Protalix is accelerating its clinical programs, led by PRX-115 for uncontrolled gout. Phase 1 data showed a single dose reduced serum urate below 6 mg/dL across all cohorts, with the effect sustained for up to 12 weeks at higher dose levels and a favorable tolerability profile marked by only mild, transient events. An IND for the planned Phase 2 trial became effective in October 2025 following the FDA’s 30-day review, and the first U.S. clinical sites are now activated. Concurrently, the company is advancing PRX-119, a PEGylated, long-acting DNase I designed to degrade neutrophil extracellular traps and mitigate inflammation and fibrosis in rare renal diseases, leveraging a newly announced RNA-based collaboration with Secarna Pharmaceuticals to broaden its preclinical pipeline.

Protalix’s near-term cash flow is underpinned by partnerships with Chiesi Global Rare Diseases, Pfizer Inc. and Fundação Oswaldo Cruz. In 2025, Elfabrio® launch execution tracked to plan across the United States, European Union and additional markets, with treated patient counts and market share steadily growing. The global Fabry market is projected to reach $3.4 billion by 2030, and Protalix and Chiesi expect Elfabrio to capture 15%–20% of that total. Elelyso® sales through Pfizer and Fiocruz also continue to provide stable, predictable revenue streams that support operating resilience.

An appeal of the European Medicines Agency’s negative opinion on the proposed 2 mg/kg every-four-weeks dosing regimen for Elfabrio is underway, with a decision expected in Q1 2026. This effort seeks to expand flexible dosing options without affecting the existing bi-weekly label. In the U.S., Protalix and Chiesi are collaborating on real-world evidence generation to reinforce the differentiated clinical profile of Elfabrio and support broader payer coverage and formulary placement.

For 2026, Protalix is focused on three core objectives: sustaining and growing commercial performance with existing partners, advancing PRX-115 toward pivotal studies as a potential best-in-class therapy for uncontrolled gout, and building a differentiated renal pipeline based on PRX-119 and RNA-based candidates. Management believes this balanced approach—mixing profitable partnered products with high-value, internally developed assets—limits downside risk while preserving upside potential, positioning the company to deliver durable revenue growth and unlock long-term shareholder value.