NEW HAVEN, Connecticut, April 27, 2026, 15:02 (EDT)
Veradermics, Incorporated shares surged Monday, after the company reported its experimental oral hair-loss treatment, VDPHL01, hit all main and key secondary endpoints in a Phase 2/3 study of men with mild-to-moderate pattern hair loss. The Phase 2/3 trial—a mid- to late-stage human study—is designed to assess safety and efficacy ahead of a potential approval filing.
Veradermics gets the data just as it pushes to reposition minoxidil—known for decades as a hair-loss therapy—into an extended-release oral pill. The New Haven, Connecticut biotech is betting doctors will prescribe its formulation for a market still dominated by topicals, generic finasteride, and off-label oral minoxidil.
Investors piled in, betting that the results could back Veradermics’ claim that its pill might become the first FDA-approved oral treatment for pattern hair loss in close to 30 years. The company points to roughly 50 million U.S. men affected, and says the total jumps to about 80 million Americans when factoring in women.
Veradermics shares surged roughly 40% to $95.28 in early afternoon action, after touching an intraday peak of $101.59. The stock, listed as MANE on the New York Stock Exchange, drew heavy interest.
Researchers enrolled 519 men in Study ‘302,’ splitting them into groups for VDPHL01 at 8.5 mg once daily, 8.5 mg twice daily, or placebo. The primary endpoint focused on the number of non-vellus target area hairs—basically, thicker visible hairs, not the softer peach-fuzz kind—counted in a specific part of the scalp.
Six months in, patients taking the drug once daily saw hair density rise by an average of 30.3 hairs per square centimeter. The figure ticked up to 33.0 for those on the twice-daily regimen. Placebo recipients gained 7.3 hairs per square centimeter, the company said.
Patient feedback added more support for the trial results. According to Veradermics, 79.3% of those taking the drug once daily and 86.0% on the twice-daily regimen saw at least some increase in hair coverage, while just 35.6% of patients getting placebo reported any improvement.
Dr. Maryanne Makredes Senna, dermatologist at Beth Israel Lahey Health and assistant professor at Harvard Medical School, said VDPHL01 “if approved” could shift the way both patients and doctors deal with male pattern hair loss. Michael Gold, trial investigator, pointed out that dermatology has relied on a medication “borrowed from cardiology” and described VDPHL01 as the first oral minoxidil specifically engineered for pattern hair loss. Veradermics, Inc.
Veradermics CEO Reid Waldman said the company’s extended-release formulation produced “marked increases in hair growth” and aimed to lower cardiac risk—an important consideration for oral minoxidil, which originated as a blood-pressure drug. Veradermics, Inc.
Safety stays in the spotlight. According to Veradermics’ SEC filing, six-month data showed no treatment-related or heart-related serious adverse events flagged as special interest. The list of common treatment-emergent issues included peripheral edema and hypertrichosis—excess hair growth.
Competition here is anything but straightforward. Should VDPHL01 win approval, it would be up against Rogaine and other topical minoxidil products, plus a crowded field of generic finasteride—long defined by Propecia—as well as telehealth players like Hims & Hers Health and Ro, which already offer hair-loss treatments. Cantor Fitzgerald’s Prakhar Agrawal now sees a “stronger” commercial case for VDPHL01 following the latest data, according to BioPharma Dive.
Veradermics isn’t done yet—it still needs to complete its pivotal trials and secure regulatory approval. According to the company, the second Phase 3 trial in men, Study ‘304,’ should deliver results in the back half of 2026. Meanwhile, Study ‘306,’ which targets female pattern hair loss in a Phase 2/3 format, is in the recruitment phase.
The catch? Even a solid trial doesn’t ensure the FDA will sign off, or that Veradermics can fend off low-cost generics when it comes to price and market share. The company itself flagged risks tied to its outlook—competition, potential side effects, regulatory hurdles, and the critical need for VDPHL01 to actually succeed in the market all loom large.