Arrowhead Pharma Stock Price, News & Analysis

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.

Arrowhead Pharmaceuticals (NASDAQ: ARWR) has secured a $500 million strategic financing facility with Sixth Street, strengthening its balance sheet with long-term, non-dilutive capital. The deal includes $400 million funded at close and the potential for an additional $100 million. This financing immediately enhances Arrowhead's ability to advance plozasiran towards a 2025 launch and expands possibilities to fund innovation across its RNAi therapeutics pipeline.

The seven-year credit facility bears an annual interest rate of 15% and matures on August 7, 2031. It provides flexible repayment mechanics, aligning outflows with future inflows from partnerships, collaborations, and commercial revenue. This structure allows Arrowhead to confidently build its commercial capabilities while supporting growth and innovation across its pipeline.

Arrowhead Pharmaceuticals (NASDAQ: ARWR) has announced the approval of inducement grants for 33 new employees by its Board of Directors on July 25, 2024. These grants, made under NASDAQ Listing Rule 5635(c)(4), are outside the company's stockholder-approved equity incentive plans. The grants collectively allow the new employees to receive up to 60,900 restricted stock units. These units will vest annually over a four-year period, providing a long-term incentive for the new hires to align their interests with the company's performance.

Arrowhead Pharmaceuticals (NASDAQ: ARWR) has announced a webcast and conference call scheduled for August 8, 2024, at 4:30 p.m. ET to discuss its fiscal 2024 third quarter financial results for the period ended June 30, 2024. Investors can access the live audio webcast on the company's website, with a replay available approximately two hours after the call concludes. Analysts wishing to participate in the conference call are required to register in advance to receive dial-in information and a personalized PIN code for access.

Arrowhead Pharmaceuticals announced the advancement of plozasiran into the Phase 3 CAPITAN cardiovascular outcomes trial, following successful Phase 2 MUIR study results. The CAPITAN trial will enroll patients with mixed hyperlipidemia and residual atherosclerotic cardiovascular disease (ASCVD) risk. The company is also continuing its pivotal Phase 3 PALISADE and SHASTA studies for plozasiran in patients with familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (SHTG), respectively.

Plozasiran has shown consistent efficacy in reducing triglycerides and other atherogenic lipoproteins in trials. Arrowhead will focus its resources on plozasiran's development and may seek partners for further development of zodasiran. An R&D webinar will be held on June 25, 2024, detailing clinical data and future plans for plozasiran.