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.”
A key priority is PRX-115, the company’s investigational therapy for uncontrolled gout. Bashan wrote that Phase 1 data showed PRX-115 delivered a “rapid and durable urate-lowering effect with a favorable tolerability profile,” supporting its potential as a differentiated treatment.
He noted that gout prevalence continues to rise globally and that many patients remain uncontrolled despite available therapies.
“Uncontrolled gout is a high–need, high–value indication and PRX-115 has the potential to deliver a differentiated clinical profile with rapid onset and durable urate control,” Bashan wrote, adding that the program could become a third commercial product from Protalix’s internal pipeline.
The company submitted an investigational new drug application to the US Food and Drug Administration in October 2025 to support a planned Phase 2 trial of PRX-115, which has since become effective.
Bashan wrote that Phase 1 results showed the therapy was generally well tolerated, with urate levels reduced below target thresholds across all cohorts.
Protalix is also increasing its focus on rare kidney diseases, beginning with PRX-119, a long-acting DNase I program aimed at reducing inflammation and fibrosis. The renal strategy reflects the company’s commitment to addressing diseases with high unmet need while creating long-term value, according to Bashan.
On the commercial side, Bashan highlighted continued execution with partner Chiesi Global Rare Diseases following the launch of Elfabrio for Fabry disease. He wrote that performance indicators across the United States, Europe and other markets “continue to track to plan,” with Elfabrio expected to remain the company’s primary revenue driver.
Bashan also noted that a re-examination is underway of the European Medicines Agency’s November 2025 negative opinion on a proposed every-four-weeks dosing regimen for Elfabrio, with an appeal outcome expected in the first quarter of 2026. He noted that the existing bi-weekly label remains unaffected.
In addition, Protalix expects ongoing contributions from Elelyso through its collaborations with Pfizer Inc (NYSE:PFE, XETRA:PFE) and Brazil’s Fundação Oswaldo Cruz.
“We move forward with confidence, commitment, and an unwavering focus on creating long–term value for patients, partners, and shareholders alike,” Bashan concluded.