pattern hair loss, and Study '304' met all primary and secondary endpoints with high statistical significance.
Combined with previously reported positive topline findings from Part A of the Phase 2/3 trial, the company says this represents the full placebo-controlled data set to support VDPHL01's potential to become the first FDA-approved non-hormonal oral treatment for the 50 million men with pattern hair loss in the U.S.
Statistically Significant Hair Growth Across Both Doses
Participants received either an 8.5-milligram dose once daily, an 8.5-milligram dose twice daily, or a placebo. Over six months, the active treatment arms showed substantial increases in hair count, with rapid onset of efficacy visible as early as Month 2.
At Month 6, patients achieved an average increase in non-vellus hair count of 28.6 hairs per square centimeter in the once-daily cohort and 36.4 hairs per square centimeter in the twice-daily cohort, compared to 6.6 hairs per square centimeter for placebo.
On the Androgenetic Alopecia Impact Rating Scale, 78.8% of once-daily patients and 85.0% of twice-daily patients noted improved hair coverage, versus 35.3% on placebo. And 55.7% of once-daily participants and 68.7% of twice-daily participants reported being 'improved' or 'much improved,' compared to 15.0% of the placebo group.
Clinicians backed this up via the Investigator Global Assessment scale, noting improvements in 78.4% of once-daily and 82.7% of twice-daily participants.
CEO Reid Waldman said the combined results from more than 1,000 participants demonstrated meaningful hair growth with an encouraging safety profile.
Clean Safety Profile and Upcoming Clinical Readouts
VDPHL01 was generally well tolerated across both active arms. Investigators observed no treatment-related serious adverse events and no cardiac-related adverse events of special interest. That matters for an oral minoxidil product, since the cardiovascular angle is the thing everyone watches.
Veradermics expects to report data from Part B of Study '302' later this year. The company also finished enrollment in August for Study '306', a Phase 2/3 trial in female pattern hair loss, with topline results projected in the first half of 2027.
Veradermics Price Action
MANE Price Action: Veradermics shares were up 10.11% at $119.82 at the time of publication on Monday, according to market data.
