Arrowhead Pharmaceuticals Inc.

ARWR

Held by 9 specialist biotech funds

High Convergence

9 funds opened new positions. Next phase2 readout (ARO-DIMERPA): Jun 2026. Short interest: 10.6% of float.

BiotechnologyCEO: Christopher R. AnzaloneIPO: 1993Website ↗

Arrowhead Pharmaceuticals, Inc., founded in 1989 and based in Pasadena, California, is a biopharmaceutical company dedicated to discovering and advancing innovative treatments for complex and challenging-to-treat diseases within the United States. The company's extensive therapeutic pipeline primarily leverages RNA interference (RNAi) technology. Among its advanced clinical programs are: ARO-AAT, a Phase II therapeutic targeting liver diseases associated with alpha-1 antitrypsin deficiency; ARO-APOC3, which is undergoing both Phase 2b and Phase 3 clinical evaluations for hypertriglyceridemia; ARO-ANG3, currently in Phase 2b development to reduce the production of angiopoietin-like protein 3; and ARO-HIF2, a Phase 1b candidate designed to treat clear cell renal cell carcinoma. Arrowhead also has several compounds in earlier clinical development, including ARO-HSD in Phase 1/2a for other liver diseases, ARO-ENaC in Phase 1/2a, aimed at decreasing the epithelial sodium channel alpha subunit in lung airways, and ARO-C3, also in Phase 1/2a, for complement-mediated diseases. Further expanding its diverse portfolio, the company is actively developing ARO-Lung2 for chronic obstructive pulmonary disorder (COPD), ARO-DUX4 for facioscapulohumeral muscular dystrophy, ARO-XDH for uncontrolled gout, and ARO-COV for COVID-19 and other pulmonary-borne pathogens. Beyond its core internal programs, Arrowhead is involved in the progression of JNJ-3989, a subcutaneously administered RNAi therapeutic for chronic hepatitis B virus infection; Olpasiran, intended to reduce apolipoprotein A production; and ARO-AMG1, which targets genetically validated cardiovascular pathways. Strategic collaborations are integral to Arrowhead's development efforts. The company holds a licensing and research agreement with Janssen Pharmaceuticals, Inc. for the co-development of ARO-JNJ1, ARO-JNJ2, and ARO-JNJ3, all RNAi therapeutics focused on liver-expressed targets. Additionally, Arrowhead has a licensing and research partnership with Takeda Pharmaceuticals U.S.A., Inc. to develop an RNAi therapeutic candidate specifically for liver disease.

Catalysts

Phase 2Q4 2015ARC-520 InjectionChronic Hepatitis BNCT02349126

Primary: Efficacy: To evaluate the depth and duration of HBsAg decline in response to a single dose of ARC 520 in combination with entecavir or tenofovir in patients with chronic HBV infection (Through Day 85 post-dosing)0Sites: 1NA, TREATMENT

Phase 2Q4 2016ARC-AAT InjectionAlpha-1 Antitrypsin DeficiencyNCT02900183

Primary: Incidence and frequency of adverse events as a measure of safety and tolerability of multiple doses of ARC-AAT Injection (Baseline through Day 287 End-of Study Visit)0Sites: 4NA, TREATMENT

Phase 2NegativeQ4 2016ARC-520Hepatitis B, Hepatitis DNCT02577029

Primary: Percentage of Participants Achieving a 1-log Reduction in Hepatitis B Surface Antigen (HBsAg) at Week 60 Compared to Baseline (Baseline, Week 60)Enrollment:79/79Sites: 33NON_RANDOMIZED, TREATMENT

Phase 2NegativeQ4 2016ARC-520Hepatitis BNCT02604212

Primary: Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 113 (Baseline, Day 113)Enrollment:32/32Sites: 16RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2NegativeQ4 2016ARC-520 InjectionHepatitis BNCT02738008

Primary: Percentage of Initial Responders to ARC-520 Therapy Achieving a 1-log Reduction in HBsAg at Week 36 Compared to Baseline (Baseline, Week 36)Enrollment:12/12Sites: 6NA, TREATMENT

Phase 2NegativeQ1 2017ARC-520 InjectionHepatitis BNCT02604199

Primary: Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 113 (Baseline, Day 113)Enrollment:58/58Sites: 16RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2NegativeQ1 2017ARC-520Hepatitis B, ChronicNCT02065336

Primary: Change From Baseline Over Time in Quantitative Hepatitis B Surface Antigen (HBsAG) (Baseline, through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 253 Cohort 10))Enrollment:58/58Sites: 2RANDOMIZED, TRIPLE, TREATMENT

Phase 2Q2 2020ARO-HBVHepatitis BNCT03365947

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment (NHV participants: up to Day 29 (± 2 days); CHB participants: Day 113 (± 2 days))Enrollment:114/114Sites: 7RANDOMIZED, DOUBLE, TREATMENT

Phase 2NegativeQ2 2021ARO-ENaCCystic Fibrosis, PulmonaryNCT04375514

Phase 2Q3 2021ARO-HSD InjectionNon-alcoholic SteatohepatitisNCT04202354

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment (From first dose of study drug through Day 113 (±5 days))Enrollment:50/50Sites: 1RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q4 2021Fazisiran InjectionAlpha 1-Antitrypsin DeficiencyNCT03945292

Primary: Percent Change From Baseline in Serum Z-Alpha-1 Antitrypsin (Z-AAT) at Week 16 (Baseline, Week 16 (+/- 2 weeks))Enrollment:40/40Sites: 21RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2PositiveQ2 2022ARO-AATAlpha 1-Antitrypsin DeficiencyNCT03946449

Phase 2Q3 2022ARO-ANG3Mixed DyslipidemiaNCT04832971

Phase 2PositiveQ1 2023ARO-APOC3Mixed DyslipidemiaNCT04998201

Phase 2PositiveQ1 2023ARO-APOC3Severe HypertriglyceridemiaNCT04720534

Primary: Percent Change From Baseline at Week 24 in Fasting Triglycerides (TG) (Baseline, Week 24)Enrollment:229/229Sites: 74RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q2 2023ARO-ANG 3 InjectionHomozygous Familial HypercholesterolemiaNCT05217667

Primary: Percent Change from Baseline in Fasting Calculated Low-Density Lipoprotein-Cholesterol (LDL-C) and LDL-C by Preparative Ultracentrifugation (LDL-C [PUC]) up to Week 24 (Baseline, up to Week 24)Enrollment:18/18Sites: 7RANDOMIZED, TREATMENT

Phase 3ApprovedQ2 2024PlozasiranFamilial ChylomicronemiaNCT05089084

Phase 3Q3 2024Tranexamic AcidHemorrhagic Shock, Trauma InjuryNCT03469947

Phase 2NegativeQ4 2024ARO-MUC5ACAsthma, Chronic Obstructive Pulmonary DiseaseNCT05292950

Phase 2Q2 2025ARO-RAGEAsthmaNCT05276570

Phase 2Q2 2025ARO-C3C3 Glomerulopathy, Ig A NephropathyNCT05083364

Phase 3Q2 2025Calcium carbonateUterine Contraction, Labor Complication, Labor Active Dilated CmNCT07056062

Phase 2Q3 2025ARO-MMP7 Inhalation SolutionIdiopathic Pulmonary FibrosisNCT05537025

Phase 2Q3 2025ARO-APOC3DyslipidemiasNCT05413135

Phase 3Q2 2026Plozasiran InjectionHypertriglyceridemiaNCT06347133

Phase 2Q2 2026ARO-DIMERPAHyperlipidemia; MixedNCT07223658

Primary: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (Up to Week 36)Enrollment:Target 78Sites: 17RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q2 2026Plozasiran InjectionSevere HypertriglyceridemiaNCT06347003

Primary: Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo (Baseline, Month 12)Enrollment:446/446Sites: 196RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q2 2026Plozasiran InjectionSevere HypertriglyceridemiaNCT06347016

Primary: Percent change in fasting serum TG levels from baseline to Month 12 compared to placebo (Baseline, Month 12)Enrollment:311/311Sites: 149RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q4 2026ARO-DUX4 for InjectionFacio-Scapulo-Humeral DystrophyNCT06131983

Primary: Number of Participants With Treatment-Emergent Adverse Events Over Time Through End of Study (Part 1: Up to Day 90; Part 2: Up to Day 360)Enrollment:Target 60Sites: 16RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q4 2026ARO-DM1 Intravenous (IV) InfusionMyotonic Dystrophy 1NCT06138743

Primary: Number of Participants with Treatment-emergent Adverse Events Over Time Through End of Study (EOS) (Single-dose phase (Part 1): Up to Day 90 (EOS); multiple-dose phase (Part 2): Up to Day 180 (EOS))Enrollment:Target 78Sites: 35RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q1 2027ARO-ALK7Obesity, Diabetes Mellitus, Type 2NCT06937203

Primary: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (Up to Day 253 End of Study (EOS))Enrollment:Target 150Sites: 8RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q2 2027ARO-MAPT-SCAlzheimer Disease, Alzheimer Disease, Early OnsetNCT07221344

Phase 3Jun 30, 2027StatinsIntracerebral HemorrhageNCT03936361

Phase 3Q3 2027zodasiran InjectionHomozygous Familial HypercholesterolemiaNCT07037771

Phase 2Q3 2027ARO-INHBEObesityNCT06700538

Phase 2Q4 2027ARO-RAGEAsthmaNCT07241546

Phase 3Q3 2028Plozasiran InjectionHypertriglyceridemiaNCT06822790

Phase 3Q3 2028ZodasiranHomozygous Familial HypercholesterolemiaNCT07473843

Phase 3Q1 2029PlozasiranSevere HypertriglyceridemiaNCT06880770

Phase 2Q4 2029ARO-INHBEMetabolic Dysfunction-Associated SteatohepatitisNCT07859813

Arrowhead Pharmaceuticals Inc.

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