Late-stage studies achieve all primary and secondary goals
Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) shares jumped 18% on Wednesday after the company announced positive topline data from its Phase 3 SHASTA-3 and SHASTA-4 clinical trials evaluating plozasiran in patients with severe hypertriglyceridemia.
Both studies successfully met their primary endpoint of reducing triglyceride levels compared with placebo, while also achieving every prespecified secondary endpoint.
Patients receiving plozasiran as a 25 mg subcutaneous injection once every three months experienced median triglyceride reductions of 79% in SHASTA-3 and 81% in SHASTA-4 after 12 months. By comparison, the placebo group recorded reductions of approximately 27%.
Treatment lowers pancreatitis risk
A pre-planned pooled analysis of both trials also demonstrated a statistically significant reduction in acute pancreatitis events among patients treated with plozasiran compared with those receiving placebo.
The company said the therapy continued to show a favourable safety and tolerability profile throughout the studies, with no new safety concerns identified and no clinically meaningful differences observed in routine laboratory testing.
Regulatory expansion planned
Plozasiran is already marketed under the brand name REDEMPLO and has received regulatory approval in the United States, the European Union, China, Australia and Canada for the treatment of adults with familial chylomicronemia syndrome.
Following the latest trial results, Arrowhead plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration before the end of 2026 to seek approval for the treatment of severe hypertriglyceridemia.
Full data presentation scheduled for August
The company said detailed findings from the SHASTA-3 and SHASTA-4 studies will be presented during the European Society of Cardiology Congress in Munich on August 30, 2026.
Arrowhead Pharmaceuticals stock price
