Protalix Biotherapeutics Inc. (PBDA)
XDUS 
Summary
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Protalix and Chiesi seek EMA re-examination of Elfabrio dosing opinion
Protalix Biotherapeutics Inc (NYSE-A:PLX) and Chiesi Global Rare Diseases said they have requested a re-examination of a recent negative opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) concerning a new dosing regimen for Elfabrio. The CHMP's opinion relates to a proposal to add a 2 mg/kg every-four-weeks (E4W) dosing option to the currently approved 1 mg/kg every-two-weeks (E2W) regimen for the treatment of adults with Fabry disease.
Protalix, Chiesi reaffirm commitment to Fabry disease patients after EMA panel setback
Protalix Biotherapeutics Inc (NYSE-A:PLX) and Chiesi Global Rare Diseases said they remain committed to advancing treatment options for Fabry disease after a European Medicines Agency committee declined to recommend approval of a new, less frequent dosing regimen for Elfabrio (pegunigalsidase alfa). The Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on the proposed dosing schedule of 2 mg/kg every four weeks, in addition to the already approved 1 mg/kg every two weeks regimen.
Protalix: Speculative Buy On Promising Plant-Cell Platform And Elfabrio Ramp
Protalix BioTherapeutics uses a plant-cell approach with ProCellEx. This has given it two approved ERTs plus PRX-115 and PRX-119. Its main focus is on a growing rare-disease pipeline. The main value driver is Elfabrio, which targets Fabry's rapidly growing TAM. PLX's valuation multiples also look compelling, especially after the stock retraced significantly in the last few weeks.
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Protalix Biotherapeutics Inc. Profile
| Biotechnology Industry | Healthcare Sector | Dror Bashan CEO | XDUS 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.
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