Cosmo Pharma set to file for approval of clascoterone

Ireland incorporated Cosmo Pharmaceuticals (SIX: COPN) saw its shares rise more than 3% to $91.80 yesterday, after it announced compelling top-line results from its two pivotal Phase III trials of clascoterone.

The drug is a 5% topical solution for male androgenetic alopecia (AGA, also known as male-pattern hair loss), marking a potential first major therapeutic breakthrough in hair-loss treatment in more than three decades, Cosmo claimed.

Based on the findings, Cosmo said it is on track to complete the required 12 -month safety follow-up in spring 2026. On completion of the full dataset, Cosmo plans to promptly pursue parallel regulatory submissions in the USA and Europe. Clascoterone 5% topical solution is positioned to become the first topical androgen receptor inhibitor ever approved for AGA, subject to regulatory authorization.