Cosmo Enters Scale Up Phase with 104M Revenue, 128M Cash, and Breakout AI and Dermatology Platforms
Ad hoc announcement pursuant to Art. 53 LR 2025 marks a key execution year in Cosmo’s Vision 2030, strengthening the Company’s foundations for scalable, innovation-driven growth across AI-enabled MedTech and pharma. Financial Highlights: High quality growth: €104 million revenue at guidance midpoint (€102 to €107 million) with recurring revenues representing the majority of sales and accelerating year over year Strategic firepower: Year-end cash, cash equivalents and short-term investments...
2026-01-12 1:02 AM EST
Cosmo Announces Breakthrough Phase III Topline Results from Scalp 1 and Scalp 2 for Clascoterone 5% Solution in Male Hair Loss, Showing up to 539% Relative Improvement in Target-Area Hair Count vs Placebo; US and EU Submissions are Underway
Ad hoc announcement pursuant to Art. 53 LR 1,465 patients were randomized into the two identical-in-design clinical studies Scalp 1 (NCT05910450) and Scalp 2 (NCT05914805) Both studies reached statistically significant endpoints in TAHC (Target-Area Hair Count), with one reaching 539% relative improvement to placebo and the second study reaching 168% relative improvement to placebo Positive safety profile demonstrated across both studies Positive safety profile demonstrated across both studie...
2025-12-03 1:12 AM EST
Winlevi(R) Receives Regulatory Approval in Brazil - Expanding Global Access to a Breakthrough Acne Treatment
Dublin, Ireland--(Newsfile Corp. - November 14, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN), a global leader in AI-driven healthcare and dermatology innovations, today announced that the Brazilian Health Regulatory Agency (ANVISA) has approved Winlevi® (clascoterone) cream 1% for the treatment of acne vulgaris in patients aged twelve years and older. This milestone marks another key step in Cosmo’s mission to build health confidence worldwide, expanding access to its first-in-class topical...
2025-11-14 1:10 AM EST
Cosmo's ESG Rating Upgraded by S&P Global; Strengthens Supplier Sustainability Oversight Engagement, and Italian Manufacturing Plant Awarded EcoVadis Bronze Medal
Dublin, Ireland--(Newsfile Corp. - November 11, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN), a global leader in AI-powered healthcare and specialty pharma, today announced two major milestones in its sustainability journey, underscoring its commitment to transparency, responsible operations, and ESG leadership. Cosmo’s 2025 S&P Global Corporate Sustainability Assessment has been upgraded to the 67th percentile, a significant improvement from last year’s 55th percentile. This advancement...
2025-11-11 1:01 AM EST
Cosmo Receives CE Certification for ColonPRO EU - The Most Advanced AI Software Platform for Colonoscopy in Europe
Dublin, Ireland--(Newsfile Corp. - November 3, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN), a global leader in AI-powered healthcare and specialty pharma, today announced that ColonPRO EU, the Company’s next-generation artificial intelligence software for colonoscopy, has received CE certification. Following FDA clearance in the United States, this certification brings to Europe the most advanced AI-assisted colonoscopy platform ever developed. The system has already been used to support...
2025-11-03 12:59 AM EST
Cosmo Pharmaceuticals Receives Regulatory Approval by the European Commission for Winlevi(R) in the EU, Following on the Positive CHMP Opinion
Dublin, Ireland--(Newsfile Corp. - October 21, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN), a global leader in AI-powered healthcare and specialty pharma, today announced that the European Commission has granted regulatory approval in the EU for Winlevi® (clascoterone 1% cream) for the treatment of acne vulgaris in both adults and adolescents aged 12 to <18 years, with usage in adolescents limited to facial application. This formal approval came following on the positive recommendation for...
2025-10-21 1:36 AM EDT
Cosmo Pharmaceuticals Announces Regulatory Approval of Winlevi(R) in South Korea
Dublin, Ireland--(Newsfile Corp. - October 7, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN), a global leader in AI-driven healthcare and specialty pharmaceuticals, today announced that the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea has approved Winlevi® (clascoterone) cream 1% for the treatment of acne vulgaris in patients aged twelve years and older. This approval marks another important milestone in Cosmo’s global dermatology expansion and reinforces the Company’s...
2025-10-07 1:09 AM EDT
Cosmo Receives Positive CHMP Opinion for Winlevi(R) for Treatment of Acne in Adults and Adolescents, Following Successful Re-Examination
Dublin, Ireland--(Newsfile Corp. - August 27, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN), a global leader in AI-powered healthcare and specialty pharma, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending European approval of Winlevi® (clascoterone 1% cream) for the treatment of facial acne vulgaris in both adults and adolescents aged 12 to <18 years. The decision follows a successful...
2025-08-27 1:05 AM EDT
Cosmo and Takeda Renew Strategic Manufacturing Agreement for Global Supply of Oral Treatment for Ulcerative Colitis
Dublin, Ireland--(Newsfile Corp. - August 8, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN), a global leader in AI-driven healthcare and specialty pharmaceuticals, today announced the renewal of its multi-year manufacturing and supply agreement with Takeda (TSE: 4502) (NYSE: TAK), to produce Mesalazine MMX 1200 mg (marketed as Lialda® in the USA and as Mezavant in Europe) oral, once-daily treatment for ulcerative colitis, reinforcing its position as a trusted partner for global production of...
2025-08-08 1:18 AM EDT
Cosmo Pharmaceuticals Confirms No Exposure to Proposed U.S. Tariffs and Reaffirms Growth Momentum
Dublin, Ireland--(Newsfile Corp. - August 6, 2025) - Cosmo Pharmaceuticals N.V. (“Cosmo”) notes the recent market volatility following reports on potential U.S. tariffs on Swiss pharmaceutical companies. Cosmo confirms that its operations and revenue streams are not impacted by any potential U.S. tariff measures, as the Company does not export products from Switzerland to the United States and operates on long-term contracts with global partners. Cosmo remains confident in its growth...
2025-08-06 11:11 AM EDT
Cosmo Delivers Strong Performance in H1 2025, Raises Full-Year EBITDA Guidance and Accelerates Recurring Revenue Growth Across AI and Dermatology
Dublin, Ireland--(Newsfile Corp. - July 23, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN), a global leader in AI-powered healthcare and specialty pharma, today reported strong half-year results for 2025, underscoring the Company’s strategic execution, commercial momentum, and capital discipline across its key growth platforms. On the back of robust performance in H1 2025, Cosmo has raised its full-year EBITDA guidance by €4.5 million and reconfirmed its total
2025-07-23 1:09 AM EDT
Cosmo Announces Launch of Winlevi(R) for Treatment of Acne in Singapore and Malaysia
Dublin, Ireland--(Newsfile Corp. - July 17, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN), a global leader in AI-driven healthcare and specialty pharmaceuticals, is pleased to announce the launch of Winlevi® (clascoterone) cream 1% in Singapore and Malaysia, marking its first entry into Southeast Asia through the partnership with Hyphens Pharma International Limited (“Hyphens Pharma”). Winlevi® is a topical treatment for acne vulgaris in patients aged twelve years and older, marking a...
2025-07-17 1:11 AM EDT
Cosmo Accelerates Global ESG Leadership with Major Ratings Upgrades, UN Compact Commitment, and Climate Action Pledge
Dublin, Ireland--(Newsfile Corp. - July 16, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN), a global leader in AI-powered healthcare and specialty pharma, today announced a major leap forward in its sustainability journey, underscoring its ambition to lead the next decade of healthcare innovation with purpose, transparency, and impact. In the past year, Cosmo has taken bold steps to embed ESG into the core of its business. This has been delivering measurable results that now place the Company...
2025-07-16 1:08 AM EDT
Cosmo Unveils Bold 2030 Vision and Strategy; Launches AI-Driven Growth Phase at Investor Day 2025
Dublin, Ireland--(Newsfile Corp. - July 1, 2025) - Cosmo N.V. (SIX: COPN), a global leader in AI-driven healthcare and specialty pharmaceuticals, today announced its vision through 2030, along with a bold strategic plan, during its Investor Day event in Zurich. Hosted by CEO Giovanni Di Napoli, CFO Svetlana Sigalova, and members of Cosmo’s leadership team, the event brings together investors, analysts, and media for a deep dive into Cosmo’s growth strategy, innovative p
2025-07-01 1:09 AM EDT
Cosmo Announces Sale of "Digital Trust" in Strategic Portfolio Streamlining Move
Dublin, Ireland--(Newsfile Corp. - June 25, 2025) - Cosmo today announced the signing of an agreement to sell “Digital Trust” to its existing customer Tinexta InfoCert, Europe’s largest Certification Authority and a subsidiary of Tinexta S.p.A., a publicly listed company in Italy. The transaction is expected to close by the end of June 2025 and will generate €8.3 million in revenue for Cosmo. “Digital Trust” provides services within the digital security sector, offering IT solutions for...
2025-06-25 1:06 AM EDT
Cosmo to Unveil First-of-its-Kind Clinical Study on the Use of GI Genius(TM) with Apple Vision Pro at Rush University Medical Center
Dublin, Ireland--(Newsfile Corp. - June 24, 2025) - Cosmo Pharmaceuticals N.V. (“Cosmo”) today announced that in July 2025, it will initiate their first usability study of a medical device software application connecting the Medtronic GI Genius™ intelligent endoscopy module, an AI-powered platform for gastrointestinal endoscopy, with Apple Vision Pro. The study, to be conducted at Rush University Medical Center in Chicago under the leadership of Irving Waxman, MD, James R. Lowenstine...
2025-06-24 1:06 AM EDT
Voting Results of Cosmo's 2025 AGM
Dublin, Ireland--(Newsfile Corp. - May 30, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN) (FSE: C43) (“Cosmo”) announced that its shareholders approved all voting items at today’s Ordinary Annual General Meeting. A total of 9,135,061 ordinary shares of the share capital of Cosmo were represented at this general meeting of shareholders. These shares make up 52.07% of the total outstanding ordinary shares in the share capital of Cosmo as of the record date. Among others, the shareholders of...
2025-05-30 9:10 AM EDT
Cosmo Highlights Strategic AI and GI Innovation Agenda at Digestive Disease Week(R) 2025
Dublin, Ireland--(Newsfile Corp. - May 5, 2025) - Cosmo is attending this year’s Digestive Disease Week® (DDW), held in San Diego, California from May 3-6, where its leadership team is advancing a focused agenda of strategic meetings with key opinion leaders (KOLs), innovators, and potential partners in AI and gastrointestinal (GI) drug development. DDW is the world’s premier gathering in the field, attracting each year over 13,000 gastroenterologists, researchers, and industry leaders from...
2025-05-05 12:59 AM EDT
Cosmo Announces EU MDR Certification for Endovision's Cerebro, expanding its real-time AI ecosystem
Dublin, Ireland--(Newsfile Corp. - May 2, 2025) - Cosmo is excited to announce that Endovision Limited, a leading innovator in endoscopic imaging solutions, has received EU MDR certification[1] for Cerebro, a Real-Time AI-powered guide for complete Esophagogastroduodenoscopy (EGD) procedures. As one of the first Computer-Assisted Quality (CAQ) tools for endoscopy, Cerebro marks a significant step forward in transforming procedures by elevating inspection quality, standardizing protocols, and...
2025-05-02 1:08 AM EDT
Cosmo Pharmaceuticals Confirms Financial Guidance Following CHMP Opinion on Winlevi(R)
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...
2025-04-29 9:11 AM EDT