On Thursday, Piper Sandler maintained its Overweight rating and $62.00 stock price target for Arrowhead Pharma (NASDAQ:ARWR). Arrowhead Pharma recently held an obesity key opinion leader event and announced plans to file Clinical Trial Applications (CTAs) for ARO-INHBE and ARO-ALK7 by the end of 2024.
The company anticipates releasing initial Phase I/IIa data in the second half of 2025, which will include biomarker, weight loss, and body composition imaging data for obese, non-diabetic patients.
Arrowhead's Phase III PALISADE trial for Familial Chylomicronemia Syndrome (FCS) successfully met its primary endpoint, showing a significant reduction in triglycerides. The full PALISADE data is scheduled for presentation at the European Society of Cardiology (ESC) on September 2nd. Following this, the company expects to submit a New Drug Application (NDA) by the end of 2024, potentially leading to its first drug approval and market launch in 2025.
The biopharmaceutical company has also initiated Phase III SHASTA-3 and SHASTA-4 trials for severe hypertriglyceridemia (SHTG) in the second quarter of 2024. Moreover, Arrowhead plans to commence the CAPITAN Cardiovascular Outcomes Trial (CVOT) to possibly extend the use of its drug candidate plozasiran.
To support its pipeline development, Arrowhead Pharma secured a $400 million loan from Sixth Street, which has bolstered its pro forma cash position to approximately $837 million. This financial boost aims to advance and expand the company's TRiM platform, which is central to its research and development efforts. Piper Sandler's reiterated rating and price target reflect confidence in Arrowhead Pharma's ongoing and future clinical programs.
In other recent news, Arrowhead Pharmaceuticals (NASDAQ:ARWR) has unveiled its plans to advance two RNA interference (RNAi) candidates, ARO-INHBE and ARO-ALK7, into the final stages of preclinical development for obesity and metabolic disease treatment.
The company plans to file clinical trial applications by the end of 2024 and initiate studies in early 2025. The new candidates have shown potential in preclinical studies to reduce body weight and fat mass while preserving lean muscle mass.
In financial news, Arrowhead reported a net loss of $170.8 million for its fiscal 2024 third-quarter performance, with cash and investments totaling $436.7 million. The company also announced a $500 million senior secured credit facility with Sixth Street and a $50 million milestone payment from Royalty Pharma.
As part of its future plans, Arrowhead is preparing for the commercial launch of its first drug candidate, plozasiran, for familial chylomicronemia syndrome (FCS), pending approval. The company aims to expand its pipeline to at least 20 clinical stage or marketed products by next year.
Arrowhead is also planning to initiate a Phase 3 CAPITAN trial for mixed hyperlipidemia and prepare regulatory filings for other indications. These are the latest developments in Arrowhead's ongoing efforts to advance its portfolio and improve patient outcomes.
InvestingPro Insights
As Arrowhead Pharma (NASDAQ:ARWR) continues to advance its clinical programs, recent data from InvestingPro provides a mixed outlook. The company's market capitalization stands at $2.82 billion, and it operates with a moderate level of debt.
However, analysts have voiced concerns, with 9 analysts revising their earnings downwards for the upcoming period, reflecting skepticism about the company's near-term financial performance. This is further underscored by the expectation of a sales decline in the current year and a projection that the company will not be profitable this year.
InvestingPro data also highlights that Arrowhead Pharma's stock has experienced significant volatility, with a one-week price total return of -12.19% and a one-month return of -21.34%. The company's P/E ratio stands at -4.87, suggesting that investors are pricing in the challenges the company faces. Moreover, Arrowhead Pharma is trading at a high Price / Book multiple of 8.54, which may raise concerns about valuation among investors.
Despite these challenges, Arrowhead Pharma's liquid assets exceed its short-term obligations, providing some financial flexibility as it navigates its clinical trials and seeks to bring new treatments to market. For those interested in a deeper analysis, there are additional InvestingPro Tips available at https://www.investing.com/pro/ARWR, which provide further insights into Arrowhead Pharma's financial health and market position.
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