CLINUVEL: advancing peptides for photomedicine and vitiligo care at AAD 2026

MELBOURNE, Australia, April 15, 2026 (GLOBE NEWSWIRE) -- CLINUVEL’s innovative photomedicine and vitiligo programs featured extensively at the recent American Academy of Dermatology (AAD) Annual Meeting, the world’s largest gathering of dermatology professionals. Through the Company’s bespoke Pavilion of Photomedicine and conference sessions across five days, the development and commercialisation of CLINUVEL’s proprietary peptides in dermatology was presented to over 20,000 delegates.

Building on momentum from the 2025 AAD meeting, AAD 2026 saw CLINUVEL’s ambition translate into deeper engagement with the medical community, with the Pavilion now an established hub for meaningful scientific exchange and candid dialogues. The CLINUVEL team welcomed thousands of visitors, including many returning physicians eager to review the progress of the Company’s clinical programs.

New insights in vitiligo therapy

The 2026 meeting reflected a maturing dialogue regarding the standard of care and potential of new therapies for patients with vitiligo. While the recent focus in the field has been on immune-suppressing JAK inhibitors, clinicians are increasingly identifying the practical challenges of long-term treatment dependency and the prevalence of relapse upon cessation of treatment. This shift in treatment discourse highlights an increasing demand for therapies that prioritise sustained stability and patient safety over the long term.

CLINUVEL’s investigational approach offers a fundamentally different path. The Company’s ongoing Phase III vitiligo study (CUV105) is evaluating afamelanotide as a systemic therapy with adjunct narrowband ultraviolet B (NB-UVB) phototherapy to stimulate repigmentation and stabilise the disease, rather than suppressing the body’s immune system. Afamelanotide, a linear peptide administered in a controlled-release injectable implant, is not currently approved for vitiligo anywhere in the world.

At the Global Vitiligo Foundation (GVF) Annual Symposium, Professor Antoine Bertolotti (University Hospital of La Réunion) presented patient case studies from CUV105, reporting repigmentation following 20 weeks of afamelanotide with adjunct NB-UVB. Crucially, the data showed that patients with darker skin types (Fitzpatrick skin types IV–VI) maintained their pigmentation up to the six month follow-up visit subsequent to withdrawal of therapy. Notably, even patients with active disease (i.e. where the condition is actively spreading) showed a response to therapy in these clinical cases.

Holistic patient care

While CLINUVEL’s primary clinical focus remains its rigorous path toward regulatory approval in vitiligo, the Company’s work at the Pavilion highlighted a holistic philosophy that extends beyond the clinic. Unlike standard models, CLINUVEL takes a long-term view of patient care by creating dedicated spaces for patients to share their experiences and advocate for improvements in clinical trial diversity and mental health support.

The three-day speaker program emphasised this commitment, featuring patients, physicians, and even healthcare partners coming together to exchange insights on topics ranging from fostering inclusivity when engaging with patient communities, to the regulatory and cultural differences in managing vitiligo in different parts of the world.

Technology and digital impact: creating a global buzz

The innovations showcased in Denver extended into the digital sphere, creating significant engagement across social media. CLINUVEL’s outreach efforts reached over 314,000 unique users, with daily wrap-up content generating thousands of interactions. This digital buzz mirrors the energy at the Pavilion, where the Company introduced its proprietary Vitiligo Visual Algorithm (VVA) – an artificial intelligence (AI)-driven tool designed to objectively assess pigmentation using standardised clinical photographs, tracking an individual patient’s treatment progress over time. This tool is now being refined with the assistance of physicians, patients and researchers.

Social media highlights

• featured a walk-through of the Pavilion, highlighting CLINUVEL’s vitiligo program
• featured the Pavilion’s distinctive façade in a playful commentary on AAD’s unmissable exhibition spaces
• ’s reel heavily features CLINUVEL’s Pavilion of Photomedicine

Commentary

“Returning to the AAD for a second year has allowed us to witness a significant maturation in the clinical dialogue surrounding vitiligo,” said Dr Linda Teng, CLINUVEL’s Director of North American Operations. “Our engagement in Denver confirms a growing recognition among the medical community that the next frontier in vitiligo care must prioritise long-term physiological stability and safety beyond immune-suppression.

“The overwhelming response to the Pavilion this year validates our longstanding focus on melanocortin peptides and reinforces our mission to advance clinical programs that truly reflect the life-long needs of the patients we serve.”

About CLINUVEL PHARMACEUTICALS LIMITED

CLINUVEL (ASX: CUV; ADR LEVEL 1: CLVLY; Börse Frankfurt: UR9) is a global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening, acute disorders, as well as healthcare solutions for specialised populations. As pioneers in photomedicine and the family of melanocortin peptides, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for systemic photoprotection, assisted DNA repair, repigmentation and acute or life-threatening conditions who lack alternatives.

CLINUVEL’s lead therapy, SCENESSE^® (afamelanotide 16mg), is approved for commercial distribution in Europe, the USA, 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). Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore, and the USA. For more information, please go to .

Head of Investor Relations

Mr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTD

Investor Enquiries

Forward-Looking Statements

This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. 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 risks relating to: our ability to develop and commercialise pharmaceutical products; the COVID-19 pandemic and/or other world, regional or national events affecting the supply chain for a protracted period of time, including our ability to develop, manufacture, market and sell biopharmaceutical products; competition for our products, especially SCENESSE^® (afamelanotide 16mg), PRÉNUMBRA^® or NEURACTHEL^®; 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, Israel, China and Japan 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^®, PRÉNUMBRA^® or NEURACTHEL^® which may lead to it being unable to supply its commercial markets and/or clinical trial programs; any failures to comply with any government payment system (i.e. Medicare) reporting and payment obligations; uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology 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 and related industries; potential changes to tax liabilities or legislation; environmental risks; and other factors that have been discussed in our 2023 Annual Report. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation, outside of those required under applicable laws or relevant listing rules of the Australian Securities Exchange, 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.

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