DNL.L Regulatory News (DNL)

Hardman & Co Research: Chronocort - seeking regulatory advice

Diurnal (DNL) is a commercial-stage specialty pharmaceutical company focused on diseases of the endocrine system. Its two lead products target rare conditions where medical needs are currently unmet, with the aim of building a long-term 'Adrenal Franchise'. Alkindi is being launched in key EU markets, and this was expected to be followed by Chronocort; however, headline data from its EU Phase III trial in CAH did not show superiority over standard-of-care, thereby failing to meet its primary end-point. DNL is seeking 'Scientific Advice' from the EMA about how to proceed, which should be available in 2Q'19, with a view to filing for market authorisation in Europe.

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https://www.hardmanandco.com/research/corporate-research/chronocort-seeking-regulatory-advice/

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