Arrowhead Pharmaceuticals develops and commercializes RNA interference medicines that silence genes associated with intractable diseases. The company’s TRiM™ platform is used to design targeted RNAi therapeutics for tissues including liver, lung, muscle, adipose and central nervous system tissue.
Recurring ARWR news covers REDEMPLO® (plozasiran), an siRNA medicine approved in the United States and Australia as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome. Company updates also address plozasiran data across hypertriglyceridemia, regulatory actions in additional geographies, pricing and market-access strategy, fiscal results, investor events, and clinical or partnering developments involving programs such as ARO-PNPLA3, ARO-INHBE and ARO-ALK7.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) will participate in multiple December 2025 conferences with investor and scientific presentations. Key events include Piper Sandler 37th Annual Healthcare Conference (Dec 2-4; fireside chat Dec 3, 10:30 a.m. ET), Evercore 8th Annual Healthcare Conference (Dec 2-4; fireside chat Dec 4, 10:00 a.m. ET), WCIRDC (Dec 4-6) with multiple presentations on plozasiran and FCS/acute pancreatitis topics, and the 7th Annual CNS Delivery Summit (Dec 9-11; TRiM platform talk Dec 10, 9:30 a.m. ET). Presenters include Norman Lepore, Rohit Loomba, Nihar Desai and Agnieszka Glebocka. Presentation materials and webcast links will be available on the company Events and Presentations page under Investors.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) reported fiscal year 2025 results for the year ended September 30, 2025 and announced multiple commercial and partnership milestones.
Key facts: FDA approved REDEMPLO (plozasiran) for familial chylomicronemia syndrome (FCS) after Phase 3 PALISADE showed -80% triglycerides; REDEMPLO is self-administered once every three months. Fiscal highlights: Revenue $829,448, operating income $98,346, net loss attributable to Arrowhead $(1,631), and total cash resources $781,524. Major deals: $200M upfront from Novartis, $300M milestones from Sarepta, and $130M upfront from Sanofi (Visirna sale).
Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced it earned a $200 million milestone payment from Sarepta Therapeutics (NASDAQ: SRPT) after reaching the second development milestone in the Phase 1/2 study of ARO-DM1 (SRP-1003) for type 1 myotonic dystrophy.
The milestone followed a drug safety committee review, authorization to dose escalate, and attainment of a pre-specified patient enrollment target. Arrowhead said it expects to receive the payment within 60 days. The company reported cohort 4 (6 mg/kg) accrual is nearly complete and plans to begin enrollment in cohort 5 (12 mg/kg) in Q1 2026.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced FDA approval of REDEMPLO (plozasiran) to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). REDEMPLO is the first FDA‑approved siRNA medicine for FCS and is administered by subcutaneous injection once every three months. The approval is based on Phase 3 PALISADE results showing a median triglyceride change of -80% versus -17% for pooled placebo and a lower numerical incidence of acute pancreatitis. REDEMPLO will be available in the U.S. before the end of the year, and Arrowhead is launching a patient support program and advancing commercial capabilities as it becomes a commercial‑stage company.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) will host a webcast and conference call on November 25, 2025 at 4:30 p.m. ET to discuss fiscal year 2025 results for the period ended September 30, 2025. Investors can access a live audio webcast on the Events and Presentations page in the Investors section of the Arrowhead website. A replay will be available approximately two hours after the call ends. Analysts who wish to join the conference call must register in advance to receive a dial-in number and personalized PIN.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced participation in multiple November 2025 scientific and investor events. Key appearances include the AHA Scientific Sessions (Nov 7-10) with a moderated poster on zodasiran on Nov 10, 2:34 pm CST, multiple presentations at AASLD Liver Meeting (Nov 7-11) on fazirsiran data and imaging analyses on Nov 9, 8:00 am EST, a Jefferies Global Healthcare fireside chat on Nov 19, and a TD Cowen virtual fireside on Nov 24. Webcast and materials will be posted on the company Events and Presentations investor page.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced that its board approved inducement equity grants on October 24, 2025 for 84 new employees under NASDAQ Listing Rule 5635(c)(4).
The grants entitle the recipients, in aggregate, to receive up to 127,230 restricted stock units (RSUs). These awards are outside the company's stockholder-approved equity incentive plans and vest annually over a four-year period.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced closing of its global license and collaboration agreement with Novartis on October 21, 2025, following expiration of HSR waiting periods and customary conditions.
Under the deal Novartis received an exclusive worldwide license to develop ARO-SNCA, a preclinical program using Arrowhead’s TRiMTM platform for subcutaneous CNS delivery targeting alpha-synuclein for Parkinson’s disease and related synucleinopathies. Arrowhead will complete preclinical work to enable a clinical trial application (CTA), after which Novartis will assume sole control of development, manufacturing, medical affairs, and commercialization.
Financial terms include a $200 million upfront payment, up to $2 billion in development, regulatory, and sales milestones, and tiered royalties up to the low double digits.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) filed for regulatory clearance to start a Phase 1/2a study of ARO-DIMER-PA, the company's first dual‑functional RNAi candidate designed to silence PCSK9 and APOC3 simultaneously using the TRiMTM platform.
Preclinical data showed potent lowering of PCSK9 and APOC3 and reductions in non‑HDL, LDL‑C, and triglycerides in dyslipidemic nonhuman primates. Arrowhead submitted the trial application to New Zealand regulators and, pending clearance, plans a randomized, double‑blind, placebo‑controlled, dose‑escalation study in up to 78 adults with mixed hyperlipidemia, evaluating safety, PK/PD, and effects on LDL‑C and triglycerides. The company noted potential clinical insights in 2026 and referenced an upcoming November 18, 2025 PDUFA date for plozasiran.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) has filed a Complaint for Declaratory Judgment against Ionis Pharmaceuticals in the Delaware District Court regarding Ionis's patent (No. 9,593,333). The legal action seeks to declare Ionis's patent invalid and not infringed by Arrowhead's investigational drug plozasiran, which is currently under FDA review.
The dispute centers around plozasiran, a treatment for familial chylomicronemia (FCS), a severe rare disease causing extremely high triglyceride levels. Arrowhead's CEO Christopher Anzalone emphasized that the company developed plozasiran independently through its proprietary TRiM™ platform, without any contribution from Ionis. The company is seeking a declaratory decree rather than monetary relief.