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 develops and commercializes RNA interference medicines that silence genes associated with intractable diseases. The company’s TRiM™ platform is used to design targeted RNAi therapeutics for tissues including liver, lung, muscle, adipose and central nervous system tissue.
Recurring ARWR news covers REDEMPLO® (plozasiran), an siRNA medicine approved in the United States and Australia as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome. Company updates also address plozasiran data across hypertriglyceridemia, regulatory actions in additional geographies, pricing and market-access strategy, fiscal results, investor events, and clinical or partnering developments involving programs such as ARO-PNPLA3, ARO-INHBE and ARO-ALK7.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) has completed its global licensing and collaboration agreement with Sarepta Therapeutics (NASDAQ: SRPT). The deal includes a $500 million upfront payment and $325 million through Sarepta's purchase of Arrowhead stock at $27.25 per share. Additionally, Arrowhead will receive $250 million in annual $50 million installments over 5 years.
The agreement covers multiple clinical-stage programs including ARO-DUX4 for facioscapulohumeral muscular dystrophy, ARO-DM1 for myotonic dystrophy, ARO-MMP7 for idiopathic pulmonary fibrosis, and ARO-ATXN2 for spinocerebellar ataxia 2. Three preclinical programs are also included. Arrowhead can earn up to $300 million in near-term payments for ARO-DM1 study enrollment, plus development milestones of $110-410 million and sales milestones of $500-700 million per program, along with tiered royalties up to low double digits.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) has announced a webcast and conference call scheduled for February 10, 2025, at 4:30 p.m. ET. During this event, the company will discuss its financial results for the fiscal 2025 first quarter ended December 31, 2024.
Investors can access the live audio webcast through the Events and Presentations page in the Investors section of Arrowhead's website. A replay will be available approximately two hours after the call concludes. Analysts wishing to participate in the conference call must register through the provided link to receive dial-in information and a personalized PIN code.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced FDA acceptance of its New Drug Application (NDA) for plozasiran, targeting familial chylomicronemia syndrome (FCS), a severe and rare genetic disease. The FDA set a PDUFA date of November 18, 2025, with no advisory committee meeting currently planned.
The NDA is supported by positive Phase 3 PALISADE study results, which met its primary endpoint and key secondary endpoints. The study demonstrated that plozasiran achieved an 80% median reduction in triglycerides at the 25mg dose and an 83% reduction in acute pancreatitis risk compared to placebo. The most common side effects included abdominal pain, COVID-19, nasopharyngitis, and nausea.
Arrowhead plans to submit additional regulatory applications for plozasiran FCS treatment in 2025 and is preparing for commercial launch pending FDA approval.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) has initiated a Phase 1/2a clinical trial for ARO-INHBE, its RNAi therapeutic candidate for obesity treatment. The company has dosed the first subjects and recently filed for regulatory clearance of a second obesity candidate, ARO-ALK7. Both therapeutics target a pathway that signals fat storage in adipose tissue.
Preclinical studies of ARO-INHBE showed promising results in reducing body weight and fat mass, with a potential advantage of better lean muscle mass preservation compared to existing obesity treatments. The Phase 1/2 study will evaluate ARO-INHBE both as a monotherapy in part 1 and in combination with tirzepatide in part 2, targeting patients with obesity.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced the approval of inducement grants for 20 new employees by its Board of Directors on December 13, 2024. The grants, approved under NASDAQ Listing Rule 5635(c)(4), collectively provide up to 44,350 restricted stock units. These grants are separate from the company's stockholder-approved equity incentive plans and will vest annually over a four-year period.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced interim results from their Phase 1/2a clinical study of ARO-CFB, an RNAi therapeutic targeting complement factor B for complement mediated diseases. The data, presented at the 8th Complement-Based Drug Development Summit, showed significant efficacy with:
- Up to 90% reduction in circulating CFB protein with over 3 months duration
- Near complete inhibition of alternative pathway activity (100% mean reduction) at 200mg and 400mg doses
- Generally well-tolerated safety profile with mostly mild adverse events
The company plans to complete Part 1 of the study and proceed to Part 2, focusing on patients with immunoglobulin A nephropathy, the most common glomerular disease worldwide.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) has filed for regulatory clearance to begin a Phase 1/2a clinical trial of ARO-ALK7, its second RNAi therapeutic for obesity treatment. The trial, AROALK7-1001, will evaluate safety and efficacy in up to 90 obese adults. The study includes two parts: monotherapy assessment and combination therapy with tirzepatide. ARO-ALK7 targets the ACVR1C gene in adipose tissue, aiming to reduce ALK7 production. Preclinical studies showed reduced body weight and fat mass while preserving lean muscle. The company now has two clinical-stage RNAi candidates for obesity treatment, demonstrating its leadership in delivering siRNA to multiple tissues using its TRiM™ platform.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) has announced its participation in multiple scientific conferences during December 2024. The company will present at the Piper Sandler Healthcare Conference (Dec 3) and Evercore ISI HealthCONx Conference (Dec 4). Notable presentations include the PALISADE Phase 3 study results of plozasiran for Familial Chylomicronemia Syndrome at several events, including the APA/JPS/CAP/IAP Joint Meeting and WCIRDC.
The company will also present research on siRNA for neurodegenerative disorders and complement-targeted therapies at the RNA at the Bench and Bedside IV and Complement-Based Drug Development Summit respectively.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) reported its fiscal year 2024 results, highlighting significant financial and R&D developments. The company secured major financing through a $825 million licensing agreement with Sarepta Therapeutics and a $500 million credit facility with Sixth Street, extending cash runway into 2028. Key achievements include submitting their first NDA for plozasiran and receiving Breakthrough Therapy designation from FDA. However, financial results showed a significant increase in net loss to $599.5 million compared to $205.3 million in 2023, with revenue declining to $3.6 million from $240.7 million previous year.
Sarepta Therapeutics announces a global licensing and collaboration agreement with Arrowhead Pharmaceuticals for multiple siRNA programs. Sarepta will obtain exclusive worldwide rights to four clinical-stage and three preclinical-stage programs targeting muscle, CNS, and rare pulmonary disorders. The deal includes a $500 million upfront payment and $325 million equity investment at a 35% premium to Arrowhead, plus future milestone payments and royalties. Additionally, both companies entered a discovery partnership for six targets. Sarepta's Board has approved a $500 million share repurchase program. The transaction is expected to close in early 2025.