Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) announced financial results for its fiscal 2016 second quarter ended March 31, 2016. The company is hosting a conference call at 4:30 p.m. EDT to discuss results.
Fiscal 2016 Second Quarter and Recent Company Highlights
- Completed corporate name change to Arrowhead Pharmaceuticals, Inc. to better reflect the company’s stage of development and launched a new website at ArrowheadPharma.com with an updated corporate identity
- Began dosing patients in three Phase 2b studies: the MONARCH study, 2007 long-term extension, and 2001 open-label extension
- Presented promising ARC-520 hepatitis B data at The International Liver Congress™ 2016, including the following key findings:
- ARC-520 and entecavir produced rapid HBV DNA suppression with all hepatitis B e-antigen (HBeAg) positive, treatment naïve patients achieving serum HBV DNA reductions of up to 5.5 log (99.9997%), and all HBeAg negative, treatment naïve patients achieving reductions that put them below the limit of quantitation
- ARC-520 effectively inhibited HBV cccDNA-derived mRNA with observed viral protein reduction in HBV patients of up to 2.0 log (99%) after a single dose
- ARC-520 had a long duration of effect with HBsAg still reduced by 83% after 2 months and 75% after 3 months, which is the final time point of the study, after a single dose
- Based on HBsAg epitope profile analysis, poster authors and Arrowhead collaborators had previously identified a predictive hepatitis B surface-antigen (HBsAg) Clearance Profile associated with HBsAg clearance in antiviral therapy cohorts
- There was a significant association between the development of an HBsAg Clearance Profile and ARC-520 therapy in HBV patients
- Complexed HBsAg antibodies (anti-HBs) were developed and detected in HBV patients treated with ARC-520, which may represent a recovery of the immune system response
- After monthly administration of 6-11 doses of ARC-520 in chimpanzees chronically infected with HBV, the ARC-520 target site sequences remained virtually unchanged, indicating that no drug resistance developed during the treatment period
- Filed for regulatory clearance to begin a Phase 1/2 first-in-human study to assess single and multiple-doses of ARC-521 in healthy volunteers and HBV patients
- Received Orphan Drug Designation by the European Medicines Agency
Platform and Early Pipeline
- Presented promising new preclinical data the 2016 American Academy of Allergy, Asthma & Immunology Annual Meeting suggesting that ARC-F12, an RNAi therapeutic that inhibits the production of Factor XII (F12), has the potential to treat hereditary angioedema and to prevent thrombosis
- Presented data at the American Association for Cancer Research Annual Meeting 2016 (AACR16), showing that ARC-HIF2 inhibited tumor growth and promoted tumor cell death and structural degeneration in two different renal cell carcinoma tumor bearing mouse models
- These data also show that important advancements are being made to Arrowhead’s Dynamic Polyconjugate™ (DPC™) delivery platform to include extra-hepatic targeting capabilities
- Presented data on ARC-LPA, a preclinical development program targeting lipoprotein (a), or Lp(a), for the treatment of cardiovascular disease, at the Arteriosclerosis, Thrombosis and Vascular Biology | Peripheral Vascular Disease (ATVB|PVD) 2016 Scientific Sessions
- These data show that ARC-LPA and Arrowhead’s new delivery vehicles designed for subcutaneous administration can induce deep target gene knockdown with long duration of effect that may enable monthly, bi-monthly, or even less frequent administration (Original Source)
Shares of Arrowhead Research closed today at $5.72, down $0.04 or -0.69%. 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 $5.50 and its 200-day moving average is $5.05.
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 30.7% 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 TipRanks.com, 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 -5.4% and -9.2% respectively. Yang has a success rate of 49.2% and is ranked #3527 out of 3828 analysts, while Tenthoff has a success rate of 30.1% and is ranked #3691.
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.