Articles from Arrowhead Pharmaceuticals, Inc.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced interim results from a Phase 1/2a clinical study of ARO-CFB, the company’s investigational RNA interference (RNAi) therapeutic targeting complement factor B being developed as a potential treatment for complement mediated diseases. The data were presented today, December 11, 2024, at the 8th Complement-Based Drug Development Summit being held in Boston.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has filed a request for regulatory clearance to initiate a Phase 1/2a clinical trial of ARO-ALK7, the company’s second investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for obesity. ARO-ALK7 is the first RNAi-based therapy to directly target a gene expressed in adipose tissue and highlights Arrowhead’s leadership in the delivery of siRNA to multiple tissues and cell types throughout the body utilizing its proprietary and differentiated Targeted RNAi Molecule (TRiM™) platform.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it is scheduled to participate in the following upcoming events:

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its 2024 fiscal year ended September 30, 2024. The Company is hosting a conference call today, November 26, 2024, at 4:30 p.m. ET to discuss the results.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced a global licensing and collaboration agreement with Sarepta Therapeutics (NASDAQ: SRPT). Upon closing, Arrowhead will receive $825 million, consisting of $500 million cash and $325 million as an equity investment priced at a 35% premium. Arrowhead also receives $250 million to be paid in equal installments over five years and is eligible to receive an additional $300 million in near-term payments, which Arrowhead is on track to achieve during the next 12 months. Additionally, Arrowhead is eligible to receive royalties on commercial sales and up to approximately $10 billion in future potential milestone payments.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for investigational plozasiran for the treatment of familial chylomicronemia syndrome (FCS), a severe and rare genetic disease which currently has no FDA approved treatments. Arrowhead also intends to submit applications for approval of investigational plozasiran for the treatment of patients with FCS to additional regulatory authorities in 2025.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced new results from the Phase 3 PALISADE study and the open-label extension from the Phase 2 MUIR and SHASTA-2 studies of investigational plozasiran. These data were presented in two oral presentations at the American Heart Association Scientific Sessions 2024 (AHA24) and PALISADE data was simultaneously published in the AHA journal, Circulation.

Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR) today announced that 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.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it is scheduled to participate in the following upcoming events:

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today, on FCS Awareness Day, announced the launch of a new disease awareness campaign, 'We'll Get There Soon,' to bring hope to the rare disease community affected by Familial Chylomicronemia Syndrome (FCS). The campaign seeks to raise awareness about FCS, a severe and rare condition marked by persistently high triglyceride levels despite standard treatment, which can lead to serious and potentially life-threatening symptoms, including acute pancreatitis.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that as an inducement to entering into employment with the Company, on October 11, 2024, the Company’s Board of Directors approved “inducement” grants to 34 new employees under Rule 5635(c)(4) of the NASDAQ Listing Rules. The grants entitle employees, in aggregate, to receive up to 66,750 restricted stock units. The grants are outside the Company’s stockholder-approved equity incentive plans and vest annually over four years.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has filed for regulatory clearance to initiate a Phase 1/2a clinical trial of ARO-INHBE, the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for obesity. Arrowhead also plans to file for regulatory clearance before the end of 2024 to initiate a clinical trial for its second obesity candidate, ARO-ALK7.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced results from the Phase 3 PALISADE study of investigational plozasiran in patients with familial chylomicronemia syndrome (FCS), a severe and rare genetic disease which currently has no approved treatments in the U.S. PALISADE successfully met its primary endpoint and all multiplicity-controlled key secondary endpoints, including statistically significant reductions in triglycerides (TGs), apolipoprotein C-III (APOC3), and the incidence of acute pancreatitis (AP). These data were presented today in a late-breaking oral presentation at the European Society of Cardiology (ESC) Congress 2024 and simultaneously published in The New England Journal of Medicine.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it will present new Phase 3 clinical data from the PALISADE study of plozasiran (ARO-APOC3) at the European Society of Cardiology (ESC) Congress 2024, being held in London August 30 through September 2, 2024. The company will also host a virtual analyst and investor event on September 3, 2024, at 8:00 am EDT.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today presented preclinical data and detailed its plans to advance two next generation RNAi-based candidates, ARO-INHBE and ARO-ALK7, into upcoming clinical studies for the treatment of obesity and metabolic diseases. In preclinical studies to date, these candidates demonstrated the potential to reduce body weight and fat mass with a novel mechanism of action that may lead to improved preservation of lean muscle mass compared to currently approved obesity therapies. Arrowhead plans to submit clinical trial applications with regulatory authorities for both programs by the end of 2024 with the goal of initiating clinical studies in volunteers with obesity in early 2025.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2024 third quarter ended June 30, 2024. The Company is hosting a conference call today, August 8, 2024, at 4:30 p.m. ET to discuss the results.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has entered into a strategic financing agreement with Sixth Street for significant, long-term, non-dilutive capital to fund innovation and growth opportunities across Arrowhead’s robust and diverse pipeline of RNAi therapeutics. The $500 million senior secured credit facility includes $400 million funded at close with an additional $100 million available at Arrowhead’s option, subject to mutual agreement between Sixth Street and Arrowhead, during the seven-year term of the agreement.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that as an inducement to entering into employment with the Company, on July 25, 2024, the Company’s Board of Directors approved “inducement” grants to 33 new employees under Rule 5635(c)(4) of the NASDAQ Listing Rules. The grants entitle employees, in aggregate, to receive up to 60,900 restricted stock units. The grants are outside the Company’s stockholder-approved equity incentive plans and vest annually over four years.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it will host a webcast and conference call on August 8, 2024, at 4:30 p.m. ET to discuss its financial results for the fiscal third quarter ended June 30, 2024.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced plans to advance investigational plozasiran into a Phase 3 cardiovascular outcomes trial called CAPITAN. This comes after promising results were recently announced from multiple clinical trials in three distinct patient populations, including the pivotal Phase 3 PALISADE study in patients with genetically confirmed or clinically diagnosed familial chylomicronemia syndrome (FCS), the Phase 2 SHASTA-2 study in patients with severe hypertriglyceridemia (SHTG), which was published in JAMA Cardiology1, and the Phase 2 MUIR study in patients with mixed hyperlipidemia, which was published in the New England Journal of Medicine2.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that preclinical data on ARO-INHBE, an investigational RNAi-based medicine for the treatment of obesity and metabolic diseases, were presented at the American Diabetes Association (ADA) 84th Scientific Sessions, which were held June 21-24, in Orlando, FL, and virtually.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced topline results from the pivotal Phase 3 PALISADE study of investigational plozasiran in patients with genetically confirmed or clinically diagnosed familial chylomicronemia syndrome (FCS), a severe genetic disease with significant unmet need and no FDA approved therapies. PALISADE successfully met the primary endpoint of lowering triglycerides and met all key secondary endpoints, including reducing the incidence of acute pancreatitis compared to placebo.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it is scheduled to participate in the following upcoming events:

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced results from the Phase 2b double blind, randomized ARCHES-2 study of investigational zodasiran (formerly ARO-ANG3) in patients with mixed hyperlipidemia. Zodasiran was associated with robust and durable reductions in triglycerides, triglyceride rich lipoprotein remnants, and total atherogenic lipoproteins, including LDL-C. These data were presented in a late-breaking oral presentation today at the European Atherosclerosis Society (EAS) 92nd Congress and simultaneously published in the New England Journal of Medicine.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced results from the Phase 2b double blind, randomized MUIR study of investigational plozasiran (formerly ARO-APOC3) in patients with mixed hyperlipidemia. Treatment with plozasiran in the MUIR study achieved reductions in triglyceride rich lipoproteins, a genetically validated target associated with increased risk of atherosclerotic cardiovascular disease (ASCVD)1,2. These data were presented in an oral presentation today at the European Atherosclerosis Society (EAS) 92nd Congress and simultaneously published in the New England Journal of Medicine.