Arrowhead Pharmaceuticals NASDAQ: ARWR highlighted continued commercial traction for REDEMPLO and outlined multiple anticipated clinical catalysts in the second half of 2026 as the company reported fiscal 2026 second-quarter results for the period ended March 31, 2026.
REDEMPLO launch momentum and pricing strategy
President and CEO Dr. Chris Anzalone said the company is “now on the strongest footing of our history,” pointing to an expanding commercial footprint, a broader pipeline, and a stronger balance sheet.
REDEMPLO was approved by the FDA in November 2025 as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). Anzalone described FCS as a severe rare disease that can carry a substantially increased risk of acute pancreatitis. Management said the U.S. launch continues to build on an initially strong start.
Anzalone said the company is seeing “around 30 new prescriptions written each week,” with “more than 400 prescriptions” written since launch. He added that “more than 10%” of prescriptions have been for patients switching from a competing APOC3 inhibitor. Senior Vice President and Head of the Global Cardiometabolic Franchise Andy Davis said prescriptions accelerated through the fiscal second quarter, “growing nearly threefold from the start to the end of the quarter,” and noted that total prescriptions written exceeded 400.
Davis also described early indicators of persistence, saying refill activity is “accelerating meaningfully,” which he characterized as an early validation of clinical effectiveness, patient satisfaction, and REDEMPLO’s once-quarterly dosing profile. He said the geographic distribution of prescribing has been balanced across the U.S., signaling broad territory activation rather than reliance on a small number of high-volume centers.
On patient mix, Davis said approximately 85% of prescriptions are from patients naïve to the APOC3 class, with the remainder largely switch patients. Asked about motivations for switching, Davis said the company has seen “diversity of reasons” including efficacy, safety, and tolerability.
Management also discussed a change in wholesale acquisition cost (WAC). Anzalone said Arrowhead updated REDEMPLO’s U.S. WAC to $45,000 per patient per year and described it as a premium to a competitor’s WAC, which he said the company believes is appropriate based on clinical data suggesting superior triglyceride reduction, safety profile, and convenience. Davis framed the $45,000 price as part of a strategy to optimize market access and reduce friction in formulary decisions and prior authorization.
In Q&A, CFO Daniel Apel said Arrowhead is not providing guidance on gross-to-net at this stage and said the company had not seen anything substantial in that regard beyond statutory items such as Medicaid rebates. Anzalone emphasized the WAC reduction “had nothing to do with any pushback from payers,” describing payer interactions as “quite positive,” and said the company made the move in expectation of a future severe hypertriglyceridemia (SHTG) market expansion and to reduce the likelihood of payers requiring a “step through” a competitor.
Payer coverage and diagnostic flexibility
Davis said Arrowhead’s market access team has been engaged with large U.S. payers and that discussions are proceeding as expected, with some resulting in improved coverage and additional formulary decisions expected in coming months across commercial and government segments.
He pointed to what he called an important trend: “diagnostic pathway flexibility” in payer coverage policies. Davis said policies taking shape recognize both genetic testing and clinical criteria as valid routes to diagnosis, which he said is important because a meaningful proportion of real-world FCS patients are clinically diagnosed rather than genetically confirmed.
International regulatory progress and commercialization plans
Anzalone said Arrowhead secured positive regulatory action in four additional geographies for REDEMPLO in FCS, citing approvals from Australia’s Therapeutic Goods Administration, China’s National Medical Products Administration, and Health Canada, as well as a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
Davis said Canada and China approvals came in January, with Australia following “last month,” and that all three markets are in pre-launch phases as Arrowhead works through pricing and reimbursement. In Europe, he said CHMP recommended EU marketing authorization for REDEMPLO in FCS “without requiring genetic confirmation,” and he anticipated an EMA decision in the June to July timeframe. Davis said Arrowhead intends to commercialize directly in Europe using contracted infrastructure spanning market access, account management, medical affairs support, and stakeholder engagement.
Anzalone said REDEMPLO will be marketed by Sanofi in Greater China, while Arrowhead anticipates marketing independently in Canada. Pending a European Commission decision, he said the company expects launches later this year in select EU countries and “likely in the U.K. as well.”
Pipeline milestones: plozasiran SHTG, ARO-DIMER-PA, and ARO-MAPT
Arrowhead leaders highlighted several expected clinical readouts in 2026.
- Plozasiran in SHTG (SHASTA-3/4 and supporting studies): Anzalone and Davis said top-line results from registrational Phase III studies SHASTA-3 and SHASTA-4 are expected in Q3, with Anzalone also referencing SHASTA-3 and “four studies” in SHTG and Davis describing SHASTA-3 and SHASTA-4 as the two registrational studies. Chief Medical Officer Dr. James Hamilton said SHASTA-3 and SHASTA-4 enrolled over 750 patients and have a primary endpoint of triglyceride change from baseline and key secondary endpoints of acute pancreatitis (AP) rates. Hamilton added that MUIR-3 enrolled over 1,400 patients to provide additional safety data and that SHASTA-5 is enrolling high-risk patients with AP risk reduction as a primary endpoint. He said the blinded portion of SHASTA-3, SHASTA-4, and MUIR-3 is expected to complete in mid-2026, supporting a planned top-line readout in Q3.
- Analysis of pancreatitis endpoints: In response to an analyst question, Hamilton said the plan is to pool SHASTA-3 and SHASTA-4 and conduct a meta-analysis of AP event rates, including both event rates in individual patients and total events. He said the studies remain blinded ahead of the expected Q3 data. Asked whether Arrowhead might extend the blinded period to accrue additional AP events, Hamilton said the company feels “comfortable with the number of events” seen so far and said there are “no plans to extend the study or stay blinded for a longer period at this time.” Hamilton also noted that SHASTA-2 used strict Atlanta criteria for pancreatitis events, while SHASTA-3/4 pooled analysis uses “modified Atlanta criteria” including definite, probable, and possible pancreatitis.
- ARO-DIMER-PA in mixed hyperlipidemia: Anzalone and Hamilton said early data from the Phase I/II study of ARO-DIMER-PA is expected in Q3. Hamilton described ARO-DIMER-PA as the first dual-functional siRNA intended to silence two genes—PCSK9 and APOC3—with a single molecule. He said the study initiated in January and is designed as a placebo-controlled, dose-escalating trial evaluating safety, tolerability, pharmacokinetics, pharmacodynamics, and effects on LDL cholesterol and triglycerides, with up to 78 adults enrolled across single-dose and multiple-dose parts. Hamilton said enrollment has been rapid and that the company expects sufficient data for a first clinical readout in Q3. In Q&A, he said the program’s relevant biomarkers are blood-based and that the initial readout will focus on biomarker effects and safety, with development plans to be shared later.
- ARO-MAPT for tauopathies via a CNS platform: Management expects an initial ARO-MAPT readout around the end of Q3 or early Q4. Hamilton said the first subjects were dosed in December 2025 in a Phase I/II placebo-controlled, dose-escalating study in up to 64 healthy subjects and up to 48 patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s dementia. He said the study is nearing completion of enrollment for the single-dose healthy-volunteer portion and has begun multi-dose cohorts in both healthy volunteers and Alzheimer’s patients.
Separately, Hamilton highlighted long-term plozasiran data presented at the American College of Cardiology meeting in March from a two-year open-label extension of Phase IIb studies. He said median triglyceride reductions were 83% in SHTG patients from SHASTA-2 and 67% in hypertriglyceridemia patients from MUIR, and that no adjudicated acute pancreatitis events occurred in patients receiving plozasiran during the two-year extension.
Financial results, financing, and a new licensing agreement
CFO Daniel Apel reported a net loss of $132.7 million, or $0.93 per share, for the quarter ended March 31, 2026, compared with net income of $370.4 million, or $2.75 per share, in the year-ago quarter. Apel attributed the prior-year period’s income to “over $540 million in revenue solely related to the Sarepta transaction” executed at that time.
Revenue for the quarter totaled $74 million, driven primarily by licensed and collaboration agreements with Sarepta and Novartis. Apel said approximately $42 million was related to the Sarepta collaboration, including $28 million from ongoing recognition of initial Sarepta consideration, $10 million of reimbursement for preclinical collaboration costs, and $4 million for clinical supply. He also said Arrowhead recognized $20 million of a $200 million upfront payment from Novartis received in October, bringing year-to-date recognition of that upfront to $54 million, with $146 million remaining to be deferred over time as preclinical obligations are fulfilled. Apel said Arrowhead recorded $11 million related to the Sanofi-Visirna asset purchase agreement in Greater China, which he said was “almost entirely due” to China’s January approval for FCS.
Apel said Arrowhead is not yet highlighting specific REDEMPLO product sales numbers, but noted net sales can be derived as the difference between total net revenue and collaboration revenue, representing approximately $1 million for the quarter. He said this was the first full quarter of REDEMPLO sales and compared favorably on a unit basis to the first full commercial quarter of the other approved APOC3 inhibitor.
Total operating expenses were approximately $215 million, roughly flat sequentially and up from $162 million a year ago. Apel said the year-over-year increase was driven by $40 million higher R&D expense and $13 million higher SG&A, aligning with expectations. He said nearly two-thirds of year-to-date clinical trial spend was attributable to plozasiran Phase III studies and expected spending for those programs to moderate after summer readouts.
Arrowhead ended the quarter with nearly $1.8 billion in cash and investments. Apel said the company brought in over $1 billion during the quarter, including approximately $850 million net from January financing transactions consisting of concurrent offerings of $700 million of 0% coupon convertible senior notes and $230 million of common stock, along with an associated capped call transaction. He also cited a $200 million Sarepta milestone payment and a $50 million anniversary payment under the Sarepta long-term collaboration.
In addition, Anzalone discussed an exclusive worldwide license agreement with Madrigal Pharmaceuticals for ARO-PNPLA3, a clinical-stage program aimed at a genetically defined population of MASH patients. Under the agreement, he said Madrigal will pay a $25 million upfront payment and Arrowhead is eligible for up to $975 million in development, regulatory, and sales milestones, plus tiered royalties up to the mid-teens. In Q&A, Anzalone said the program originated from Arrowhead’s deal with Janssen, that Janssen conducted the Phase I, and that the asset was returned when Janssen exited MASH. He said Arrowhead did not spend money on the program and viewed Madrigal as a “pure play MASH company” suited to develop a genetically defined approach that may require a companion diagnostic.
About Arrowhead Pharmaceuticals NASDAQ: ARWR
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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