Post by StockWire X

CLINUVEL PHARMACEUTICALS LTD secures Health Canada approval for SCENESSE®, marking the fourth global market to authorise the world's only approved therapy for erythropoietic protoporphyria (EPP). The Notice of Compliance, announced on 13 July 2026, grants marketing authorisation for SCENESSE® (afamelanotide 16mg) to prevent phototoxicity in adult EPP patients — a rare metabolic disorder causing debilitating reactions to visible light. 📋 Approval Highlights: 🔹 Fourth market authorised following Europe (2014), U.S.A. (2019) and Australia (2020) 🔹 Five accredited Canadian Centers already trained and treating EPP patients under special access 🔹 Over 21,000 doses administered globally with patients receiving up to 20 years of continuous therapy 🔹 Only EPP treatment worldwide to receive marketing authorisation from any regulatory body 🔹 CLINUVEL maintains $233 million cash with 9.5 consecutive years of profitability Chief Scientific Officer Dr Dennis Wright stated: "Data from our global programs – including considerable data from postmarketing experience – were used to demonstrate the safety and clinical benefit of SCENESSE® in EPP, where the mechanism of action is well understood. The major benefit of the drug is its proven long-term and consistent safety profile. Other drugs in development for EPP lack these data." The approval extends SCENESSE®'s commercial footprint into a market where treatment infrastructure through North American Specialty Centers is already operational, connecting an estimated 1 in 140,000 Canadians affected by EPP to the therapy. Found this insightful? Hit 'like' and follow for updates on CLINUVEL's market expansion and SCENESSE® commercialisation across authorised markets. 🔗 Read the full regulatory analysis and market positioning breakdown: https://lnkd.in/g5NbWTiU