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Clinuvel Pharmaceuticals Announces On FDA Granting Marketing Approval For SCENESSE

09 Oct 2019  |  09:52:00  |  Associate analysts  |  Increase  |  Decrease  |  

Original announcement: FDA Grants Marketing Approval for SCENESSE

Clinuvel Pharmaceuticals announced the US Food and Drug Administration (FDA) has granted marketing approval to use SCENESSE (afamelanotide 16mg) for the treatment of EPP patients in the US. With the approved New Drug Application (NDA), SCENESSE is the first global systemic photoprotective drug for the treatment of patients with EPP. SCENESSE acts as a potent anti-oxidative and melanogenic agent providing pandermal (total surface) photoprotection. The Company will host an investor and analyst teleconference on 9 October 2019 to discuss the decision and its implications.

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