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The FDA approved Chiesi Group and Protalix BioTherapeutics Inc's (NASDAQ:PLX) Elfabrio (pegunigalsidase alfa-iwxj) for treating adult patients with Fabry disease.
The product is an enzyme replacement therapy for adults with a rare, inherited disease in which abnormal deposits of fatty substances build up and cause pain and sometimes end-organ failure.
Elfabrio is a PEGylated enzyme replacement therapy. It is a recombinant human α–Galactosidase–A enzyme expressed in a plant-cell culture designed to provide a long half-life.
Also Read: Protalix Clocks 40% Decline In Q1 Revenues Reflecting Lower Sales To Brazil.
Just last week, the European Commission approved PRX-102 (pegunigalsidase alfa) in the European Union for Fabry disease.
Elfabrio competes with Sanofi SA's (NASDAQ:SNY) Fabrazyme and Amicus Therapeutics Inc's (NASDAQ:FOLD) Galafold in treating Fabry disease.
Almost two years back, the companies received a Complete Response Letter (CRL) from the FDA related to the marketing application of pegunigalsidase alfa (PRX‑102) for Fabry disease.
Price Action: PLX shares are up 1.54% at $2.97 on the last check Wednesday.
