Arrowhead’s plozasiran granted FDA STAR pilot program entry

Arrowhead Pharmaceuticals (ARWR) announced FDA inclusion of plozasiran in the STAR program for its sNDA for severe hypertriglyceridemia. The program aims to expedite reviews, potentially reducing approval time to six months. SHTG increases acute pancreatitis risk, leading to hospitalizations and fatalities.

Arrowhead Pharmaceuticals (ARWR) announced FDA acceptance of plozasiran into the STAR program for its severe hypertriglyceridemia sNDA, enabling Priority Review without using a PRV. The company must submit the sNDA by year-end 2026.

Arrowhead Pharmaceuticals reported interim Phase 1/2a data for ARO-DIMER-PA, showing 72% silencing of PCSK9 and 88% of APOC3 with no serious adverse events. Analysts project $1.0B revenue and $176M earnings by 2029, with a 66% potential upside. The company plans to file for severe hypertriglyceridemia approval for REDEMPLO by year-end.

Arrowhead Pharmaceuticals (ARWR) is amending a study to add a multidose portion in mixed-hyperlipidemia patients before a Phase III study. The company reported smooth launch progress for plozasiran in familial chylomicronemia syndrome (FCS) and plans to seek approval in severe hypertriglyceridemia (SHTG). Arrowhead expects to provide further details on additional dimer candidates in 2027. The company's current net price for plozasiran is $45,000 annually. Arrowhead is also developing programs in

Arrowhead Pharmaceuticals (ARWR) plans to submit a supplemental new drug application for plozasiran in severe hypertriglyceridemia (SHTG) by year-end, with Phase 3 trials showing about an 80% reduction in triglycerides. The company acquired a priority review voucher, which could reduce review timing by four months. Arrowhead estimates plozasiran could become a $3 billion to $4 billion annual U.S. drug at peak. The company also provided updates on its zodasiran program in homozygous familial hype

Arrowhead Pharmaceuticals plans to file a supplemental application for its drug Redemplo by year-end, with CEO Chris Anzalone projecting peak U.S. sales of $3B-$4B. The company's pipeline includes zodasiran for rare high-cholesterol conditions. ARWR stock has seen a 2% year-to-date increase, with 8 analysts rating it a 'Buy'.