Stock Update (NASDAQ:ARWR): Arrowhead Pharmaceuticals Inc Files for Regulatory Clearance to Begin Phase 1/2 Study of ARC-521

Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR), recently filed a regulatory submission in New Zealand to begin a Phase 1/2 clinical trial of ARC-521, its RNAi-based therapeutic candidate for the treatment of chronic hepatitis B virus (HBV) infection. Pending approval, Arrowhead intends to proceed with ARC521-1001, a first-in-human study to assess single and multiple-doses of ARC-521 in healthy volunteers and HBV patients.

Chris Anzalone, Ph.D., president and CEO of Arrowhead Pharmaceuticals, said: “ARC-521 is our second pipeline product targeting chronic HBV and was designed to silence gene products from both HBV cccDNA and integrated HBV DNA. This is important because our clinical work with ARC-520 in HBV patients and our long-term chimpanzee study suggest that different patient groups can have different relative levels of cccDNA. We think having both ARC-520, which has been very active in patients with higher cccDNA, and ARC-521, which may be optimal for those with lower cccDNA, should provide us with the potential to treat all patients with HBV. We have an aggressive plan for the development of ARC-521 that includes an accelerated first-in-man Phase 1/2 design intended to allow rapid transition into multi-dose patient cohorts.”

The application for approval of a clinical trial was submitted to the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) for review by the Standing Committee on Therapeutic Trials (SCOTT). Arrowhead also intends to seek regulatory clearance to conduct ARC521-1001 in additional countries. (Original Source)

Shares of Arrowhead closed yesterday at $5.94, down $0.07 or -1.16%. ARWR has a 1-year high of $9.36 and a 1-year low of $3.07. The stock’s 50-day moving average is $5.18 and its 200-day moving average is $5.02.

On the ratings front, Arrowhead has been the subject of a number of recent research reports. In a report issued on March 31, Jefferies Co. analyst Eun Yang reiterated a Hold rating on ARWR, with a price target of $4, which implies a downside of 32.7% from current levels. Separately, on February 10, Piper Jaffray’s Edward Tenthoff maintained a Buy rating on the stock and has a price target of $13.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Eun Yang and Edward Tenthoff have a total average return of -3.8% and -3.9% respectively. Yang has a success rate of 55.3% and is ranked #3415 out of 3839 analysts, while Tenthoff has a success rate of 32.4% and is ranked #3469.

Arrowhead Pharmaceuticals, Inc. engages as a biopharmaceutical company developing targeted RNAi therapeutics. Its pipeline includes clinical programs in chronic hepatitis B virus and partner based programs in obesity and oncology. The company was founded by R. Bruce Stewart in 1989 and is headquartered in Pasadena, CA.


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