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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 (NYSE American: PLX) will release its financial results for Q1 2023, ending March 31, 2023, on May 4, 2023. The company, known for its proprietary ProCellEx® plant cell-based protein expression system, will host a conference call to discuss these results and recent corporate and regulatory updates at 8:30 a.m. EDT. Interested investors can access the conference call via toll-free numbers or the provided webcast links. Protalix is notable for being the first to receive FDA approval for a protein produced through a plant cell-based expression system and continues to develop several therapeutic proteins targeting established markets, including treatments for Fabry disease and severe gout.
Protalix BioTherapeutics (PLX) announced the dosing of the first patient in its phase I First in Human (FIH) clinical trial of PRX-115, a PEGylated uricase aimed at treating severe gout. This double-blind, placebo-controlled study will assess safety, pharmacokinetics, and pharmacodynamics in approximately 56 patients with high uric acid levels. The trial is taking place at New Zealand Clinical Research under regulatory guidelines and involves single ascending doses of PRX-115 versus placebo. The CEO emphasized the company's commitment to addressing unmet medical needs and continuing patient enrollment.
Protalix BioTherapeutics (NYSE American:PLX) announced that it has no cash deposits or financial relationships with Silicon Valley Bank or Signature Bank, following their recent closures. The company maintains most of its cash in major U.S. banks and does not expect any operational impact from the banks' closure. Protalix monitors the situation regarding potential effects on partners and suppliers. The company is known for its recombinant therapeutic proteins produced via its ProCellEx® system, with FDA-approved products like taliglucerase alfa and several candidates in development targeting various diseases.
Protalix BioTherapeutics (NYSE: PLX) reported strong financial results for the year ending December 31, 2022, with revenues of $25.3 million, a 51% increase from 2021. This growth was driven by sales to Pfizer, Brazil, and Chiesi. The EMA has given a positive opinion for PRX-102, recommending marketing authorization for Fabry disease, with a final decision expected in May 2023. The FDA accepted the resubmitted biologics license application for PRX-102 with an action date also set for May 9, 2023. Despite a net loss of $14.9 million, a significant reduction from a $27.6 million loss in 2021, the company remains optimistic about its future prospects and continued advancements in its pipeline.
On February 24, 2023, Chiesi Global Rare Diseases and Protalix BioTherapeutics (NYSE American: PLX) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for PRX-102 (pegunigalsidase alfa), aimed at treating adult Fabry disease patients. This groundbreaking enzyme replacement therapy demonstrates a favorable benefit-risk profile based on comprehensive clinical studies. A final decision by the European Commission is expected in May 2023, which could lead to significant advancements in treatment options for those suffering from this rare disease.
Protalix BioTherapeutics (NYSE American: PLX) has announced its participation in the 19th Annual WORLD Symposium™ 2023, scheduled for February 22–26, 2023, at the Hilton Orlando, Florida. Protalix will host an informational booth at the event. Its partner, Chiesi Global Rare Diseases, will present on key topics, including PRX–102, an investigational treatment for Fabry disease. Presentations and abstracts will be accessible on Protalix's website. Protalix is renowned for its ProCellEx® system, enabling the production of recombinant therapeutic proteins and has a diverse pipeline targeting various diseases.
Protalix BioTherapeutics (NYSE: PLX) will announce its fiscal year 2022 financial results and provide a business update on February 27, 2023. The event will include a conference call at 8:30 a.m. EST, where management will discuss the financial outcomes and recent corporate developments. The company's proprietary ProCellEx® system produces therapeutic proteins, with taliglucerase alfa being its first FDA-approved product. Protalix's pipeline includes products targeting key health issues like Fabry disease and severe gout, indicating ongoing investment in innovative biopharmaceuticals.
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