CUV
data caveat$443M—
Clinuvel Pharmaceuticals Limited
Biotechnology · Rare Disease
Global specialty pharma company with SCENESSE (afamelanotide) approved by FDA and EMA for erythropoietic protoporphyria, expanding into vitiligo and xeroderma pigmentosum.
Data HealthTrials1 of 1 active · stale enrollment
Cash data from Dec 2025 4CFigures from ASX filings · not financial advice
[ VITALS ]
Cash on Hand
$233.0M
Dec 2025 4C
Runway
—Based on Dec 2025 4C
Market Cap
$443M
Burn Rate
—
Dec 2025 4C
Shares Outstanding
50M
Pipeline Assets
5
Latest Insight(1)
12 Apr 2026substantial_holderChange in substantial holding
Changed·JPMorgan Chase & Co. and its affiliates·7.02%
3M Price
CUV.ASX$8.790-27.4% 3M
Low $8.790High $12.180
Pipeline Assets (5)
NEURACTHEL (ACTH analog)Neurological/Endocrinological disorders
PreclinicalSCENESSE (afamelanotide)Variegate Porphyria (CUV040)
Phase 2SCENESSE (afamelanotide)Xeroderma Pigmentosum (CUV801)
Phase 2SCENESSE (afamelanotide)Vitiligo (CUV105)
Phase 3SCENESSE (afamelanotide)Erythropoietic Protoporphyria (EPP)
ApprovedCapital Raises & Buybacks
show_chart
No capital raise or buyback data
Substantial Holders (5%+ threshold)
1 noticearrow_drop_upJPMorgan Chase & Co. and its affiliates
7.02%2026-04-08
Director Options & Rights
Director
Outstanding
Ex. Price
Expiry
No option data entered yet
Short Interest
ASIC ↗as of 2026-03-27 · 4-day lag
Short position
8.33%
Shares short
4.2M
Aggregated short position data published by ASIC under the Corporations Act. T+4 reporting lag applies. Short interest ≥5% is noteworthy; ≥10% is elevated. Source: ASIC Short Selling Data
Competitive Landscape
1 approved drug5 competitor trialsPhase 2+ · Non-ASX
Erythropoietic Protoporphyria (Epp)5 active trials
3 Ph31 Ph2/31 Ph2
Approved
Competitor trials from ClinicalTrials.gov (Phase 2+ historical, Phase 3+ refreshed weekly, active/recruiting, non-ASX sponsors). Approved drugs from OpenFDA (NDA/BLA only). Updated weekly via fetch_competitors.py.
expand_moreClinical Publications
Peer-reviewed papers & conference abstracts via PubMed
15 papers
Clinical Publications
Peer-reviewed papers & conference abstracts via PubMed
J Pharm Biomed Anal2026-05· afamelanotide
J Control Release2026-04· afamelanotide
Expert Opin Pharmacother2026-03· afamelanotide
Catalysts (27)· 5 upcoming · 22 past
NEURACTHEL EMA marketing authorization filing
UpcomingExpectedremoveMed30 June 2026
Health Canada SCENESSE approval (EPP)
UpcomingExpectedarrow_upwardHigh30 Sept 2026
CUV107 Phase III vitiligo trial initiation
UpcomingExpectedremoveMed31 Dec 2026
EMA filing for adolescent EPP label expansion
UpcomingExpected
Delivery Consistency Index
Historical delivery and spending consistency — data is limited for recently added companies.
Delivery Consistency Index
Delivery
–Insufficient data
0/3 data points needed
Timeline adherence · phase-adjusted tolerance · recency-weighted · min 3 catalysts
Capital discipline
–Insufficient data
1/2 data points needed
Burn rate stability · stage-adjusted thresholds · runway trend · R&D focus
Outcome quality (positive/negative readouts) reflects the science, not execution — shown above but excluded from the score.
These metrics reflect historical operational data only. They are not predictive of future performance, do not constitute investment advice, and should not be used as the basis for any investment decision.
⚠ TIMELINE CHANGESCT.GOV · AUTO-DETECTED
These changes were automatically detected by comparing ClinicalTrials.gov records over time. A slipped date means the trial's expected completion moved later; pulled forward means it moved earlier.
★ RESULTS
Clinical Trials(7)
1 activeClinicalTrials.gov ↗
Ph3Active Not RecruitingEnrollment stale · 924d
Afamelanotide and NB-UVB LightNB-UVB Light
A Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet (NB-UVB) Light Versus NB-UVB Light Alone in Patients With Vitiligo
Vitiligo
RandomizedOpen Label12 Years+
Primary endpoint Percentage of patients achieving T-VASI 50 on the body