Arrowhead Research: Non-Significant Undervaluation Rationale, Potential High Alpha
Kanak Kanti De • 51 Comments
Kanak Kanti De • 51 Comments
Arrowhead Research - Ground-Floor Opportunity Or Biotech Bubble Baby?
Stephen Simpson, CFA
Stephen Simpson, CFA
Wed, Apr. 13, 9:17 AM
- Arrowhead Pharmaceuticals (NASDAQ:ARWR) jumps 12% premarket on increased volume in response to its announcement of encouraging data from studies assessing lead product candidate, ARC-520, for the treatment of hepatitis B virus (HBV) infection. Detailed results will be released in three presentations at The International Liver Congress 2016 in Barcelona, Spain this week.
- ARC-520 and entecavir [Bristol-Myers Squibb's (NYSE:BMY) Baraclude] achieved up to 5.5 log (99.9997%) knockdown of HBV DNA in hepatitis B e-antigen (HBeAg)-positive treatment-naive patients, achieving reductions below the level of quantitation.
- ARC-520 inhibited HBV cccDNA (covalently closed circular DNA, a special DNA structure that arises during HBV viral replication)-derived mRNA with observed viral protein reduction in HBV patients up to 2.0 log (99%) after a single dose.
- Phase 2-stage ARC-520 is an RNAi-based therapeutic that acts at the mRNA (messenger RNA) level, upstream from nucleotide and nucleoside analogues.
- Read now Unlocking Deep Value With Arrowhead Research
Wed, Apr. 13, 9:16 AM
Tue, Mar. 8, 9:13 AM
- Sydney, Australia-based Benitec (NASDAQ:BNTC) announces that its DNA-directed RNA interference (ddRNAi) candidate, BB-HB-331, showed robust and durable hepatitis B virus (HBV) suppression in vivo following a single administration.
- The HBV suppression activity of BB-HB-331 was assessed in the Phoenix mouse model in which murine liver cells were replaced by human hepatocytes which made them susceptible to HBV infection. Once infected, the mice received a single systemic injection of BB-HB-331. Serum antigen levels, HBV viral proteins and extracellular HBV DNA were measured once per week for the duration of the eight-week study.
- Results showed a 1.83 log knockdown of serum HBV DNA, equivalent to a 98.5% reduction of circulating HBV. In addition, intracellular HBV DNA was reduced 94.9% while HBV surface antigen (HBsAg) and e antigen (HBeAg) were reduced by 97.6% and 92.6%, respectively. The results validated the previously reported in vitro findings.
- BB-HB-331 combines the gene silencing of RNA interference with the therapeutic potential of gene therapy. It is comprised of an AAV8 capsid (protein shell of a virus) and recombinant DNA engineered to express three short hairpin RNAs that target and inhibit viral RNA expressed from three regions across multiple HBV genotypes. The company plans to advance BB-HB-331 to clinical development.
- Previously: Benitec Biopharma's ddRNAi therapeutic candidate shows potent anti-HBV antigen activity in preclinical testing; shares up 14% (Dec. 7, 2015)
- HBV-related tickers: (NASDAQ:GILD)(OTCQB:COCP)(NYSE:GSK)(NASDAQ:IONS)(NASDAQ:DVAX)(NYSE:JNJ)(NASDAQ:ARWR)(NYSE:MRK)(NASDAQ:CTRV)(NASDAQ:ABUS)(NYSE:SNY)(NASDAQ:ALNY)(NYSE:BMY)
- Update: Shares up 26% in early trading.
Dec. 14, 2015, 5:41 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 | 714 Comments
Nov. 16, 2015, 5:43 PM
Nov. 16, 2015, 9:12 AM
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
Jun. 17, 2015, 5:37 PM
Apr. 14, 2015, 12:45 PM
Apr. 14, 2015, 9:12 AM
Arrowhead Research Corp. is a biopharmaceutical company developing targeted RNAi therapeutics. It is leveraging its proprietary drug delivery technologies to develop drugs based on the RNA interference mechanism that efficiently silences disease-causing genes. Its pipeline includes clinical... More
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