FDA smiles on local companies

Two Australian companies have announced good news from the FDA this week.

West Australian biotech Argenica Therapeutics has been granted a Rare Pediatric Disease Designation (RPDD) by the FDA for its flagship product ARG-007 for the treatment of Hypoxic Ischaemic Encephalopathy (HIE) in newborn term infants.

With the RRPD designation, when the FDA approves a New Drug Application for ARG-007 it may also award a Priority Review Voucher, which can be redeemed to accelerate the review of a subsequent marketing application, or may be sold or transferred to a third party. Such a sale can earn tens of millions of dollars.