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.
News and updates for Protalix BioTherapeutics, Inc. (PLX) center on its activities as a biopharmaceutical company focused on rare disease therapeutics and recombinant proteins produced with its proprietary ProCellEx® plant cell-based expression system. This page aggregates company press releases, financial announcements and clinical program updates that reflect how Protalix is developing and commercializing enzyme replacement therapies and advancing its pipeline.
Investors and followers of PLX can find coverage of commercial performance for the company’s approved products, including Elfabrio® for Fabry disease and Elelyso® (taliglucerase alfa) for Gaucher disease, supplied to partners such as Chiesi, Pfizer and Fiocruz in Brazil. News items also describe how these established revenue streams support Protalix’s research and development efforts.
Another key theme in Protalix news is pipeline progress. The company regularly reports on PRX–115, a plant cell-expressed recombinant PEGylated uricase for uncontrolled gout, including Phase 1 data and regulatory milestones like the submission of an IND to the FDA for a planned Phase 2 trial. Updates also cover PRX–119, a long-acting DNase I candidate for NETs-related and rare renal diseases, and the company’s collaboration with Secarna Pharmaceuticals to discover antisense oligonucleotide therapies for rare kidney indications.
Regulatory and corporate developments appear frequently in PLX news, such as EMA evaluations of new dosing regimens for Elfabrio, inclusion in the Russell 3000® and 2000® Indexes, at-the-market equity program amendments, executive appointments and outcomes of stockholder meetings or legal matters. Bookmark this page to follow how Protalix’s commercial partnerships, clinical trials and strategic collaborations evolve over time.
Protalix BioTherapeutics, Inc. (NYSE American: PLX) announced the pricing of its underwritten public offering of 7,608,695 shares at $4.60 each, aiming to raise approximately $32.9 million post-underwriting expenses. The offering is set to close on February 17, 2021. Proceeds will support clinical trials, R&D activities, and general corporate purposes. BofA Securities is the book-running manager for the offering, which includes a 30-day option for underwriters to acquire an additional 1,141,304 shares.
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.