Welcome to our dedicated page for Protalix Biother news (Ticker: PLX), a resource for investors and traders seeking the latest updates and insights on Protalix Biother stock.
Protalix BioTherapeutics (NYSE: PLX) is a biopharmaceutical innovator leveraging its proprietary ProCellEx® plant cell-based technology to develop enzyme replacement therapies for rare diseases. This page provides investors and industry stakeholders with timely updates on clinical developments, regulatory milestones, and strategic partnerships.
Access comprehensive coverage of PLX's advancements in treating Gaucher disease, Fabry disease, and other rare conditions. Track updates across three key areas: clinical trial progress for pipeline candidates, commercial partnerships with global pharmaceutical leaders, and manufacturing innovations through the ProCellEx® platform.
Our curated news collection enables efficient monitoring of FDA submissions, earnings reports, and licensing agreements. Stay informed about the company's unique approach to cost-effective bioproduction and its expanding role in addressing unmet medical needs through plant-based protein expression systems.
Bookmark this page for direct access to verified press releases and objective analysis of Protalix's position within the competitive rare disease therapeutics market. Regular updates ensure you maintain current awareness of developments impacting both clinical outcomes and investment considerations.
Protalix BioTherapeutics (NYSE American: PLX) announced its participation in virtual investor meetings at the 10th Annual LifeSci Partners Corporate Access Event from January 6-8 and 11-14, 2021. Additionally, Dror Bashan, the company's President and CEO, will present a corporate overview at the H.C. Wainwright BioConnect 2021 Conference on January 11, 2021, at 6:00 AM ET. Attendees can access the presentation on-demand via a dedicated website. Protalix continues to develop its unique plant cell-based expression system, ProCellEx, which has successfully produced FDA-approved therapeutic products.
Protalix BioTherapeutics (NYSE American: PLX) reflected on significant achievements in 2020, including submitting a Biologics License Application (BLA) for PRX-102 to the FDA for Fabry disease. The application is on an expedited timeline, with an action date of April 27, 2021. The company raised approximately $44 million in March 2020 and established an at-the-market offering for an additional $30 million. Notable partnerships were formed, including a collaboration with SarcoMed USA for PRX-110. Protalix is optimistic about 2021, anticipating a commercial launch in a multi-billion dollar market.
Protalix BioTherapeutics (NYSE American:PLX) and Chiesi Global Rare Diseases have released final results from the BRIDGE Phase III clinical trial for Pegunigalsidase Alfa, a treatment for Fabry disease. The study showed significant improvement in renal function with a mean annualized estimated Glomerular Filtration Rate (eGFR) slope improving from -5.90 mL/min/1.73m²/year on agalsidase alfa to -1.19 mL/min/1.73m²/year on PRX-102. Of 22 patients enrolled, 20 completed the trial, with 18 opting for long-term treatment. The findings will support a Marketing Authorization Application submission to the EMA.
Protalix BioTherapeutics (PLX) announced that the FDA has extended the PDUFA date for its Biologics License Application (BLA) for pegunigalsidase alfa (PRX–102) by three months to April 27, 2021. This application seeks accelerated approval for treating Fabry disease. The FDA previously granted Priority Review for PRX–102, indicating its potential to significantly improve treatment options. The BLA includes extensive clinical data from various studies of PRX–102, which is designed to meet the unmet needs of Fabry patients.
Protalix BioTherapeutics (NYSE American:PLX) announced that CEO Dror Bashan will present at the H.C. Wainwright 6th Annual Israel Conference on November 12, 2020, at 7:30 AM EST. The event will be held virtually. Interested parties can access the live webcast on Protalix's website or via the event calendar page.
Protalix specializes in developing recombinant therapeutic proteins using its ProCellEx® system and was the first to receive FDA approval for a protein produced through this method. Its pipeline includes treatments for Fabry disease and Cystic Fibrosis, among others.
Protalix BioTherapeutics (NYSE: PLX) has rescheduled its conference call to discuss the third-quarter financial results and business update to October 30, 2020, at 8:30 a.m. EDT due to technical issues. The company focuses on developing recombinant therapeutic proteins through its ProCellEx® plant cell-based expression system, and previously announced financial results for Q3 2020. The call will provide insights into corporate and clinical developments, showcasing Protalix's commitment to innovation in biopharmaceuticals.
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.
