Arrowhead Pharmaceuticals to Webcast Fiscal 2025 First Quarter Results
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) today announced that it will host a webcast and conference call on February 10, 2025, at 4:30 p.m. ET to discuss its financial results for the fiscal 2025 first quarter ended December 31, 2024.
Arrowhead Pharmaceuticals Announces Acceptance of New Drug Application by U.S. FDA of Plozasiran for the Treatment of Familial Chylomicronemia Syndrome
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational plozasiran for the treatment of familial chylomicronemia syndrome (FCS), a severe and rare genetic disease. The FDA provided a Prescription Drug User Fee Act (PDUFA) action date of November 18, 2025, and indicated it is not currently planning to hold an advisory committee meeting. 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 Initiates Phase 1/2a Study of ARO-INHBE for the Treatment of Obesity
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) today announced that it has dosed the first subjects in 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 filed recently a request for regulatory clearance to initiate a clinical trial for its second obesity candidate, ARO-ALK7. Both ARO-INHBE and ARO-ALK7 are designed to intervene in a known pathway that signals the body to store fat in adipose tissue.
Arrowhead Pharmaceuticals Reports Inducement Grants under NASDAQ Listing Rule 5635(c)(4)
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) today announced that as an inducement to entering into employment with the Company, on December 13, 2024, the Company’s Board of Directors approved “inducement” grants to 20 new employees under Rule 5635(c)(4) of the NASDAQ Listing Rules. The grants entitle employees, in aggregate, to receive up to 44,350 restricted stock units. The grants are outside the Company’s stockholder-approved equity incentive plans and vest annually over four years.
Arrowhead Pharmaceuticals Presents Interim Clinical Data on ARO-CFB for the Treatment of Complement Mediated Diseases
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) 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 Requests Regulatory Clearance to Initiate Phase 1/2a Study of ARO-ALK7 for the Treatment of Obesity
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) 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 to Participate in Upcoming December 2024 Conferences
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) today announced that it is scheduled to participate in the following upcoming events:
Arrowhead Pharmaceuticals Reports 2024 Fiscal Year-End Results
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) 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 Submits New Drug Application to U.S. FDA for Plozasiran for the Treatment of Familial Chylomicronemia Syndrome
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) 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 Presents New Data at AHA24 from PALISADE Phase 3 Study and Open-Label Extension from MUIR and SHASTA-2 Studies of Plozasiran
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) 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 to Webcast 2024 Fiscal Year End Results
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) 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 to Participate in Upcoming November 2024 Conferences
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) today announced that it is scheduled to participate in the following upcoming events:
Arrowhead Pharmaceuticals Launches New Disease Awareness Campaign, ‘We’ll Get There Soon,’ to Inspire Hope for the Rare Disease Community Affected by Familial Chylomicronemia Syndrome
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) 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 Reports Inducement Grants under NASDAQ Listing Rule 5635(c)(4)
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) 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 Files for Regulatory Clearance to Initiate Phase 1/2a Study of ARO-INHBE for the Treatment of Obesity
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) 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 Receives FDA Breakthrough Therapy Designation for Plozasiran
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) today announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to investigational plozasiran as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), a severe and rare genetic disease characterized by extremely high triglyceride levels which can cause acute and potentially fatal pancreatitis. There are currently no approved treatments in the U.S. for FCS.
Arrowhead Pharmaceuticals Presents New Pivotal Phase 3 Data at ESC 2024 from PALISADE Study of Plozasiran in Patients with Familial Chylomicronemia Syndrome
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) 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 to Present New Phase 3 Data at ESC 2024 from PALISADE Study of Plozasiran in Patients with Familial Chylomicronemia Syndrome
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) 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 to Advance Two New RNAi-Based Obesity Candidates, ARO-INHBE and ARO-ALK7, Into Clinical Studies
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) 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 Reports Fiscal 2024 Third Quarter Results
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) 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 Announces $500 Million Strategic Financing Facility with Sixth Street
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) 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 Reports Inducement Grants under NASDAQ Listing Rule 5635(c)(4)
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) 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 to Webcast Fiscal 2024 Third Quarter Results
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) 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 to Advance RNAi-based Plozasiran into Phase 3 CAPITAN Cardiovascular Outcomes Trial
Arrowhead Pharmaceuticals, Inc. (
NASDAQARWR) 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.
