Fri, Sep. 25, 9:12 AM
Thu, Sep. 24, 12:40 PM
Thu, Sep. 24, 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)
Fri, Sep. 11, 9:11 AM
Wed, Aug. 26, 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.
Tue, Aug. 4, 4:04 PM
Wed, Jun. 17, 5:37 PM
Wed, Jun. 10, 12:57 PM
- The FDA designates Arrowhead Research's (ARWR +2.8%) ARC-AAT an Orphan Drug for the treatment of liver disease associated with Alpha-1 Antitrypsin Deficiency, a rare genetic disease that severely damages the liver and lungs.
- ARC-AAT, currently in Phase 1 development, is an RNAi-based therapeutic which reduces the liver's production of mutant AAT protein.
- Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
Tue, May 12, 10:21 AM| Tue, May 12, 10:21 AM | 2 Comments
Mon, May 11, 4:07 PM
Wed, Apr. 15, 1:32 PM
- UnitedHealth Group (UNH -2.5%) upgraded to Buy with a $141 (21% upside) price target by Jefferies.
- AbbVie (ABBV +1.1%) upgraded to Outperform with a $68 (9% upside) price target by BMO Capital Markets. Analyst Alex Arfaei cites improved prospects for Imbruvica and increased confidence that the company can defend Humira against biosimilars.
- Clovis Oncology (CLVS +7.3%) upgraded to Buy with a $117 (27% upside) price target by Goldman Sachs.
- NuVasive (NUVA -4%) downgraded to Hold with a $49 (14% upside from today's down move) price target by Cannaccord Genuity.
- Arrowhead Research (ARWR -3.3%) downgraded to Hold with a $9 (28% upside from today's down move) price target by Jefferies.
- Cellular Dynamics (ICEL +0.1%) downgraded to Market Perform with a $16.50 price target by Leerink Swann (unsurprising since the company is being acquired by Fujifilm for $16.50).
Tue, Apr. 14, 12:45 PM
Tue, Apr. 14, 9:12 AM
Mon, Apr. 13, 9:15 AM
Mon, Apr. 13, 7:53 AM
- The FDA gives the green light to Arrowhead Research (NASDAQ:ARWR) to initiate a Phase 2b study of ARC-520 for the treatment of chronic hepatitis B infection. The study, called Heparc-2004, will involved 12 patients, eight will receive 1 mg/kg of ARC-520 and four will receive placebo.
- The trial is designed to assess multiple doses of ARC-520 (2 mg/kg and 4 mg/kg) but FDA has a partial clinical hold in place until it reviews data from the 1 mg/kg arm.
- The company expects to begin patient enrollment in ~1 month.
- Previously: Arrowhead drops after FDA partial clinical hold on hep B candidate (Jan. 12)
Thu, Mar. 5, 9:15 AM
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