Protalix BioTherapeutics Inc (NYSEAMERICAN: PLX) is making a run for the top in the market this morning, trading on gains over 71% on ridiculously high volume. The gains come after the company announced positive news from the United States Food and Drug Administration. Here’s what’s going on:
PLX Stock Soars On Positive FDA News
In a press release issued early this morning, Protalix BioTherapeutics announced that it, and its partner Chiesi, have completed a successful Type B Pre-Biologics License Application meeting with the FDA. The meeting surrounded the potential for the Accelerated Approval pathway for pegunigalsidase alfa (PRX-102) for the treatment of Fabry disease.
In the release, PLX said that it and Chiesi met with the FDA on October 15, 2019. At the meeting, the parties discussed key information surrounding the treatment and the proposed BLA filing under the Accelerated Approval pathway.
Importantly, the comapny said that it has reached alignment with the FDA on the Accelerated Approval pathway for pegunigalsidase alfa. As such, the BLA is expected to be submitted to the FDA relatively soon. The data submitted will include the Phase I/II clinical trial data as well as data from its ongoing Phase III BRIDGE clinical trial.
In a statement, Dror BAshan, President and CEO at PLX, had the following to offer:
The confirmation by the FDA regarding the proposed BLA submission, together with the finalization of the BALANCE study enrollment (78 patients) and the very promising interim results from the BRIDGE study, are three recent significant consecutive milestones achieved with respect to our Fabry late-stage clinical program. We are committed to the completion of this program with positive results for the benefit of the Fabry patient community.
Why This News Is So Exciting
It’s common that we see meetings between the FDA and biotechnology companies. Often times, these meetings are positive. However, they don’t all lead to such a strong reaction in the market. So, what’s the deal? Why is the news so exciting? Here’s why:
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