Cosmo Pharmaceuticals Confirms Financial Guidance Following CHMP Opinion on Winlevi(R)

Rhea-AI Summary

Cosmo Pharmaceuticals has maintained its 2025 financial guidance despite receiving a negative CHMP opinion for Winlevi® (clascoterone cream 1%) in Europe. The company expressed disappointment but emphasized that this development will not materially impact their financial expectations for the year.

Key points:

• Company remains confident in Winlevi's clinical profile
• Management sees Winlevi as addressing an important unmet need in dermatology
• Team is preparing a re-examination submission
• Commitment to securing European patient access remains strong

The company will continue to provide updates throughout the re-examination process, maintaining transparency with stakeholders.

Positive

• Financial guidance for 2025 remains unchanged despite setback
• No material impact expected on current financial expectations

Negative

• CHMP negative opinion for Winlevi marketing authorization in Europe
• Regulatory setback requiring re-examination submission
• Delayed European market entry for key product Winlevi

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

 

For further information, please contact:

investor.relations@cosmopharma.com

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.

Attachments

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To view the source version of this press release, please visit https://www.newsfilecorp.com/release/250117

FAQ

How does the CHMP opinion on Winlevi affect Cosmo Pharmaceuticals (CMOPF) 2025 guidance?

Cosmo Pharmaceuticals confirms that its 2025 financial guidance remains unchanged despite the CHMP opinion on Winlevi. The company states the opinion will not have any material impact on current financial expectations.

What is Cosmo Pharmaceuticals' next step after CHMP's opinion on Winlevi in Europe?

Cosmo Pharmaceuticals is preparing a re-examination submission for Winlevi and remains committed to securing access for European patients. The company will provide updates as the re-examination process continues.

Will the CHMP opinion impact Winlevi's market potential for Cosmo Pharmaceuticals?

While Cosmo Pharmaceuticals expresses disappointment with the CHMP opinion, they maintain strong confidence in Winlevi's clinical profile and its potential to address unmet dermatology needs.

What is the current status of Winlevi's European marketing authorization application?

The CHMP has issued an opinion regarding Winlevi's (clascoterone cream 1%) marketing authorization application in Europe, and Cosmo Pharmaceuticals is preparing for a re-examination submission.

How is Cosmo Pharmaceuticals (CMOPF) responding to the European regulatory setback for Winlevi?

Cosmo Pharmaceuticals is actively preparing a re-examination submission while maintaining their 2025 financial guidance, showing confidence in both their financial outlook and Winlevi's potential.