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%...
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,...
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...
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...
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....
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...
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...
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...
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 ...
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
Investors Call today at 2 pm CET. Dublin, Ireland--(Newsfile Corp....
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...
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...
2025-07-16 1:08 AM EDT
Cosmo Unveils Bold 2030 Vision and Strategy; Launches AI-Driven Growth Phase at Investor Day 2025
AI-driven growth and innovation.Dublin, Ireland--(Newsfile Corp. - July 1, 2025) - Cosmo N.V. (SIX: COPN), a global leader in AI-driven healthcare and specialty ...
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. ...
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...
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...
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...
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...
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...
2025-04-29 9:11 AM EDT
Cosmo Receives Negative CHMP Opinion on Winlevi(R) (clascoterone Cream 1%) in Europe and Will Appeal the Decision
Ad hoc announcement pursuant to Art. 53 LR Dublin, Ireland--(Newsfile Corp. - April 29, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN) announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a negative opinion on the marketing authorization application (MAA) for Winlevi® (clascoterone cream 1%) for the treatment...
2025-04-29 1:25 AM EDT