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CLINUVEL PHARMACEUTICALS LTD announced its tenth consecutive annual profit and further rise in free cash in the financial year ended 30 June 2026 (FY2026).

MELBOURNE, Australia and NEW YORK, July 23, 2026 (GLOBE NEWSWIRE) -- CLINUVEL PHARMACEUTICALS LTD (ASX: CUV | Nasdaq: CUVL) today announced a strategic reorganisation of its operations and workforce, effective 1 January 2027, concurrent with the relocation of its corporate headquarters to the United States.

MELBOURNE, Australia and NEW YORK, July 20, 2026 (GLOBE NEWSWIRE) -- CLINUVEL PHARMACEUTICALS LTD today announced that its American Depositary Share (ADS) is expected to commence trading on the Nasdaq Stock Market (Nasdaq) later today (New York time) under the ticker symbol CUVL. The announcement follows the declaration from the U.S. Securities and Exchange Commission (SEC) on 17 July that the Company's publicly filed 20-F Registration Statement is deemed effective, and approval received from Nasdaq to list the ADS.

Health Canada NOC enables treatment for porphyria, metabolic disorder Health Canada NOC enables treatment for porphyria, metabolic disorder

EXECUTIVE SUMMARY final European scientific advice received for pivotal Phase III vitiligo study EMA emphasised its “totality of evidence” approach central photographic review and validated disease assessment tools agreed CUV107 to compare SCENESSE® with adjunct NB-UVB vs NB-UVB monotherapy CUV107 study (n=300) to commence in 2H 2026 MELBOURNE, Australia, April 24, 2026 (GLOBE NEWSWIRE) -- CLINUVEL PHARMACEUTICALS LTD today announced that the European Medicines Agency (EMA) has provided final scientific advice on the design of the planned pivotal Phase III CUV107 study and anticipated evaluation of evidence of CLINUVEL's drug SCENESSE® (afamelanotide) as a systemic vitiligo treatment. EMA's Scientific Advice¹ Following over 12 months of interaction, two formal submissions and a Discussion Meeting with the EMA's Scientific Advice Working Party (SAWP), the Committee for Medicinal Products for Human Use (CHMP), has issued Scientific Advice on CLINUVEL's program evaluating SCENESSE® as a systemic therapy for adults and adolescents with non-segmental vitiligo.

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.

Clinuvel Pharmaceuticals Limited (CLVLY) Q2 2026 Earnings Call Transcript

Clinuvel Pharmaceuticals Limited (OTCPK:CLVLY) Shareholder/Analyst Call October 16, 2025 7:00 PM EDT Company Participants Jeffrey Rosenfeld Susan Smith Matthew Pringle Malcolm Bull - Head of Australian Operations & Investor Relations Philippe Wolgen - CEO, MD & Director Conference Call Participants Peter Renda Conversation Jeffrey Rosenfeld Good morning, ladies and gentlemen. My name is Professor Jeffrey Rosenfeld, and I have the privilege of being the Chair of CLINUVEL Pharmaceuticals Limited.