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Posted by Defense World Staff on Jul 25th, 2026

Affinity Asset Advisors LLC lifted its stake in shares of Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR – Free Report) by 185.7% during the first quarter, according to its most recent disclosure with the Securities and Exchange Commission (SEC). The firm owned 200,000 shares of the biotechnology company’s stock after acquiring an additional 130,000 shares during the quarter. Affinity Asset Advisors LLC owned about 0.14% of Arrowhead Pharmaceuticals worth $12,540,000 at the end of the most recent reporting period.

A number of other institutional investors have also recently added to or reduced their stakes in ARWR. Tsfg LLC acquired a new stake in shares of Arrowhead Pharmaceuticals during the 4th quarter valued at $25,000. iSAM Funds UK Ltd bought a new stake in Arrowhead Pharmaceuticals during the third quarter worth approximately $29,000. First Horizon Corp acquired a new stake in shares of Arrowhead Pharmaceuticals in the fourth quarter worth $32,000. WPG Advisers LLC lifted its stake in shares of Arrowhead Pharmaceuticals by 384.8% in the fourth quarter. WPG Advisers LLC now owns 543 shares of the biotechnology company’s stock worth $36,000 after buying an additional 431 shares during the last quarter. Finally, Hantz Financial Services Inc. boosted its holdings in shares of Arrowhead Pharmaceuticals by 177.1% during the 4th quarter. Hantz Financial Services Inc. now owns 737 shares of the biotechnology company’s stock worth $49,000 after buying an additional 471 shares during the period. 62.61% of the stock is currently owned by institutional investors and hedge funds.

Arrowhead Pharmaceuticals Stock Down 1.4% Shares of NASDAQ ARWR opened at $85.60 on Friday. The stock has a market capitalization of $12.06 billion, a P/E ratio of -39.81 and a beta of 1.26. The stock’s fifty day moving average is $77.94 and its 200 day moving average is $69.97. Arrowhead Pharmaceuticals, Inc. has a 52 week low of $15.01 and a 52 week high of $95.49. The company has a debt-to-equity ratio of 1.41, a quick ratio of 6.23 and a current ratio of 6.23.

Arrowhead Pharmaceuticals (NASDAQ:ARWR – Get Free Report) last released its earnings results on Thursday, May 7th. The biotechnology company reported ($0.93) EPS for the quarter, beating the consensus estimate of ($1.10) by $0.17. The firm had revenue of $73.74 million for the quarter, compared to analyst estimates of $73.84 million. Arrowhead Pharmaceuticals had a negative net margin of 48.38% and a negative return on equity of 55.09%. The business’s quarterly revenue was down 86.4% compared to the same quarter last year. During the same period last year, the firm earned $2.75 EPS. Sell-side analysts forecast that Arrowhead Pharmaceuticals, Inc. will post -3.08 earnings per share for the current fiscal year.

Insider Activity at Arrowhead Pharmaceuticals In related news, Director Hongbo Lu sold 2,970 shares of the firm’s stock in a transaction that occurred on Tuesday, May 12th. The stock was sold at an average price of $76.88, for a total transaction of $228,333.60. Following the completion of the sale, the director owned 52,012 shares of the company’s stock, valued at $3,998,682.56. This trade represents a 5.40% decrease in their ownership of the stock. The transaction was disclosed in a document filed with the SEC, which is available at the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. 3.60% of the stock is currently owned by insiders.

Analysts Set New Price Targets A number of brokerages have issued reports on ARWR. Morgan Stanley lifted their price objective on Arrowhead Pharmaceuticals from $100.00 to $120.00 and gave the company an “overweight” rating in a report on Thursday. JPMorgan Chase & Co. lifted their price target on shares of Arrowhead Pharmaceuticals from $88.00 to $95.00 and gave the company an “overweight” rating in a report on Friday, July 17th. Sanford C. Bernstein boosted their price target on shares of Arrowhead Pharmaceuticals from $35.00 to $46.00 and gave the company a “market perform” rating in a research report on Wednesday, May 13th. Royal Bank Of Canada upped their price objective on shares of Arrowhead Pharmaceuticals from $80.00 to $87.00 and gave the stock an “outperform” rating in a research note on Friday, May 8th. Finally, Piper Sandler reaffirmed an “overweight” rating and set a $126.00 price objective (up from $110.00) on shares of Arrowhead Pharmaceuticals in a report on Thursday. One analyst has rated the stock with a Strong Buy rating, nine have assigned a Buy rating, three have assigned a Hold rating and one has given a Sell rating to the company’s stock. Based on data from MarketBeat.com, Arrowhead Pharmaceuticals currently has a consensus rating of “Moderate Buy” and an average target price of $93.83.

Get Our Latest Stock Analysis on ARWR

Arrowhead Pharmaceuticals Company Profile (Free Report)

Arrowhead Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of RNA interference (RNAi) therapeutics. Since its founding in 2008, Arrowhead has leveraged its proprietary delivery platform—known internally as the Advanced RNAi Compound (ARC) technology—to silence disease-causing genes in patients suffering from genetically defined diseases. The company’s approach aims to offer durable, targeted treatments across a range of therapeutic areas.

The company’s pipeline includes multiple candidates in various stages of development.

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Hypertriglyceridemia is the presence of high levels of triglycerides (a type of fat) in the blood. The disease substantially raises the likelihood of fatal acute pancreatitis and frequent hospitalizations.

Trial Outcomes And Efficacy HighlightsBoth Phase 3 investigations successfully achieved their primary milestone by cutting triglyceride levels compared to a placebo.

Additionally, the studies satisfied all secondary objectives, demonstrating a statistically meaningful drop in acute pancreatitis occurrences.

Patients receiving a quarterly 25 mg subcutaneous dose of plozasiran experienced median triglyceride decreases of 79% in SHASTA-3 and 81% in SHASTA-4 after 12 months, whereas placebo groups saw reductions of around 27%.

A combined analysis indicated a statistically significant drop in single-event patient rates (p<0.0221) and overall event frequency (p<0.0077).

Across the broader patient group with triglyceride counts exceeding 500 mg/dL, cumulative pancreatitis events fell by 78%.

Notably, high-risk patients possessing triglyceride levels above 880 mg/dL alongside a history of acute pancreatitis achieved a 100% reduction in pancreatitis incidents compared to placebo.

Safety Metrics And Regulatory RoadmapPlozasiran exhibited a favorable safety profile, showing treatment-related adverse events in line with earlier trial observations.

Researchers recorded no novel safety concerns, standard laboratory variations, hypersensitivity cases, or thrombocytopenia risks. Liver enzyme changes remained clinically insignificant, and liver fat content evaluations matched placebo levels.

While complete evaluation of the trials continues ahead of future publications, plozasiran currently holds regulatory clearance under the brand name Redemplo across several regions, including the U.S., European Union, China, Australia, and Canada, for familial chylomicronemia syndrome.

The company plans to use data from SHASTA-3, SHASTA-4, and MUIR-3 to submit a supplemental new drug application to the U.S. FDA before the end of 2026, alongside seeking global authorizations.

ARWR Stock Price Activity: Arrowhead shares were up 22% at $90.96 at last check on Wednesday, according to Benzinga Pro data.

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[url="]Arrowhead Pharmaceuticals, Inc.[/url] (NASDAQ: ARWR) today announced topline results for the global Phase 3 SHASTA-3 and SHASTA-4 clinical studies of pl

PASADENA, Calif.--(BUSINESS WIRE)---- $arwr--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced topline results for the global Phase 3 SHASTA-3 and SHASTA-4 clinical studies of plozasiran in patients with severe hypertriglyceridemia (sHTG), a condition that significantly increases the risk of acute pancreatitis (AP), which is associated with repeated hospital admissions and can be fatal. SHASTA-3 and SHASTA-4 successfully met the primary endpoint of triglyceride reduction versus placebo and m.

PASADENA, Calif.--(BUSINESS WIRE)---- $arwr--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it will host a webcast and conference call on August 4, 2026, at 4:30 p.m. ET to discuss its financial results for the fiscal 2026 third quarter ended June 30, 2026.Webcast and Conference Call DetailsInvestors may access a live audio webcast on the Events and Presentations page under the Investors section of the Arrowhead website. A replay of the webcast will be available approximately two hour.

Arrowhead Pharmaceuticals, Inc. (ARWR) Discusses Cardiometabolic Pipeline and Clinical Development Programs Transcript

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PASADENA, Calif.--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced its plan to host a 2026 Summer Series of R&D webinars that highlight multiple clinical stage RNA interference (RNAi) based medicines that utilize the company’s proprietary Targeted RNAi Molecule (TRiM™) platform. Each webinar in the Summer Series will focus on a specific therapeutic area and will feature presentations by Arrowhead team members about the company’s clinical candidates and external key opinion leaders, who will discuss the respective disease areas and treatment landscapes.

Part I of Arrowhead’s 2026 Summer Series of R&D Webinars will focus on Arrowhead’s cardiometabolic pipeline and will be held on June 29, 2026, at 11:30 AM EDT. The webinar will feature a presentation from Steven Nissen, M.D., Chief Academic Officer for the Heart and Vascular Institute at the Cleveland Clinic, the Lewis and Patricia Dickey Chair in Cardiovascular Medicine and Professor of Medicine at the Lerner College of Medicine. The webinar will also feature presentations from Arrowhead management.

The agenda for Part I – Cardiometabolic is listed below:

Overview of Cardiometabolic Pipeline

Vince Anzalone, CFA, Arrowhead

Arrowhead’s Technology and R&D Process

James Hamilton, M.D., MBA, Arrowhead

Plozasiran (APOC3)

Jennifer Hellawell, M.D., Arrowhead

Zodasiran (ANGPTL3)

Jennifer Hellawell, M.D.

ARO-DIMER-PA (PCSK9/APOC3)

James Hamilton, M.D., MBA

Mixed Hyperlipidemia & ASCVD Treatment Landscape

Steven Nissen, M.D.​, Cleveland Clinic

Q&A

Panel

Each event in the 2026 Summer Series of R&D Webinars will be approximately 60-90 minutes in duration with live webcasts and replays available on the Events and Presentations page under the Investors section of the Arrowhead website. Registration links and additional details regarding times, agendas, and speakers will be provided on the Arrowhead website and social media channels prior to each event.

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 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 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 “continue” 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 or product candidates, including anticipated regulatory submissions and clinical program results, prospects or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; our expectations regarding the potential benefits of the partnership, licensing and/or collaboration arrangements and other strategic arrangements and transactions we have entered into or may enter into in the future; our beliefs and expectations regarding milestone, royalty or other payments that could be due to or from third parties under existing agreements; and our estimates regarding future revenues, research and development expenses, capital requirements and payments to third parties. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the safety and efficacy of our product candidates, 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, our ability to successfully develop and commercialize drug candidates, 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.

More News From Arrowhead Pharmaceuticals, Inc.

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– If confirmed by the European Commission, REDEMPLO would be the first and only siRNA medicine authorized in the EU for both genetically confirmed and clinically diagnosed adult patients with FCS

– People living with FCS have extremely high triglyceride levels and a substantially higher risk of acute pancreatitis and related long-term complications, often resulting in a reduced quality of life

– The CHMP opinion is based on positive results from the Phase 3 PALISADE study where REDEMPLO reduced triglycerides by a median of 80% from baseline and significantly fewer cases of acute pancreatitis were seen in patients using REDEMPLO compared with those using placebo

PASADENA, Calif.--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (EMA CHMP) has adopted a positive opinion, recommending the approval of REDEMPLO® (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglyceride levels in adult patients with familial chylomicronemia syndrome (FCS). FCS remains widely underdiagnosed and affects an estimated 1 to 13 people per million globally. This rare disease is characterized by triglyceride levels that can be orders of magnitude higher than normal, leading to a substantially higher risk of developing acute, recurrent, and potentially fatal pancreatitis.

We are pleased with the CHMP’s recommendation, which brings us closer to potential approval of REDEMPLO as a new treatment option for people living with genetically or clinically confirmed FCS across Europe

Share The European Commission is expected to issue a decision on REDEMPLO’s Marketing Authorization in the second quarter of 2026. If approved, REDEMPLO will be the first and only siRNA medicine authorized in the European Union for both genetically confirmed and clinically diagnosed adult patients with FCS. This recommendation follows approvals in the United States, Canada, and China, as Arrowhead continues its efforts to increase global access to care for people living with FCS.

In a press release announcing the positive opinion, EMA stated, "Although other authorised medicines can help people with FCS confirmed by genetic testing, REDEMPLO does not require genetic confirmation of the condition, thus providing a treatment option for more adults with FCS and addressing the unmet medical need in these patients."

“We are pleased with the CHMP’s recommendation, which brings us closer to potential approval of REDEMPLO as a new treatment option for people living with genetically or clinically confirmed FCS across Europe,” said Christopher Anzalone, Ph.D., President and CEO at Arrowhead Pharmaceuticals. “This milestone reflects the strength of the clinical data and the ability of our TRiM™ platform to enable targeted siRNA therapies to potentially reach multiple tissues and disease areas. We believe REDEMPLO could represent an important new option for the FCS community in Europe, and we are working with regulators and the healthcare community to bring this therapy to more patients as quickly as possible.”

Harnessing Arrowhead’s proprietary Targeted RNAi Molecule (TRiM™) platform, REDEMPLO is designed to silence the mRNA encoding apolipoprotein C-III (apoC-III). ApoC-III is a key regulator of triglyceride metabolism that inhibits triglyceride catabolism and clearance, resulting in elevated triglyceride levels. Individuals with genetic loss-of-function variants in APOC3 typically have markedly lower triglyceride levels and a reduced risk of atherosclerotic cardiovascular disease.

The CHMP positive opinion was supported by clinical data from the Phase 3 PALISADE study, a randomized, double-blind, placebo-controlled trial in adults with clinically diagnosed or genetically confirmed FCS. The PALISADE study met its primary endpoint and all multiplicity-controlled key secondary endpoints, including demonstrating significant reductions in triglycerides and apoC-III and in the incidence of acute pancreatitis in the pooled dose groups. In PALISADE, 25 mg REDEMPLO reduced triglycerides by a median of 80% from baseline versus a 17% reduction with placebo and significantly fewer cases of acute pancreatitis were seen in patients using REDEMPLO compared with those using placebo. REDEMPLO is self-administered via subcutaneous injection once every three months.1,2

The most common adverse reactions are hyperglycaemia (12.8%), headache (6.8%), nausea (4.7%), and injection site reaction (4.7%).

“Patients with FCS face a substantial burden of disease and are at life-long risk of acute pancreatitis, with few effective treatment options available,” said Gerald F Watts, DSc, PhD, MD, FRCP, Professor of Cardio-metabolic Medicine, University of Western Australia. “The results from the PALISADE study demonstrate that plozasiran can achieve substantial and sustained reductions in triglycerides in patients with FCS. These data highlight the potential of targeted RNA interference approaches in addressing conditions like FCS that have so far been difficult to treat. Plozasiran is a major advance in the care of FCS and a significant step toward expanding treatment options for patients across Europe.”

The efficacy and safety results from the PALISADE study were presented at the European Society of Cardiology (ESC) Congress 2024 and the American Heart Association Scientific Sessions 2024 (AHA24) and simultaneously published in The New England Journal of Medicine and Circulation, respectively. ESC, AHA24, and other plozasiran presentations may be accessed on the Events and Presentations page in the Investors section of the Arrowhead website.

REDEMPLO has been granted Orphan 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.

About FCS

Familial chylomicronemia syndrome (FCS) is a severe and rare disease leading to extremely high triglyceride (TG) levels, typically over 10 mmol/L (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, there are limited therapeutic options to adequately treat FCS.

About the PALISADE Phase 3 Study

The PALISADE study (NCT05089084) was a Phase 3 placebo-controlled study to evaluate the efficacy and safety of plozasiran in adults with genetically confirmed or clinically diagnosed FCS. The primary endpoint of the study was percent change from baseline in fasting TG versus placebo at Month 10. A total of 75 subjects distributed across 39 different sites in 18 countries were randomized to receive 25 mg plozasiran, 50 mg plozasiran, or matching placebo once every three months. Participants who completed the randomized period were eligible to continue in a 2-part extension period, where all participants receive plozasiran.

About REDEMPLO® (plozasiran)

REDEMPLO (plozasiran) is the first and only siRNA treatment approved in these countries that has been studied in both genetically confirmed and clinically diagnosed patients living with FCS. REDEMPLO is a first-in-class siRNA therapeutic designed to suppress the production of apoC-III, a protein produced in the liver that raises triglyceride levels by slowing their breakdown and clearance. By targeting apoC-III with sustained silencing, REDEMPLO delivers significant reductions in triglyceride levels. REDEMPLO is self-administered via subcutaneous injection once every three months.

The EMA CHMP has adopted a positive opinion recommending the European Marketing Authorization of REDEMPLO (plozasiran), which is already approved by the U.S. Food and Drug Administration, Health Canada, and China’s National Medical Products Administration as an adjunct to diet to reduce triglycerides for adults with Familial Chylomicronemia Syndrome (FCS).

In addition to approvals of REDEMPLO in the U.S., Canada, and China, plozasiran has been submitted to additional global regulatory authorities for review and marketing authorization. Plozasiran is also being investigated in the SHASTA-3 (NCT06347003), SHASTA-4 (NCT06347016), and SHASTA-5 (NCT06880770) Phase 3 studies in adults with severe hypertriglyceridemia and the MUIR-3 (NCT06347133) Phase 3 study in adults with hypertriglyceridemia. In December 2025, plozasiran was granted Breakthrough Therapy designation by the U.S. FDA in severe hypertriglyceridemia.

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 “continue” 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 if approved; 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 the safety and efficacy of our products and product candidates, pricing and reimbursement decisions related to our products if approved, 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.

1 Watts GF, Rosenson RS, Hegele RA, Goldberg IJ, Gallo A, Mertens A, Baass A, Zhou R, Muhsin M, Hellawell J, et al. Plozasiran for managing persistent chylomicronemia and pancreatitis risk. N Engl J Med. 2024;392:127–137. https://doi.org/10.1056/nejmoa2409368 PMID: 39225259
2 Watts GF, Hegele RA, Rosenson RS et al. Temporal Effects of Plozasiran on Lipids and Lipoproteins in Persistent Chylomicronemia. Circulation. 2025:151(10); 733-736; https://doi.org/10.1161/CIRCULATIONAHA.124.072860 PMID:39549263

More News From Arrowhead Pharmaceuticals, Inc.

– REDEMPLO is the first and only medicine approved for use in the treatment of FCS in Australia, and is authorized for both genetically confirmed and clinically diagnosed adult patients with FCS

– People living with FCS have extremely high triglyceride levels and a substantially higher risk of acute pancreatitis and related long-term complications, often resulting in a reduced quality of life

– The approval in Australia is based on positive results from the Phase 3 PALISADE study where REDEMPLO reduced triglycerides by a median of 80% from baseline and significantly reduced the incidence of acute pancreatitis across pooled doses, as compared with those using placebo

PASADENA, Calif.--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the Australian Therapeutic Goods Administration (TGA) has approved REDEMPLO® (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglyceride levels for adult patients with familial chylomicronemia syndrome (FCS) for whom standard triglyceride lowering therapies have been inadequate. FCS is a severe, rare disease characterized by triglyceride levels that can be orders of magnitude higher than normal, leading to a substantially higher risk of developing acute, recurrent, and potentially fatal pancreatitis. FCS remains widely underdiagnosed and affects an estimated 1 to 13 people per million globally.

We are pleased that REDEMPLO is now the first-ever approved treatment for Australians living with genetic or clinical FCS

Share REDEMPLO is the first and only medicine approved for use in the treatment of FCS in Australia, and is authorized for both genetically confirmed and clinically diagnosed adult patients with FCS. This approval by TGA follows approvals in the United States, Canada, and China, and a positive opinion recommending marketing authorization from EMA as Arrowhead continues its efforts to increase global access to care for people living with FCS.

“We are pleased that REDEMPLO is now the first-ever approved treatment for Australians living with genetic or clinical FCS,” said Christopher Anzalone, Ph.D., President and CEO of Arrowhead Pharmaceuticals. “This approval underscores the strength of the clinical data and the ability of our TRiM™ platform to develop targeted siRNA therapies to potentially reach multiple tissues and disease areas. We believe REDEMPLO could represent an important medicine for the FCS community in Australia, and we are working to bring this therapy to more patients as quickly as possible.”

Harnessing Arrowhead’s proprietary Targeted RNAi Molecule (TRiM™) platform, REDEMPLO is designed to silence the mRNA encoding apolipoprotein C-III (apoC-III). ApoC-III is a key regulator of triglyceride metabolism that inhibits triglyceride catabolism and clearance, resulting in elevated triglyceride levels. Individuals with genetic loss-of-function variants in APOC3 typically have markedly lower triglyceride levels and a reduced risk of atherosclerotic cardiovascular disease.

The Therapeutic Goods Administration approval was supported by clinical data from the Phase 3 PALISADE study, a randomized, double-blind, placebo-controlled trial in adults with clinically diagnosed or genetically confirmed FCS. The clinical study was conducted across 39 global sites, including 5 study locations in Australia. The PALISADE study met its primary endpoint and all multiplicity-controlled key secondary endpoints, including demonstrating significant reductions in triglycerides and apoC-III and in the incidence of acute pancreatitis in the pooled dose groups. In PALISADE, 25 mg REDEMPLO reduced triglycerides by a median of 80% from baseline versus a 17% reduction with placebo. Moreover, the odds of acute pancreatitis were 83% lower in the pooled dose groups (combined doses of 25 mg and 50 mg plozasiran) when compared with the placebo group (2 events in 2 subjects (4%) vs. 7 events in 5 subjects (20%), respectively). REDEMPLO is self-administered via subcutaneous injection once every three months.1,2

The Australian Product Information notes the most common adverse reaction is hyperglycaemia (12.8%). Other common adverse reactions include headache (6.8%), nausea (4.7%), and injection site reaction (4.7%).

“Patients with FCS face a substantial burden of disease and are at life-long risk of acute pancreatitis, with few effective treatment options available,” said Gerald F Watts, DSc, PhD, MD, FRCP, Professor of Cardio-metabolic Medicine, University of Western Australia. “The results from the PALISADE study demonstrate that plozasiran can achieve substantial and sustained reductions in triglycerides in patients with FCS. These data highlight the potential of targeted RNA interference approaches in addressing conditions like FCS that have so far been difficult to treat. Plozasiran is a major advance in the care of FCS and a significant step toward expanding treatment options for patients.”

The efficacy and safety results from the PALISADE study were presented at the European Society of Cardiology (ESC) Congress 2024 and the American Heart Association Scientific Sessions 2024 (AHA24) and simultaneously published in The New England Journal of Medicine and Circulation, respectively. ESC, AHA24, and other plozasiran presentations may be accessed on the Events and Presentations page in the Investors section of the Arrowhead website.

REDEMPLO was reviewed via the priority review pathway by Australia’s TGA and was granted Breakthrough Therapy Designation, Fast Track Designation, and Orphan Drug Designation by the U.S. FDA, as well as Orphan Medicinal Product Designation by the European Medicines Agency for the treatment of patients with FCS.

About FCS

Familial chylomicronemia syndrome (FCS) is a severe and rare disease leading to extremely high triglyceride (TG) levels, typically over 10 mmol/L (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, there are limited therapeutic options to adequately treat FCS.

About the PALISADE Phase 3 Study

The PALISADE study (NCT05089084) was a Phase 3 placebo-controlled study to evaluate the efficacy and safety of plozasiran in adults with genetically confirmed or clinically diagnosed FCS. The primary endpoint of the study was percent change from baseline in fasting TG versus placebo at Month 10. A total of 75 subjects distributed across 39 different sites in 18 countries were randomized to receive 25 mg plozasiran, 50 mg plozasiran, or matching placebo once every three months. Participants who completed the randomized period were eligible to continue in a 2-part extension period, where all participants receive plozasiran.

About REDEMPLO® (plozasiran)

REDEMPLO (plozasiran) is the first and only siRNA treatment approved in these countries that has been studied in both genetically confirmed and clinically diagnosed patients living with FCS. REDEMPLO is a first-in-class siRNA therapeutic designed to suppress the production of apoC-III, a protein produced in the liver that raises triglyceride levels by slowing their breakdown and clearance. By targeting apoC-III with sustained silencing, REDEMPLO delivers significant reductions in triglyceride levels. REDEMPLO is self-administered via subcutaneous injection once every three months.

The EMA CHMP has adopted a positive opinion recommending the European Marketing Authorization of REDEMPLO (plozasiran), which is already approved by the U.S. Food and Drug Administration, Health Canada, and China’s National Medical Products Administration as an adjunct to diet to reduce triglycerides for adults with Familial Chylomicronemia Syndrome (FCS).

Plozasiran is also being investigated in the SHASTA-3 (NCT06347003), SHASTA-4 (NCT06347016), and SHASTA-5 (NCT06880770) Phase 3 studies in adults with severe hypertriglyceridemia and the MUIR-3 (NCT06347133) Phase 3 study in adults with hypertriglyceridemia. In December 2025, plozasiran was granted Breakthrough Therapy designation by the U.S. FDA in severe hypertriglyceridemia.

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 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 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 “continue” 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 candidate 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; 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.

More News From Arrowhead Pharmaceuticals, Inc.

-

- Conference Call and Webcast Today, May 7, 2026, at 4:30 p.m. ET

PASADENA, Calif.--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2026 second quarter ended March 31, 2026. The Company is hosting a conference call today, May 7, 2026, at 4:30 p.m. ET to discuss the results.

Arrowhead continues to show strong execution in meeting and exceeding our commercial, R&D, and corporate goals.

Share “Arrowhead continues to show strong execution in meeting and exceeding our commercial, R&D, and corporate goals. The company is on extremely strong footing to continue to drive growth in the near-term with numerous opportunities to create long-term shareholder value,” said Christopher Anzalone, Ph.D., President and CEO at Arrowhead Pharmaceuticals. “We remain focused on a few key areas as being critical sources of sustainable growth for Arrowhead, and we have made tangible advancements across these areas. These include: strengthening our commercial presence to bring REDEMPLO® and potentially other cardiometabolic products in the future to the many patients and physicians who need it; continuing to deliver best-in-class in discovery, development, and regulatory capabilities in support of a deep pipeline of RNAi therapeutics capable of silencing genes expressed throughout the body to treat various diseases; and, being strategic and disciplined around pipeline, portfolio, and financial management.”

Key REDEMPLO® Commercial Events

Continued to build strong and consistent momentum since launching REDEMPLO (plozasiran) independently in the U.S. following its approval by the FDA on November 18, 2025, as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). Key metrics include: Total prescriptions received and in process to date exceeds 400, representing greater than 40% growth over just the last four weeks alone; A total of approximately 180 patients to date have received at least one pre-filled syringe shipment; New weekly prescriptions are accelerating - currently averaging approximately 30 new written prescriptions per week; Approximately 85% of prescriptions were for patients naive to the APOC3 class — a strong signal that physicians are identifying and treating patients with FCS who have never had access to an effective therapy. Patients switching from other APOC3 targeted therapies largely account for the remainder; Updated the U.S. wholesale acquisition cost (WAC) of REDEMPLO to $45,000 per patient per year, representing a premium to the competing APOC3 inhibitor approved for FCS which the company believes is supported by its clinical evidence. This price reflects Arrowhead’s commitment to optimize market access for all patients with FCS. As part of the One-REDEMPLO unified pricing model, the new price is intended to remain consistent across FCS and severe hypertriglyceridemia (SHTG), if that indication is approved, which potentially simplifies payer contracting and eliminates pricing complexity that could complicate future formulary negotiations; Key R&D Events

Following U.S. FDA approval of REDEMPLO in 2025, secured positive regulatory action in four additional geographies for patients with genetically confirmed and clinically diagnosed FCS: The Australian Therapeutic Goods Administration (TGA) approved REDEMPLO (plozasiran), as an adjunct to diet to reduce triglyceride levels for adult patients with familial chylomicronaemia syndrome in Australia; Received positive CHMP opinion recommending approval of REDEMPLO (plozasiran) to reduce triglycerides in adults with familial chylomicronemia syndrome in Europe. The European Commission is expected to issue a decision on REDEMPLO’s Marketing Authorization in the second quarter of 2026; The Chinese National Medical Products Administration (NMPA) approved REDEMPLO (plozasiran) for the reduction of triglyceride levels in adult patients with familial chylomicronemia syndrome. REDEMPLO will be marketed in Greater China by Sanofi under an agreement between Sanofi and Arrowhead; Health Canada issued a Notice of Compliance (NOC) authorizing REDEMPLO (plozasiran) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome for whom standard triglyceride lowering therapies have been inadequate. REDEMPLO is expected to be available later this year in Canada and the company anticipates it will be marketed independently by Arrowhead; Presented new long-term efficacy and safety data for plozasiran across a spectrum of hypertriglyceridemia at the American College of Cardiology’s 75th Annual Scientific Session and Expo. Key highlights include: Patients with severe hypertriglyceridemia achieved an 83% median reduction in triglycerides (TG), with 96% of patients achieving TG levels below 500 mg/dL, a threshold associated with increased risk of acute pancreatitis; No adjudicated acute pancreatitis events occurred in any patient receiving plozasiran during the two-year Phase 2b open-label expansion (OLE) study; Favorable and durable improvements in atherogenic lipoproteins, including remnant cholesterol, non-HDL cholesterol, and ApoB, were observed, with a safety profile consistent with earlier trials; Initiated and dosed the first subjects in a Phase 1/2a clinical trial of ARO-DIMER-PA, the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for atherosclerotic cardiovascular disease (ASCVD) due to mixed hyperlipidemia: ARO-DIMER-PA is designed to silence expression of the proprotein convertase subtilisin kexin 9 (PCSK9) and apolipoprotein C3 (APOC3) genes. This represents an important step forward for the RNAi field as it is the first dual-functional clinical candidate to target two genes simultaneously in one molecule; Announced interim clinical data on our RNAi-based obesity candidates, ARO-INHBE and ARO-ALK7, showing weight loss in obese patients with diabetes and improved measures of body composition; In obese patients with type 2 diabetes mellitus, ARO-INHBE in combination with tirzepatide achieved -9.4% weight loss at week 16, representing an approximately two-fold improvement versus -4.8% on tirzepatide alone; ARO-INHBE drove robust fat reduction including -23.2% visceral fat, -15.4% total fat, and -76.7% liver fat reduction, representing an approximately three-fold improvement in all three measures versus tirzepatide alone in obese diabetic patients; ARO-ALK7 is the first RNAi-therapeutic to show knockdown in humans of an adipocyte expressed gene, achieving a mean reduction of -88% in ALK7 mRNA with a maximum reduction of -94%; ARO-ALK7 monotherapy achieved a reduction of -14.1% (single dose, week 8) in placebo adjusted visceral fat; Key Corporate Events

Announced, earlier this week, an exclusive worldwide license agreement with Madrigal Pharmaceuticals for ARO-PNPLA3, Arrowhead’s clinical stage RNAi therapeutic designed to reduce liver expression of patatin-like phospholipase domain containing 3 (PNPLA3) as a potential treatment for patients with metabolic dysfunction-associated steatohepatitis (MASH): Under the terms of the agreement, Madrigal will make a $25 million upfront payment to Arrowhead. Arrowhead is also eligible to receive development, regulatory, and sales milestone payments of up to $975 million. Arrowhead is further eligible to receive tiered royalties on commercial sales ranging from high-single digits to the mid-teens; In a Phase 1 single-ascending dose clinical study, ARO-PNPLA3 achieved encouraging results, including a dose-dependent mean reduction in liver fat of up to 40% in patients homozygous for the I148M mutation, no apparent treatment emergent increases in triglycerides or LDL-cholesterol, and a positive safety and tolerability profile at all doses studied; Meaningfully strengthened the balance sheet through two concurrent public offerings with gross proceeds totaling $930 million and consisting of: $700 million of 0.00% convertible senior notes with a 35% conversion premium (initial conversion price of approximately $87.08 per share of common stock) due 2032; $230 million through issuance of shares of common stock, at a public offering price of $64.50 per share (or, in lieu of shares of common stock to certain investors, pre-funded warrants); A capped call transaction to reduce dilution, with the cap price set at $119.33, representing a premium of approximately 85% over the public offering price of $64.50 per share in the common stock offering; Webcast and Conference Call and Details

Investors may access a live audio webcast on the Events and Presentations page under the Investors section of the Arrowhead website. A replay of the webcast will be available approximately two hours after the conclusion of the call.

For analysts that wish to participate in the conference call, please register at https://register-conf.media-server.com/register/BI94a3f6754bd3471e8e895704fb645ee5. Once registered, you will receive the dial-in number and a personalized PIN code that will be required to access the call.

Selected Fiscal 2026 Second Quarter Financial Results 

ARROWHEAD PHARMACEUTICALS, INC.

CONSOLIDATED CONDENSED FINANCIAL INFORMATION

(in thousands, except per share amounts)

  Three months Ended March 31,

OPERATING SUMMARY

2026

2025

Revenue

$

73,737

$

542,709

Operating Expenses:

Research and development

173,253

133,102

General and administrative expenses

41,744

28,405

Total operating expenses

214,997

161,507

Operating (loss) income

(141,260

)

381,202

Total other income (expense)

3,695

(11,586

)

(Loss) income before income tax expense and noncontrolling interest

(137,565

)

369,616

Income tax expense

7

1,753

Net (loss) income including noncontrolling interest

(137,572

)

367,863

Net loss attributable to noncontrolling interest, net of tax

(4,840

)

(2,582

)

Net (loss) income attributable to Arrowhead Pharmaceuticals, Inc.

(132,732

)

370,445

Net (loss) income per share attributable to Arrowhead Pharmaceuticals, Inc. - Diluted

$

(0.93

)

$

2.75

Weighted-average shares used in calculating - Diluted

142,417

134,484

  March 31,

September 30,

2026

2025

FINANCIAL POSITION SUMMARY

(unaudited)

Cash, cash equivalents and restricted cash

$

188,517

$

226,548

Available-for-sale securities, at fair value and short-term investments

1,595,574

692,818

Total cash resources (Cash, cash equivalents and restricted cash and Available-for-sale securities, at fair value and short-term investments)

1,784,091

919,366

Other current and long-term assets

484,174

465,929

Total Assets

$

2,268,265

$

1,385,295

Liability related to the sale of future royalties

$

383,829

$

367,397

Credit Facility

199,639

254,883

Deferred revenue

157,158

2,399

Convertible notes, net

681,940

-

Other liabilities

246,783

257,200

Total Liabilities

$

1,669,349

$

881,879

  Total Arrowhead Pharmaceuticals, Inc. Stockholders' Equity

613,977

466,052

Noncontrolling Interest

(15,061

)

37,364

Total Noncontrolling Interest and Stockholders' Equity

$

598,916

$

503,416

Total Liabilities, Noncontrolling Interest and Stockholders' Equity

$

2,268,265

$

1,385,295

  Shares Outstanding

140,571

135,702

About REDEMPLO® (plozasiran)

REDEMPLO (plozasiran) is approved by the U.S. Food and Drug Administration as an adjunct to diet to reduce triglycerides in adults with Familial Chylomicronemia Syndrome (FCS). REDEMPLO is an siRNA therapeutic designed to suppress the production of apoC-III, a protein produced in the liver that raises triglyceride levels by slowing their breakdown and clearance. By targeting apoC-III with sustained silencing, REDEMPLO delivers significant reductions in triglyceride levels. REDEMPLO is the first and only siRNA FDA-approved treatment studied in both genetically confirmed and clinically diagnosed patients living with FCS.

For more information about REDEMPLO, visit Our Medicines.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

None.

ADVERSE REACTIONS

Most common adverse reactions in REDEMPLO treated patients (incidence ≥10% of patients treated with REDEMPLO and >5% more frequently than with placebo) are hyperglycemia, headache, nausea, and injection site reaction.

Please see full U.S. Prescribing Information for REDEMPLO®.

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 “continue” 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 candidate 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; and our believes 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 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.

More News From Arrowhead Pharmaceuticals, Inc.

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Arrowhead Pharmaceuticals presents a compelling bull case with a strong pipeline and a new commercialization status thanks to REDEMPLO FDA approval. ARWR's cardiometabolic pipeline, including REDEMPLO's potential updating and ARO-DIMER-PA's dual-target RNAi, supports future growth and market reach. The CNS drug ARO-MAPT that targets tauopathies linked to diseases like Alzheimer's will produce Phase 1 data in 2H 2026. This could drive a positive valuation rerating for ARWR.

Arrowhead Pharmaceuticals, Inc. (ARWR) Presents at Bank of America Global Healthcare Conference 2026 Transcript

[url="]Arrowhead Pharmaceuticals, Inc.[/url] (NASDAQ: ARWR) today presented new positive clinical data for plozasiran supporting its use in patients with moder

-

- Targeting Activin E may represent a novel therapeutic strategy for metabolic dysfunction-associated steatohepatitis (MASH) and obesity‑related metabolic dysfunction

- ARO-INHBE produced meaningful reductions in liver fat content as a monotherapy or in combination with low-dose tirzepatide in individuals with obesity with or without Type 2 Diabetes Mellitus (T2DM)

- Longer exposure to ARO-INHBE silencing resulted in continued improvements in visceral fat and liver fat from Week 12 to Week 24

PASADENA, Calif.--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today presented interim results from a Phase 1/2a clinical trial of ARO-INHBE, the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for obesity and metabolic dysfunction-associated steatohepatitis (MASH). The data presented at the European Association for the Study of the Liver Congress (EASL 2026) demonstrate that ARO-INHBE treatment led to clinically meaningful reductions in liver fat as a monotherapy and in combination with low-dose tirzepatide, a GLP-1/GIP receptor co-agonist, in adults with obesity. Arrowhead is currently engaging with regulatory authorities on additional designs and endpoints for potential Phase 2 studies in MASH and obesity.

We believe that targeting the Activin E/ALK7 pathway, a genetically validated pathway that regulates adipose fat storage, is a promising strategy to address MASH and obesity‑related metabolic dysfunction.

Share “Building on prior interim results from a Phase 1/2a study of ARO-INHBE, which showed encouraging signals on weight loss and improved measures of body composition in obese patients with diabetes, today we presented additional results at the EASL 2026 congress. These data provide encouraging signals on the safety, activity, and efficacy of ARO-INHBE, particularly with respect to liver fat reductions as a monotherapy or in combination with low-dose tirzepatide in patients with or without Type 2 Diabetes Mellitus,” said James Hamilton, M.D., MBA, Chief Medical Officer and Head of R&D at Arrowhead. “We believe that targeting the Activin E/ALK7 pathway, a genetically validated pathway that regulates adipose fat storage, is a promising strategy to address MASH and obesity‑related metabolic dysfunction and may complement existing incretin-based approaches in the treatment of obesity.”

The EASL 2026 poster may be accessed on the Events and Presentations page on the Investors section of the Arrowhead website.

Select ARO-INHBE Phase 1/2a Results

In participants with obesity, dose-dependent reductions in Activin E were observed following a single administration of ARO-INHBE, with a mean maximum reduction of 85.3% achieved with ARO-INHBE 400 mg and persistent effect beyond 3 months Similar Activin E reductions were observed in participants with obesity and T2DM receiving two doses of ARO-INHBE (200 mg or 400 mg) in combination with tirzepatide 5 mg, demonstrating persistent effect through Week 24 with the potential for infrequent twice per year dose administration Participants with obesity and baseline liver fat content (LFC) greater than 8% receiving 200mg or greater of ARO-INHBE monotherapy (n=10; baseline LFC 14.5±5.1%) had a placebo-adjusted post-dose LFC reduction of 44% (t-test: p < 0.01) ARO-INHBE in combination with low-dose tirzepatide (5 mg) resulted in enhanced reductions in visceral adipose tissue and LFC compared to tirzepatide alone in participants with obesity with or without T2DM Longer exposure to ARO-INHBE resulted in continued improvements in visceral fat and LFC from Week 12 to Week 24 Safety and Tolerability

ARO-INHBE has been generally well tolerated to date as a monotherapy and in combination with tirzepatide in participants with obesity with and without type 2 diabetes. Most treatment emergent adverse events (TEAE) were mild in severity. No TEAEs led to study or study drug discontinuation. Injection site reactions were generally mild and self-limited.

About ARO-INHBE

ARO-INHBE is designed to reduce the hepatic expression of the INHBE gene and its secreted gene product, Activin E. INHBE is a promising genetically validated target in which loss-of-function INHBE variants in humans are associated with improved fat distribution and lower risk of metabolic diseases, such as type 2 diabetes. Activin E acts as a ligand in a pathway that regulates energy homeostasis in adipose tissue. Inhibiting this pathway with investigational ARO-INHBE treatment has the potential to increase lipolysis, and reduce adipose hypertrophy and dysfunction, visceral adiposity, and insulin resistance.

About the AROINHBE-1001 Phase 1/2 Study

AROINHBE-1001 (NCT06700538) is a Phase 1/2a dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-INHBE in up to 78 adult volunteers with obesity. Part 1 of the study is designed to assess single and multiple doses of ARO-INHBE monotherapy, and Part 2 of the study is designed to assess ARO-INHBE in combination with tirzepatide, a subcutaneously administered GLP-1/GIP receptor co-agonist that has been approved in the United States and the European Union for management of type 2 diabetes mellitus since 2022 and weight management since 2023/2024 respectively.

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 “continue” 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 candidate or other characterizations of future events or circumstances are forward-looking statements. 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 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.

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PASADENA, Calif.--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it is scheduled to participate in the following upcoming events:

2026 Jefferies Global Healthcare Conference – June 2-4, 2026

Type: Fireside Chat Presentation
Date/Time: June 3, 2026, 8:10 am EDT

Goldman Sachs 47th Annual Global Healthcare Conference – June 8-10, 2026

Type: Fireside Chat Presentation
Date/Time: June 10, 2026, 9:00 am EDT

Presentation materials and webcast links, if applicable, may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.

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 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 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 “continue” 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 or product candidates, including anticipated regulatory submissions and clinical program results, prospects or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; our expectations regarding the potential benefits of the partnership, licensing and/or collaboration arrangements and other strategic arrangements and transactions we have entered into or may enter into in the future; our beliefs and expectations regarding milestone, royalty or other payments that could be due to or from third parties under existing agreements; and our estimates regarding future revenues, research and development expenses, capital requirements and payments to third parties. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the safety and efficacy of our product candidates, 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, our ability to successfully develop and commercialize drug candidates, 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.

More News From Arrowhead Pharmaceuticals, Inc.

Want Diversified Upside in Biotechnology? Check out LABUArrowhead Pharmaceuticals NASDAQ: ARWR executives outlined upcoming clinical catalysts, early commercial trends and pipeline priorities during a Jefferies fireside chat, with Chief Medical Officer James Hamilton emphasizing that the company remains focused exclusively on siRNA therapeutics through its TRiM, or Targeted RNAi Molecule, platform.

Hamilton said Arrowhead has advanced 20 clinical candidates into various stages of development. Partnered programs include olpasiran with Amgen, fazirsiran with Takeda, hepatitis B and MASH programs with GSK, a broad discovery collaboration with Sarepta and a recently announced discovery collaboration with Novartis. On the wholly owned side, Hamilton highlighted REDEMPLO, which was recently approved for familial chylomicronemia syndrome, as well as plozasiran in severe hypertriglyceridemia, zodasiran in homozygous familial hypercholesterolemia, obesity candidates ARO-ALK7 and ARO-INHBE, and ARO-MAPT for tau-related neurological diseases.

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SHASTA Data Remain on Track for Third Quarter Hamilton said the company remains on schedule to report topline data in the third quarter from SHASTA-3 and SHASTA-4, pivotal studies of plozasiran in severe hypertriglyceridemia. He said the final patients are expected to complete visits “over the next month or so,” but Arrowhead is not narrowing its guidance to a specific month because late acute pancreatitis events or serious adverse events could still require adjudication.

On the acute pancreatitis endpoint, Hamilton said Arrowhead remains “cautiously optimistic” while blinded to the data. He said the company has previously indicated that roughly nine or more acute pancreatitis events, with event rates similar to those seen in CORE and CORE2 studies, would provide around 80% power. He added that events have not appeared “wildly out of our range of expectations,” but said the outcome will not be known until the third-quarter readout.

Hamilton said Arrowhead does not plan changes to its statistical analysis plan and has long planned to pool acute pancreatitis data from SHASTA-3 and SHASTA-4. He also said baseline triglyceride values across the combined studies are about 860, compared with about 600 in the SHASTA-2 study, where the company saw approximately a 70% triglyceride reduction. He said a 10% decline in the placebo group “wouldn’t surprise” him, reflecting diet adherence and potential reversion to the mean.

Safety, Liver Fat and Competitive Context Asked about Ionis’ olezarsen, Hamilton said he expects approval and said acute pancreatitis may be included in the label, though he said it is unclear where such information would appear. He described the CORE and CORE2 data as “really good and really convincing,” particularly on acute pancreatitis.

Hamilton also discussed safety differences between Arrowhead’s siRNA approach and antisense oligonucleotide, or ASO, therapies. He said Arrowhead is not seeing hypersensitivity reactions or thrombocytopenia, which he characterized as more consistent with ASO class effects. On liver fat, Hamilton said Arrowhead did not observe an increase at the 25-milligram dose in SHASTA-2, which he described as the go-to-market dose, though a 2% absolute increase from baseline was seen at a 50-milligram dose the company is no longer using. He said Arrowhead should provide an update on liver fat when it reports severe hypertriglyceridemia data.

REDEMPLO Launch and Pricing Daniel Apel, Arrowhead’s chief financial officer, said the REDEMPLO launch in familial chylomicronemia syndrome is trending better than Ionis’ launch at a similar time point when normalized for price and viewed on a unit basis, though he cautioned against overemphasizing early numbers in an ultra-rare indication. He said there was some pent-up demand from expanded access program switches and some patients switching from TRYNGOLZA, but most demand has been new to class.

Apel said Arrowhead expects continued largely linear growth, primarily from patients naive to the APOC3 class, with some contribution from switchers. He cited REDEMPLO’s three-month dosing schedule, potency and lack of warnings, precautions or contraindications as factors the company believes will support physician choice.

On pricing, Apel said payer feedback has been positive after Arrowhead reduced REDEMPLO’s wholesale acquisition cost to $45,000 from $60,000. He said the move maintained a premium position while keeping the therapy within a range that payers view as cost comparable, and said payer discussions are proceeding well and aligned with the approved label.

Obesity, MASH and CNS Programs Hamilton said recent EASL data for ARO-INHBE showed about a 40% reduction in liver fat from baseline in patients with hepatic steatosis, supporting a potential monotherapy pathway in MASH. He said Arrowhead is also evaluating ARO-INHBE with GLP-1 therapy, especially in diabetics, where it has seen additional weight loss versus GLP-1 alone.

Hamilton said ARO-ALK7 and ARO-INHBE studies are fully enrolled with about 240 total patients across monotherapy and tirzepatide combination cohorts. Additional ARO-INHBE cohorts include higher-dose monotherapy in Type 2 diabetics and combinations with 5 mg and 15 mg tirzepatide. He said Arrowhead plans more ARO-ALK7 data in the second half, focusing on body composition, weight loss, visceral fat and lean mass.

For ARO-MAPT, Hamilton said later-year data will focus on safety and tau knockdown in healthy volunteers, with patient data likely next year. He said Arrowhead would like to see total tau knockdown in cerebrospinal fluid comparable to the 50% to 60% reported by Ionis in Alzheimer’s patients, and said successful subcutaneous CNS knockdown would be important for the broader platform.

Additional Catalysts Hamilton said Arrowhead plans to report third-quarter data from its APOC3-PCSK9 dimer program in patients with mixed hyperlipidemia. He said initial success would include total ApoB reductions of about 40% or better, with the company ultimately aiming to move toward outcomes testing after establishing long-term safety and dose.

Apel said Arrowhead is not planning to out-license additional programs or disclose new business development activity. He listed upcoming catalysts including SHASTA-3 and SHASTA-4 data, dimer data, ARO-MAPT cerebrospinal fluid data, additional obesity data and potential full enrollment of the zodasiran program later this year. No specific cash runway update was provided in the discussion.

About Arrowhead Pharmaceuticals NASDAQ: ARWRArrowhead Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of RNA interference (RNAi) therapeutics. Since its founding in 2008, Arrowhead has leveraged its proprietary delivery platform—known internally as the Advanced RNAi Compound (ARC) technology—to silence disease-causing genes in patients suffering from genetically defined diseases. The company's approach aims to offer durable, targeted treatments across a range of therapeutic areas.

The company's pipeline includes multiple candidates in various stages of development.

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