Precigen submits BLA with request for priority review to FDA for PRGN-2012

Precigen (PGEN) announced the completion of the rolling submission for a biologics license application, BLA, to the US Food and Drug Administration, FDA, for PRGN-2012 for the treatment of adult patients with recurrent respiratory papillomatosis, RRP. The submission is in the initial 60 day review period, during which time the FDA will decide whether to accept the BLA for further review and set the Prescription Drug User Fee Act, PDUFA, action date. The BLA included a request for priority review, which, if granted, would reduce the review timeline from the standard 10-month to a priority 6-month review from the date the submission is accepted by the FDA.