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CLINUVEL PHARMACEUTICALS LIMITED — Investor Relations & Filings

Ticker · CUV ISIN · AU000000CUV3 LEI · 5299004VJH3VCYLK6519 ASX Manufacturing
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Filings indexed 1,252 across all filing types
Latest filing 2026-05-06 Regulatory Filings
Country AU Australia
Listing ASX CUV

About CLINUVEL PHARMACEUTICALS LIMITED

https://www.clinuvel.com

CLINUVEL PHARMACEUTICALS LIMITED is a biopharmaceutical company focused on developing and commercializing treatments for severe genetic, metabolic, and life-threatening disorders. The company’s lead product, SCENESSE (afamelanotide 16mg), is a first-in-class systemic photoprotective agent designed to prevent phototoxicity in adult patients with erythropoietic protoporphyria (EPP). By mimicking the naturally occurring alpha-melanocyte stimulating hormone (α-MSH), the therapy stimulates melanin production to provide a biological barrier against ultraviolet and visible light. Beyond EPP, the company is expanding its clinical pipeline to address conditions such as vitiligo, arterial ischaemic stroke, and xeroderma pigmentosum. CLINUVEL maintains a specialized focus on melanocortins and their role in protecting the skin and central nervous system from oxidative stress and DNA damage.

Recent filings

Filing Released Lang Actions
Notification regarding unquoted securities - CUV 6 pages 19.5KB
Regulatory Filings
2026-05-06 English
CLINUVEL update on Level II ADR upgrade, Nasdaq uplist 2 pages 74.5KB
Regulatory Filings
2026-04-27 English
FDA relaxes SCENESSE postmarketing requirement 2 pages 112.1KB
Regulatory Filings Classification · 85% confidence The document is an ASX announcement regarding the FDA’s regulatory decision to remove a postmarketing QT study requirement for CLINUVEL’s drug SCENESSE®. It is not an earnings release, management report, capital raising, or board change. Rather, it is a regulatory update/announcement. It does not constitute a full report or investor presentation but a general regulatory filing to the market. Therefore, it falls under the catch-all “Regulatory Filings” category.
2026-04-26 English
Final EMA scientific advice for pivotal Phase III vitiligo 3 pages 121.7KB
Regulatory Filings Classification · 75% confidence The document is an ASX announcement describing CLINUVEL’s receipt of final EMA scientific advice on its Phase III vitiligo study. It is not a full report (annual, interim, audit, etc.), nor an investor presentation, proxy statement, or dividend notice. It constitutes a general regulatory announcement to the exchange and does not fit any more specific category, so it defaults to Regulatory Filings (RNS).
2026-04-23 English
Notification of cessation of securities - CUV 4 pages 14.7KB
Share Issue/Capital Change Classification · 75% confidence The document is an ASX Appendix 3H form notifying the cessation (lapse) of unquoted performance rights and the resulting change in the entity’s issued capital. It is not an earnings release, AGM material, management change, or legal notice, but specifically a capital change announcement. Therefore it falls under Share Issue/Capital Change (Code: SHA).
2026-04-16 English
Change in substantial holding 35 pages 2.1MB
Major Shareholding Notification Classification · 100% confidence The document is titled 'Form 604' and references the Corporations Act 2001, Section 671B, which pertains to notices of change of interests of substantial holders. The content details changes in voting power, relevant interests, and transactions of a substantial shareholder (JPMorgan Chase & Co. and affiliates) in CLINUVEL PHARMACEUTICALS LTD. It includes detailed tables of shareholdings, changes, and associations, consistent with a substantial holding notification. There is no indication of financial statements, earnings data, management commentary, or other report types. This document is a notification of a major shareholding change, specifically a substantial holder notice under Australian law.
2026-04-12 English

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