Clinuvel Pharmaceuticals Limited (AU:CUV) has released an update.
Clinuvel Pharmaceuticals Limited has announced that its drug SCENESSE® (afamelanotide) received a positive opinion from the European Medicines Agency for an orphan drug designation to treat variegate porphyria (VP), a rare genetic disorder. This designation could extend SCENESSE®’s current label and offers ten years of market exclusivity in the European Union, acknowledging the drug’s potential to address the unmet medical need in VP treatment. The company previously obtained approval from the US FDA for the same drug in 2016, highlighting its ongoing commitment to addressing rare and severe disorders.
For further insights into AU:CUV stock, check out TipRanks’ Stock Analysis page.
