Arrowhead Pharma Stock Price, News & Analysis

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.

Arrowhead Pharmaceuticals announced a global licensing and collaboration agreement with Sarepta Therapeutics. The deal includes an immediate $825 million payment ($500M cash + $325M equity investment at 35% premium), plus $250 million over five years. Arrowhead is eligible for $300 million in near-term clinical trial milestone payments and up to $10 billion in future milestones plus royalties.

The agreement covers multiple clinical and preclinical programs in rare genetic diseases affecting muscle, CNS, and lungs. Sarepta can select up to six new targets using Arrowhead's TRiM™ platform. The transaction extends Arrowhead's cash runway into 2028 and is expected to close in early 2025.

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.

Arrowhead Pharmaceuticals (NASDAQ: ARWR) has submitted a New Drug Application (NDA) to the FDA for plozasiran, targeting familial chylomicronemia syndrome (FCS), a severe genetic disease with no current FDA-approved treatments. The submission is based on positive Phase 3 PALISADE study results, which showed an 80% median reduction in triglycerides and an 83% reduction in acute pancreatitis risk compared to placebo. The company plans to submit additional regulatory applications in 2025. The drug demonstrated promising efficacy in treating FCS, a condition characterized by extremely high triglyceride levels and increased risk of acute pancreatitis.