Why is PLX up today during the premarket hours? The stock price of Protalix BioTherapeutics, Inc. (NYSE American: PLX) surged more than 40% in less than an hour today during the premarket. Here is why this happened.
On Monday, April 4, 2022, at 6:50 EST, Protalix BioTherapeutics, Inc. (NYSE American: PLX) announced Topline Results from the Phase III BALANCE Clinical Trial of PRX-102 for the Treatment of Fabry Disease. The clinical trial was in collaboration with Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused Healthcare Group (Chiesi Group).
Traders and investors found the news positive, and it created a strong uptrend with more than 2.6M volumes in the first hour of publication.
Protalix BioTherapeutics, Inc. (NYSE American: PLX) is a biopharmaceutical company dedicated to developing and commercializing recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx.
The announcements included topline results from the BALANCE pivotal Phase III clinical trial to evaluate pegunigalsidase alfa (PRX–102), 1 mg/kg, administered every two weeks, compared to agalsidase beta (Fabrazyme®) for the treatment of Fabry disease.
PRX–102 is a new PEGylated enzyme replacement therapy (ERT). Scientists are developing it for the treatment of Fabry disease.
The trial was a 24–month, randomized, double-blind, active-control study of PRX–102 in adult Fabry patients with deteriorating renal function. It was designed to evaluate the safety and efficacy of 1 mg/kg of PRX–102 administered every two weeks compared to agalsidase beta. The 78 patients participating in this study were previously treated with agalsidase beta for at least one year with an estimated glomerular filtration rate (eGFR) slope at screening worse than –2 mL/min/1.73 m2/year.
What is Fabry Disease?
Fabry disease is an X-linked inherited disease that results from deficient activity of the lysosomal α–Galactosidase–A enzyme resulting in progressive accumulation of abnormal deposits of a fatty substance called globotriaosylceramide (Gb3) in blood vessel walls throughout a person’s body.