Clinuvel Confirms Mid-2026 Target to File Adrenocorticotropic Hormone Formulation Therapy Candidate with European Regulator

MT Newswires Live

2025/12/02

Clinuvel Pharmaceuticals (ASX:CUV) confirmed a mid-2026 target to file its NEURACTHEL Instant therapy candidate, a generic injectable adrenocorticotropic hormone formulation, with a European regulatory authority via a national procedure, according to a Tuesday Australian bourse filing.

It validated the end-to-end Good Manufacturing Practice processes for NEURACTHEL Instant. Three consecutive batches were produced, confirming a reproducible and reliable process. This stock is now available for clinical use, pending regulatory approval.

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