Pelage Pharmaceuticals Announces Positive Phase 2a Clinical Trial Results for PP405 in Regenerative Hair Loss Therapy

LOS ANGELES–(BUSINESS WIRE)–Pelage Pharmaceuticals, a clinical-stage regenerative medicine company, today announced positive results from its Phase 2a clinical trial of PP405 — a topical therapy for androgenetic alopecia advancing through the FDA clinical development pathway. PP405 is designed to reactivate dormant hair follicle stem cells, offering a potential first-in-class approach for both men and women experiencing hair loss.

The Phase 2a randomized controlled trial enrolled a total of 78 men and women with androgenetic alopecia, representing a diverse range of skin phototypes and hair textures. The subjects applied PP405 or a placebo on their scalp once daily for 4 weeks and were followed out to 12 weeks. The study met its primary safety endpoint and secondary pharmacokinetic endpoint: the drug was well tolerated with no systemic absorption of PP405 detected in the blood, underscoring a robust safety profile. Exploratory endpoints assessed early signs of new hair growth.

Business News Today Article: Myopia drug breakthrough: Sydnexis’ SYD-101 approved in Europe, Ryjunea launch next

Sydnexis, a privately held U.S. biopharmaceutical company, secured a critical regulatory victory on June 5, 2025, with the European Commission granting marketing authorization for SYD-101, its proprietary low-dose atropine eye drop.

Valuation expectations are rising. If SYD-101 succeeds in both the EU and U.S., Sydnexis could command a biotech valuation in the range of $1.5 billion to $2 billion, based on typical pre-commercial revenue multiples. Investor interest is expected to accelerate in Q4 as FDA decision timelines approach.