Welcome to our dedicated page for Arrowhead Pharma news (Ticker: ARWR), a resource for investors and traders seeking the latest updates and insights on Arrowhead Pharma stock.
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) regularly issues news on its RNA interference (RNAi) pipeline, regulatory milestones, clinical data, and capital markets activity. This ARWR news page on Stock Titan aggregates those updates so readers can follow how the company’s gene-silencing therapeutics are progressing across cardiometabolic, obesity, and neurodegenerative indications.
Recent company announcements highlight approvals and regulatory actions for REDEMPLO (plozasiran), a small interfering RNA medicine targeting apoC-III for adults with familial chylomicronemia syndrome (FCS). Arrowhead has reported approvals for REDEMPLO in the United States, Canada, and China, as well as Breakthrough Therapy designation for investigational plozasiran in severe hypertriglyceridemia and ongoing Phase 3 trials in broader triglyceride disorders.
News items also cover interim clinical data for investigational obesity candidates ARO-INHBE and ARO-ALK7, which the company is studying for effects on visceral fat, total fat, liver fat, and body weight, including in obese patients with type 2 diabetes mellitus. Additional coverage includes the initiation of a Phase 1/2a study of ARO-MAPT for tauopathies such as Alzheimer’s disease, using a TRiM-based delivery system intended to reach the central nervous system after subcutaneous administration.
Investors and observers will also find Arrowhead’s press releases on public offerings of common stock, pre-funded warrants, and 0.00% convertible senior notes due 2032, as well as collaboration and licensing updates such as the agreement with Novartis for ARO-SNCA and arrangements involving Visirna Therapeutics and Sanofi in Greater China. Bookmark this page to review Arrowhead’s earnings-related 8-K references, conference participation, and ongoing disclosures about its RNAi programs and commercial activities.
Arrowhead Pharmaceuticals (NASDAQ:ARWR) has announced it will host a webcast and conference call on November 26, 2024, at 4:30 p.m. ET to discuss its financial results for the 2024 fiscal year ended September 30, 2024. Investors can access the live audio webcast through the Events and Presentations page on the company's website. A replay will be available approximately two hours after the call concludes. Analysts wishing to participate must register through the provided link to receive dial-in details and a personalized PIN code.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) has announced its participation in several major healthcare conferences in November 2024. The company will present research on multiple drug candidates including Plozasiran at the American Conference on Pharmacometrics and American Heart Association Scientific Sessions. Key presentations focus on treatments for hypertriglyceridemia and familial chylomicronemia syndrome.
The company will also showcase research on Fazirsiran for alpha-1 antitrypsin deficiency-associated liver disease at The Liver Meeting 2024. Additional presentations are scheduled at the UBS Global Healthcare Conference, TIDES Europe, and Jefferies London Healthcare Conference, covering various aspects of their therapeutic pipeline and platform technologies.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) launched 'We'll Get There Soon,' a disease awareness campaign for Familial Chylomicronemia Syndrome (FCS) on FCS Awareness Day. The initiative includes a website, www.LowerTriglycerides.com, and social media presence to support the FCS community. The campaign features Julie Klueckman's story, highlighting the challenges of living with FCS, including a decade-long diagnosis journey, multiple hospitalizations, and the need to maintain an extremely low-fat diet of up to 20 grams daily. The campaign aims to educate about maintaining triglyceride levels below 500 mg/dL to reduce acute pancreatitis risk and bring hope to those affected by this rare condition.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) has announced the approval of inducement grants for 34 new employees by its Board of Directors on October 11, 2024. These grants, made under NASDAQ Listing Rule 5635(c)(4), are outside the company's stockholder-approved equity incentive plans and collectively allow the new employees to receive up to 66,750 restricted stock units. The grants are designed to vest annually over a four-year period, serving as an incentive for the new hires to join the company.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) has filed for regulatory clearance to initiate a Phase 1/2a clinical trial of ARO-INHBE, an investigational RNA interference (RNAi) therapeutic for obesity treatment. The company plans to file for a second obesity candidate, ARO-ALK7, by the end of 2024. Both therapies target the pathway signaling fat storage in adipose tissue.
Preclinical studies suggest these treatments may reduce body and fat mass while preserving lean muscle mass. The planned study, AROINHBE-1001, will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in up to 78 adult volunteers with obesity. It includes monotherapy assessment and combination therapy with tirzepatide, an approved GLP-1/GIP receptor co-agonist for diabetes and weight management.
ARO-INHBE aims to reduce hepatic expression of the INHBE gene and its product, Activin E, potentially increasing lipolysis and reducing adipose dysfunction, visceral adiposity, and insulin resistance.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) has received FDA Breakthrough Therapy designation for plozasiran, an investigational drug for familial chylomicronemia syndrome (FCS). The PALISADE Phase 3 results showed plozasiran reduced triglycerides by 80% from baseline and decreased the risk of acute pancreatitis by 83% in FCS patients. There are currently no FDA-approved treatments for FCS, a severe genetic disease characterized by extremely high triglyceride levels. Arrowhead plans to submit a New Drug Application to the FDA by year-end 2024 and seek additional global regulatory approvals thereafter. Plozasiran has also received Orphan Drug Designation and Fast Track Designation from the FDA, and Orphan Drug Designation from the European Medicines Agency.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced positive results from its Phase 3 PALISADE study of plozasiran for treating familial chylomicronemia syndrome (FCS). The study met its primary endpoint, showing an 80% reduction in triglycerides from baseline and an 83% reduction in acute pancreatitis risk. Key findings include:
- Similar responses in genetically confirmed and clinically diagnosed FCS patients
- Plans to file a New Drug Application by year-end 2024
- Results published in The New England Journal of Medicine
- Median triglyceride reduction of 80% in the 25 mg group and 78% in the 50 mg group vs 17% for placebo
- APOC3 reductions of 93% and 96% in treatment groups vs 1% for placebo
- Favorable safety profile with common adverse events similar to placebo
Arrowhead Pharmaceuticals (NASDAQ: ARWR) has announced the presentation of new Phase 3 clinical data from the PALISADE study of plozasiran (ARO-APOC3) at the European Society of Cardiology (ESC) Congress 2024 in London. The presentation, titled 'A phase 3 study to evaluate the efficacy and safety of ARO-APOC3 in adults with familial chylomicronemia syndrome,' will be given by Professor Gerald Watts on September 2, 2024. Arrowhead will host a virtual analyst and investor event on September 3, 2024, featuring an encore presentation of the ESC data and discussion by company management.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) has announced plans to advance two new RNAi-based obesity candidates, ARO-INHBE and ARO-ALK7, into clinical studies. These candidates have shown potential in preclinical studies to reduce body weight and fat mass while preserving lean muscle mass. The company aims to submit clinical trial applications by the end of 2024 and initiate studies in early 2025.
ARO-INHBE targets the hepatic expression of the INHBE gene and Activin E production, while ARO-ALK7 targets adipose tissue expression of the ALK7 gene. Both targets are genetically validated and associated with lower risk of obesity and metabolic diseases. The company believes these novel mechanisms may represent the future of obesity treatment and management.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) reported fiscal 2024 Q3 results, highlighting significant progress in clinical studies and approaching commercialization of RNAi therapeutics. Key financial events include a $500 million credit facility with Sixth Street and a $50 million milestone payment from Royalty Pharma. R&D highlights feature successful Phase 3 results for plozasiran in FCS patients, with up to 80% triglyceride reduction. The company also reported promising data from Phase 2 studies of plozasiran and zodasiran in mixed hyperlipidemia. Arrowhead's Q3 financials show a net loss of $170.8 million, with total cash resources of $436.7 million as of June 30, 2024.