Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) announced today that it will present important data at this week’s American Heart Association Scientific Sessions in Chicago.
AHA 2026 Oral Presentations
Date & Time: Saturday, November 7, 3:15 – 4:30 pm CT
Session Title: FS.05: Featured Science Session on Novel Lipid Lowering Therapies
Location: Learning Studio 2‚ Science and Technology Hall‚ South Hall
Title: First-in-Human Trial of a Dual Functional RNAi Molecule to Silence Expression of Both PCSK9 and APOC3 in Mixed Hyperlipidemia (ARO-DIMER-PA)
Presenter: Luke Laffin, M.D., Co-Director, Center for Blood Pressure Disorders, and Medical Director of Cardiac Rehabilitation at the Cleveland Clinic, Cleveland, OH
Date & Time: Saturday, November 7, 3:15 – 4:30 pm CT
Session Title: FS.05: Featured Science Session on Novel Lipid Lowering Therapies
Location: Learning Studio 2‚ Science and Technology Hall‚ South Hall
Title: Triglyceride Lowering and Acute Pancreatitis (AP) Risk Reduction with Plozasiran in Severe Hypertriglyceridemia (sHTG): A Pooled Analysis of SHASTA-3 and SHASTA-4
Presenter: Christie Ballantyne, M.D., Chief of Cardiology and Cardiovascular Research, Baylor College of Medicine, and Director, Center for Cardiometabolic Disease Prevention at the Houston Methodist DeBakey Heart and Vascular Center, Houston, TX
Moderated Poster Sessions
Date & Time: Saturday, November 7, 9:15 am CT
Session Title: PL.MDP.01: Transforming Lipid Care Across the Lifespan
Location: Moderated Digital Poster 21‚ Population Science Zone
Topic: Long Term Efficacy and Safety of Plozasiran in Patients with Familial Chylomicronemia Syndrome: 3-Year Data from the PALISADE Study and the Open-Label Extension
Presenter: Robert Rosenson, M.D., Dr. Rony Shimony Distinguished Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai and System Director of Metabolism and Lipids for the Mount Sinai Health System, New York, NY
Date & Time: Saturday, November 7, 1:45 pm CT
Session Title: PL.MDP.01: Innovations in Lipid Science: Emerging Therapies and Population Impact
Location: Moderated Digital Poster 22‚ Population Science Zone
Topic: Impact of GLP-1 Receptor Agonist Use on Triglyceride Reduction with Plozasiran, PL.MDP.05: Innovations in Lipid Science: Emerging Therapies and Population Impact
Presenter: Daniel Gaudet, M.D., Ph.D., Department of Medicine, Université de Montréal and ECOGENE 21 Clinical Research Center, Chicoutimi, Quebec, QC, Canada
About ARO-DIMER-PA
ARO-DIMER-PA is an investigational dual-functional RNAi molecule designed to silence expression of both PCSK9 and APOC3 genes in hepatocytes. Prior clinical experience with other investigational and approved agents suggests that PCSK9 and APOC3 inhibition may lead to robust reductions in LDL-C, triglycerides (TGs), triglyceride-rich lipoprotein remnants, and total atherogenic lipoproteins.
ARO-DIMER-PA is the first clinical candidate designed to selectively silence the expression of two genes with a single RNAi molecule. ARO-DIMER-PA-1001 (NCT07223658) is a Phase 1/2a placebo-controlled dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and effects on LDL-C and triglycerides of single and multiple doses of ARO-DIMER-PA in adults with mixed hyperlipidemia.
About Mixed Hyperlipidemia
Mixed hyperlipidemia is a highly prevalent disorder characterized by elevated levels of both low-density lipoprotein cholesterol (LDL-C) and triglycerides (TGs) and is a major risk factor for atherosclerotic cardiovascular disease (ASCVD), which is the leading cause of mortality worldwide and associated with substantial morbidity and healthcare costs. Despite the efficacy of LDL-C-lowering therapies in reducing ASCVD risk, there remains substantial residual risk in patients with mixed hyperlipidemia.
About SHASTA-3 and SHASTA-4 Phase 3 Studies
SHASTA-3 (NCT06347003) and SHASTA-4 (NCT06347016) are global double-blind, placebo-controlled, Phase 3 studies to evaluate the efficacy and safety of plozasiran in adults with sHTG. Between the two studies, approximately 750 participants were randomized to receive 4 doses (one every 3 months) of 25 mg plozasiran or placebo. The primary endpoint is percent change in fasting serum triglyceride levels from baseline to month 12 compared to placebo. After month 12, eligible participants are offered an opportunity to continue in an optional open-label extension.
About Plozasiran in the Treatment of Severe Hypertriglyceridemia
Plozasiran, the active ingredient in REDEMPLO, was granted Breakthrough Therapy designation in December 2025 for the treatment of severe hypertriglyceridemia (sHTG), and in October 2026 was granted entry in the FDA Split Real Time Application Review (STAR) pilot program in connection with Arrowhead’s upcoming supplemental new drug application (sNDA) in sHTG. Plozasiran is not currently approved for the treatment of sHTG.
About Severe Hypertriglyceridemia
Severe hypertriglyceridemia (sHTG) is characterized by TG levels greater than 500 mg/dL, with the most severe form being familial chylomicronemia syndrome (FCS) where TGs typically exceed 880 mg/dL. SHTG significantly increases the risk of acute pancreatitis (AP), which can often include recurrent attacks requiring repeat hospital admissions and worsening outcomes. AP risk is proportional to the number, characteristics, and concentration of triglyceride-rich lipoproteins, particularly chylomicrons, and increases as TGs rise. Elevated TGs can also increase the risk of ASCVD. Limited treatment options exist to sustainably reduce TGs below guideline-directed risk thresholds.
About REDEMPLO® (plozasiran)
REDEMPLO (plozasiran) is currently approved by the U.S. Food and Drug Administration, Health Canada, China’s National Medical Products Administration, the Australian Therapeutic Goods Administration, the UK Medicines and Healthcare products Regulatory Agency, and by the European Commission as an adjunct to diet to reduce triglycerides for adults with FCS. REDEMPLO is the first and only siRNA treatment approved in these countries to be studied in both clinically diagnosed and genetically confirmed patients living with FCS.
REDEMPLO is designed to suppress the production of apolipoprotein C-III (APOC3), a protein produced in the liver that raises triglyceride levels by slowing their breakdown and clearance. By targeting APOC3 with sustained silencing, REDEMPLO delivers significant reductions in triglyceride levels. REDEMPLO is self-administered via subcutaneous injection once every three months.
REDEMPLO has been granted Orphan Medicinal Product Designation by the EMA for the treatment of patients with FCS, and Breakthrough Therapy Designation, Fast Track Designation, and Orphan Drug Designation by the U.S. FDA for the treatment of patients with FCS.
Sanofi acquired the rights to develop and commercialize REDEMPLO in Greater China, with Arrowhead retaining rights to REDEMPLO in all geographies, outside of Greater China.
For more information about REDEMPLO, visit Our Medicines.
About Familial Chylomicronemia Syndrome
Familial chylomicronemia syndrome (FCS) is a severe and rare genetic disease often caused by various monogenic mutations. FCS leads to extremely high triglyceride (TG) levels, typically over 880 mg/dL. Such severe elevations can lead to various serious signs and symptoms including acute and potentially fatal pancreatitis, chronic abdominal pain, diabetes, hepatic steatosis, and cognitive issues. Currently, the therapeutic options that can adequately treat FCS are limited.
About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals (NASDAQ: ARWR) is a commercial-stage pharmaceutical company developing medicines that treat intractable diseases by silencing the genes that cause them, harnessing the natural RNA interference (RNAi) mechanism. The Company has built a broad portfolio of clinical and commercial RNAi therapeutics through its industry-leading targeted RNAi molecule (TRiM™) platform, which can precisely silence genes in a wide range of cell types, including liver, lung, muscle, adipose, and central nervous system tissue. At Arrowhead, we rapidly advance potential best- and first-in-class RNAi treatments for diseases with significant unmet medical need, because every day matters to the patients we serve.
For more information, please visit www.arrowheadpharma.com, or follow us on X (formerly Twitter) at @ArrowheadPharma, LinkedIn, Facebook, and Instagram. To be added to the Company’s email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts.
Safe Harbor Statement under the Private Securities Litigation Reform Act:
This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “hope,” “intend,” “plan,” “project,” “could,” “estimate,” “continue,” “target,” “forecast” or the negative of these words or other variations thereof or comparable terminology are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline, products or product candidates, or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about our beliefs and expectations regarding the long-term impacts of REDEMPLO® (plozasiran) on patient health and the health care system; our beliefs and expectations regarding the pricing, value, or expected timing for availability of our drugs and drug candidates; our beliefs and expectations regarding the potential safety, efficacy, and therapeutic benefit of ARO-DIMER-PA and plozasiran in sHTG; the timing of any regulatory submissions for plozasiran in sHTG; and our beliefs and expectations around the potential uses and value of the TRiM™ platform. These statements are based upon our current expectations and speak only as of the date hereof. Actual results or outcomes may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties including but not limited to the safety and efficacy of our products and product candidates, pricing and reimbursement decisions related to our products, demand for our products, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.
Source: Arrowhead Pharmaceuticals, Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20261102145649/en/
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