COSMO Pharmaceuticals N.V. ( (CH:COPN) ) just unveiled an announcement.
Cosmo Pharmaceuticals has announced its intention to appeal a negative recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use regarding the marketing authorization of Winlevi® (Clascoterone Cream 1%) for treating acne vulgaris in Europe. The decision was based on a negative benefit-risk assessment for adolescents, despite positive results in adults. Cosmo argues that the assessment did not appropriately differentiate between these age groups and emphasizes the product’s established safety and efficacy in both clinical studies and real-world use, particularly in the USA. The company remains confident in Winlevi’s potential as a treatment option and plans to engage with the EMA to ensure broader access across Europe.
More about COSMO Pharmaceuticals N.V.
Cosmo Pharmaceuticals N.V. is a pharmaceutical company focused on revolutionizing healthcare through the development of innovative products addressing unmet needs in Healthtech/AI, Dermatology, and Gastroenterology. Founded in 1997, the company collaborates with global partners like Medtronic and Sun Pharma for product commercialization and distribution. Headquartered in Dublin, Ireland, with offices in the USA and Italy, Cosmo employs around 330 people.
YTD Price Performance: -25.38%
Average Trading Volume: 542
Technical Sentiment Signal: Buy
Current Market Cap: CHF802.3M
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