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.
Protalix BioTherapeutics (NYSE: PLX) is a biopharmaceutical innovator leveraging its proprietary ProCellEx® plant cell-based technology to develop enzyme replacement therapies for rare diseases. This page provides investors and industry stakeholders with timely updates on clinical developments, regulatory milestones, and strategic partnerships.
Access comprehensive coverage of PLX's advancements in treating Gaucher disease, Fabry disease, and other rare conditions. Track updates across three key areas: clinical trial progress for pipeline candidates, commercial partnerships with global pharmaceutical leaders, and manufacturing innovations through the ProCellEx® platform.
Our curated news collection enables efficient monitoring of FDA submissions, earnings reports, and licensing agreements. Stay informed about the company's unique approach to cost-effective bioproduction and its expanding role in addressing unmet medical needs through plant-based protein expression systems.
Bookmark this page for direct access to verified press releases and objective analysis of Protalix's position within the competitive rare disease therapeutics market. Regular updates ensure you maintain current awareness of developments impacting both clinical outcomes and investment considerations.
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.
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