Protalix BioTherapeutics Inc. (US74365A3095)
XSTU 
Summary
US74365A3095 Chart
A March Decision That Could Change Protalix BioTherapeutics Outlook
Protalix Bio Therapeutics (PLX) received a positive CHMP opinion for Elfabrio's every-four-weeks dosing in stable adult Fabry patients, pending EC approval by March. PLX's Elfabrio could halve infusion frequency, improving patient quality of life and potentially strengthening its competitive position in the Fabry market. Elfabrio drove over half of PLX's FY24 product revenue, with sales rising and a potential $25 million milestone tied to EU approval.
Protalix wins EU panel backing for expanded dosing of Fabry disease drug
Protalix Biotherapeutics Inc (NYSE-A:PLX, FRA:PBDA) said on Friday that the European Medicines Agency's human medicines committee has issued a positive opinion recommending approval of an expanded dosing regimen for Elfabrio, its treatment for Fabry disease, in adult patients. The Committee for Medicinal Products for Human Use (CHMP) recommended approval of a 2 mg/kg every-four-weeks dosing schedule for Elfabrio in adult Fabry patients who are stable on enzyme replacement therapy, following a re-examination of the application.
Protalix BioTherapeutics CEO outlines 2026 priorities, highlights progress across clinical pipeline
Protalix Biotherapeutics Inc (NYSE-A:PLX) on Monday shared an update from its CEO Dror Bashan, who highlighted the company's strategic priorities for 2026, with a focus on advancing its clinical pipeline while building on its partnered commercial base. In a letter to stockholders, Bashan wrote that Protalix remains focused on “building with our partners a growing, profitable business and an innovative pipeline for patients with high-need rare diseases.
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Protalix BioTherapeutics Inc. Profile
| Biotechnology Industry | Healthcare Sector | Dror Bashan CEO | XSTU Exchange | US74365A3095 ISIN |
| US Country | 213 Employees | - Last Dividend | 20 Dec 2019 Last Split | 15 May 1998 IPO Date |
Overview
Protalix BioTherapeutics, Inc. is a notable player in the biopharmaceutical industry, focusing on the development, production, and commercialization of recombinant therapeutic proteins using its innovative ProCellEx plant cell-based protein expression system. The company's global presence extends across the United States, Australia, Canada, Israel, Brazil, Russia, Turkey, among other international markets. Founded in 1993 and having its headquarters in Karmiel, Israel, Protalix BioTherapeutics operates as a subsidiary of Protalix Ltd. It holds strategic agreements and partnerships with influential entities such as Pfizer, Fundação Oswaldo Cruz, and Chiesi Farmaceutici S.p.A, underscoring its collaborative approach to advancing healthcare solutions.
Products and Services
- Elelyso
- Elfabrio
- PRX-115
- PRX-119
A groundbreaking treatment developed by Protalix BioTherapeutics for Gaucher disease, Elelyso showcases the company's capability to address rare and debilitating disorders. This product represents a significant advancement in the field of enzyme replacement therapies, offering patients a plant-cell based, recombinant therapeutic protein alternative.
Another notable entry in Protalix’s portfolio, Elfabrio, has been designed to treat adult patients confirmed to have Fabry disease. This addition emphasizes the company's dedication to expanding its offering of therapeutic solutions for rare genetic diseases, leveraging its proprietary ProCellEx technology to bring innovative treatments to the market.
Currently in Phase I clinical trial, PRX-115 is a pioneer project for Protalix, exploring the potential of plant cell-expressed recombinant PEGylated Uricase in the treatment of gout. This study represents the company's ongoing commitment to the development of novel therapies for widespread conditions utilizing its unique protein expression system.
In the preclinical phase, PRX-119 is a promising venture into developing a plant cell-expressed PEGylated recombinant human DNase I product for the treatment of NETs-related diseases. The initiative to explore treatments for this complex condition illustrates Protalix BioTherapeutics' dedication to leveraging its platform for addressing a broad spectrum of diseases.
