Protalix Biotherapeutics PLX Stock News

Protalix BioTherapeutics Inc (NYSEAMERICAN: PLX) is making a run for the top in the premarket hours this morning, and for good reason. The company announced that the FDA has accepted a Biologics License Application, or BLA. Here’s what’s going on:

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PLX Stock Is Climbing

In the press release, Protalix BioTherapeutics announced that it, and its commercialization partner, Chiesi Global Rare Disease, received acceptance of a Biologics License Application from the FDA. Moreover, the FDA has granted Priority Review designation for the drug.

The application surrounds the potential approval of pegunigalsidase alfa for the treatment of adult patients with Fabry disease. In the release, the company said that the BLA was submitted through the Accelerated Approval Pathway.

PLX went on to say that the FDA set an action date on the application of January 27, 2021, under the PDUFA. Moreover, the FDA said that it does not intend on holding an advisory committee meeting to discuss the application.

In a statement, Dror Bashan, President and CEO at PLX, had the following to offer:

The FDA’s acceptance of the BLA and grant of priority review for PRX-102 are significant achievements for Protalix and Chiesi, and represent a crucial step forward as we look to establish a new treatment option to the Fabry patient community. Based on the encouraging results for PRX-102 we have seen to date, we are eager to continue discussions with the FDA and to continue our other development efforts for PRX-102, as marketing approval of PRX-102 is our top priority.

The above statement was followed up by Giocomo Chiesi, Head of Global Rare Disease. Here’s what he had to offer:

PRX-102 represents an important advance in research with the potential to deliver significant advantages to patients with Fabry disease. We are very encouraged by the strong interest in this therapy among both patients and clinicians and we look forward to the prospect of making it available to patients around the world who can benefit from treatment.

This News Is Huge

The news released by Protalix this morning proved to be overwhelmingly positive. After all, the acceptance of a BLA and setting of a PDUFA date means that within a few short months, the company may have an approved product. However, there’s more to be excited about here.

Priority review is only granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. As a result, the designation shortens the review period and offers further benefits to the company.

With commercialization likely just around the corner, now is the time to pay close attention to PLX.

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