Cosmo Pharmaceuticals Confirms Financial Guidance Following CHMP Opinion on Winlevi(R)
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.
Cosmo Pharmaceuticals ha confermato le previsioni finanziarie per il 2025 nonostante il parere negativo del CHMP su Winlevi® (crema clascoterone 1%) in Europa. L'azienda ha espresso delusione, sottolineando però che questo evento non influenzerà sostanzialmente le aspettative finanziarie per l'anno.
Punti chiave:
- L'azienda resta fiduciosa nel profilo clinico di Winlevi
- La direzione considera Winlevi una risposta a un bisogno importante e non soddisfatto in dermatologia
- Il team sta preparando una richiesta di riesame
- Rimane forte l'impegno per garantire l'accesso dei pazienti europei
L'azienda continuerà a fornire aggiornamenti durante il processo di riesame, mantenendo trasparenza con gli stakeholder.
Cosmo Pharmaceuticals ha mantenido sus previsiones financieras para 2025 a pesar de recibir una opinión negativa del CHMP sobre Winlevi® (crema de clascoterona al 1%) en Europa. La compañía expresó su decepción, pero enfatizó que este hecho no afectará de manera significativa sus expectativas financieras para el año.
Puntos clave:
- La empresa mantiene confianza en el perfil clínico de Winlevi
- La dirección ve a Winlevi como una solución para una necesidad importante no cubierta en dermatología
- El equipo está preparando una solicitud de reexamen
- El compromiso para asegurar el acceso de los pacientes europeos sigue siendo fuerte
La compañía continuará proporcionando actualizaciones durante el proceso de reexamen, manteniendo la transparencia con los interesados.
Cosmo Pharmaceuticals는 유럽에서 Winlevi® (클라스코테론 크림 1%)에 대해 CHMP의 부정적 의견을 받았음에도 불구하고 2025년 재무 전망을 유지했습니다. 회사는 실망을 표명했으나 이 사안이 연간 재무 기대에 실질적인 영향을 미치지 않을 것임을 강조했습니다.
주요 내용:
- 회사는 Winlevi의 임상 프로필에 대해 자신감을 유지하고 있습니다
- 경영진은 Winlevi가 피부과에서 중요한 미충족 수요를 해결한다고 보고 있습니다
- 팀은 재심사 제출을 준비 중입니다
- 유럽 환자 접근성 확보에 대한 의지는 강력합니다
회사는 재심사 과정 전반에 걸쳐 지속적으로 업데이트를 제공하며 이해관계자와의 투명성을 유지할 것입니다.
Cosmo Pharmaceuticals a maintenu ses prévisions financières pour 2025 malgré un avis négatif du CHMP concernant Winlevi® (crème de clascotérone à 1 %) en Europe. La société a exprimé sa déception, tout en soulignant que cette évolution n'aura pas d'impact significatif sur ses attentes financières annuelles.
Points clés :
- L'entreprise reste confiante dans le profil clinique de Winlevi
- La direction considère Winlevi comme une réponse à un besoin important non satisfait en dermatologie
- L'équipe prépare une demande de réexamen
- L'engagement à assurer l'accès des patients européens demeure fort
La société continuera de fournir des mises à jour tout au long du processus de réexamen, en maintenant la transparence avec les parties prenantes.
Cosmo Pharmaceuticals hat trotz einer negativen CHMP-Stellungnahme zu Winlevi® (Clascoteron-Creme 1 %) in Europa seine Finanzprognose für 2025 beibehalten. Das Unternehmen zeigte sich enttäuscht, betonte jedoch, dass diese Entwicklung die finanziellen Erwartungen für das Jahr nicht wesentlich beeinflussen werde.
Wichtige Punkte:
- Das Unternehmen bleibt vom klinischen Profil von Winlevi überzeugt
- Das Management sieht Winlevi als Antwort auf einen wichtigen ungedeckten Bedarf in der Dermatologie
- Das Team bereitet eine erneute Prüfungsanfrage vor
- Das Engagement für den Zugang europäischer Patienten bleibt stark
Das Unternehmen wird während des erneuten Prüfungsverfahrens weiterhin Updates bereitstellen und Transparenz gegenüber den Stakeholdern wahren.
- Financial guidance for 2025 remains unchanged despite setback
- No material impact expected on current financial expectations
- 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
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 |
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| Jefferies Healthcare Conference, New York | June 3-5, 2025 |
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| Investor Day, Zurich | July 1, 2025 |
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| 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.
Attachments
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FAQ
How does the CHMP opinion on Winlevi affect Cosmo Pharmaceuticals (CMOPF) 2025 guidance?
What is Cosmo Pharmaceuticals' next step after CHMP's opinion on Winlevi in Europe?
Will the CHMP opinion impact Winlevi's market potential for Cosmo Pharmaceuticals?
What is the current status of Winlevi's European marketing authorization application?
How is Cosmo Pharmaceuticals (CMOPF) responding to the European regulatory setback for Winlevi?
