Clinuvel Unlikely to Seek Scenesse's Vitiligo Approval Before Phase 3 Completion, Says Jefferies

MT Newswires Live08:14

Clinuvel Pharmaceuticals (ASX:CUV) is unlikely to seek regulatory approval for Scenesse in vitiligo until the Phase 3 CUV105 and CUV107 clinical trials are completed, according to a Friday Jefferies note.

The company said on Friday that the European Medicines Agency (EMA) has proposed evaluating the company's Scenesse drug for the treatment of systemic vitiligo based on a "totality of evidence" regulatory approach.

Jefferies said that the EMA's decision is a positive for the company because of the high unmet medical need for Vitiligo treatment.

The investment firm has pushed back its revenue expectations from Scenesse in vitiligo, which is now expected to begin in the second half of fiscal 2029 rather than fiscal 2028.

Jefferies kept a buy rating on Clinuvel and cut its price target to AU$39.20 from AU$40.50.

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