Company: ARWR
Filing Date: 2025-02-10
Form Type: 10-Q
Source: 0001628280-25-004634
Chunk: 92

Company: ARROWHEAD PHARMACEUTICALS, INC.
Filing Date: 2025-02-10
Form: 10-Q
Item: Part I, Item 2
Chunk 92
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-licensed to Amgen);

•Inflammatory pulmonary conditions - ARO-RAGE;

•Idiopathic pulmonary fibrosis - ARO-MMP7;

22

•Metabolic-dysfunction associated steatohepatitis (MASH) - GSK-4532990 (formerly ARO-HSD, outlicensed to GSK);

•Alpha-1 antitrypsin deficiency (AATD) - fazirsiran (formerly ARO-AAT, a collaboration with Takeda);

•Chronic hepatitis B virus - daplusiran/tomligisiran (GSK5637608, formerly JNJ-3989, out-licensed to GSK); 

•Complement mediated diseases - ARO-C3;

•Metabolic-dysfunction associated steatohepatitis (MASH) - ARO-PNPLA3 (formerly JNJ-75220795 or ARO-JNJ1);

•Facioscapulohumeral muscular dystrophy - ARO-DUX4;

•Dystrophia myotonica protein kinase (DMPK) - ARO-DM1;

•Hepatic expression of complement factor B (CFB) - ARO-CFB;

•Obesity - ARO-INHBE; and

•Spinocerebellar ataxia 2 - ARO-ATXN2.

The Company operates lab facilities in California and Wisconsin, where its research and development activities, including the development of RNAi therapeutics, take place. The Company’s principal executive offices are located in Pasadena, California.

The Company continues to develop other clinical candidates for future clinical trials. Clinical candidates are tested internally and through Good Laboratory Practice (GLP) toxicology studies at outside laboratories. Drug materials for such studies and clinical trials are either manufactured internally or contracted to third-party manufacturers. The Company engages third-party contract research organizations (CROs) to manage clinical trials and works cooperatively with such organizations on all aspects of clinical trial management, including plan design, patient recruiting, and follow up. These outside costs, including toxicology/efficacy testing and manufacturing costs, as well as the preparation for and administration of clinical trials, are referred to as “candidate costs.” As clinical candidates progress through clinical development, candidate costs will increase. 

The First Quarter of Fiscal 2025 Business Highlights

Key recent developments through the first quarter of fiscal 2025 included the following: 

•Submitted a New Drug Application (NDA) to the U.S.