Protalix reports Q3 2026 results, reaffirms revenue guidance, RELEASE gout study enrolling

Protalix BioTherapeutics reported financial and business results for the third quarter ended September 30, 2026, on November 10, 2026. The company said patient enrollment continues in its Phase 2 RELEASE study (NCT07280156) of PRX-115, a recombinant PEGylated uricase, for the treatment of uncontrolled gout, with anticipated top-line results in the second half of 2027¹. The trial is a double-blind, placebo-controlled study testing a fixed 36 mg dose of PRX-115 across five treatment arms of 30 patients each, including dosing every 4 weeks without methotrexate, and every 4, 6, or 8 weeks with methotrexate, plus a placebo arm¹. The primary endpoint is the proportion of patients who demonstrate a reduction in serum uric acid levels to below 6.0 mg/dL for at least 80% of the time during Month 6¹.

Separately, Protalix is presenting new Phase 1 data for PRX-115 at ACR Convergence 2026. The poster analysis covers the 18 mg, 24 mg and 36 mg cohorts, with six participants per cohort who received a single infusion and were followed for 85 days¹. The company said the new individual patient data reinforce earlier findings and show the effect associated with PRX-115 plasma levels remaining measurable for up to 85 days¹.

On the commercial side, Protalix said Elfabrio received marketing authorization in Brazil for both the every-two-weeks and every-four-weeks dosing regimens¹, with Chiesi Global Rare Diseases serving as the company's partner for the global development and commercialization of Elfabrio¹.

Protalix reaffirmed its 2026 revenue guidance, expecting total revenues of approximately $78.0 million to $83.0 million, a figure that includes a $25.0 million milestone payment the company received from Chiesi in the first quarter of 2026¹. Within that, the company projected full-year Elfabrio sales revenue, excluding milestones, of approximately $33.0 million to $35.0 million, and full-year Elelyso sales revenue of approximately $20.0 million to $23.0 million¹.

Protalix reported cash, cash equivalents, and short-term bank deposits of $48.5 million as of September 30, 2026¹, and said it has no outstanding debt or warrants¹.