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) has announced a public offering of 6,500,000 shares of its common stock, with an additional option for underwriters to purchase 975,000 more. Proceeds will fund clinical trials, research, and general corporate purposes. The offering is pursuant to an effective shelf registration statement. BofA Securities is the book-running manager, with Oppenheimer & Co. as co-manager. This initiative aims to support Protalix's development of recombinant therapeutic proteins, including treatments for Fabry disease and respiratory conditions.
Protalix BioTherapeutics (PLX) announced an exclusive license agreement with SarcoMed USA for alidornase alfa (PRX-110), designed for treating human respiratory diseases, including sarcoidosis. Protalix will receive an initial payment of $3.5 million, with potential milestone payments and royalties on net sales. The parties plan to negotiate supply agreements within 60 days. Alidornase alfa received Orphan Drug Designation from the FDA in July 2020, aimed at rare diseases affecting fewer than 200,000 individuals in the U.S.
Protalix BioTherapeutics (NYSE American: PLX) announced the final results of its Phase III BRIDGE clinical trial for pegunigalsidase alfa, aimed at treating Fabry disease. The findings indicate a significant improvement in renal function, with the eGFR slope changing from -5.90 to -1.19 mL/min/1.73m²/year after switching from agalsidase alfa. The trial involved 22 patients, of whom 20 completed the study, with most opting for a long-term study extension. Safety assessments showed that pegunigalsidase alfa was well tolerated, with mostly mild adverse events reported. Further details will be shared at the WORLD Symposium 2021.
Protalix BioTherapeutics (NYSE: PLX) announced its participation in the 17th Annual WORLD Symposium scheduled for February 8-12, 2021. The company will deliver an oral presentation and a poster presentation featuring data from the BRIDGE Phase III study on pegunigalsidase alfa for Fabry disease. The oral presentation will occur on February 10, 2021, at 1:24 PM EST, while the poster session takes place from 2:30 to 3:30 PM EST. Protalix is also advancing its pipeline, which includes therapeutic proteins for various conditions.
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.
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