Cosmo Pharmaceuticals Nv Stock Price, News & Analysis

Cosmo (OTC:CMOPF) reported topline Phase III results for clascoterone 5% topical solution in male androgenetic alopecia from two identically designed studies (total 1,465 patients) with statistically significant Target-Area Hair Count (TAHC) improvements of 5.39x (539%) and 1.68x (168%) versus vehicle.

Patient-reported outcomes were significant combined, safety and tolerability were comparable to vehicle, and Cosmo plans parallel US and EU regulatory submissions after completing a 12-month safety follow-up expected in spring 2026. Patent protection is stated through 2036 and the U.S. market opportunity was estimated above $20B.

Cosmo (OTC:CMOPF) announced that Brazil's ANVISA approved Winlevi (clascoterone) cream 1% for acne vulgaris in patients aged 12 years and older on November 14, 2025. The approval expands Winlevi availability to one of Latin America's largest dermatology markets and, together with Mexico, brings access to over 50% of the Latin American population. Sun Pharmaceutical will commercially launch Winlevi in Brazil. This marks the 13th territory where Winlevi has regulatory approval worldwide.

Winlevi is a first‑in‑class topical androgen receptor inhibitor that acts locally on sebaceous glands without systemic hormonal effects.

Cosmo Pharmaceuticals (OTC: CMOPF) announced ESG progress on November 11, 2025, reporting an upgraded S&P Global Corporate Sustainability Assessment score at the 67th percentile, up from last year’s 55th percentile. Cosmo SpA, the Group’s Italian manufacturing unit, earned an EcoVadis Bronze Medal with a 64/100 score and a ranking above 71% of rated companies. The company said it has partnered with EcoVadis to assess suppliers on environmental, social, ethical, and procurement criteria to boost supply-chain transparency and risk management. Cosmo affirmed alignment with TCFD and CSRD and plans to publish its 2025 ESG Report in early March 2026.

Cosmo (OTC: CMOPF) announced on November 3, 2025 that ColonPRO EU, its next‑generation AI software for colonoscopy, received CE certification, following prior FDA clearance. The platform has supported more than 4 million procedures worldwide and integrates four AI modules: real‑time polyp detection, characterization, sizing, and procedure quality assessment.

Key clinical performance claims include an 8.3 percentage‑point adenoma detection rate (ADR) improvement from COLO‑DETECT, a 9% reduction in false positives in the latest detector version, and METER study sizing accuracy of 85.8% with 90.8% correct surveillance‑interval assignments.

Cosmo Pharmaceuticals (CMOPF) announced that the European Commission approved Winlevi (clascoterone 1% cream) for treatment of acne vulgaris in adults and adolescents aged 12 to <18 years (adolescent use limited to facial application) on 21 October 2025, following a positive CHMP opinion on 25 August 2025.

Cosmo said it is preparing commercial launches across 20 European markets with its partners. Winlevi is described as a first-in-class topical androgen-receptor inhibitor that acts locally in sebaceous glands and has prior approvals in the United States, United Kingdom, Canada, Australia and several other countries.

Cosmo Pharmaceuticals (OTC:CMOPF) announced that South Korea's Ministry of Food and Drug Safety approved Winlevi (clascoterone) cream 1% for the treatment of acne vulgaris in patients aged 12 years and older on October 7, 2025. Under a June 2023 license agreement, Hyundai Pharm holds exclusive rights to register and commercialize Winlevi in South Korea while Cosmo remains the exclusive product supplier. Winlevi is now approved in 10 countries, expanding Cosmo's global dermatology footprint and commercial access.

Cosmo Pharmaceuticals (CMOPF) has received a positive CHMP opinion recommending European approval for Winlevi® (clascoterone 1% cream) for treating facial acne vulgaris in both adults and adolescents aged 12 to <18 years. This follows a successful re-examination of an initial negative opinion from April.

The approval marks a significant milestone as Winlevi® becomes the first-in-class topical anti-androgen therapy for Europe's largest acne treatment segment. The drug works by inhibiting androgen receptors in the skin, reducing sebum production and inflammation. The treatment is already approved in several markets including the United States, Canada, and the UK.

Cosmo is preparing to launch Winlevi® across 20 European markets, targeting a significant expansion of its addressable market, particularly in the adolescent population.

Cosmo Pharmaceuticals (OTC:CMOPF) has renewed its strategic manufacturing agreement with Takeda (NYSE:TAK) for the production of Mesalazine MMX 1200 mg, marketed as Lialda in the USA and Mezavant in Europe, for ulcerative colitis treatment.

The multi-year agreement will be executed at Cosmo's 18,000 m² manufacturing facility in Lainate, Italy, which is ISO 13485 certified and approved by multiple regulatory authorities worldwide. The facility has been supporting global pharmaceutical production for over 30 years.

This renewal aligns with Cosmo's Vision 2030 strategy to expand trusted partnerships and strengthen its Contract Development and Manufacturing Organization (CDMO) leadership globally.

Cosmo Pharmaceuticals (OTC:CMOPF) has addressed market concerns regarding potential U.S. tariffs on Swiss pharmaceutical companies, confirming that its operations and revenue streams remain unaffected. The company emphasized that it does not export products from Switzerland to the United States and operates through long-term contracts with global partners.

The company has reported increased EBITDA in its latest half-year results and maintains a positive outlook on its growth trajectory, supported by strong fundamentals and continued execution of its strategic plan.