Clinuvel Pharmaceuticals (ASX:CUV) said its new drug submission to Health Canada for its photoprotective therapy Scenesse was validated and accepted for review ahead of the regulator's target validation window, according to a Monday filing with the Australian bourse.
Scenesse was designed to prevent phototoxicity in adult patients with erythropoietic protoporphyria an inherited metabolic disorder.
The submission is now under review by Health Canada's Health Products and Food Branch, which has a 300-day target to complete its evaluation and issue a marketing authorization decision, the filing said. A decision is expected by the fourth quarter of 2025.
Clinuvel Pharmaceuticals shares rose nearly 1% in morning trade Monday.
Price (AUD): $11.90, Change: $+0.11, Percent Change: +0.93%
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