StockMarketWire.com - Diurnal Group said it planned to submit a marketing application to the European Medicines Agency for a treatment for congenital adrenal hyperplasia in the fourth quarter of this year.

The updated timeline comes as the company said it had a 'positive meeting' with the regulator last month.

The positive outcome followed 'the submission of a regulatory package requesting Scientific Advice to the EMA for Chronocort based on detailed analysis of data from its Phase 3 study,' the company said.

'We welcome the outcome of our meeting with the EMA based on detailed analysis of data from our studies in patients with congenital adrenal hyperplasia (CAH),' said Martin Whitaker, Chief Executive Officer of Diurnal.

'This condition still results in significant increased morbidity and mortality for patients worldwide, with new therapies needed to improve these outcomes. We therefore continue to believe that Chronocort represents a valuable treatment option for these patients, in a market estimated at $300 million in Europe, and we look forward to submitting a Marketing Authorisation Application in Q4 2019.'






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