In his January 5 letter to stockholders, CEO Dror Bashan outlined Protalix’s dual focus for 2026: advancing an innovative clinical pipeline while leveraging partnered commercial products to drive profitability. The company’s core strategy centers on expanding collaborations—most notably with Chiesi Global Rare Diseases and Pfizer Inc.—to support near-term revenue, while allocating R&D resources toward high-value rare disease indications. Bashan emphasized that Protalix will prioritize PRX-115 for uncontrolled gout and PRX-119 for rare renal conditions, reflecting a disciplined approach to capital deployment in areas with growing prevalence and significant unmet medical need.

Protalix has submitted an IND for PRX-115, a recombinant PEGylated uricase designed for once-every-four-weeks dosing. The FDA’s 30-day review concluded in October 2025, activating sites for a planned Phase 2 study (NCT05745727). Phase 1 results showed a single dose lowered serum urate below 6 mg/dL across all cohorts, with effects lasting up to 12 weeks at higher doses and a favorable tolerability profile marked by predominantly mild, transient events. Preclinical work on PRX-119, a long-acting DNase I, continues to progress under a new RNA-based collaboration with Secarna Pharmaceuticals, which leverages AI-driven oligonucleotide design to target inflammation and fibrosis in rare kidney diseases.

In 2025, Protalix’s partner Chiesi maintained solid launch execution for Elfabrio® in the US, EU and other markets, with treated patient counts and market share tracking to plan. The global Fabry disease market is projected to reach approximately $3.4 billion by 2030, and management expects Elfabrio to capture 15%–20% of that market. The company is appealing the EMA’s November 2025 negative opinion on a 2 mg/kg every-four-weeks dosing regimen, with a decision due in Q1 2026; current bi-weekly approval remains unaffected. Additionally, Elelyso® continues to generate steady revenues through partnerships with Pfizer and Brazil’s Fiocruz program.

Protalix enters 2026 with a profitable commercial base and a targeted pipeline, limiting downside risk while preserving upside potential. Management’s near-term priorities include supporting Chiesi’s commercial rollout of Elfabrio, advancing PRX-115 toward Phase 2 efficacy readouts, and progressing rare renal programs via bespoke modalities and strategic alliances. By focusing on high-need rare diseases with demonstrated prevalence growth—such as gout, where US rates have risen substantially over the past two decades—Protalix aims to build durable shareholder value through clinical milestones, geographic expansion and potential licensing or co-development transactions.