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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) and Chiesi Global Rare Diseases announced positive topline results from the BRIGHT Phase III trial of PRX–102, aimed at treating Fabry disease. The trial showed that 2 mg/kg of PRX–102, administered every four weeks, was well tolerated and maintained stable clinical presentation in adult patients. Encouragingly, no new anti-drug antibodies were formed, and 80% of participants opted for an extension study, indicating strong patient satisfaction. Results also demonstrated stable effectiveness, with no significant adverse events reported, paving the way for potential market approval.
Protalix BioTherapeutics (NYSE American: PLX) has successfully completed a capital raise, garnering approximately $40 million in gross proceeds. The funds will be used for clinical trials, research and development, and general corporate purposes. CEO Dror Bashan highlighted achievements during the pandemic and expressed optimism regarding the upcoming commercial launch of a new treatment option. CFO Eyal Rubin noted the addition of institutional investors and a strengthened balance sheet, aiming to accelerate clinical trials. The company remains focused on pipeline development and shareholder value.
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.