Welcome to our dedicated page for Cosmo Pharmaceuticals Nv news (Ticker: CMOPF), a resource for investors and traders seeking the latest updates and insights on Cosmo Pharmaceuticals Nv stock.
News for COSMO PHARMA NV ORD (CMOPF) centers on the activities of Cosmo Pharmaceuticals N.V., a life sciences company focused on MedTech AI, dermatology, gastrointestinal diseases, and CDMO. Company announcements highlight how Cosmo executes its Vision 2030 strategy, emphasizing recurring revenue growth, AI-enabled medical technologies, and global expansion of its dermatology and GI franchises.
Investors following CMOPF-related news can expect updates on GI Genius™ and the ColonPRO / ColonPRO EU AI platforms for colonoscopy, including regulatory milestones such as CE certification in Europe and clinical evidence from international trials. News also covers the evolution of GI Genius™ into a scalable AI platform, deployment across clinical sites, and initiatives such as spatial-computing usability studies that integrate AI endoscopy modules with advanced visualization devices.
Dermatology news frequently focuses on Winlevi® and clascoterone 5% topical solution. Releases describe new regulatory approvals for Winlevi® in regions including the European Union, South Korea, Brazil, and other territories, as well as commercialization through partners. For clascoterone 5% solution in male androgenetic alopecia, news has detailed Phase III topline results, patient-reported outcomes, safety data, and plans for regulatory submissions in the United States and Europe.
Additional updates include progress in clinical programs for bile acid diarrhea and distal ulcerative colitis, renewal of manufacturing agreements such as the multi-year supply arrangement with Takeda for Mesalazine MMX 1200 mg, and financial communications on revenue mix, recurring revenue trends, and cash position. Bookmark this page to monitor regulatory events, clinical milestones, partnership announcements, and financial disclosures that relate to CMOPF and Cosmo Pharmaceuticals’ multi-platform growth strategy.
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.
Cosmo Pharmaceuticals (OTC:CMOPF), a leader in AI-powered healthcare and specialty pharma, reported strong H1 2025 results and raised its EBITDA guidance by €4.5 million. The company achieved total revenues of €51.7 million, including €41.9 million in recurring revenues.
Key growth drivers include GI Genius™ recurring revenues up 128% YoY and Winlevi® recurring revenues up 23% YoY. The company maintains a strong financial position with €133.3 million in cash and investments. Updated FY2025 guidance projects total revenues of €102-107 million and EBITDA of €5.5-7.5 million.
Operating expenses were controlled with R&D at €18.0 million (-6% YoY) and SG&A at €14.3 million (-13% YoY). The company operates across four strategic platforms: AI-powered MedTech, Dermatology, GI innovation, and CDMO services.
Cosmo Pharmaceuticals (OTC:CMOPF) has launched Winlevi® (clascoterone) cream 1% in Singapore and Malaysia through its partnership with Hyphens Pharma, marking its first entry into Southeast Asia. Winlevi® is the first topical androgen receptor inhibitor for acne treatment in over 40 years, approved for patients aged 12 and older.
The treatment demonstrated superior efficacy in two Phase III studies, showing significant improvements in both non-inflammatory and inflammatory lesion counts. Hyphens Pharma has in-licensed the product for distribution across ten Southeast Asian countries, with progressive rollout planned for other markets in the region.
This launch aligns with Cosmo's 2030 vision for sustainable revenue growth through geographic expansion, addressing a market where acne affects over 90% of the population at some point in their lives.
Cosmo Pharmaceuticals (OTC:CMOPF), a global AI-powered healthcare and specialty pharma company, has announced significant progress in its ESG initiatives. The company achieved an MSCI ESG rating upgrade from "BBB" to "A" and saw its LSEG ESG score double to 62.98, ranking #42 globally among peers.
Key developments include becoming a signatory to the UN Global Compact and committing to the Science Based Targets initiative (SBTi) for emissions reduction. These achievements align with Cosmo's Vision 2030 strategy, positioning the company to attract investments from ESG-focused funds, particularly those aligned with SFDR Articles 8 and 9.
Cosmo N.V. (SIX: COPN) unveiled its ambitious 2030 vision and strategic roadmap during its Investor Day 2025 in Zurich. The company aims to achieve €480 million in recurring revenues by 2030, representing a five-year CAGR of 39%, with €260 million expected from core business and €220 million from late-stage assets and Digital AI platforms.
The company targets an EBITDA of €195 million by 2030, representing a 40% margin. The core business growth (23% CAGR) will be driven by the expansion of GI Genius™ platform, global adoption of Winlevi®, and stable growth from Gastroenterology and CDMO businesses.
The Investor Day event featured presentations on the company's strategic roadmap across Medtech AI, Dermatology, Gastro, and CDMO franchises, along with insights from KOLs and technology demonstrations. Cosmo also revealed its refreshed corporate identity, positioning itself as a digitally native, patient-impact-focused company.