About CUV (ASX: CUV)
Clinuvel Pharmaceuticals Limited is a biopharmaceutical company focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening disorders, with commercial operations spanning Australia, Europe, the United States, Switzerland, and other international markets. The company's core work centres on the melanocortin system, applying this therapeutic platform across photoprotection, neurology, endocrinology, and degenerative disease, as well as providing photocosmetic products for individuals at risk of ultraviolet and high energy visible light exposure who require support with DNA repair and skin melanogenesis.
Its lead approved drug is SCENESSE, a systemic photoprotective agent indicated for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria. The pipeline extends to CUV9900, an alpha-melanocyte stimulating hormone analogue, PRENUMBRA, a liquid injectable formulation of afamelanotide, and NEURACTHEL, an adrenocorticotropic hormone candidate targeting neurological, endocrinological, and degenerative disorders, alongside broader pharmaceutical formulations built on melanocortin technology. Incorporated in 1999, the company is headquartered in Melbourne, Australia.
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Latest Announcements
- Clinuvel Pharmaceuticals (ASX: CUV) – Clinuvel Level II ADR upgrade to NasdaqApril 28, 2026CLINUVEL Pharmaceuticals has announced that the U.S. Securities and Exchange Commission is progressing its review of the company’s draft registration statement, with the process expected to conclude before 30 June 2026. The company has already navigated four rounds of SEC questioning as it works toward upgrading its American Depositary Receipt program from Level I to […]
- Clinuvel Pharmaceuticals (ASX: CUV) – FDA Relaxes SCENESSE Postmarketing RequirementsApril 27, 2026Clinuvel Pharmaceuticals has secured a significant regulatory milestone with the FDA’s removal of a cardiac repolarization study requirement from SCENESSE’s postmarketing obligations. The removal reflects the agency’s confidence in the drug’s long-term safety profile based on real-world data accumulated since the product’s US approval in October 2019. This decision reduces future regulatory burden and validates […]
- Clinuvel Pharmaceuticals (ASX: CUV) – Final EMA Scientific Advice Vitiligo Phase IIIApril 24, 2026Clinuvel Pharmaceuticals has received final regulatory guidance from the European Medicines Agency on the design of its Phase III vitiligo trial, clearing the path for a pivotal study that could determine the company’s commercial prospects in a major European market. The EMA’s scientific advice, delivered after more than 12 months of dialogue and two formal […]
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