Protalix Biotherapeutics (PLX) announced an update on their ongoing clinical study.
Claim 30% Off TipRanks
- Unlock hedge fund-level data and powerful investing tools for smarter, sharper decisions
- Discover top-performing stock ideas and upgrade to a portfolio of market leaders with Smart Investor Picks
The RELEASE trial is a mid stage clinical study run by Protalix to test a new gout treatment called PRX-115. The official title shows the study is focused on how well the drug works, how safe it is, and which dosing schedule is best when compared with placebo in adults with gout.
The treatment being tested is PRX-115, an infused biologic drug designed to lower uric acid and reduce gout burden. It is given alone or together with low dose oral methotrexate, which may help the body accept the drug and improve its effect over time.
The study is interventional and randomized, meaning patients are assigned by chance to PRX-115 or placebo groups. It is double blind with multiple masked parties, so patients and study staff do not know who gets active drug, and the main goal is to treat gout rather than just observe it.
Patients receive drug or placebo on fixed schedules every 4, 6, or 8 weeks to find the best balance between benefit and convenience. Placebo groups mirror the active groups, which lets the sponsor compare results across different dosing cycles in a clean way.
The planned start date is December 3, 2025, marking the beginning of patient enrollment and dosing. The latest update on February 23, 2026 confirms the trial is recruiting and that the sponsor has recently reviewed the design and operational plans.
For investors, this update signals that Protalix is pushing deeper into the gout market, which is now dominated by drugs from Takeda, Horizon, and others. A positive phase 2 outcome could support a premium on Protalix’s valuation as a platform company and diversify its pipeline beyond existing rare disease programs.
Competitors and larger pharma groups may track the data closely as next generation gout therapies draw strategic interest. The market reaction before results is likely to be modest and news driven, with bigger moves tied to future data readouts and any signs of regulatory support or partnership deals.
The RELEASE study is currently active with recent updates, and more detailed information is available on the ClinicalTrials portal.
To learn more about PLX’s potential, visit the Protalix Biotherapeutics drug pipeline page.