Protalix reports Q2 2026 results, reaffirms PRX-115 gout trial timeline and 2026 revenue guidance

Protalix BioTherapeutics reported second quarter 2026 results on August 12, 2026, alongside a business and clinical update. The company said patient enrollment continues in the RELEASE Phase 2 clinical trial, registered as NCT07280156, of PRX-115, a recombinant PEGylated uricase for uncontrolled gout, and the company continues to anticipate top-line results in the second half of 2027.¹

On the intellectual property front, the USPTO issued U.S. Patent No. 12,674,146, titled "Modified Uricase and Uses Thereof," to Protalix Ltd. on July 7, 2026, which the company said strengthens its intellectual property position around PRX-115.¹

For Elfabrio (pegunigalsidase alfa-iwxj), the USPTO issued a Patent Term Extension certificate on May 4, 2026 for U.S. Patent No. 9,194,011 covering the drug, adding five years to the patent term and moving the U.S. expiration date to November 17, 2035.¹ Separately, Elfabrio received orphan drug designation and marketing authorization in South Korea in May 2026, with Kwangdong Pharmaceutical Co., Ltd. named as the local marketing authorization holder.¹

On the preclinical side, the company continues to advance PRX-119, a long-acting DNase I program, as part of a wider strategic push into rare renal indications and other research collaborations.¹

Protalix reaffirmed its financial outlook. Total revenue for 2026 is still expected to range from approximately $78.0 million to $83.0 million, including a $25.0 million milestone already received from Chiesi, with Elfabrio sales excluding milestones expected between $33.0 million and $35.0 million, and Elelyso sales expected between $20.0 million and $23.0 million.¹

On cash, cash, cash equivalents, and short-term bank deposits stood at $40.7 million as of June 30, 2026.¹ CEO Dror Bashan said with $40.7 million in cash and short-term deposits, the company is well-positioned to fund execution across its operations.¹