Shares in Clinuvel Pharmaceuticals Limited (ASX: CUV) surged 14% to $12.15 on Monday, as the company advanced its plans to launch its flagship product in the USA.
Clinuvel is a small-cap biopharmaceutical company, specialised in skin disorders. Its main product is Scenesse, a photoprotective drug used to treat a rare condition known as EPP.
The medicine has already received marketing authorisation in the EU. Today, Clinuvel announced an application to the United States Food and Drug Administration (FDA) for the use of Scenesse as the first proposed therapy for patients with EPP in the USA. The FDA may provide a response as soon as early 2019.
In the first half of FY18, Clinuvel had revenue of just $7 million, enough to generate positive cash flows and NPAT of $1.4 million. The stock trades at a sky-high P/E ratio of 100.
Receiving marketing authorisation in the USA would significantly boost Clinuvel’s revenue base, but the real game changer for the company would be the adoption of Scenesse in the treatment of other skin disorders. The medicine is being tested for vitiligo, a rather common condition causing depigmented patches of skin.
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Motley Fool contributor Tommaso Autorino has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.