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PASADENA, Calif. - Arrowhead Pharmaceuticals, Inc. (NASDAQ: NASDAQ:ARWR) has sought regulatory approval to begin a Phase 1/2a clinical trial for ARO-INHBE, an RNA interference (RNAi) therapy aimed at treating obesity, the company announced today. The investigational treatment is designed to reduce body weight and fat mass while preserving lean muscle mass, a potential advantage over existing obesity therapies.
ARO-INHBE targets the INHBE gene and its product, Activin E, which plays a role in energy homeostasis and fat storage in adipose tissue. Preclinical studies suggest that inhibiting this pathway can lead to reduced body mass and fat mass. James Hamilton, M.D., Chief of Discovery (NASDAQ:WBD) and Translational Medicine at Arrowhead, expressed optimism about the therapy's potential based on promising preclinical data and the upcoming clinical studies.
The trial application has been submitted for review in New Zealand. If approved, the study, AROINHBE-1001, will involve up to 78 adult volunteers with obesity to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-INHBE. The study will be conducted in two parts: the first assessing ARO-INHBE monotherapy and the second combining ARO-INHBE with tirzepatide, an approved drug for type 2 diabetes and weight management.
Arrowhead also plans to file for regulatory clearance to initiate a clinical trial for a second obesity candidate, ARO-ALK7, by the end of 2024. Both ARO-INHBE and ARO-ALK7 are part of Arrowhead's portfolio of RNAi-based therapeutics, which aim to silence genes causing intractable diseases.
Arrowhead Pharmaceuticals is known for developing RNAi-based therapeutics that trigger gene silencing to reduce the production of specific proteins. The company's approach leverages the natural RNA interference mechanism present in living cells.
This news is based on a press release statement and forward-looking statements within the release are subject to various factors and uncertainties, including regulatory decisions and the impact of the ongoing COVID-19 pandemic. Arrowhead's actual results may differ from the anticipated outcomes outlined in the forward-looking statements.
In other recent news, Arrowhead Pharmaceuticals has been making significant strides in its clinical trials. The company's drug, plozasiran, has been granted Breakthrough Therapy designation by the FDA for the treatment of familial chylomicronemia syndrome (FCS), a rare genetic disorder. Clinical trials have shown plozasiran to reduce triglycerides by 80% from baseline and lower the risk of acute pancreatitis by 83% in patients with FCS.
Arrowhead plans to submit a New Drug Application to the FDA by the end of 2024 and is also advancing two RNA interference candidates, ARO-INHBE and ARO-ALK7, into the final stages of preclinical development for obesity and metabolic disease treatment.
The company reported a net loss of $170.8 million for its fiscal 2024 third-quarter performance, with cash and investments totaling $436.7 million. To support its pipeline development, Arrowhead secured a $400 million loan from Sixth Street.
In terms of analyst ratings, Arrowhead received a reiterated Buy rating from TD Cowen and H.C. Wainwright analysts. Citi and Piper Sandler also maintained their respective Neutral and Overweight ratings on Arrowhead. These recent developments reflect the latest steps in Arrowhead's ongoing efforts to improve patient outcomes.
InvestingPro Insights
As Arrowhead Pharmaceuticals (NASDAQ: ARWR) forges ahead with its innovative RNAi-based therapies, the company's financial health and market performance provide a backdrop to its scientific endeavors. Arrowhead's market capitalization currently stands at $2.59 billion, reflecting its position in the biotechnology sector. However, the company's financial metrics indicate challenges, including a negative P/E ratio of -4.49, which suggests that investors are anticipating future growth despite current unprofitability.
InvestingPro Tips reveal that Arrowhead is rapidly depleting its cash reserves and analysts have expressed concerns by revising their earnings downwards for the upcoming period. Furthermore, the consensus is that sales may decline this year, and profitability is not expected within the same timeframe. Despite these financial headwinds, Arrowhead's liquid assets do exceed its short-term obligations, providing some financial stability as it progresses with its clinical trials.
From a stock performance perspective, ARWR has experienced a notable decline over the past month, with a -16.06% return, and it is currently trading near its 52-week low. This could represent a potential entry point for investors who believe in the long-term prospects of the company's RNAi therapies and are willing to weather the current volatility. Arrowhead's fair value, as per InvestingPro's analysis, stands at $15.28, while analysts have set a higher target of $50.5, indicating a divergence in valuation perspectives.
For those interested in a deeper dive into Arrowhead's financials and future prospects, InvestingPro offers additional tips and metrics, with a total of 13 InvestingPro Tips available at https://www.investing.com/pro/ARWR. These insights can help investors make more informed decisions regarding their interest in a company that is at the forefront of RNAi therapeutic development but is navigating through financial challenges.
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