Cosmo Pharmaceuticals Nv Stock Price, News & Analysis

Cosmo (OTC:CMOPF) has announced the sale of its "Digital Trust" business to Tinexta InfoCert for €8.3 million. The transaction, expected to close by end of June 2025, involves the divestment of digital security services focused on identity protection and process dematerialization for healthcare organizations.

This strategic move is part of Cosmo's portfolio streamlining initiative, allowing the company to focus on core business areas including AI-powered medical devices, gastrointestinal therapeutics, dermatology, and high-value CDMO services. The company aims to strengthen its position as a focused, innovation-driven healthcare organization with global reach.

Cosmo Pharmaceuticals (OTC:CMOPF) has announced a groundbreaking clinical study integrating their GI Genius™ AI endoscopy module with Apple Vision Pro, set to begin in July 2025 at Rush University Medical Center. The first-of-its-kind usability study will evaluate a new software application that enables physicians to view AI-generated insights during live colonoscopy procedures through Apple Vision Pro.

The GI Genius™ system has demonstrated the ability to increase adenoma detection rates by 14.4%. The study results will support Cosmo's upcoming FDA submission. The technology is commercially distributed globally through Cosmo's partnership with Medtronic, their exclusive distributor since 2019.

Cosmo Pharmaceuticals announced successful voting results from its 2025 Annual General Meeting, with shareholders approving all items on the agenda. The meeting saw representation of 9,135,061 ordinary shares, constituting 52.07% of total outstanding shares. A key highlight was the approval of a €2.05 per share dividend, marking a 2.5% increase from the previous year. The dividend will be distributed with an ex-dividend date of June 4, 2025, and payment date of June 6, 2025. Chairman Alessandro Della Chà expressed gratitude for shareholders' trust, while CEO Giovanni Di Napoli announced an upcoming Investor Day scheduled for July 1 in Zurich to discuss ongoing and future projects.

Cosmo (CMOPF) is participating in Digestive Disease Week® (DDW) 2025 in San Diego, California from May 3-6. The company's leadership team is conducting strategic meetings with key opinion leaders, innovators, and potential partners in AI and gastrointestinal (GI) drug development. DDW, attracting over 13,000 gastroenterologists, researchers, and industry leaders annually, serves as a platform for Cosmo to advance its position in AI-powered endoscopy and GI therapeutics.

CEO Giovanni Di Napoli emphasized DDW's importance as the epicenter of GI innovation. The company has also convened its AI Advisory Board at the event to guide strategic priorities and accelerate development across its AI platform. Cosmo's participation demonstrates its commitment to advancing GI care through technology integration and strategic partnerships.

Cosmo (CMOPF) announces that Endovision Limited has received EU MDR certification for Cerebro, an AI-powered guide for Esophagogastroduodenoscopy (EGD) procedures. Cerebro will be distributed through the AI Access platform integrated into the Medtronic GI Genius endoscopy system. The software uses deep learning algorithms to analyze real-time endoscopic imaging across multiple modalities, highlighting anatomical landmarks and identifying quality issues during procedures. This expansion extends Cosmo's AI capabilities to the upper gastrointestinal tract, complementing their existing lower GI solutions. The system generates detailed photo documentation with coverage scores and procedural reports, developed in collaboration with the Chinese University of Hong Kong's Faculty of Medicine.

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 faces a setback as the European Medicines Agency's CHMP adopts a negative opinion on Winlevi (clascoterone cream 1%) for acne treatment. The decision primarily stems from concerns about the benefit-risk assessment in adolescents aged 12-17, despite positive results in adults over 18.

The company plans to request a re-examination, citing:

• Strong evidence from two multi-center, randomized, double-blind clinical trials
• Successful real-world usage, particularly in the United States
• No emerging safety concerns in hundreds of thousands of adolescent patients

Prof. Andrea Lania of Humanitas University expressed difficulty understanding the negative opinion given robust clinical data. CEO Giovanni Di Napoli voiced disappointment but remains confident in Winlevi's science, emphasizing their decision to maintain adolescent inclusion was based on data, not tactics. The company will continue engaging with EMA during the re-examination process.

Cosmo Pharmaceuticals has announced its Annual General Meeting (AGM) 2025, scheduled for May 30, 2025, at 12:00 CEST in Amsterdam, Netherlands. The meeting agenda includes several key items:

• Review of the Board's report for FY2024
• Approval of Annual Report 2024
• Proposed dividend distribution of €2.05 per ordinary share
• Board member discharge and elections
• Articles of association amendments

Chairman Alessandro Della Chà emphasized that the AGM will provide shareholders an opportunity to review achievements and discuss priorities for the ongoing year. The convening notice, explanatory notes, and written proxy have been published on the company's website, with the 2024 Annual Report available in the Financial Reports section.

Cosmo Pharmaceuticals (SIX: COPN, FSE: C43) has announced the appointment of Federico Sommariva as Chief Legal Counsel, reporting directly to the CEO and joining the management team. Sommariva brings extensive legal and management experience from the Lifesciences industry, most recently serving as Director and Global Legal Business Partner Oncology at Gilead Sciences in Milan since 2013. He also held the position of interim Head of Legal and Compliance for Gilead Sciences Romania for 1.5 years.

Sommariva, a University of Milan law graduate, began his career as Legal Counsel Secondee at H&M in Rome. CEO Giovanni Di Napoli expressed confidence that Sommariva's expertise in corporate law and industry knowledge will support the company's long-term growth and help navigate the evolving regulatory landscape.