Welcome to our dedicated page for Arrowhead Research news (Ticker: ARWR), a resource for investors and traders seeking the latest updates and insights on Arrowhead Research stock.
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 (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.
Arrowhead Pharmaceuticals (ARWR) will participate in three investor conferences in September 2026, each featuring a fireside chat presentation.
The company will present at the 2026 Cantor Global Healthcare Conference/b on September 10 at 10:55 am EDT, the on September 15 at 11:30 am EDT, and the H.C. Wainwright 28th Annual Global Investment Conference on September 16 at 9:00 am EDT. Presentation materials and potential webcasts will be available via the Events and Presentations page of Arrowhead’s investor website.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) reported that Phase 3 SHASTA-3 and SHASTA-4 trials of plozasiran in adults with severe hypertriglyceridemia met primary and all prespecified secondary endpoints. Plozasiran 25 mg quarterly achieved median triglyceride reductions of 79% and 81% at Month 12 versus placebo and significantly lowered atherogenic lipoproteins.
More than 90% of treated patients reached triglycerides <500 mg/dL and over half <150 mg/dL. A pooled analysis showed a 78% reduction in acute pancreatitis events overall and 91% in patients with prior pancreatitis. Treatment-emergent adverse events were similar to placebo, with serious events in 8.3% vs 10%. Arrowhead plans to file a U.S. FDA supplemental New Drug Application for plozasiran in broader sHTG by year-end 2026, using a Priority Review Voucher.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced that new 12‑month Phase 3 data from the SHASTA‑3 and SHASTA‑4 studies of plozasiran in adults with severe hypertriglyceridemia will be presented in a HOT LINE Late‑Breaking Science session at the European Society of Cardiology Congress in Munich on August 30, 2026.
The presentation, delivered by Professor Gerald Watts, will focus on percent change in fasting serum triglycerides versus placebo after four quarterly doses of plozasiran in approximately 750 participants. A related ESC panel on next‑generation lipid‑lowering therapies and a dedicated Arrowhead investor webcast on August 31, 2026 will further review SHASTA‑3 and SHASTA‑4 results and include Q&A with external experts and Arrowhead management.
The release also outlines the current approvals, designations, and dosing profile for REDEMPLO (plozasiran) in familial chylomicronemia syndrome, and provides background on zodasiran for homozygous familial hypercholesterolemia.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced that adults in Germany with familial chylomicronaemia syndrome (FCS) now have access to REDEMPLO (plozasiran), listed in the Lauer-Taxe database and eligible for prescription, dispensing and reimbursement. The drug is authorized in the EU as an adjunct to diet to reduce triglyceride levels in adults with clinically or genetically diagnosed FCS and is administered as a subcutaneous injection once every three months.
According to Arrowhead, European marketing authorisation, granted in June 2026, was based on the Phase 3 PALISADE study in 75 adults, where the 25 mg dose significantly reduced median fasting triglycerides versus placebo at Month 10 (p <0.0001). The most common adverse reactions included hyperglycaemia (12.8%), headache (6.8%), nausea (4.7%) and injection site reactions (4.7%).
Arrowhead Pharmaceuticals (NASDAQ: ARWR) reported fiscal 2026 third quarter results for the period ended June 30, 2026, highlighted by strong REDEMPLO commercialization, major clinical milestones, and a significant licensing deal.
Quarterly revenue rose to $75.3 million from $27.8 million a year earlier, while R&D expenses increased to $198.2 million and SG&A to $47.1 million. The company reported an operating loss of $170.1 million and a net loss attributable to Arrowhead of $194.3 million, or $1.36 per diluted share. Total cash resources (cash and available-for-sale securities) reached $1.57 billion, up from $781.5 million on September 30, 2025, with total liabilities at $1.65 billion, including $682.7 million in convertible notes.
Commercially, REDEMPLO prescription volume roughly doubled, with more than 400 unique prescribers and new marketing authorizations in the EU and Australia for familial chylomicronemia syndrome. Clinically, Phase 3 SHASTA-3 and SHASTA-4 for plozasiran in severe hypertriglyceridemia met primary and all prespecified secondary endpoints, showing median triglyceride reductions of 79% and 81%, a 78% reduction in acute pancreatitis events versus placebo, and no new safety signals. Arrowhead completed enrollment in the Phase 3 YOSEMITE trial of zodasiran in HoFH, presented positive interim data for ARO-INHBE in obesity and MASH, and reported new plozasiran data supporting use in renal and hepatic impairment.
Corporate actions included acquiring an FDA Priority Review Voucher intended for a plozasiran sNDA submission before the end of 2026 and signing an exclusive worldwide license with Madrigal Pharmaceuticals for ARO-PNPLA3, with a $25 million upfront payment, up to $975 million in potential milestones, and tiered royalties.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) signed an agreement with an undisclosed third party to acquire a U.S. FDA Rare Pediatric Disease Priority Review Voucher (PRV). Arrowhead plans to use the PRV for a planned supplemental New Drug Application (sNDA) for plozasiran, expected before the end of 2026, to seek expansion of the current indication to include patients with severe hypertriglyceridemia (sHTG).
A Priority Review designation reduces the FDA’s target review time from 10 months to six months. According to Arrowhead, recent topline results from the Phase 3 SHASTA-3 and SHASTA-4 studies support confidence in plozasiran for sHTG. Plozasiran, marketed as REDEMPLO, is already approved in the U.S., EU, China, Australia, and Canada for adults with familial chylomicronemia syndrome (FCS), the most severe form of sHTG. Closing of the PRV transaction remains subject to expiration or termination of the Hart-Scott-Rodino waiting period and other customary conditions.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) reported that on July 16, 2026, its Board of Directors approved inducement equity grants to 95 new employees under NASDAQ Listing Rule 5635(c)(4). The awards cover up to 112,794 restricted stock units, granted outside existing stockholder-approved equity incentive plans.
According to Arrowhead Pharmaceuticals, these RSUs vest annually over four years, serving as an employment inducement. The company describes itself as a commercial-stage developer of RNA interference (RNAi) therapeutics based on its targeted RNAi molecule (TRiM™) platform.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) reported completion of enrollment in the global Phase 3 YOSEMITE trial of zodasiran, an investigational RNA interference therapy for homozygous familial hypercholesterolemia (HoFH). The study ultimately enrolled 70 adolescent and adult patients, above the originally planned 60, reflecting strong patient and physician interest.
YOSEMITE is a randomized, double-blind, placebo-controlled trial in patients aged ≥12 years with genetically or clinically diagnosed HoFH on maximally tolerated lipid-lowering therapy. Participants receive four doses of 200 mg zodasiran or placebo once every three months, with a primary endpoint of percent change in fasting LDL-C at month 12. Arrowhead anticipates study completion in mid‑2027 and, if results are successful, plans to seek regulatory approvals in multiple regions. Zodasiran targets ANGPTL3, has U.S. FDA Orphan Drug Designation for HoFH, and in prior studies showed dose-dependent reductions in atherogenic lipoproteins and a favorable safety profile, including no drug-related serious adverse events in the Phase 2 GATEWAY HoFH study.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) reported topline Phase 3 results from the global SHASTA-3 and SHASTA-4 studies of plozasiran in adults with severe hypertriglyceridemia (sHTG). Both double-blind, placebo-controlled trials met their primary endpoint, showing median triglyceride reductions of 79% and 81% at month 12 with 25 mg plozasiran given subcutaneously once every three months, versus about 27% on placebo.
All prespecified secondary endpoints were also met, including statistically significant reductions in acute pancreatitis (AP) events. Across the pooled sHTG population (triglycerides >500 mg/dL), cumulative AP events fell 78% versus placebo, and in the highest-risk subgroup (triglycerides >880 mg/dL with prior AP), AP events were reduced by 100% versus placebo. Plozasiran’s safety and tolerability profile was consistent with prior studies, with no new safety signals, no hypersensitivity cases, no thrombocytopenia signal, no clinically meaningful adverse liver enzyme changes, and no significant difference in mean liver fat versus placebo.
Plozasiran, marketed as REDEMPLO for familial chylomicronemia syndrome (FCS), is already approved in the U.S., EU, China, Australia, and Canada as an adjunct to diet to reduce triglycerides in adults with FCS. Arrowhead plans to use SHASTA-3, SHASTA-4, and MUIR-3 data to seek broader sHTG marketing authorizations globally, starting with a planned U.S. supplemental new drug application (sNDA) before the end of 2026. Detailed 12‑month results will be presented as a HOT LINE Late Breaker at the European Society of Cardiology Congress in Munich on August 30, 2026.