A lot to unpack there, I think the main thing for now is that the blockbuster Phase 3 into Vitiligo seems to be tracking well. The recruitment completion for CUV105 in Oct 24 was stated. FDA submission in 2 years 2026 stated. Vitiligo TAM mentioned $4.5 BILLION USD and 9% penetration years 1-2 giving $490 - $570 Million USD. Compelling evidence of the effectiveness of Clinuvel treatment of Vitiligo shown and very supportive statements from experts. I think standard of care very likely and the beautiful thing is the drug is already FDA approved so safety very well established and the path to approval much easier.
Clinuvel know the share price has been manipulated by shorters and that is why they initiated the share buyback. At these levels nothing is priced in except for EPP and everything else you get for free. Average analyst PT is mid $20s just for EPP and only one analyst is pricing in Vitiligo right now and they have a PT around $50, so when will other analysts start to price in the blockbuster which is in Phase 3 right now and slated for FDA submission in 2 years? Also on EPP the MT competitor drug was mentioned in the presentation about how it failed to meet primary endpoint and compassionate use has been discontinued - this would appear to indicate a largish pool of EPP patients actively seeking treatment are now available for recruiting for the very effective Clinuvel drug. Might be some good growth in EPP to come especially if they get the paediatric approval.
All IMO DYOR
CUV Price at posting:
$15.12 Sentiment: Buy Disclosure: Held
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