Welcome to our dedicated page for Protalix BioTherapeutics news (Ticker: PLX), a resource for investors and traders seeking the latest updates and insights on Protalix BioTherapeutics stock.
Protalix BioTherapeutics, Inc. (NYSE: PLX) is a clinical-stage biopharmaceutical company specializing in the development and commercialization of recombinant therapeutic proteins. The company leverages its proprietary ProCellEx® plant cell-based protein expression system, a novel method for producing recombinant proteins at an industrial scale.
Core Business: Protalix's main focus is developing therapeutic proteins for various diseases. Its flagship product, Taliglucerase Alfa, is an enzyme replacement therapy for Gaucher disease. This product has completed Phase III studies and is currently under FDA review, with treatment ongoing for numerous patients worldwide. Additionally, Taliglucerase Alfa has been licensed to Pfizer, excluding the Brazilian market, where Protalix retains full rights.
Protalix's second major product, Elfabrio®, was approved by both the U.S. FDA and the European Medicines Agency in May 2023. Developed in partnership with Chiesi Farmaceutici S.p.A., Elfabrio is a PEGylated enzyme replacement therapy for Fabry disease. Chiesi is actively marketing Elfabrio globally, having received approvals in multiple regions, including the U.S., EU, UK, Switzerland, and Israel.
Pipeline: Protalix has a robust pipeline featuring numerous proprietary therapeutic protein candidates:
- PRX-115: A plant cell-expressed recombinant PEGylated uricase for treating severe gout, currently in a Phase I clinical trial.
- PRX-119: A plant cell-expressed long-acting DNase I intended for NETs-related diseases, in preclinical development.
- Other early-stage assets targeting various medical conditions.
Financial Condition: Protalix has shown financial resilience, supported by revenue from product sales and milestone payments. In 2023, the FDA approval of Elfabrio triggered a $20 million milestone payment from Chiesi, adding to the company's revenue stream. Protalix's strong balance sheet positions it well for ongoing operations and future growth.
Partnerships: Protalix has strategic partnerships with industry leaders like Pfizer and Chiesi Farmaceutici S.p.A., enhancing its global reach and market penetration. These collaborations are pivotal in driving the development and commercialization of its therapeutic products.
Recent Updates: Protalix remains committed to its mission despite the current security situation in Israel. The company's operations remain unaffected, ensuring a steady supply of its critical therapies. Protalix continues to host regular investor calls and webcasts to provide updates on financial performance and clinical progress.
Protalix BioTherapeutics (NYSE American: PLX) reported its Q3 2020 financial results, highlighting FDA acceptance of the BLA for PRX-102, aimed at treating Fabry disease, and a Priority Review designation. Revenues decreased 36% to $3.3 million, primarily due to timing differences in sales, with license and R&D service revenues down 18% to $7.5 million. R&D expenses also fell by 23% to $7.7 million, while cash reserves stand at $41.3 million. Top-line results from the BRIGHT study are expected by Q1 2021.
Protalix BioTherapeutics (NYSE American: PLX) announced its participation in a Virtual KOL Roundtable scheduled for October 28, 2020, at 10:00 a.m. EDT. The event will focus on the company and its lead drug candidate, pegunigalsidase alfa (PRX–102), aimed at treating Fabry Disease. Moderated by Dror Bashan and Eyal Rubin, the discussion will include Dr. David G. Warnock from the University of Alabama to address treatment landscapes and unmet medical needs. The presentation will be accessible via the company’s website and available for replay for two weeks.
Protalix BioTherapeutics, Inc. (NYSE American: PLX) announced it will release its third quarter 2020 financial results and business update on October 29, 2020. The management will host a conference call at 8:30 a.m. EDT to discuss the results and provide insights into the company's operations. Protalix focuses on developing recombinant therapeutic proteins using its ProCellEx system, with a pipeline that includes treatments for related diseases. Investors can access the call via the company's website or designated phone numbers.
Chiesi Global Rare Diseases and Protalix BioTherapeutics (NYSE: PLX) have launched an Expanded Access Program (EAP) in the U.S. for pegunigalsidase alfa, aimed at treating Fabry disease. This initiative enables broader patient access to the investigational drug, currently under FDA review through a Biologics License Application (BLA). The EAP targets patients with Fabry disease who lack satisfactory treatment options. Treatment will involve bi-weekly infusions of pegunigalsidase alfa, with data collected on adverse events. The drug's safety and effectiveness have yet to be established by the FDA.
Protalix BioTherapeutics (NYSE American: PLX) announced on September 3, 2020, that it has regained compliance with all continued listing standards of the NYSE American. This follows a deficiency notification received on August 26, 2019. The company met the $50 million market capitalization exemption, allowing it to continue trading without restrictions. Protalix is known for its plant cell-based protein expression system, ProCellEx, and its investigational drug, pegunigalsidase alfa, is under review by the FDA for Fabry disease treatment.
Protalix BioTherapeutics, Inc. (NYSE American: PLX) announced that its CEO, Dror Bashan, will present at the H.C. Wainwright 22nd Annual Global Investment Virtual Conference on September 15, 2020, at 12:00 PM ET. This virtual event runs from September 14-16, 2020. A live webcast of the presentation will be available on Protalix's website, with a replay accessible for at least 15 days afterward. Protalix specializes in recombinant therapeutic proteins through its ProCellEx® plant-based expression system, which has FDA-approved products including taliglucerase alfa.
Protalix BioTherapeutics (NYSE American: PLX) has completed the treatment period of its Phase III BRIGHT clinical trial for pegunigalsidase alfa (PRX–102) aimed at treating Fabry disease. The company is finalizing the data analysis process amid COVID-19 restrictions and expects to announce top-line results in Q4 2020. This trial follows positive results from the earlier Phase III BRIDGE trial. Additionally, Protalix has filed a BLA for PRX–102 with the FDA, targeting a PDUFA date of January 27, 2021, marking significant progress in their drug development pipeline.
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.
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