What Protalix BioTherapeutics does

Protalix BioTherapeutics, Inc. is a publicly traded biopharmaceutical company (NYSE American: PLX) founded in 1994 and headquartered in Carmiel, Israel, that develops and manufactures recombinant therapeutic proteins through its proprietary ProCellEx plant cell-based expression platform. The company has commercialized two FDA-approved enzyme replacement therapies produced via genetically engineered plant cell suspension cultures in disposable polyethylene bioreactors: Elelyso (taliglucerase alfa) for Type 1 Gaucher disease, approved in 2012 as the first plant cell-expressed protein therapeutic approved by the FDA; and Elfabrio (pegunigalsidase alfa) for adult Fabry disease, approved by the FDA in 2023. Protalix's clinical pipeline includes PRX-115, a PEGylated recombinant uricase in Phase 2 for uncontrolled gout, and PRX-119, a PEGylated DNase I in preclinical research for NETs-related diseases.

The company operates a capital-light, partnership-driven commercialization model. All marketed products are sold through strategic channel partners rather than direct sales infrastructure: Pfizer holds global rights to Elelyso (excluding Brazil, where Fiocruz distributes), and Chiesi Global Rare Diseases holds global rights to Elfabrio. Revenue streams consist of product supply/manufacturing payments, royalties, and regulatory and commercial milestone payments from these partners, supplemented by recent milestone income (e.g., a $25M payment from Chiesi in Q1 2026 tied to European Commission approval of Elfabrio's every-four-weeks dosing regimen). FY2026 revenue is guided to $78-83M with $51.1M of cash as of March 31, 2026. End customers are patients with rare genetic lysosomal storage disorders and (in the pipeline) broader populations with gout and NETs-related diseases; the company is actively seeking additional collaborations to expand its pipeline beyond enzyme replacement therapy into oligonucleotide-based therapeutics for rare renal indications through a December 2025 agreement with Secarna Pharmaceuticals.

Name

Protalix BioTherapeutics

Legal name

Protalix BioTherapeutics Inc.

Website

https://protalix.com

Company type

Public

Founded year

1994

Operating status

Operating

Headcount range

501–1,000 employees

Short description

Protalix BioTherapeutics is an Israel-based, publicly traded biopharmaceutical company that develops and manufactures recombinant therapeutic proteins through its proprietary ProCellEx plant cell-based expression platform, commercializing FDA-approved enzyme replacement therapies Elelyso (Gaucher disease) and Elfabrio (Fabry disease) via partners Pfizer, Chiesi, and Fiocruz.

Ownership category

akta.pro rank

Product category

Biopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Recombinant Protein Therapeutics (enzymes, hormones, growth factors) (HLAAAAAB)

Keywords

• Recombinant protein production
• Enzyme replacement therapy
• Plant cell expression
• Biopharmaceutical manufacturing
• Rare disease therapeutics

Headquarters

HQ city

Carmiel

HQ country

Israel

HQ region

Middle East

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales

Revenue model

1. Product Sales (Elelyso & Elfabrio): Revenue from product sales to commercialization partners including Pfizer (Elelyso) and Chiesi (Elfabrio), as well as Fiocruz in Brazil. Products are approved in multiple markets including US, EU, Brazil, Israel and others.
2. Milestone Payments: One-time regulatory milestone payments triggered by approvals. Q1 2026 included $25 million milestone from Chiesi following European Commission approval of Elfabrio E4W dosing regimen.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels1 record

Core offering

Protalix BioTherapeutics develops and manufactures recombinant therapeutic proteins using its proprietary ProCellEx plant cell-based expression system. The company has commercialized two FDA-approved enzyme replacement therapies—Elelyso (taliglucerase alfa) for Type I Gaucher disease and Elfabrio (pegunigalsidase alfa) for Fabry disease—through strategic partnerships with Pfizer and Chiesi Global Rare Diseases.

Product overview

Protalix BioTherapeutics is a biopharmaceutical company that has developed two FDA-approved enzyme replacement therapies: Elelyso for type I Gaucher disease and Elfabrio for Fabry disease, both produced through the proprietary ProCellEx plant cell-based expression platform. The company is advancing its clinical pipeline with PRX-115 (PEGylated uricase for uncontrolled gout in Phase 2) and PRX-119 (PEGylated DNase I for NETs-related diseases in research/preclinical stages).

Differentiator

Problem solved

Functional benefit

Brands

• ProCellEx: Proprietary plant cell-based protein expression platform used to produce recombinant therapeutic proteins
• Elfabrio
• Elelyso

Products and services

• Elfabrio (pegunigalsidase alfa) Elfabrio is an enzyme replacement therapy (ERT) for adult patients with Fabry disease, replacing the deficient alpha-galactosidase-A enzyme through intravenous infusion. It is expressed in plant cell culture with a covalently bound polyethylene glycol polymer linker, commercialized globally by Chiesi Global Rare Diseases.
• Elelyso (taliglucerase alfa) Elelyso is an enzyme replacement therapy for patients with Type 1 Gaucher disease, replacing the deficient glucocerebrosidase enzyme with a recombinant form of the protein produced through the ProCellEx platform. It was the first plant cell-based recombinant therapeutic protein approved by the FDA, commercialized globally by Pfizer (excluding Brazil) and by Fiocruz in Brazil.
• PRX-115 PRX-115 is a recombinant PEGylated uricase enzyme in development for the potential treatment of uncontrolled gout. The uricase enzyme converts uric acid to allantoin, designed to lower uric acid levels with low immunogenicity and increased half-life.
• PRX-119 PRX-119 is a PEGylated Deoxyribonuclease (DNase) I enzyme in development for NETs-related diseases, designed to degrade circulating NETs-related cell-free DNA levels and decrease NET-mediated pathology.
• ProCellEx Plant Cell-Based Protein Expression Platform ProCellEx is Protalix's proprietary plant cell-based expression platform for producing and manufacturing recombinant therapeutic proteins, offering an alternative to mammalian cell-based production with production, regulatory, and cost benefits. Protalix actively offers the platform for collaborations and co-development of new rare disease therapeutics with high unmet medical need.

Quantifiable outcome

• Elfabrio approved in US, EU, Great Britain, Switzerland, Israel
• +3 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Four partnerships are on record, tiered minor and core.

• Secarna PharmaceuticalsminorStrategic or Co-development Partner · 17 December 2025Collaboration and option agreement to develop oligonucleotide therapies for rare renal indications. Leverages Protalix's expertise in rare diseases and Secarna's AI platform. Joint research with Protalix obtaining exclusive option to license active compounds for clinical development. Companies aim to advance therapies from preclinical stages through clinical trials and potential commercialization.
• Chiesi Global Rare DiseasescoreChannel Partner/ Reseller/ Distributor · 1 January 2017Chiesi Global Rare Diseases (business unit of Chiesi Group) is the global partner for commercialization of Elfabrio (pegunigalsidase alfa) for Fabry disease. Collaboration began in 2017 and was expanded in 2018. Chiesi received exclusive rights to commercialize for all markets. Protalix manufactures the drug substance for commercial purposes and post-approval clinical studies. The partnership includes collaboration on clinical development and regulatory approvals, including a $25M milestone payment to Protalix for EC approval of E4W dosing regimen.
• Pfizer Inc.coreChannel Partner/ Reseller/ Distributor · 1 November 2009Pfizer is the global partner for commercialization of Elelyso (taliglucerase alfa) for Gaucher disease, excluding Brazil. The collaboration was initiated in November 2009 and restated in October 2015. Under the arrangement, Pfizer received exclusive rights to commercialize taliglucerase alfa for all markets outside Brazil. Protalix manufactures the Elelyso drug substance for commercial purposes. Both companies collaborate in clinical development and regulatory process.
• Fundação Oswaldo Cruz (Fiocruz)coreChannel Partner/ Reseller/ DistributorFiocruz, an arm of the Brazilian Ministry of Health, is the partner for commercialization of alfataliglicerase (Elelyso) in Brazil. Protalix sells the product to Fiocruz at negotiated prices.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Amicus Therapeutics: Amicus commercializes Galafold (migalastat) for Fabry disease and is developing AT-GAA for Pompe disease, making it a direct therapeutic-area competitor to Protalix's Elfabrio in Fabry and a peer in the rare-disease enzyme replacement / small-molecule chaperone space.
• BioMarin Pharmaceutical: BioMarin is a rare-disease specialist with multiple enzyme replacement and biologic therapies (e.g., Naglazyme, Vimizim, Aldurazyme). It shares Protalix's focus on enzyme-based therapeutics for lysosomal storage and rare metabolic disorders.
• Ultragenyx Pharmaceutical: Ultragenyx develops biologics and enzyme replacement therapies for rare genetic diseases (e.g., Crysvita, Dojolvi). It is a direct comparator in the rare-disease recombinant biologics space targeting similarly small patient populations.
• Swedish Orphan Biovitrum (Sobi): Sobi is a European rare-disease specialist with enzyme replacement therapies (e.g., Eloctate, Alprolix, Gamifant) and direct overlap with Protalix's commercial model of partnering with larger pharma for distribution.

Broad incumbents

• Sanofi (Genzyme): Sanofi's Genzyme unit markets Fabrazyme (agalsidase beta) for Fabry disease and Cerezyme (imiglucerase) for Gaucher disease — the dominant incumbents in Protalix's two core approved indications and the primary share-take competition.
• Takeda Pharmaceutical (Shire): Takeda acquired Shire and markets Replagal (agalsidase alfa) for Fabry and Vpriv (velaglucerase alfa) for Gaucher, competing head-to-head with Elfabrio and Elelyso in the same enzyme-replacement market segments.
• AstraZeneca (Alexion): Alexion, AstraZeneca's rare-disease unit, commercializes biologics (e.g., Soliris, Strensiq) for ultra-rare conditions. It overlaps with Protalix in rare-disease biologic commercialization infrastructure and orphan-drug commercial strategy.
• Amgen: Amgen's acquisition of Horizon Therapeutics added rare-disease and inflammation assets (e.g., Tepezza, Krystexxa for refractory gout). Krystexxa is a direct competitor to PRX-115 in uncontrolled/refractory gout.
• Regeneron Pharmaceuticals: Regeneron is a large-cap biopharmaceutical company with deep recombinant-protein manufacturing capabilities (VelociSuite) and rare-disease exposure. While not a direct competitor in Protalix's indications, it represents a comparable recombinant-protein platform company at much larger scale.

Emerging players

• iBio: iBio uses a plant-based protein expression platform (FastPharming) similar in concept to Protalix's ProCellEx. It represents the closest emerging technology peer for plant-cell biomanufacturing capability.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/protalix-biotherapiutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Funding overview

Funding rounds9 records

Investors11 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Protalix BioTherapeutics