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Clinuvel Pharmaceuticals ( (AU:CUV) ) just unveiled an update.
CLINUVEL Pharmaceuticals announced that Health Canada has requested additional time and information to complete its review of SCENESSE® for treating erythropoietic protoporphyria (EPP), extending the review into 2026. Despite the delay, Canadian patients continue to receive treatment under the Special Access Program, and the company remains committed to addressing Health Canada’s requests. This development highlights the challenges in gaining regulatory approval in new markets, potentially impacting Canadian patients’ access to the treatment.
The most recent analyst rating on (AU:CUV) stock is a Buy with a A$32.84 price target. To see the full list of analyst forecasts on Clinuvel Pharmaceuticals stock, see the AU:CUV Stock Forecast page.
More about Clinuvel Pharmaceuticals
CLINUVEL PHARMACEUTICALS LIMITED is a global specialty pharmaceutical group focused on developing and commercializing treatments for patients with genetic, metabolic, systemic, and life-threatening acute disorders. The company is a pioneer in photomedicine and melanocortin peptides, with its lead therapy, SCENESSE®, approved for systemic photoprotection in Europe, the USA, Israel, and Australia. Headquartered in Melbourne, Australia, CLINUVEL operates in Europe, Singapore, and the USA.
Average Trading Volume: 145,748
Technical Sentiment Signal: Sell
Current Market Cap: A$610.9M
For an in-depth examination of CUV stock, go to TipRanks’ Overview page.