Protalix BioTherapeutics (PLX +2%) and development partner Chiesi Farmaceutici S.p.A. announce that the FDA has signed off on the initial study plan for pegunigalsidase alpha (PRX-102) in pediatric patients with Fabry disease, an inherited disorder caused by the buildup of a certain type of fat in cells due to mutations in an essential enzyme.
The companies intend to request accelerated approval in the U.S. when they file a marketing application in April.
PRX-102 is chemically modified version of a recombinant therapeutic enzyme called alpha-galactosidase A.
https://seekingalpha.com/news/3539276-protalix-advancing-study-plan-of-prxminus-102-in-pediatric-fabry-patients
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