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.
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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.
Protalix BioTherapeutics (NYSE American: PLX) reflects on its significant achievements in 2022 in a letter to shareholders. The company, in collaboration with Chiesi, has submitted marketing applications for its Fabry disease treatment PRX-102 to both the FDA and EMA, with the latter under review. The FDA has set a decision date of May 9, 2023. Additionally, Protalix is progressing with PRX-115 for severe gout, showing promising preclinical results. The firm expresses optimism for continued growth in 2023, underscoring the potential market for PRX-102 and ongoing pipeline developments.
Protalix BioTherapeutics (NYSE American: PLX) will voluntarily delist its common stock from the Tel Aviv Stock Exchange (TASE) to focus on trading on the NYSE American. This decision is expected to streamline operations, reducing costs and regulatory compliance. The delisting process will begin immediately, with an expected completion time of three months. During this transition, PLX shares will continue to trade on the TASE and will eventually transfer to the NYSE American. The company remains committed to complying with U.S. SEC regulations and will provide further updates on the delisting timeline.