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 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.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) unveiled preclinical data on its RNAi-based obesity program, ARO-INHBE, at the ADA 84th Scientific Sessions. The data demonstrated that ARO-INHBE significantly reduced hepatic INHBE gene expression, which is linked to decreased abdominal fat and improved metabolic profiles. Promising results showed a 95% reduction in INHBE mRNA expression, 19% suppression of body weight, 26% fat mass loss, and preservation of lean mass in obese and diabetic mouse models. Regulatory clearance for clinical trials is planned for late 2024. Co-treatment with tirzepatide and INHBE siRNA indicated potential dose reduction benefits without losing therapeutic efficacy. Arrowhead's pipeline, including ongoing Phase 3 trial results and preclinical programs, will be discussed in upcoming R&D webinars in June and August 2024.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced successful topline results from the Phase 3 PALISADE study of plozasiran, an investigational RNAi-based therapy for familial chylomicronemia syndrome (FCS).
The study achieved its primary endpoint with an 80% median reduction in triglycerides and secondary endpoints, including a reduction in acute pancreatitis incidents versus placebo. Additionally, mean reductions in APOC3 reached up to 94% at month 10.
Plozasiran demonstrated a favorable safety profile with fewer severe adverse events compared to placebo. Arrowhead plans to discuss these results at their June 25, 2024 Cardiometabolic event and is preparing to engage with regulatory authorities for a New Drug Application.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) will participate in several key conferences in June 2024. The company will present its developments in RNAi molecule platforms for glaucoma at the 16th European Glaucoma Society Congress on June 2. Arrowhead will also discuss fazirsiran treatment for liver disease at the EASL Congress on June 7, and ARO-C3 for complement C3 targeting at the APCN on June 13. Additionally, Arrowhead will present insights into its RNA therapeutics at the ADA Scientific Sessions on June 24 and the RNA Therapeutics Conference from June 26-28. Presentation materials will be available on the Arrowhead website.