SHERIDAN, WYOMING – October 15, 2025 – Pelage Pharmaceuticals has raised $120 million in Series B financing to advance its novel stem cell–activating therapy for hair loss into Phase III clinical trials. The funding positions the California-based biotech to accelerate clinical development of PP405, a first-in-class topical molecule designed to rejuvenate dormant hair follicle stem cells and restore natural hair growth.
Breakthrough Molecule Targets Follicle Stem Cells
Pelage’s lead candidate, PP405, is a small-molecule topical formulation that reawakens hair follicle stem cells — the biological “engines” responsible for hair regeneration. Unlike current treatments such as finasteride or minoxidil, which act on hormonal or vascular pathways, PP405 directly targets the follicular stem cell compartment. The approach could potentially benefit patients traditionally underserved by existing therapies, including women and individuals with advanced or longstanding hair loss.
Promising Phase IIa Results in Androgenetic Alopecia
In a Phase IIa clinical study involving 78 male and female patients with androgenetic alopecia, PP405 demonstrated strong safety and early efficacy signals. After eight weeks of treatment:
- 31% of patients receiving PP405 achieved at least a 20% increase in hair density, compared to 0% in the placebo arm.
- The drug showed no systemic absorption, meeting key pharmacokinetic safety endpoints.
- Early regrowth was observed even in follicles previously showing no visible hair.
“Typically, visible hair regrowth requires 6–12 months of continuous therapy, suggesting PP405 may yield a more rapid clinical response than current treatments,” the company said, adding that “unlike existing drugs, hair growth started from follicles where no hair was present.”
Industry Momentum and Expanding Market Demand
Androgenetic alopecia, which affects both postpubescent men and postmenopausal women, remains one of the most common and persistent forms of hair loss worldwide. While hormonal blockers and topical vasodilators dominate the $23.6 billion global hair restoration market, few therapies directly address follicular regeneration. With the market expected to grow to $31.5 billion by 2028, investor confidence in novel regenerative approaches has surged across dermatology and aesthetic biotech.
Strategic Use of Series B Funding
The $120 million financing follows Pelage’s $16.75 million Series A in early 2024. The new capital will fund pivotal Phase III studies of PP405, expand manufacturing capabilities, and strengthen the company’s clinical and regulatory infrastructure. The Phase III trial is planned for 2026 and will evaluate efficacy in a broader androgenetic alopecia population.
A New Era for Hair Regrowth Therapies
By focusing on follicle stem cell activation rather than hormonal modulation, Pelage aims to redefine the therapeutic paradigm for hair loss. The company’s regenerative dermatology platform may also extend to other skin and follicular disorders over time, reflecting a broader trend of biotech-driven innovation in aesthetic medicine and tissue repair.
Learn more about Pelage Pharmaceuticals and its clinical pipeline at www.pelagepharma.com.