StockMarketWire.com - Diurnal Group said it planned to submit a new drug application to the FDA for a treatment for paediatric adrenal insufficiency in the fourth quarter of 2019.

The timeline confirmed previous guidance and was reiterated after the company had a 'positive meeting' with the regulator.

Final acceptance of the filing by the FDA was anticipated by the company in 2020.

'If accepted by the FDA, Alkindi will be the first licensed treatment in the US specifically designed for use in children with adrenal insufficiency, where there is a significant unmet patient need,' chief executive Martin Whitaker said.

'Following this positive development, we are now progressing discussions with potential partners for Alkindi in the US who are able to optimise market access for this important product.'


At 2:31pm: [LON:DNL] Diurnal Group Plc share price was -1p at 27p



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