Dublin, Ireland–(Newsfile Corp. – April 29, 2025) – Following the recent CHMP opinion regarding the marketing authorization application for Winlevi® (clascoterone cream 1%) in Europe, Cosmo Pharmaceuticals N.V. (SIX: COPN) confirms that its financial guidance for 2025 remains unchanged.
While the company is disappointed by the opinion, it maintains strong confidence in the clinical profile of Winlevi® and its potential to address a significant unmet need in dermatology. The outcome of the CHMP opinion is not expected to have any material impact on the company’s current financial expectations.
The Cosmo team is already preparing the re-examination submission. The company remains fully committed to securing access to Winlevi® for patients in Europe.
Cosmo will provide updates as the re-examination process progresses.
About Cosmo
Cosmo Pharmaceuticals N.V. is committed to revolutionizing healthcare and transforming people’s lives by researching and developing innovative products that tackle unfulfilled healthcare demands. As a pharmaceutical company, Cosmo is active in the areas of Healthtech/AI, dermatology, gastroenterology and contract manufacturing & development. For the commercialization and distribution of its products, Cosmo collaborates with leading partners worldwide, including Medtronic and Sun Pharma. Founded in 1997, Cosmo is headquartered in Dublin (Ireland) and has offices also in San Diego (USA), and Lainate/Rome/Catania (Italy). The Company has approximately 330 employees at the end of 2024, all dedicated to making a significant impact in the field of healthcare. For more information, please visit www.cosmopharma.com.
Financial calendar
| Ordinary Annual General Meeting of Shareholders | May 30, 2025 |
| Jefferies Healthcare Conference, New York | June 3-5, 2025 |
| Investor Day, Zurich | July 1, 2025 |
| 2025 Half-Year Results and Report | July 23, 2025 |
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Disclaimer
Some of the statements in this press release may be forward-looking statements or statements of future expectations based on currently available information. Such statements are naturally subject to risks and uncertainties. Factors such as the development of general economic conditions, future market conditions, unusual catastrophic loss events, changes in the capital markets and other circumstances may cause the actual events or results to be materially different from those anticipated by such statements. Cosmo does not make any representation or warranty, express or implied, as to the accuracy, completeness or updated status of such statements. Therefore, in no case whatsoever will Cosmo and its affiliate companies be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages.
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