Our history

Giovanni Di Napoli appointed as CEO; Alessandro Della Chà became Chairman. Executive leadership strengtehend by new Head of Global Business Development and Chief Financial Officer.

Achieved historically highest revenues of €267 million (+188% YoY) and operating profit of €149 million, driven by strong performance of GI Genius™ and Winlevi®, and expansion of the AI advanced endoscopy partnership with Medtronic.

Winlevi® surpassed 1.3 million prescriptions in the U.S.; launched in Australia and received regulatory approval in Singapore and New Zealand with submissions completed in 11 additional countries.

GI Genius™ Module 300 received FDA 510(k) clearance, enhancing AI-driven functionality and enabling integration with electronic medical records (EMRs).

Completed patient enrollment for the Phase III trial of clascoterone in male androgenetic alopecia. Continued clinical development in distal ulcerative colitis, bile acid diarrhea, and advanced solid tumors.

Announced Net Zero target by 2035, launching company-wide sustainability initiatives aligned with the Science-Based Targets initiative (SBTi).

Expanded partnership with Medtronic to advance AI-driven healthcare solutions, building on previous achievements in intelligent endoscopy.

Achieved debt-free status through full redemption of €175 million convertible bonds.

Submitted a new dermatology therapy for regulatory review to the European Medicines Agency (EMA).

Entered new global licensing agreements for dermatology and gastrointestinal therapies, expanding reach in the Middle East, North Africa, Europe, South Africa, and Korea.

Signed a license and supply agreement with Adalvo for a gastrointestinal product in multiple regions; concluded a previous agreement for the same product.

Initiated Phase III clinical trials for a treatment in androgenetic alopecia in males; received regulatory approvals for therapies in Japan and Canada; expanded agreements for a gastrointestinal imaging agent in China.

Maintained leadership in topical dermatology therapy prescriptions in the U.S.; expanded commercial partnerships in multiple international markets.

Reported U.S. clinical trial results showing significant reduction in missed colorectal polyps using AI-assisted endoscopy.

Recognized in Fortune’s ‘Change the World’ list for AI innovation in endoscopy.

Achieved growth in gastrointestinal therapy volumes and revenue in the U.S.; submitted a New Drug Application for a therapy in Japan.

Expanded distribution agreements for endoscopic injectables and imaging agents.

Reported positive Phase III trial results in China for a gastrointestinal imaging agent.

Announced positive Phase II clinical trial results for a gastrointestinal therapy in irritable bowel syndrome with diarrhea.

Licensed rights for a gastrointestinal imaging agent to a European partner.

Received FDA approval for an AI-powered endoscopy device.

Published clinical study results demonstrating reduced missed polyp rates with AI assistance.

Entered licensing and supply agreements for dermatology therapies in the U.S. and Canada.

Launched a dermatology therapy in the U.S.; completed acquisition of a dermatology company.

Sublicensed U.S. rights for a sedative therapy and acquired a stake in a partner company.

Announced positive results from a clinical study of an AI-powered endoscopy device.

Received regulatory approvals for AI-powered endoscopy and sedation therapies in multiple countries.

Received marketing authorization for a gastrointestinal antibiotic in Italy and for a gastrointestinal imaging agent in Europe.

Expanded licensing and supply agreements for gastrointestinal therapies in Asia.

Entered licensing agreement for a gastrointestinal antibiotic in the U.S.; signed partnership for AI-based endoscopy solutions.

Launched AI-based lesion detection product; began global validation partnership.

Entered new distribution agreements for endoscopic injectables.

Received Investigational New Drug acceptance for an oncology product.

NDA accepted for a sedative therapy; restructured U.S. operations.

Received regulatory approvals for endoscopic injectables in Canada and launched direct marketing for a gastrointestinal antibiotic.

Launched AI-powered endoscopy sales in Europe.

Received FDA approval for a gastrointestinal antibiotic for traveler’s diarrhea; European approval for a similar therapy.

Advanced clinical studies for gastrointestinal therapies.

Expanded licensing and supply agreements for multiple products and regions.

Completed a significant bond placement for financing.

NDA for a gastrointestinal imaging agent accepted by the FDA.

Built U.S. sales and marketing organization.

Launched endoscopic injectable in the U.S.; entered new distribution agreements.

Submitted NDA for a gastrointestinal antibiotic; filed for marketing authorization in Europe.

Completed clinical trials for sedative therapies; commenced new clinical trials for gastrointestinal therapies.

Raised additional capital through private placement; completed new manufacturing facility.

Achieved clinical endpoints in pivotal Phase III trials for gastrointestinal imaging and antibiotic therapies.

Established subsidiaries to support U.S. commercialization.

Invested in external innovation; received regulatory approvals for endoscopic injectables in Europe.

Transitioned company headquarters to the Netherlands and later Luxembourg.

Entered licensing agreement for a gastrointestinal therapy in Japan.

Spun off a dermatology company.

Changed company domicile to Luxembourg.

Shareholders approved change of seat to Luxembourg.

Announced positive Phase II results for an acne therapy.

Developed a new submucosal injectable for polyp removal.

Completed sale of remaining shares in a partner company.

Launched a gastrointestinal therapy in the U.S.

Received approval for a gastrointestinal therapy in the Netherlands.

NDA for a gastrointestinal therapy accepted by the FDA.

Filed for additional regulatory approvals in the U.S. and Europe.

Reported positive Phase II clinical trial results for a gastrointestinal imaging agent.

Filed NDA for a gastrointestinal therapy in the U.S.; filed for marketing authorization in the EU.

Reported positive clinical trial results for a gastrointestinal imaging agent.

Reported successful Phase III trial results for a gastrointestinal therapy in the U.S. and EU.

Completed acquisition of a biotechnology company.

Reported positive Phase II results for an acne therapy.

Announced public tender offer to acquire a biotechnology company.

Entered strategic collaborations and licensing agreements for gastrointestinal therapies.

Awarded U.S. patent for proprietary formulation technology.

Launched a gastrointestinal therapy in the UK and U.S. through licensing partners.

Completed IPO on the Swiss Stock Exchange.

Received FDA approval for tablet manufacturing for the U.S. market.

Completed expansion of manufacturing facilities in Milan.

Completed first major financing round.

Entered supply agreement for a gastrointestinal therapy.

Opened a new R&D laboratory in Italy.

Out-licensed a gastrointestinal therapy globally.

Filed first patent for proprietary formulation technology.

Adopted a strategy to develop novel oral formulations of established pharmaceuticals.

Founded through the acquisition of a manufacturing unit in Lainate (Milan).