Arrowhead reports Phase 3 data showing potentially best-in-class triglyceride reduction, eyes FDA filing

Arrowhead Pharmaceuticals announced topline results from two late-stage Phase 3 trials (SHASTA-3 and SHASTA-4) of its siRNA drug plozasiran in patients with severe hypertriglyceridemia (sHTG).

The studies, enrolling about 750 patients, met the primary endpoint of triglyceride reduction versus placebo and achieved all prespecified secondary endpoints, including a lower incidence of acute pancreatitis.

Analysts described the profile as "potentially best-in-class," suggesting plozasiran could compete with Ionis Pharmaceuticals' recently approved Tryngolza, which received FDA approval for the same indication last month.

Following the announcement, Arrowhead's share price jumped more than 20% at market open, while Ionis shares slipped slightly. The company said it plans to submit a filing for FDA approval by the end of the year.