London-listed Diurnal Group (AIM: DNL ) announced on Wednesday that it had received validation by the European Marketing Authorisation for its Chronocort® product which treats a rare genetic disorder.
The UK-based pharmaceutical company, which focuses on treatments for hormonal diseases, said that a formal review process of its hormonal drug product, Chronocort®, can now begin.
The group said it is in “a strong cash position” to progress through to the anticipated approval date for Chronocort® following its recent $52.5m US licensing agreement for its Alkindi® Sprinkle product and a £11.2m placing.
Diurnal filed for authorisation in December following an earlier confirmation of a clinical and regulatory pathway for Chronocort® as a treatment for congenital adrenal hyperplasia (CAH).
Shares in Diurnal Group were trading flat at 30.5p during Wednesday trading.
CAH results in low levels of cortisol and high levels of male hormones in the body, causing the development of male characteristics in females, and early puberty in both boys and girls.
The group has recognised the need for therapies for adults living with CAH which is estimated to affect over 441,000 patients globally and results in “increased morbidity and mortality.”
Whitaker further acknowledged the validation as “another important step” towards the targeted recommendation for the approval of a second product in the first quarter of 2021.
In a previous statement, the group also said it would continue to assess “the optimum path and timing” to develop and commercialise Chronocort® in the US.
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