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Protalix BioTherapeutics, Inc. develops, manufactures and commercializes recombinant therapeutic proteins for rare diseases using its proprietary plant cell-based expression system, ProCellEx®. The company’s recurring news includes financial results, business updates, regulatory developments for Elfabrio® in Fabry disease, and commercial or partnership activity tied to approved enzyme replacement therapies.
Company updates also cover pipeline programs such as PRX-115, a recombinant PEGylated uricase candidate for uncontrolled gout, and PRX-119, a long-acting DNase I program associated with rare kidney disease research. Protalix also reports on collaborations involving RNA-based therapeutic discovery and on its licensed relationship with Pfizer for taliglucerase alfa, Elelyso®, for Gaucher disease outside Protalix-retained rights in Brazil.
Protalix BioTherapeutics (PLX) announced that the FDA has accepted its Biologics License Application (BLA) for pegunigalsidase alfa and granted it Priority Review for treating Fabry disease. The FDA set a decision date for January 27, 2021, under the Accelerated Approval pathway. The submission includes data from completed Phase I/II trials and ongoing studies of PRX-102. This designation significantly shortens the review period, indicating potential for substantial benefits in treating serious conditions. The company aims to establish a new treatment option for Fabry patients.
Protalix BioTherapeutics (NYSE American: PLX) reported its Q2 2020 financial results, highlighting significant milestones despite COVID-19 challenges. The company announced positive topline results from its BRIDGE Phase III trial of PRX–102 for Fabry disease and submitted a Biologics License Application (BLA) to the FDA. Q2 revenues reached $10.9 million, a 12% year-on-year decrease mainly due to lower R&D revenues. Research expenses fell by 31% to $9.2 million. Protalix remains financially stable with $4.8 million in cash and $35.2 million in bank deposits, indicating a solid foundation for future growth.
Protalix BioTherapeutics, Inc. (NYSE American: PLX) announced its participation in the BTIG Virtual Biotechnology Conference on August 10-11, 2020. Dror Bashan, the CEO, will present in a fireside chat format on August 10 at 2:00 PM ET. The presentation can be viewed live on the company’s website and will be available for replay for 15 days. Protalix is known for its proprietary ProCellEx® system for producing therapeutic proteins and has a pipeline targeting diseases like Fabry disease and cystic fibrosis.
Protalix BioTherapeutics (NYSE: PLX) announced it will release its second quarter 2020 financial results and business update on August 10, 2020, at 8:30 a.m. EDT. A conference call with management will follow to discuss the results. Protalix, known for its ProCellEx® plant cell-based protein expression system, has developed recombinant therapeutic proteins, including taliglucerase alfa. The company has ongoing partnerships for product development, notably with Chiesi Farmaceutici for pegunigalsidase alfa aimed at Fabry disease.
Protalix BioTherapeutics (NYSE American: PLX) announced a non-binding term sheet with SarcoMed USA for the development of PRX-110 (alidornase alfa) targeting Pulmonary Sarcoidosis. This follows the FDA granting Orphan Drug Designation to alidornase alfa for the treatment of this rare disease on July 21, 2020. Protalix, known for its ProCellEx® plant-based protein expression system, seeks to advance its pipeline that includes various recombinant therapeutic proteins. The company has previously collaborated with Pfizer for another product, taliglucerase alfa.