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Yesterday, 6:39 AM
Tue, Feb. 9, 4:04 PM
Tue, Jan. 19, 10:18 AM
- The European Medicines Agency (EMA) designates Arrowhead Research's (ARWR -1.1%) RNAi therapeutic candidate, ARC-AAT, an Orphan Drug for the treatment of congenital alpha-1 antitrypsin (AAT) deficiency, a rare genetic disorder that leads to lung and liver problems. AAT is a protein that protects the lungs.
- Among the benefits of Orphan Drug status in the EU is a 10-year period of market exclusivity for the indication, if approved.
- The FDA designated ARC-AAT an Orphan Dug for AAT deficiency last June.
- Previously: Arrowhead Research's ARC-AAT an Orphan Drug for rare genetic liver disease (June 10, 2015)
Dec. 14, 2015, 5:41 PM
Dec. 14, 2015, 4:12 PM
Dec. 7, 2015, 12:48 PM
Dec. 7, 2015, 11:37 AM
- Micro cap Arrowhead Research (ARWR +11.6%) moves up on modestly higher volume in response to its announcement of positive results for lead product candidate ARC-520, an RNAi-based therapeutic, in a study involving chronically hepatitis B-infected chimpanzees. Seven of nine (78%) showed signs of immune reactivation after receiving the combination of ARC-520 and nucleoside analogs, a necessary step for achieving a functional cure of chronic HBV.
- Two mid-stage studies evaluating ARC-520 in HBV are ongoing. Chronic HBV infection afflicts as many as 400M people worldwide.
- Previously: Arrowhead's hep B candidate ARC-520 knocks down circulating surface antigen as much as 99% after single dose in mid-stage study; shares up 35% premarket (Sept. 24)
Dec. 7, 2015, 9:19 AM| Dec. 7, 2015, 9:19 AM | 170 Comments
Nov. 16, 2015, 5:43 PM
Nov. 16, 2015, 9:12 AM
Nov. 4, 2015, 12:48 PM
- Johnson & Johnson (JNJ) acquires privately held Novira Therapeutics, a clinical stage biopharmaceutical firm developing therapies to cure chronic hepatitis B infection within one year of treatment, for an undisclosed sum. The transaction should close this quarter.
- Novira's lead product candidate is NVR 3-778, a orally available, small molecule, direct-acting antiviral that inhibits the HBV core or capsid protein. HBV core is an attractive drug target since it is plays a key role in viral replication and survival. NVR 3-778 disrupts the HBV life cycle by inducing the assembly of defective capsids. According to the company, its inhibitors, when used in combination with current standard-of-care drugs (nucleosides and interferon), should deliver greater and faster suppression of viral DNA and new virus production.
- Selected HBV-related tickers: (ARWR +2.1%)(GILD -1%)(CTRV -3.2%)(ABUS +2.6%)(DVAX -1.8%)(MRK +0.7%)(SNY -0.8%)(GSK +0.1%)(ISIS +2.1%)(ALNY +3.1%)(BMY -0.6%)
Sep. 25, 2015, 9:12 AM
Sep. 24, 2015, 12:40 PM
Sep. 24, 2015, 9:05 AM
- Arrowhead Research (NASDAQ:ARWR) is up 35% premarket on robust volume in response to its announcement of positive top-line results in a Phase 2a clinical trial, called Heparc-2001, assessing its RNAi-based therapeutic candidate, ARC-520, for the treatment of chronic hepatitis B infection. The company will present the data this morning at 11:00 am ET at its analyst day in NY.
- HBV patients who were E-antigen positive (HBeAg-positive) who were on entecavir therapy [Bristol-Myers Squibb's (NYSE:BMY) BARACLUDE] who received a single 4 mg/kg dose of ARC-520 showed a mean maximal 92% (1.2 log) reduction in circulating HBeAg and a best reduction of 98% (1.7 log). Similar knockdowns were also observed in HBV core-related antigen (HBcrAg) from both E-antigen-positive and -negative patients.
- In treatment-naive HBeAg-positive patients, the best peak reduction in surface antigen (HBsAg) was 99% (1.9 log). The mean maximum HBsAg knockdown was 1.05 log through 15 days post-ARC-520 treatment. Data collection is ongoing and will be continued through Day 85 post-ARC-520 treatment.
- About 95% of people with chronic HBV infection have not been treated with nucleoside/nucleotide (NUC) analogue therapy. About half of these are believed to be HBeAg-positive. Patients testing positive for HBV antigens have an active infection. About 350M people worldwide are chronically infected with hep B.
- Related ticker: (NASDAQ:GILD)
Sep. 11, 2015, 9:11 AM
Aug. 26, 2015, 6:57 PM
- Biotech analysts at Piper Jaffray say they are buyers on weakness of four biotech names - Vertex Pharma (NASDAQ:VRTX), Novavax (NASDAQ:NVAX), Alnylam Pharma (NASDAQ:ALNY) and Arrowhead Research (NASDAQ:ARWR) - that boast strong enough balance sheets to make it through upcoming value-driving events.
- The firm notes VRTX holds more than $1B in cash, and expects a dramatic increase in treatable cystic fibrosis patients with the newly approved Orkambi, which will help drive revenue growth and a return to near-term profitability.
- Jaffray says it has increased confidence in NVAX following positive Phase 2 data in its RSV-F in elderly subjects; the company ended the quarter with $315M in cash, which can fund "at least one" pivotal RSV trial.
- ALNY ended the recent quarter with $1.4B in cash, with key patisiran and revusiran Phase II in OLE updates expected in Q4.
- On ARWR, the firm looks to an expected September update of Phase IIa HEPARC 2001 data.
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