Clinuvel Pharmaceuticals Limited·Healthcare
Clinuvel Pharmaceuticals Limited, a biopharmaceutical company, focuses on developing and commercializing treatments for patients with genetic, metabolic, and life-threatening disorders in Australia, Europe, the United States, Switzerland, and internationally. Its lead drug candidate is SCENESSE, a systemic photoprotective drug for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). The company's pipeline products include CUV9900, an alpha-melanocyte stimulating hormone analogue; Parvysmelanotide (VLRX001), which provoke increased and prolonged cellular activity; and PRÉNUMBRA, a liquid injectable formulation of afamelanotide. Clinuvel Pharmaceuticals Limited has a collaboration agreement with HK Winhealth Pharma Group Co. Limited t to treat EPP patients with SCENESSE under a named patient program in the People's Republic of China. The company was founded in 1987 and is headquartered in Melbourne, Australia.

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.