Clinuvel Pharmaceuticals Ltd CUVL
Clinuvel Pharmaceuticals Ltd (Nasdaq: CUVL) is a dermatology drug developer. Its lead program, SCENESSE (afamelanotide), is in Phase 3 for Erythropoietic protoporphyria (EPP). Its next catalyst on record is SCENESSE vitiligo (CUV105): Topline results announcement (December 2026).
Upcoming catalysts
- December 2026SCENESSE vitiligo (CUV105) — Topline results announcement
Topline results are anticipated to be announced in December 2026, with a full analysis of the data expected to be completed before the end of fiscal 2027.
Next further out: SCENESSE adolescent EPP — EMA regulatory re-submission (H2 2026). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| SCENESSE (afamelanotide) | Erythropoietic protoporphyria (EPP) - adult | protein/peptide | Approved |
| SCENESSE (afamelanotide) | Vitiligo (darker skin types III-VI) | protein/peptide | Phase 3 |
| SCENESSE (afamelanotide) | EPP - adolescent patients (aged 12-17) | protein/peptide | Phase 2 |
| SCENESSE (afamelanotide) | Variegate porphyria | protein/peptide | Phase 2 |
| NEURACTHEL (ACTH) | Neurological/endocrinological disorders (infantile spasms, MS exacerbations) | protein/peptide | Pre-clinical |
| VLRX-L (liquid injectable controlled-release melanocortin platform) | Unmet medical needs (TBD) | protein/peptide | Pre-clinical |
| CYACÊLLE | PhotoCosmetic product (UV/HEV protection) | unclear | NA_NON_THERAPEUTIC |
Recent results and decisions
- Oct 30, 2026submitted CLINUVEL files marketing authorization dossier for NEURACTHEL® Instant with European regulators through decentralised procedure in three EU Member States.
CLINUVEL has filed a dossier for marketing authorisation of its second pharmaceutical product, NEURACTHEL® Instant (tetracosactide), with national European regulators as part of the European decentralised procedure (DCP).
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 dermatology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.