Arrowhead Pharmaceuticals Plans Supplemental Drug Approval Application

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 (ARWR) reported early positive data for ARO-DIMER-PA, showing reductions in bad cholesterol and triglycerides. The company expects peak sales of $3-$4B for Redemplo and highlighted a strong pipeline. Retail traders on Stocktwits have turned 'extremely bullish' on ARWR, with some buying on recent selloffs. ARWR stock is up 2% year-to-date.

Arrowhead Pharmaceuticals (ARWR) reported interim Phase 1/2a trial data for ARO-DIMER-PA, showing 72% reduction in PCSK9 and 88% in APOC3. The drug demonstrated favorable lipid changes, including 54% LDL-C reduction. Analysts maintain Buy ratings with price targets up to $120. Shares rose 0.68% premarket.

Arrowhead Pharmaceuticals reported interim Phase I/IIa trial results for ARO-DIMER-PA, showing dose-dependent reductions in PCSK9 (72%) and APOC3 (88%) in mixed hyperlipidaemia patients. The treatment also reduced LDL-C (54%), triglycerides (73%), and other lipids. No serious adverse events were reported. The trial is ongoing to assess repeat dosing. According to the company, this marks the first clinical validation of targeting two genes simultaneously with RNAi therapeutics.

Arrowhead Pharmaceuticals (ARWR) fell 8.93% to $73.47 after announcing interim Phase 1/2a trial data for ARO-DIMER-PA, an RNAi therapeutic targeting PCSK9 and APOC3 genes. The company reported robust reductions in LDL-C and other lipoproteins, validating its Targeted RNAi Molecule platform.