Cosmo Pharmaceuticals Nv Stock Price, News & Analysis

Cosmo Pharmaceuticals (OTC: CMOPF) announced ESG progress on November 11, 2025, reporting an upgraded S&P Global Corporate Sustainability Assessment score at the 67th percentile, up from last year’s 55th percentile. Cosmo SpA, the Group’s Italian manufacturing unit, earned an EcoVadis Bronze Medal with a 64/100 score and a ranking above 71% of rated companies. The company said it has partnered with EcoVadis to assess suppliers on environmental, social, ethical, and procurement criteria to boost supply-chain transparency and risk management. Cosmo affirmed alignment with TCFD and CSRD and plans to publish its 2025 ESG Report in early March 2026.

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.