If Clinuvel achieves FDA approval for blockbuster indication Vitiligo, with their drug which is already FDA approved and safe, what does everyone think this will do to the share price? Vitiligo impacting 1 to 2% of the planet is a pretty big deal and Clinuvel with their unique drug that does not use immunosuppression with those side effects.
Vitiligo Phase 3 running, slated for FDA submission 2026, drug already FDA approved and SAFE for EPP. Vitiligo TAM mentioned $4.5 BILLION USD and 9% penetration years 1-2 giving $490 - $570 Million USD. Compelling pictures of treatment shown and lots of centres ready to go if/when approved (120 MINIMUM is the target I believe). Global Vitiligo expert panel assembled and Pearl Grimes on Clinuvel board. Chairman mentioned at AGM that Phase 3 recruitment was at 75% (maybe higher now?) and PW mentioned that by giving the control group the Clinuvel drug after they have done the trial is better because there is now double data from that trial. It seems they could well be submitting to the FDA just on this Phase 3 while another Phase 3 runs in the background (just in case) and so submission to FDA might surprise us?
Clinuvel could have a tanning/bronzing photo cosmetic on the market before Vitiligo approval - this would seem to be how they are going to achieve their 'household name' ambition by 2026 - so who knows how that holy grail product and widespread awareness of this little gem will impact the share price. However, ignoring that amazing possibility, just on Vitiligo approval and Clinuvel's estimates or less, what will that do to the share price? EPP is likely to be growing profits strongly at least until then and they will still have their market monopoly in EPP (and they are undervalued just on this little indication) and there are only 50 Million shares on issue (48.5 Million if they buy back 1.5 Million as stated) so it would seem there is a vast upside to CUV in just a couple of years. Throw in a few million open shorts to close out and progress in other indications like Stroke, XP, VP and even Parkinson's and things could become interesting at some point.
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Clinuvel price after NEXT FDA approval in blockbuster Vitiligo
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Last
$11.26 |
Change
0.460(4.26%) |
Mkt cap ! $558.8M |
Open | High | Low | Value | Volume |
$11.00 | $11.45 | $10.88 | $901.6K | 80.90K |
Buyers (Bids)
No. | Vol. | Price($) |
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5 | 124 | $11.24 |
Sellers (Offers)
Price($) | Vol. | No. |
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$11.27 | 113 | 8 |
View Market Depth
No. | Vol. | Price($) |
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5 | 461 | 11.310 |
3 | 203 | 11.300 |
4 | 370 | 11.290 |
4 | 270 | 11.280 |
3 | 235 | 11.270 |
Price($) | Vol. | No. |
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11.360 | 473 | 14 |
11.370 | 182 | 5 |
11.380 | 75 | 2 |
11.390 | 7 | 1 |
11.400 | 50 | 1 |
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