ARROWHEAD PHARMACEUTICALS (ARWR) Company Report

Arrowhead Pharmaceuticals achieved a significant milestone with the FDA approval of Redemplo on November 18, 2025, its first approved medicine, indicated for familial chylomicronemia syndrome (FCS). The annual wholesale acquisition cost (WAC) for Redemplo is $60,000.
For fiscal year 2025, the company reported $829 million in revenue, driven entirely by license and collaboration agreements, and concluded the year with a strong balance sheet, holding $919 million in cash and investments as of September 30, 2025.
The company announced a new global licensing collaboration with Novartis for ArrowSNCA, including a $200 million upfront payment and eligibility for up to $2 billion in future milestone payments. Additionally, a $200 million milestone payment from Sarepta for ARO-DM1 is anticipated in Q1 fiscal year 2026.
Pipeline advancements include the initiation of the Phase III Yosemite clinical trial for Zodasiran and the filing of a CTA for a Phase I/II clinical trial of ArrowMapT, Arrowhead's first therapy utilizing a new proprietary CNS delivery system.

7 days ago

Transcript

Arrowhead Pharmaceuticals Announces Redemplo FDA Approval, Strong FY2025 Financials, and Pipeline Progress

ARWR

Product Launch

Earnings

New Projects/Investments

Arrowhead Pharmaceuticals announced the FDA approval of Redemplo on November 18, 2025, for familial chylomicronemia syndrome (FCS), marking its first FDA-approved medicine and transition into a commercial stage. The drug, priced at an annual WAC of $60,000, was commercially launched a week post-approval.
For fiscal year 2025, Arrowhead reported $829 million in revenue and a net loss of $2 million. The company's cash and investments stood at $919 million as of September 30, 2025, with a cash runway projected into fiscal year 2028.
The company secured a $200 million upfront payment from Novartis for a new ARO-SNCA collaboration and earned a $200 million milestone payment from Sarepta for ARO-DM1. Arrowhead anticipates top-line data for Plozasiran (SHTG) in Q3 2026 and early data for its obesity programs in early January 2026.
Bruce Given, Chief Medical Officer, is retiring from day-to-day operations after nearly 15 years, with James Hamilton having already assumed many of his responsibilities.

7 days ago

Transcript

Arrowhead Pharmaceuticals Announces Redemplo FDA Approval and Q4 2025 Financial Results

ARWR

Product Launch

Earnings

New Projects/Investments

Arrowhead Pharmaceuticals announced the FDA approval of Redemplo on November 18, 2025, for familial chylomicronemia syndrome (FCS), marking its transition into a commercial stage with an annual WAC price of $60,000.
For fiscal year 2025, the company reported revenue of $829 million and a net loss of $2 million (or $0.01 per share).
Cash and investments stood at $919 million as of September 30, 2025, with an additional $200 million upfront payment received from Novartis and a $200 million milestone payment expected from Sarepta in January 2026. The cash runway is projected to extend into fiscal year 2028.
Key pipeline updates include the initiation of the Yosemite phase III clinical trial for Zodasiran and the filing for regulatory clearance for a phase I/II clinical trial for ArrowDiamond PA. Enrollment was completed for the Shasta III and Shasta IV phase III studies for Plozasiran, with top-line data anticipated in Q3 2026.

7 days ago

Transcript

Arrowhead Pharmaceuticals Reports FY 2025 Results and First FDA Approval

ARWR

Earnings

Product Launch

Revenue Acceleration/Inflection

Arrowhead Pharmaceuticals reported its 2025 fiscal year-end results with revenue of $829.4 million and a net loss of $(1.6) million, a significant improvement from the prior year's net loss of $(599.5) million.
The company achieved a transformational milestone with the FDA approval of REDEMPLO (plozasiran), its first FDA-approved medicine, for familial chylomicronemia syndrome (FCS), marking its transition to a commercial-stage company.
Arrowhead secured substantial financial inflows through strategic partnerships, including a $200 million upfront payment from Novartis for ARO-SNCA and $300 million in milestone payments from Sarepta Therapeutics for ARO-DM1. Additionally, its subsidiary Visirna Therapeutics will receive a $130 million upfront payment from Sanofi.

7 days ago

8-K

Arrowhead Pharmaceuticals Updates on Obesity Pipeline and Redemplo Launch

ARWR

Product Launch

New Projects/Investments

Guidance Update

Arrowhead Pharmaceuticals expects to release data from its INHBE and ALK-7 obesity programs in early January 2026.
The company recently received first approval for Redemplo in Familial Chylomicronemia Syndrome (FCS) and will provide launch updates on its upcoming quarterly call.
New Phase 1 studies for the ApoC3 PCSK9 dimer and ArrowMapT programs are expected to begin in early 2026.
A strategic decision on the future of the INHBE and ALK-7 obesity programs, including potential partnerships, is projected for the first half of 2026.

8 days ago

Transcript

Arrowhead Pharmaceuticals Provides Updates on Redemplo Approval and Upcoming Obesity Program Data

ARWR

Product Launch

New Projects/Investments

Guidance Update

Arrowhead Pharmaceuticals recently received approval for Redemplo in FCS and will provide launch updates on its upcoming quarterly call.
The company anticipates releasing data from its INHBE and ALK-7 obesity programs in early January 2026. Preclinical data for ALK-7 showed a 40% differential in fat mass in diet-induced obesity models.
Arrowhead expects to initiate Phase 1 studies for its ApoC3 PCSK9 dimer and ArrowMapT programs in early 2026.
A decision on the path forward for the INHBE and ALK-7 obesity programs is expected in the first half of 2026, following further data from combo cohorts.

8 days ago

Transcript

Arrowhead Pharmaceuticals Discusses Redemplo Approval and Pipeline Catalysts

ARWR

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

Arrowhead Pharmaceuticals received FDA approval for Redemplo (Plozasiran) to treat familial chylomicronemia syndrome (FCS) and has set its annual wholesale acquisition cost (WAC) at $60,000.
The company plans to expand Redemplo's label into the severe hypertriglyceridemia (SHTG) market, targeting a core high-risk population of 750,000 to 1 million patients out of an estimated 3.5 million total, with top-line data from the Shasta III and IV Phase III studies anticipated in mid-2026.
Key upcoming catalysts for 2026 include early data for the ARO-MAPT Alzheimer's drug and the PCSK9 ApoC3 dimer for ASCVD in the summer, alongside an expected $200 million milestone payment by the end of 2025 from the Sarepta partnership for DM1 dosing.

Nov 19, 2025, 11:00 AM

Transcript

Arrowhead Pharmaceuticals Discusses Redemplo Approval, Pipeline, and Market Strategy

ARWR

Product Launch

New Projects/Investments

Guidance Update

Arrowhead Pharmaceuticals received FDA approval for Redemplo (Plozasiran) to treat Familial Chylomicronemia Syndrome (FCS) and plans to price it at $60,000 annually, with a strategy to expand into the larger Severe Hypertriglyceridemia (SHTG) market.
The company is advancing Redemplo through three Phase III studies (Shasta III, IV, and V) for SHTG, with top-line data for Shasta III and IV expected by mid-2025.
Key pipeline catalysts for mid-2025 include data from the PCSK9/ApoC3 dimer program for lowering LDL and triglycerides, and early data for ARO-MAPT in Alzheimer's patients, administered via subcutaneous injection.
Arrowhead expects to trigger a $200 million milestone based on DM1 dosing by the end of 2025 from its partnership with Sarepta.

Nov 19, 2025, 11:00 AM

Transcript

Arrowhead Pharmaceuticals Discusses Recent FCS Approval and Pipeline Catalysts

ARWR

Product Launch

New Projects/Investments

Guidance Update

Redemplo (Plozasiran) received FDA approval for familial chylomicronemia syndrome (FCS) on November 18, 2025, and is priced at an annual WAC of $60,000.
The company plans to expand Redemplo's label to the severe hypertriglyceridemia (SHTG) market, which includes approximately 3.5 million people with triglycerides above 500, with a core high-risk population of 750,000 to 1 million.
Key pipeline catalysts for 2026 include top-line data from three Phase III studies for Redemplo (Shasta III, Shasta IV for SHTG, and MIR3 for mixed dyslipidemia) in mid-2026, early data for the Alzheimer's drug (ARO-MAPT) in summer 2026, and data for the PCSK9/ApoC3 dimer in summer 2026.
Arrowhead expects to trigger a $200 million milestone by the end of 2025 based on DM1 dosing in its Sarepta partner program.

Nov 19, 2025, 11:00 AM

Transcript

Arrowhead Pharmaceuticals Announces FDA Approval of REDEMPLO for FCS

ARWR

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

Arrowhead Pharmaceuticals announced on November 18, 2025, the U.S. Food and Drug Administration (FDA) approval of REDEMPLO (plozasiran) to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
REDEMPLO is the first and only FDA-approved siRNA medicine for FCS, a rare disease affecting an estimated 6,500 people in the U.S., and represents Arrowhead's first FDA-approved medicine, marking its transition into a commercial-stage company.
The approval is based on positive Phase 3 PALISADE study results, showing a median reduction of -80% in triglycerides from baseline with 25 mg REDEMPLO, compared to -17% for placebo, and a lower numerical incidence of acute pancreatitis.
REDEMPLO is expected to be available in the U.S. before the end of the year.

Nov 18, 2025, 7:49 PM

8-K

Earnings Transcripts

Quarterly earnings call transcripts for ARROWHEAD PHARMACEUTICALS.