Monitor the CUV105 top-line results expected in December 2026, which will provide the first controlled efficacy data for SCENESSE in vitiligo. Positive results could open a new commercial market beyond the current EPP indication.
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Executive Summary
Clinuvel Pharmaceuticals announced that new patient cases from its CUV105 trial of SCENESSE (afamelanotide) with NB-UVB phototherapy in vitiligo patients are being presented at the EADV conference. All three patients with Fitzpatrick skin types V and VI showed repigmentation, with spontaneous repigmentation continuing up to 24 weeks after treatment cessation. Top-line results from the CUV105 study are due in December 2026.
Key Facts
- Three vitiligo patients (Fitzpatrick skin types V and VI) treated with 7 SCENESSE implants and NB-UVB twice weekly for 20 weeks showed repigmentation
- Spontaneous repigmentation observed up to 24 weeks after cessation of therapy in all three participants
- Top-line results from the CUV105 study are due in December 2026
- Data presented at the European Academy of Dermatology and Venerology (EADV) conference in Vienna
Financial Impact
No financial data provided in the filing
Risk Factors
- Small sample size (3 patients) limits generalizability of these case results
- Vitiligo is not an approved indication for SCENESSE; regulatory pathway uncertain
- Top-line results still 2+ months away; interim case data may not predict final outcomes
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001493152-26-045210 |
| Document: form6-k.htm | 0001493152-26-045210 |
| Document: 0001493152-26-045210-index-headers.html | 0001493152-26-045210 |
| Document: 0001493152-26-045210-index.html | 0001493152-26-045210 |
| Document: 0001493152-26-045210.txt | 0001493152-26-045210 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 15, 2026 12d ago | 6-K | $5.06 | awaiting T+20 | — | $5.02 (−0.79%) |
Oct 7, 2026 20d ago | 6-K | $5.80 | awaiting T+20 | — | $5.02 (−13.45%) |
Oct 2, 2026 25d ago | 6-K | $6.03 | awaiting T+20 | — | $5.02 (−16.75%) |
Oct 1, 2026 26d ago | 6-K | $5.66 | awaiting T+20 | — | $5.02 (−11.31%) |
Aug 27, 2026 8w ago | 6-K | $6.77 $5.78 | ▼ −14.62% | ▼ −14.12% | $5.02 (−25.85%) |
Aug 27, 2026 8w ago | Press Release | $6.77 $5.78 | ▼ −14.62% | ▼ −14.12% | $5.02 (−25.85%) |
Aug 20, 2026 9w ago | 6-K | $7.80 $5.90 | ▼ −24.36% | ▼ −24.36% | $5.02 (−35.64%) |
Jul 23, 2026 13w ago | 6-K | $6.95 $7.80 | ▲ +12.23% | ▲ +8.92% | $5.02 (−27.77%) |
US Market Status
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