Hardman & Co: Clarity for Chronocort regulatory pathway
Diurnal (DNL) is a commercial-stage specialty pharmaceutical company focused on diseases of the endocrine system. Its two lead products are targeting rare conditions where medical need is currently unmet, with the aim of building a long-term 'Adrenal Franchise'. The first product, Alkindi(R), is being launched in key EU markets, and this was expected to be followed by the adult version, Chronocort(R). After unexpected Phase III results, positive feedback from the EMA has cleared the path for regulatory submission of Chronocort for adult CAH in Europe before the end of 2019, and allowed DNL to revise the primary endpoint in the protocol for the US Phase III trial.
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