Arrowhead Pharmaceuticals (NASDAQ:ARWR) Reports Fiscal 2026 First Quarter Results

Pasadena, CA — February 5, 2026 — Leads & Copy — Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) has announced its financial results for the fiscal 2026 first quarter, which concluded on December 31, 2025.

The company hosted a conference call today, February 5, 2026, at 4:30 p.m. ET, to discuss the financial outcomes.

Christopher Anzalone, Ph.D., President and CEO at Arrowhead, said the company had another quarter of strong execution across all areas of its business, and that Arrowhead is extremely well positioned to build on this progress throughout 2026 and beyond.

Anzalone noted the recent months included some of the more significant achievements in the Company’s history. These include:

  • Received regulatory approval for REDEMPLO® in familial chylomicronemia syndrome in three different countries and launched its first commercial product in the U.S.
  • Continued to grow its cardiometabolic portfolio
  • Had encouraging early results from its obesity programs
  • Advanced its TRiM™ platform and CNS pipeline
  • Meaningfully improved its financial position to advance these and other programs forward.

Key Commercial Events

On November 18, 2025, the U.S. FDA approved REDEMPLO® (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).

FCS is a severe, rare disease, with an estimated 6,500 people in the U.S. living with genetic or clinical FCS, characterized by triglyceride levels that can be 10 to 100 times higher than normal leading to a substantially higher risk of developing acute, recurrent, and potentially fatal pancreatitis.

This marks Arrowhead’s first FDA-approved medicine, marking a major milestone for the company as it transitions into commercial-stage.

Arrowhead launched REDEMPLO independently in the U.S. with the One-REDEMPLO pricing model that creates a consistent price across current and potential future indications. Initial trends in prescriptions, payor reviews and reimbursement, and early shipments have been encouraging and include the following, to date:

  • Over 100 prescriptions for REDEMPLO have been received from a diverse prescriber base, with geographically balanced uptake across the U.S.
  • Early patient starts fall into three categories: patients transitioning from our Expanded Access Program, patients naïve to the APOC3 class, and patients switching from olezarsen.
  • Patients receiving REDEMPLO include both clinically diagnosed and genetically confirmed FCS, with the majority not required to submit genetic testing to gain access.

The company also launched Rely On REDEMPLO, a patient support program providing support services and resources for patients at each stage of the treatment journey with REDEMPLO, including financial assistance options for eligible patients.

The Chinese National Medical Products Administration (NMPA) has 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 has 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 will be available later this year in Canada and the company anticipates it will be marketed independently by Arrowhead.

Key R&D Events

Arrowhead 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-function clinical candidate to target two genes simultaneously in one molecule.

The company also announced interim clinical data on its RNAi-based obesity candidates, ARO-INHBE and ARO-ALK7, showing weight loss in obese patients with diabetes and improved measures of body composition.

ARO-INHBE in combination with tirzepatide achieved -9.4% weight loss at week 16 in obese patients with type 2 diabetes mellitus, demonstrating 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 these 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 and achieved a mean reduction of -88% in ALK7 mRNA with a maximum reduction of -94%.

ARO-ALK7 monotherapy achieved a -14.1% (single dose, week 8) placebo adjusted visceral fat reduction.

The first subjects have been dosed in a Phase 1/2a clinical trial of ARO-MAPT, the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for tauopathies including Alzheimer’s disease. ARO-MAPT is Arrowhead’s first investigational RNAi-based therapy to utilize a new proprietary delivery system which, in preclinical studies, has achieved blood-brain-barrier penetration and deep knockdown of target genes across the central nervous system (CNS), including deep brain regions, after subcutaneous injection.

The U.S. FDA has granted Breakthrough Therapy designation to investigational plozasiran as an adjunct to diet to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (SHTG) (TG levels greater than or equal to 500 mg/dL).

Key Corporate Events

Arrowhead closed two concurrent public offerings with gross proceeds totaling $930,000,000 and consisting of (i) 0.00% convertible senior notes due 2032 (the “notes”) and (ii) 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).

The company triggered a $200.0 million milestone payment from Sarepta Therapeutics, Inc., which was earned on November 20, 2025, when the Company reached the second of two prespecified enrollment targets and subsequent authorization to dose escalate in a Phase 1/2 clinical study of SRP-1003 (formerly ARO-DM1), an investigational RNAi therapeutic for the treatment of type 1 myotonic dystrophy (DM1).

Arrowhead announced a global licensing and collaboration agreement with Novartis, which closed on October 17, 2025, for ARO-SNCA, Arrowhead’s preclinical stage siRNA therapy against alpha-synuclein for the treatment of synucleinopathies, such as Parkinson’s Disease, and for other additional collaboration targets that will utilize Arrowhead’s proprietary Targeted RNAi Molecule (TRiM™) platform. Financial terms of the agreement include:

  • Arrowhead received a $200 million upfront payment from Novartis.
  • Arrowhead is also eligible to receive development, regulatory, and sales milestone payments of up to $2 billion.
  • Arrowhead is further eligible to receive tiered royalties on commercial sales up to the low double digits.

Selected Fiscal 2026 First Quarter Financial Results

Revenue for the three months ended December 31, 2025, was $264,033,000, compared to $2,500,000 for the same period in 2024. Research and development expenses were $177,203,000, compared to $137,002,000 in 2024. General and administrative expenses totaled $46,021,000, versus $26,910,000 in 2024. Operating income was $40,809,000, compared to an operating loss of ($161,412,000) in 2024. Net income attributable to Arrowhead Pharmaceuticals, Inc. was $30,811,000, or $0.22 per share, compared to a net loss of ($173,085,000), or ($1.39) per share in 2024.

Cash, cash equivalents and restricted cash totaled $201,642,000 as of December 31, 2025, compared to $226,548,000 as of September 30, 2025. Available-for-sale securities, at fair value and short-term investments totaled $714,967,000 versus $692,818,000 on September 30, 2025. Total assets were $1,604,181,000 compared to $1,385,295,000 on September 30, 2025.

Shares outstanding totaled 137,391 on December 31, 2025, compared to 135,702 on September 30, 2025.

Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes.

RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

Source: Arrowhead Pharmaceuticals

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