Arrowhead Pharma Stock Price, News & Analysis

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.

Arrowhead Pharmaceuticals (NASDAQ: ARWR) has submitted a regulatory clearance request to begin a Phase 1/2a clinical trial of ARO-MAPT, an RNAi therapeutic targeting Alzheimer's disease and other tauopathies. The investigational drug utilizes a novel proprietary delivery system that has shown promising results in preclinical studies, achieving blood-brain-barrier penetration and CNS target gene knockdown through subcutaneous administration.

The planned study will evaluate ARO-MAPT in up to 112 participants, including both healthy subjects and those with early Alzheimer's disease. The trial design includes multiple dosing schedules, with subjects receiving either one or three weekly doses, followed by monthly doses. Preclinical data presented at the RNA Leaders USA Congress 2025 demonstrated potent MAPT mRNA and Tau protein suppression throughout the CNS, suggesting potential for monthly or quarterly dosing regimens.

Arrowhead Pharmaceuticals (NASDAQ: ARWR) has entered into a significant global licensing and collaboration agreement with Novartis for ARO-SNCA, a preclinical stage siRNA therapy targeting Parkinson's Disease and other synucleinopathies.

The deal includes an upfront payment of $200 million to Arrowhead, with potential milestone payments of up to $2 billion plus tiered royalties reaching low double digits. The agreement centers on Arrowhead's proprietary TRiM™ platform, which has shown promising preclinical results in CNS delivery through subcutaneous administration.

Under the agreement, Arrowhead will complete preclinical research for CTA filing, after which Novartis will take control of development, manufacturing, and commercialization. The transaction is expected to close in H2 2025, subject to regulatory approvals.

Arrowhead Pharmaceuticals (NASDAQ: ARWR) has announced its participation in seven major conferences during September 2025. The company will present clinical data at the European Society of Cardiology (ESC) Congress, including results from the PALISADE study on Plozasiran for FCS patients and ARCHES-2 study on Zodasiran for mixed hyperlipidemia.

Additionally, Arrowhead will participate in several investor conferences, including Citi's Biopharma Back to School Conference, Cantor Global Healthcare Conference, H.C. Wainwright Global Investment Conference, and Morgan Stanley Global Healthcare Conference. The company will also present research on RNAi therapeutics for neurodegenerative diseases at the RNA Leaders USA Congress.

Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced a strategic financial transaction with Sarepta Therapeutics involving a recently earned $100 million milestone payment. The milestone was triggered by reaching enrollment targets and dose escalation authorization in the Phase 1/2 clinical study of ARO-DM1, an RNAi therapeutic for type 1 myotonic dystrophy.

Arrowhead elected to receive $50 million in cash and approximately $50 million worth of its own stock from Sarepta, which will be placed into treasury, effectively reducing outstanding shares. Sarepta, which previously held 11,926,301 Arrowhead shares, sold its remaining holdings in a separate block trade. The company's balance sheet is expected to fund operations into fiscal 2028.

Arrowhead Pharmaceuticals (NASDAQ: ARWR) reported its fiscal Q3 2025 results, highlighting significant progress in its pipeline with four candidates in Phase 3 studies. The company announced a major deal where its subsidiary Visirna Therapeutics will receive $130 million upfront from Sanofi, plus potential milestone payments of $265 million for plozasiran rights in Greater China.

Financial results showed revenue of $27.8 million and a net loss of $175.2 million ($1.26 per share). The company maintains a strong balance sheet with $900.4 million in total cash resources. Notable achievements include earning a $100 million milestone payment from Sarepta for ARO-DM1 progress, with potential for an additional $200 million milestone by year-end.

Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced that its majority-owned subsidiary Visirna Therapeutics has signed an asset purchase agreement with Sanofi for the rights to develop and commercialize plozasiran in Greater China. Sanofi will pay $130 million upfront and up to $265 million in potential regulatory milestone payments.

Plozasiran, a first-in-class RNA interference therapeutic targeting APOC3, is being developed to treat familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia. The drug has already completed a successful Phase 3 trial in Chinese FCS patients and received Breakthrough Therapy Designation and Priority Review from China's NMPA, with an NDA submitted and accepted in January 2025.