CUV
data caveat$442M—
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 4C(5mo old)Figures from ASX filings · not financial advice
[ VITALS ]
Cash on Hand
$233.0M
Dec 2025 4C
Runway
—Based on Dec 2025 4C
Market Cap
$442M
Burn Rate
—
Dec 2025 4C
Shares Outstanding
50M
Pipeline Assets
5
Latest Insightprice-sensitive announcements & broker notes
Price-sensitiveRegulatory26 Apr 2026
FDA relaxes SCENESSE postmarketing requirement
The FDA has removed a postmarketing requirement for a cardiac repolarization (QT) study for SCENESSE, determining it would no longer provide useful safety information based on the drug's established long-term safety profile. This reflects the FDA's recognition of extensive safety data submitted by CLINUVEL since SCENESSE received marketing authorization in October 2019.
FDA·Erythropoietic protoporphyria (EPP)·positive
3M Price
CUV.ASX$8.720-13.9% 3M
Low $8.720High $10.130
Capital Raises & Buybacks
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No capital raise or buyback data
Other ticker dataInsider activity, holders, grants, publications
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Insider activity, holders, grants, publications
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 2026-05-28 · 4-day lag
Short position
9.37%
arrow_drop_up+1.04% over 7 reports
Shares short
4.7M
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
Catalysts (29)· 5 upcoming · 24 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
Track RecordDelivery Consistency Index
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Delivery Consistency Index
Historical delivery and spending consistency. Data is limited for recently added companies.
Delivery Consistency Index
Delivery
–Insufficient data
2/3 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
Hit 2 of 2 guided dates· rolling 2yr(limited sample)· of 29 tracked
Completed catalysts
✓Final EMA scientific advice for pivotal Phase III vitiligo· readout — subject to clinical uncertainty— The EMA has issued final scientific advice recommending a 'totality of evidence' approach for evaluating SCENESSE® in vitiligo, with T-VASI50 as the primary endpoint and F-VASI75 as a secondary endpoint. The EMA highlighted that patients with darker skin tones (Fitzpatrick IV-VI) would be the first to benefit from systemic treatment. The pivotal Phase III CUV107 study (n=300) comparing SCENESSE® with adjunct NB-UVB versus NB-UVB monotherapy is planned to commence in 2H 2026.
On time
✓SCENESSE (afamelanotide) FDA — FDA relaxes SCENESSE postmarketing requirement— The FDA has removed a postmarketing requirement for a cardiac repolarization (QT) study for SCENESSE, determining it would no longer provide useful safety information based on the drug's established long-term safety profile. This reflects the FDA's recognition of extensive safety data submitted by CLINUVEL since SCENESSE received marketing authorization in October 2019.
On time
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.
Clinical Trials(7)
1 activeClinicalTrials.gov ↗
Ph3Active Not RecruitingEnrollment stale · 973d
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
ENROL200
no manual snapshots — enter via record_enrollment.py
Announcements(15)
verified
RegulatoryPSauto_awesome
FDA relaxes SCENESSE postmarketing requirement26 Apr 2026
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