Arrowhead Pharmaceuticals reports positive Phase 3 trial data for plozasiran, showing significant triglyceride reductions in patients with severe hypertriglyceridemia.
Arrowhead Pharmaceuticals reported positive topline data from two late-stage Phase 3 trials, SHASTA-3 and SHASTA-4, evaluating the drug plozasiran for patients with severe hypertriglyceridemia. The results showed that plozasiran achieved triglyceride reductions of 79% and 81% from baseline, respectively, significantly outperforming the placebo group. The studies also met all secondary endpoints, including a notable reduction in acute pancreatitis events. Analysts suggest the data positions plozasiran as a "best-in-class" candidate that could compete directly with Ionis Pharmaceuticals’ recently approved treatment, Tryngolza. Arrowhead Pharmaceuticals noted that the drug maintained a consistent safety and tolerability profile with no new safety signals identified. Following these results, Arrowhead Pharmaceuticals plans to submit a supplemental New Drug Application to the FDA before the end of 2026 to seek approval for severe hypertriglyceridemia. The company will present detailed findings at the European Society of Cardiology Congress on August 30. Shares of Arrowhead Pharmaceuticals rose more than 18% following the announcement.