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Cosmo Announces Breakthrough Phase III Topline Results from Scalp 1 and Scalp 2 for Clascoterone 5% Solution in Male Hair Loss, Showing up to 539% Relative Improvement in Target-Area Hair Count vs Placebo; US and EU Submissions are Underway
Ad hoc announcement pursuant to Art. 53 LR 1,465 patients were randomized into the two identical-in-design clinical studies Scalp 1 (NCT05910450) and Scalp 2 (NCT05914805) Both studies reached statistically significant endpoints in TAHC (Target-Area Hair Count), with one reaching 539% relative improvement to placebo and the second study reaching 168% relative improvement to placebo Positive safety profile demonstrated across both studies Positive safety profile...
About this update from Cosmo Pharmaceuticals Nv
[{"type":"text","content":"Ad hoc announcement pursuant to Art. 53 LR","length":42,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"1,465 patients were randomized into the two identical-in-design clinical studies Scalp 1 (NCT05910450) and Scalp 2 (NCT05914805)","length":128,"tagName":"p"}]},{"val":[{"type":"text","content":"Both studies reached statistically significant endpoints in TAHC (Target-Area Hair Count), with one reaching 539% relative improvement to placebo and the second study reaching 168% relative improvement to placebo","length":212,"tagName":"p"}]},{"val":[{"type":"text","content":"Positive safety profile demonstrated across both studies","length":56,"tagName":"p"}]},{"val":[{"type":"text","content":"Positive safety profile demonstrated across both studie Largest Phase III program ever conducted for a Topical Treatment for Male Androgenetic Alopecia (AGA)","length":157,"tagName":"p"}]},{"val":[{"type":"text","content":"First novel mechanism of action and first potential innovation in over 30 years in male hair loss","length":97,"tagName":"p"}]},{"val":[{"type":"text","content":"Preparations are underway for parallel regulatory submissions in the United States and Europe","length":93,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":743,"olType":false},{"type":"text","content":"Dublin, Ireland--(Newsfile Corp. - December 3, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN), a global leader in AI-powered healthcare and specialty pharma, today announced compelling topline results from its two pivotal Phase III trials of clascoterone 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.","length":458,"tagName":"p"},{"type":"text","content":"Across 1,465 patients enrolled in two identically designed Phase III studies conducted in the United States and Europe, clascoterone 5% solution delivered robust, statistically significant (p<0.05), and clinically meaningful improvements with a safety and tolerability profile comparable to the placebo vehicle. One study demonstrated a 5.39x (539 percent) relative improvement in Target-Area Hair Count (TAHC) versus vehicle, while the second study showed a 1.68x (168 percent) relative improvement. Treatment Emergent Adverse Eve...