Arrowhead Pharmaceuticals develops and commercializes RNA interference medicines that silence genes associated with intractable diseases. The company’s TRiM™ platform is used to design targeted RNAi therapeutics for tissues including liver, lung, muscle, adipose and central nervous system tissue.
Recurring ARWR news covers REDEMPLO® (plozasiran), an siRNA medicine approved in the United States and Australia as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome. Company updates also address plozasiran data across hypertriglyceridemia, regulatory actions in additional geographies, pricing and market-access strategy, fiscal results, investor events, and clinical or partnering developments involving programs such as ARO-PNPLA3, ARO-INHBE and ARO-ALK7.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) is scheduled to participate in investor conference fireside chats on November 18 and December 2, 2026.
The Jefferies Global Healthcare Conference session in London is at 11:00 am GMT on November 18. The Citi Global Healthcare Conference session is at 2:20 pm EST on December 2, followed by the Piper Sandler 38th Annual Healthcare Conference session at 3:00 pm EST.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) presented plozasiran trial results showing a 78% reduction in acute pancreatitis event rates versus placebo. The pooled SHASTA-3/4 analysis included 757 adults with severe hypertriglyceridemia, or very high blood triglycerides; the reduction was 91% among patients with pancreatitis within five years before screening.
In the PALISADE extension for familial chylomicronemia syndrome, median triglyceride reductions were 76% through up to 36 months of treatment. The extension lacked a concurrent placebo control. Worsening glycemic control occurred in 14% of plozasiran patients versus 8.7% on placebo in SHASTA-3/4.
Interim Phase 1/2a single-dose ARO-DIMER-PA results showed mean LDL cholesterol reductions of 26%–65% and median triglyceride reductions of 56%–78% from baseline, not placebo-adjusted. All 21 treated participants reported treatment-emergent adverse events; none were serious.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) completed a refinancing with funds managed by Sixth Street, replacing its existing facility with a $400 million loan. The retired facility was prepaid at a $68 million discount to its contractual minimum repayment amount. The new loan bears annual interest at the three-month Secured Overnight Financing Rate (SOFR) plus 5.50%, compared with 15% annually under the retired facility.
The new senior secured loan matures on November 2, 2031, with all principal due then and no scheduled principal repayments beforehand. It eliminates required repayments from specified partnership receipts and commercial revenue. Substantially all company assets secure the obligations on a first-priority basis, subject to exceptions. Additional fees and early repayment premiums apply. Arrowhead said the refinancing extends maturity and improves near-term liquidity and operational flexibility.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) will host a webcast and conference call on November 12, 2026, to discuss its fiscal year-end results. The call is scheduled for 4:30 p.m. ET and covers the fiscal year ended September 30, 2026. A live audio webcast will be available through the Investors section of Arrowhead’s website, with a replay available approximately two hours after the call concludes.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) will present clinical data at the American Heart Association Scientific Sessions on November 7, 2026, in Chicago.
Two oral presentations in the Featured Science Session on Novel Lipid Lowering Therapies will cover Phase 1/2a results for investigational ARO-DIMER-PA in mixed hyperlipidemia and a pooled SHASTA-3/4 analysis of triglyceride lowering and acute pancreatitis risk reduction with plozasiran in severe hypertriglyceridemia. Both are scheduled for 3:15–4:30 pm CT.
Moderated posters will address three-year efficacy and safety data from PALISADE and its open-label extension in familial chylomicronemia syndrome, and the impact of GLP-1 receptor agonist use on triglyceride reduction with plozasiran.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) has received UK marketing authorisation for REDEMPLO, a treatment to reduce triglycerides in adults with familial chylomicronaemia syndrome.
The approval covers use alongside diet in patients diagnosed genetically or clinically. NICE recommends NHS funding in England and Wales for genetically confirmed cases when diet and conventional triglyceride-lowering therapies have been inadequate, under a commercial arrangement. Approval was based on PALISADE, a Phase 3 placebo-controlled study in 75 adults. At the recommended 25 mg dose, plozasiran significantly reduced median fasting triglyceride levels versus placebo at month 10 (p <0.0001).
Arrowhead Pharmaceuticals (ARWR) reported interim Phase 1/2a ARO-MAPT results showing mean cerebrospinal fluid tau reduction of up to 73% in healthy volunteers. The investigational treatment uses RNA interference to reduce production of tau protein. At Day 105, mean reductions were 40%, 69%, and 73% at 2.1, 6.4, and 12.8 mg/kg, respectively; the highest-dose group had a maximum individual reduction of 85%. Day 105 was 90 days after the final dose, supporting potential dosing every three months or less frequently.
Most treatment-emergent adverse events were mild; none were serious or led to discontinuation, and no deaths were reported. Effects on brain tau tangles, cognition, function, and disease progression remain to be investigated in patients. Healthy-volunteer cohorts are fully enrolled. Arrowhead plans further dosing and continued early Alzheimer’s enrollment, with data updates expected in 2027.
Arrowhead Pharmaceuticals (ARWR) gained FDA STAR pilot program entry for plozasiran’s planned supplemental application to treat severe hypertriglyceridemia, a condition that raises pancreatitis risk.
The program qualifies the application for 6-month Priority Review, versus a 10-month standard review. FDA generally targets expedited action, potentially at least 1 month before the Priority Review goal date. Arrowhead retains its Priority Review Voucher purchased in August 2026 because STAR entry does not require its use.
Arrowhead expects to submit the supplemental new drug application by year-end 2026 and plans to seek additional global approvals afterward. Plozasiran, marketed as REDEMPLO, is already approved in the United States, European Union, China, Australia and Canada as an adjunct to diet to reduce triglycerides in adults with genetically confirmed or clinically diagnosed familial chylomicronemia syndrome.
Arrowhead Pharmaceuticals (ARWR) will host an October 14 webinar on interim Phase 1/2a ARO-MAPT data and its central nervous system pipeline.
ARO-MAPT is an investigational treatment for Alzheimer’s disease and other tauopathies. The placebo-controlled study is designed to assess safety, tolerability and how the drug behaves and works in the body. It may enroll up to 64 healthy volunteers and up to 48 people with early Alzheimer’s disease. No interim findings were disclosed in the announcement.
Arrowhead Pharmaceuticals (ARWR) reported interim topline results from a Phase 1/2a trial of ARO-DIMER-PA, a first-in-class dual-functional RNAi therapeutic being developed for atherosclerotic cardiovascular disease due to mixed hyperlipidemia. In participants with mixed hyperlipidemia receiving a single dose, ARO-DIMER-PA achieved dose-dependent mean maximal reductions in serum PCSK9 of 72% and APOC3 of 88%.
Silencing of both genes led to mean maximal reductions of 54% in LDL-C, 73% in triglycerides, 61% in non-HDL cholesterol, and 50% in apolipoprotein B. Single-dose escalation has been completed through 400 mg. The most common treatment-emergent adverse events were injection site reactions and headaches, and no drug-related serious adverse events were reported. The ongoing study is now assessing safety and tolerability of multiple doses.