One of the most important and recent development published by Protalix BioTherapeutics Inc (NYSEMKT:PLX) related to its progress in the treatment of Fabry disease patients. The company has recently concluded its meeting with the Food and Drugs Administration (FDA) post the release of the Phase II data. In this meeting, the company proposed to put forth Biologics License Application (BLA) for PRX-102, which is aimed to treat patients with Fabry disease.
The company signalled that the meeting with the FDA has been positive, as the latter is likely to accept its application to begin Phase III study of PRX-102. The phase III study will determine the efficacy and safety of PRX-102 in Fabry patients. Meanwhile, Protalix BioTherapeutics Inc. (NYSEMKT:PLX) is preparing to submit Special Protocol Assessment (SPA) request to the FDA by the year end, ahead of the commencement of the study in early 2016. The primary and the secondary endpoints of the study are gastrointestinal symptoms and renal function respectively.
Apart from this study, Protalix is also eyeing to commence another phase III head-to-head study, which will determine the effectiveness of PRX-102 against Sanofi SA (ADR) (NYSE:SNY)’s Fabrazyme. The primary endpoint of this study will be to evaluate the improvement in eGFR or epidermal growth factor receptor. The company also noted that the FDA has ruled out the need for conducting any additional non-clinical studies to back BLA for PRX-102, which is a welcome development.
Earlier last month, Protalix BioTherapeutics Inc (NYSEMKT:PLX) had issued its third quarter results, where its earnings per share came in at ($0.04), higher than the market EPS estimate of ($0.08). However, Protalix missed reporting revenues in line, which came $0.7 million below the market estimates at $4.3 million.
The stock price of the company was marginally up by 0.30% at $44 during the after-hours trading session.