ProMetic Life Sciences Inc.’s (PFSCF.OB) (PLI.TO) Biologic License Application for Ryplazim, proposed for the treatment of congenital plasminogen deficiency, awaits a ruling from the FDA on April 14, 2018.
Congenital plasminogen deficiency, a rare genetic disorder caused by an alteration to the plasminogen gene, can result in inflamed growths on the mucous membranes, such as the eyelids and inside of the mouth. It is an extremely rare condition, with an incidence of 1 to 2 persons per million individuals, according to Rare Disease Report.
ProMetic’s Ryplazim, a plasminogen replacement therapy, which is tagged an orphan drug, also has fast track status, and rare pediatric designation.
If approved, Ryplazim will be eligible to receive a rare pediatric disease priority review voucher.
PFSCF.OB closed Tuesday’s (Mar.27) trading at $0.97, down 8.21%.