Shares of the Protalix BioTherapeutics, Inc. (PLX) stock were declining today on October 11, 2021. PLX stock price saw a downtrend of 10.53% to drop at $1.19 a share at the time of this writing. The stock was performing well in the previous trade and went up by 2.31% at closing.
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Protalix BioTherapeutics, Inc is the biopharmaceutical stock that develops and commercializes recombinant therapeutic proteins in Israel, Brazil, U.S, and across the globe. Let’s understand the reason behind this bearish sentiment.
PLX stock and Chiesi Global Rare Diseases announced a regulatory update on PRX-102:
PLX stock along with Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A today announced the regulatory update related to pegunigalsidase alfa for the proposed treatment of Fabry disorder. The regulatory update included official Type A meeting minutes receipt from the U.S Food and Drug Administration concerning the complete response letter received for the PRX–102 Biologics License Application that confirmed the potential path of BLA resubmission for PRX–102.
On September 09, 2021, the type A meeting was held. The meeting minutes that FDA provided included the preliminary comments and discussions between the attendees. It was concluded that the proposed data package for the BLA resubmission has enough potential to support the traditional approval of PRX–102 to treat Fabry disorder. The final two-year analysis will be included in the planned data package for the resubmission of BLA in the phase III BALANCE clinical trial.
Meeting with Rapporteur and Co-Rapporteur of the European Medicines Agency:
PLX stock and Chiesi also reported about their meeting with Rapporteur and Co-Rapporteur of the European Medicines Agency on October 8, 2021, concerning PRX–102. In the meeting, Chiesi and PLX stock talk about the scope of the Marketing Authorization Application for the EU. Rapporteur and Co-Rapporteur supported the planned MAA submission for PRX–102. Chiesi and PLX stock are anticipating submitting the MAA for PRX-102 in the first quarter of 2021.
Financial View of Protalix stock:
In the second quarter of 2021, Protalix stock generated $3.2 million in revenue from the selling of goods, $0.4 million lower than the same prior-year period. License and R&D services revenues decreased to $3.2 million from $7.3 million in the same period of 2020. The company suffered $11.2 million in net loss and spent $7.7 million in research and development expenses in the recently reported quarter. The stock had $76.9 million in cash and cash equivalents by the end of the second quarter of 2021.