from Today's $tockhead. Argenica Therapeutics (ASX:AGN) In...

from Today's $tockhead.
Argenica Therapeutics (ASX:AGN)
In March, Argenica’s shares jumped on the back of an FDA-related announcement.
The brain-tissue-focused biotech said the US FDA had granted its neuroprotective drug ARG-007 – a Rare Pediatric Disease Designation (RPDD) for the treatment of Hypoxic Ischaemic Encephalopathy (HIE) in newborn term infants.
The granting is a key stepping stone for Argenica as it could lead to the FDA awarding it a Priority Review Voucher (PRV), provided that HIE is the first indication for which the drug is approved.
Argenica says a PRV voucher can also be sold or transferred to a third party, with an estimated resale price of a PRV often in the tens of millions of dollars.
HIE occurs when the brain does not receive enough oxygen or blood flow for a period of time. It may occur at any time prior to labour, during labour and delivery, or immediately following delivery.
The initial injury that is caused by a loss or reduction of oxygen supply is followed by progressive brain cell death.
Argenica’s CEO, Dr Liz Dallimore, said there are currently no therapeutic drugs available to treat this devastating condition.
“This RPDD will provide the company with potential significant upside at the end of a clinical program in HIE to receive a priority review to get the drug on the market quickly, or the option to sell the voucher to a third party.”