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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 (PLX) and Chiesi Global Rare Diseases announced updates on the clinical development of pegunigalsidase alfa (PRX–102) for Fabry disease. Currently in a Phase III BALANCE trial, PRX–102 shows promising interim results with 78 patients enrolled. The interim efficacy analysis indicates favorable safety data, with no deaths reported. Protalix intends to submit a Marketing Authorization Application (MAA) to the EMA, aiming for regulatory approval in both the EU and the U.S. after further clinical assessments.
Protalix BioTherapeutics (NYSE American: PLX) reported Q1 2021 results, noting a revenue decline of 10% to $4.5 million, influenced by decreased sales in Brazil. License and R&D service revenues fell 59% to $6.8 million. The FDA issued a Complete Response Letter for PRX-102, though no safety or efficacy issues were identified. A $10 million milestone payment from Chiesi is expected to bolster cash flow. Cash reserves stood at $70.4 million, with a net loss of $5.5 million for the quarter. The company anticipates continued progress in clinical trials while addressing regulatory requirements.
Protalix BioTherapeutics (NYSE American: PLX) will release its first quarter 2021 financial results and provide a business update on May 14, 2021, at 8:30 a.m. EDT. The conference call will cover recent corporate and clinical developments. Protalix develops recombinant therapeutic proteins using its proprietary ProCellEx® plant cell-based expression system, securing FDA approval for its first product, taliglucerase alfa, in May 2012. The company is advancing several product candidates targeting various diseases.
Protalix BioTherapeutics (NYSE American: PLX) announced an update regarding the Complete Response Letter (CRL) it received from the FDA for its Biologics License Application (BLA) for pegunigalsidase alfa (PRX–102) targeting Fabry disease. The CRL does not raise safety or efficacy concerns but requires an FDA inspection of Protalix's manufacturing facility before approval. The FDA plans to define a path for future inspections. Protalix aims to schedule a Type-A meeting with the FDA to discuss accelerating approval.
Protalix BioTherapeutics (NYSE American: PLX) and Chiesi Global Rare Diseases received a Complete Response Letter (CRL) from the FDA regarding the Biologics License Application for pegunigalsidase alfa (PRX-102) intended for treating Fabry disease. The companies are evaluating the regulatory feedback to outline steps for potential approval. Despite the setback, executives express confidence in their clinical data and commitment to advancing the treatment. The PRX-102 BLA was granted Priority Review by the FDA, emphasizing its potential significance in addressing unmet medical needs in Fabry patients.
Protalix BioTherapeutics (PLX) reported financial results for FY 2020, highlighting revenues of $16.2 million from sales and $46.7 million from licenses, marking increases from 2019. The net loss narrowed to $6.5 million, or $0.22 per share, compared to a loss of $18.3 million in 2019. The company advanced its clinical trials, notably for PRX–102, with a significant PDUFA date set for April 27, 2021. Protalix also secured funding through a $40.2 million public offering in February 2021, strengthening its financial position to support upcoming milestones.
Protalix BioTherapeutics, Inc. (NYSE American: PLX) will release its fiscal year 2020 financial results and provide a business update on March 30, 2021, at 8:30 a.m. EDT. The company will host a conference call to discuss recent corporate and clinical developments. Protalix specializes in recombinant therapeutic proteins using its proprietary plant cell-based expression system, ProCellEx. The call will be accessible via domestic and international numbers, and will be webcast live on the company's website.
Protalix BioTherapeutics (NYSE American: PLX) will present a corporate overview at the H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. CEO Dror Bashan's recorded presentation will be available from 7:00 am ET on March 9 at this link. A webcast will also be accessible on Protalix's event calendar page, with a replay available for 90 days. Protalix specializes in recombinant therapeutic proteins through its ProCellEx® system, with its first product approved by the FDA in May 2012.
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.
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