Protalix BioTherapeutics, Inc. (NYSE: PLX) is having an incredibly strong start to the trading session in the pre-market hours this morning, and for good reason. The company announced that a key treatment it is working on has been granted Fast Track Designation by the United States Food and Drug Administration. Today, we’ll talk about the designation, what we’re seeing from the stock as a result, and what we’ll be watching for with regard to PLX ahead.
PLX Gains On Fast Track Designation
As mentioned above, Protalix BioTherapeutics is having an a great start to the trading session in the pre-market hours this morning after announcing that it has received Fast Track Designation from the United States Food and Drug Administration. The Fast Track Designation was granted surrounding pegunigalsidase alfa, also known as PRX-102. PRX-102 is a plant cell-expressed recombinant, pegylated, cross-linked a-galoctosidase-A candidate, designed for the treatment of Fabry disease. The Fast Track designation provided to PLX is a designation that’s designed to facilitate the development and expedite the review of drugs and vaccines for serious conditions that fill unmet medical need.
PLX also gave details on what Fast Track Designation actually means. Essentially, Fast Track designation was designed as a way to facilitate the development and expedite the review of drugs that treat serious conditions in which other treatments have proven to be inadequate. As a result, Fast Track Designation results in more frequent meetings with the FDA to improve the development process and support trug approval, mor frequent written communication with the FDA, eligibility for accelerated approval and priority review, and eligibility for a rolling review, allowing PLX to submit portions of the NDA at a time, rather than waiting until all the data is available and submitting the entire application. In a statement, Moshe Manor, President and CEO at PLX, had the following to offer:
We are very pleased that the FDA has recognized the potential for pegunigalsidase alfa to fill an unmet need for Fabry patients… We believe that Fast Track designation will help facilitate our development program for pegunigalsidase alfa and may shorten the timeline to an anticipated approval, which will greatly benefit Fabry patients.
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