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Clinuvel reports repigmentation in 3 vitiligo cases

Two cases were new and one had been presented previously, with follow-up extending up to 24 weeks after treatment.

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Form Type
6-K

Rhea-AI Filing Summary

Clinuvel Pharmaceuticals Ltd announced that three CUV105 vitiligo cases are being presented at EADV, with all participants showing follicular repigmentation after SCENESSE® and adjunct narrowband ultraviolet B (NB-UVB) phototherapy. Two cases were new, and one had been presented previously. The participants completed seven SCENESSE® implants and NB-UVB twice weekly for 20 weeks, with up to 41 sessions, then were followed for up to 24 weeks after therapy ended. Clinuvel reported treatment was well tolerated and spontaneous repigmentation was observed in all three participants during follow-up. Top-line CUV105 results are due in December 2026.

Participants 3 participants Adult vitiligo cases from CUV105
New cases 2 cases Two new cases and one previously presented case
SCENESSE® implants 7 implants Treatment described for the participants
Treatment duration 20 weeks NB-UVB was given twice a week
NB-UVB sessions Up to 41 sessions Treatment protocol
Follow-up Up to 24 weeks After cessation of therapy
CUV105 top-line results December 2026 Expected timing stated by the company
narrowband ultraviolet B (NB-UVB) phototherapy medical
"adjunct narrowband ultraviolet B (NB-UVB) phototherapy"
follicular repigmentation medical
"follicular repigmentation (initial response)"
Fitzpatrick skin types medical
"Fitzpatrick skin types V and VI"
A six-category system that classifies human skin by how it reacts to ultraviolet light, ranging from very fair skin that always burns to very dark skin that rarely burns. Think of it like a numerical label for how likely skin is to burn or tan when exposed to sun. Investors encounter it in dermatology, cosmetics, sunscreen regulation, and clinical trials because it guides product testing, safety claims, labeling, and market targeting.
confluence medical
"reaching confluence (advanced repigmentation)"

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did CUVL report from the CUV105 vitiligo cases?
Clinuvel reported that all three participants showed follicular repigmentation after SCENESSE® and adjunct NB-UVB phototherapy. Spontaneous repigmentation was also noted in all three during follow-up for up to 24 weeks after treatment ended.

When are CUVL's CUV105 top-line results due?
Top-line results from CUV105 are due in December 2026.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of October 2026

 

Commission File Number: 001-43353

 

CLINUVEL PHARMACEUTICALS LIMITED

 

Level 22, 535 Bourke Street

Melbourne, VIC 3000

Australia

(Address of principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

 

Form 20-F ☒ Form 40-F ☐

 

 

 

 

 

 

INFORMATION CONTAINED IN THIS FORM 6-K REPORT

 

On October 1, 2026, Clinuvel Pharmaceuticals Limited filed with the Australian Securities Exchange an announcement captioned “SCENESSE® response in vitiligo: new cases from the CUV105 trial presented to EADV”, a copy of which announcement is attached to this Form 6-K as Exhibit 99.1.

 

Exhibits

 

Exhibit No.   Description
     
99.1   Press release dated October 1, 2026

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  CLINUVEL PHARMACEUTICALS LIMITED
     
Date: October 1, 2026 By: /s/ Philippe Wolgen
  Name: Philippe Wolgen
  Title: Managing Director and Chief Executive Officer

 

 

 

 

Exhibit 99.1

 

 

SCENESSE® response in vitiligo: new cases from the CUV105 trial presented to EADV

 

Melbourne / Singapore – 1 October 2026 – CLINUVEL PHARMACEUTICALS LTD (ASX: CUV | Nasdaq: CUVL) today announced that new patient cases demonstrating the clinical response to SCENESSE® (afamelanotide) with adjunct narrowband ultraviolet B (NB-UVB) phototherapy in vitiligo patients are being presented to the European Academy of Dermatology and Venerology (EADV) conference in Vienna.

 

Treatment effect in three adult patients

 

Two new cases, from study sites in Kenya and the U.S.A., and one previously presented from Kenya, completed treatment of seven SCENESSE® and NB-UVB twice a week for 20 weeks (up to 41 sessions), and were followed up to 24 weeks after cessation of therapy.

 

All three participants, with Fitzpatrick skin types V and VI, responded to the treatment, i.e. follicular repigmentation (initial response) was observed within the lesions, with areas on the body and face either reaching confluence (advanced repigmentation) or homogeneity (complete blending in of pigmentation) at the end of the treatment. Treatment was well tolerated.

 

As previously reported from the CUV105 study, spontaneous repigmentation for up to 24 weeks after completing the treatment, and without further intervention, was noted in all three participants, along with maintenance of repigmentation. Top line results from the CUV105 study are due in December 2026.

 

Commentary

 

“Across all cases from CUV105 shared publicly to date we see progressive repigmentation over 20 weeks in response to treatment with afamelanotide and adjunctive NB-UVB,” said Dr Emilie Rodenburger, CLINUVEL’s Director Global Clinical Affairs.

 

“In these three patients, despite different degrees of responses at the end of the treatment, it is encouraging to observe spontaneous repigmentation up to the last study visit, six months after completing the therapy.

 

“Our teams are still working on data collection from the study. In the interim, we look forward to feedback from the EADV meeting to understand expert responses to these latest cases.”

 

Case Study 1 (U.S.A.)

 

52 year-old female | Fitzpatrick Skin Type VI | Vitiligo diagnosed in 2021
Progressive disease | No family history of vitiligo

 

  After 7 implants   At follow-up
Baseline    34 NB-UVB sessions   No further treatment
         
   

 

ASX Announcement

PAGE 1 OF 4

 

 

  After 7 implants   At follow-up
Baseline    34 NB-UVB sessions   No further treatment
         
   
         
   

 

Follicular response with some confluence is seen following treatment on the participant’s anterior arms, thighs, and abdomen. Spontaneous repigmentation with further confluence is observed after cessation of therapy. Participant is progressively returning to baseline skin colour at the time of assessment.

 

Case Study 2 (Kenya)

 

38 year-old female | Fitzpatrick Skin Type V | Vitiligo diagnosed in 2008

Non-progressive disease | No family history of vitiligo

 

  After 7 implants   At follow-up   At final visit
Baseline    41 NB-UVB sessions   No further treatment   No further treatment
             
     
             
     
             
     

 

Follicular response with initial confluence is seen following treatment on the participant’s face, anterior arm and legs. Spontaneous repigmentation with further confluence is observed after cessation of treatment , with participant returning to baseline skin colour at the end of the study.

 

ASX Announcement

PAGE 2 OF 4

 

 

Case Study 3 (Kenya)

 

38 year-old female | Fitzpatrick Skin Type V | Vitiligo diagnosed in 2008

Non-progressive disease | No family history of vitiligo

 

  After 7 implants   At follow-up   At final visit
Baseline    39 NB-UVB sessions   No further treatment   No further treatment
             
     
             
     
             
     

 

Participant shows extensive repigmentation on the face, torso, legs and arms following treatment. Spontaneous repigmentation with further confluence and homogeneity is observed after cessation of treatment. Repigmentation achieved is maintained and participant returned to baseline skin colour at the end of the study.

 

All images from the three patient cases from the CUV105 study as presented to the EADV are courtesy of the patients and treating physicians.

– END –

 

ASX Announcement

PAGE 3 OF 4

 

 

About CLINUVEL PHARMACEUTICALS LIMITED

 

CLINUVEL is a global biopharmaceutical company focused on developing and delivering innovative therapies for patients with genetic, metabolic, and dermatological disorders. The Company’s portfolio is centred around melanocortin peptides, with programs advancing in photomedicine and vitiligo. CLINUVEL is listed on the Australian Securities Exchange (ASX: CUV) and the Nasdaq Stock Market (Nasdaq: CUVL).

 

CLINUVEL’s lead therapy, SCENESSE® (afamelanotide 16mg), is approved for commercial distribution in Europe, the USA, Canada, Israel, and Australia as the world’s first systemic photoprotective drug for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). For further information, visit www.clinuvel.com.

 

Authorised for ASX release by the Managing Director on behalf of Board of Directors of CLINUVEL PHARMACEUTICALS LTD.

 

Head of Investor Relations

 

Mr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTD

 

Investor Enquiries

 

https://www.clinuvel.com/investors/contact-us

 

Forward-Looking Statements

 

This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. All statements other than statements of historical or current facts made in this document are forward-looking. We identify forward-looking statements in this document by using words or phrases such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “foresee,” “intend,” “likely,” “may,” “objective,” “potential,” “plan,” “predict,” “project,” “seek,” “should,” “will” and similar words or phrases and their negatives. Forward-looking statements reflect our current expectations and are inherently uncertain. Actual outcomes or results could differ materially for a variety of reasons. Statements may involve a number of known and unknown risks that could cause our future results, performance, or achievements to differ significantly from those expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include but are not limited to risks relating to: our ability to develop and commercialise pharmaceutical products; pandemics, epidemics, public health emergencies, geopolitical conflicts, trade restrictions, natural disasters and other disruptions affecting global supply chains, including our ability to develop, manufacture, market and sell biopharmaceutical and PhotoCosmetic products; competition for our products, especially SCENESSE® (afamelanotide 16mg), CYACÊLLE, PRÉNUMBRA®, NEURACTHEL® or products developed and characterised by us as PhotoCosmetics; our ability to achieve expected safety and efficacy results in a timely manner through our innovative R&D efforts; the effectiveness of our patents and other protections for innovative products, particularly in view of national and regional variations in patent laws; our potential exposure to product liability claims to the extent not covered by insurance; increased government scrutiny in either Australia, the U.S., Europe, the UK, Israel, China, Japan, and/or LATAM regions of our agreements with third parties and suppliers; our exposure to currency fluctuations and restrictions as well as credit risks; the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement; that the Company may incur unexpected delays in the outsourced manufacturing of SCENESSE®, CYACÊLLE, PRÉNUMBRA®, NEURACTHEL® or products developed as PhotoCosmetics which may lead to the Company being unable to launch, supply or serve its commercial markets, special access programs and/or clinical trial programs; any failures to comply with any government payment system (i.e. Medicare, Medicaid, and U.S. Department of Veteran’s Affairs) reporting and payment obligations; uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology, cosmetic and consumer based products; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; our ability to retain or attract key personnel and managerial talent; the impact of broader change within the pharmaceutical industry, cosmetic industry and related industries; potential changes to tax liabilities or legislation; environmental risks including the risk factors described in the Company’s Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission, together with the Company’s announcements lodged with the Australian Securities Exchange. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation except as required by applicable law, the rules of the Australian Securities Exchange, the U.S. Securities and Exchange Commission, Nasdaq, or other applicable regulatory requirements, to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. More information on preliminary and uncertain forecasts and estimates is available on request, whereby it is stated that past performance is not an indicator of future performance.

 

Contact:

 

Tel: +61 3 9660 4900

Fax: +61 3 9660 4909

Email: mail@clinuvel.com

Australia (Head Office), Level 22, 535 Bourke Street, Melbourne, Victoria, 3000, Australia

 

 

ASX Announcement

PAGE 4 OF 4

 

Source: View Original Filing on SEC EDGAR

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