Arrowhead Research Corporation - ARWR STOCK NEWS

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.

Arrowhead Pharmaceuticals has reported positive results from its Phase 2b ARCHES-2 study on zodasiran (ARO-ANG3) for treating mixed hyperlipidemia. The treatment showed significant reductions in triglycerides, LDL-C, and other atherogenic lipoproteins at 24 weeks. Zodasiran also demonstrated a favorable safety profile with balanced adverse events between treatment and placebo groups. These findings were presented at the European Atherosclerosis Society 92nd Congress and published in the New England Journal of Medicine.

The study included various doses (50, 100, and 200 mg) and highlighted dose-dependent efficacy with the highest dose achieving up to a 63% reduction in triglycerides and 74% reduction in ANGPTL3 levels compared to placebo. Additionally, liver fat reductions were observed in patients with higher baseline liver fat fractions.