Argenica Wins EMA Paediatric Waiver, Streamlining EU Pathway for Stroke Drug ARG-007

Argenica Therapeutics Ltd ( (AU:AGN) ) has issued an update.

Argenica Therapeutics has secured a full product-specific paediatric waiver from the European Medicines Agency for its lead neuroprotective candidate ARG-007 in acute ischaemic stroke, removing the obligation to conduct paediatric clinical trials for this rare condition in children. The decision, recommended by the EMA’s Paediatric Committee, allows the company to advance ARG-007 through the European approval pathway for adult stroke without paediatric studies, significantly streamlining development, cutting cost and time, and reducing regulatory complexity. This milestone strengthens Argenica’s global regulatory strategy, accelerates its path toward a potential EU marketing authorisation for ARG-007 in adult stroke patients, and is expected to enhance the drug’s attractiveness to prospective pharmaceutical partners by de-risking the European development program.

The most recent analyst rating on (AU:AGN) stock is a Buy with a A$0.64 price target. To see the full list of analyst forecasts on Argenica Therapeutics Ltd stock, see the AU:AGN Stock Forecast page.

More about Argenica Therapeutics Ltd

Argenica Therapeutics Limited is an Australian biotechnology company focused on developing novel neuroprotective therapeutics to reduce brain tissue death following stroke and other acute neurological conditions. Its lead drug candidate, ARG-007, targets acute ischaemic stroke, with the company pursuing regulatory approvals and market access in major regions including the European Union.

Average Trading Volume: 214,415

Technical Sentiment Signal: Sell

Current Market Cap: A$35.97M

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