Arrowhead Research: Non-Significant Undervaluation Rationale, Potential High Alpha
Kanak Kanti De • 51 Comments
Kanak Kanti De • 51 Comments
Thu, Oct. 6, 9:31 AM
- Arrowhead Pharmaceuticals (NASDAQ:ARWR) and Spring Bank Pharmaceuticals (NASDAQ:SBPH) announce an agreement to perform collaborative studies on Arrowhead’s ARC-520 and Spring Bank’s SB 9200 for the treatment of chronic Hepatitis B (HBV). The companies plan to first conduct preclinical studies with both agents together and then advance to the clinic by adding a cohort to Arrowhead’s ongoing MONARCH Phase 2b study, in which patients will receive a dosing regimen that includes ARC-520, SB 9200, and an oral direct-acting antiviral.
- The aim is to show that a triple therapy can increase HBV functional cure rates with a more favorable tolerability profile and possibly a shorter treatment duration compared to interferon-based regimens.
- SB 9200 is Spring Bank’s novel small molecule, orally-available selective immunomodulator compound being developed as both monotherapy and combination therapy as a backbone for the treatment of chronic HBV and other viral diseases.
- Arrowhead’s ARC-520 is being investigated for its potential to produce functional cures in patients with HBV infection. ARC-520 intervenes upstream of the reverse transcription process where current standard-of-care nucleotide and nucleoside analogs act, and is designed to silence the production of all HBV gene products.
Thu, Sep. 29, 9:15 AM
Thu, Sep. 29, 8:11 AM
- Arrowhead Pharmaceuticals (NASDAQ:ARWR) is ahead 21% premarket on average volume in response to is announcement of two collaboration deals with Amgen (NASDAQ:AMGN) for RNA interference (RNAi) therapies for cardiovascular disease (CVD) based on its proprietary subcutaneous RNAi delivery platform.
- Under the first agreement, Amgen receives a global exclusive license to Arrowhead's RNAi ARC-LPA program, designed to reduce elevated lipoprotein(a), a risk factor for atherosclerotic CVD. The second agreement provides Amgen an option to a global exclusive license for an RNAi therapy for an undisclosed CVD target. Amgen is responsible for clinical development and commercialization under both contracts. Financial terms are not disclosed. The ARC-LPA transaction should close in Q4.
- Arrowhead will host a conference call this morning at 9:00 am ET to discuss the collaborations.
Thu, Sep. 29, 7:29 AM
- Nasdaq halts trading in Genocea Biosciences (NASDAQ:GNCA) and Arrowhead Pharmaceuticals (NASDAQ:ARWR) pending news.
- Genocea's lead product candidate is GEN-003, a therapeutic vaccine for genital herpes. Positive results were achieved in a Phase 2 study.
- Arrowhead's lead product candidate is Phase 2-stage ARC-520, an RNAi therapeutic for the potential curative treatment of chronic hepatitis B infection.
Fri, Sep. 2, 5:35 PM
Tue, Aug. 30, 8:18 AM
- Thinly traded micro cap Kamada Ltd. (NASDAQ:KMDA) is up 7% premarket on increased volume, albeit on turnover of only 44K shares, in response to its announcement of positive results in a Phase 2 clinical trial assessing its proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD), an orphan disease currently treated by intravenous AAT augmentation therapy.
- The double-blind, placebo-controlled study enrolled 36 AATD subjects. They were treated with Kamada's inhaled AAT therapy (80 mg/day or 160 mg/day) or placebo for 12 weeks during the double-blind period, after which eligible patients (n=26) entered into a 12-week open-label extension stage with the 160 mg/day dose to further assess safety and tolerability.
- The primary efficacy endpoints included antigenic AAT levels and Anti-Neutrophil Elastase Inhibitory (ANEC) levels in the lung as well as additional anti-proteolitic and anti-inflammatory biomarkers.
- Patients in the inhaled AAT therapy cohort showed a statistically significant increase in endothelial lining fluid (ELF) AAT antigenic level compared to placebo (p<0.0005). The levels were more than twice the increase observed in an earlier study of intravenous (IV) AAT therapy. ELF ANEC levels also showed statistically valid increases for both doses and, again, were more than twice those observed with IV AAT.
- The company intends to initiated a pivotal study in the U.S. to confirm the results.
- AATD is a rare inherited disorder that severely damages the lungs and liver.
- Related tickers: (NASDAQ:ARWR)(NASDAQ:NTLA)
Fri, Aug. 19, 8:01 AM
- Arrowhead Pharmaceuticals (NASDAQ:ARWR) initiated with Buy rating and $15 (112% upside) price target by Cantor Fitzgerald.
- Karyopharm Therapeutics (NASDAQ:KPTI) initiated with Buy rating and $15 (92% upside) price target by H.C. Wainwright.
- Mediwound Ltd. (NASDAQ:MDWD) initiated with Outperform rating and $14 (75% upside) price target by Wells Fargo.
- SCYNEXIS (NASDAQ:SCYX) initiated with Buy rating and $15 (436% upside) price target by Guggenheim Securities.
- Patheon NV (Pending:PTHN) initiated with Neutral rating and $30 (7% upside) price target by Credit Suisse. Initiated with Buy rating and $32 (14% upside) price target by Jefferies. Initiated with Overweight rating and $31 (11% upside) price target by Morgan Stanley.
- GlycoMimetics (NASDAQ:GLYC) initiated with Outperform rating by Cowen and Company. Initiated with Outperform rating and $32.50 (306% upside) price target by Raymond James.
- Audentes Therapeutics (Pending:BOLD) initiated with an Outperform rating by Cowen and Company. Initiated with Outperform rating and $20 (33% upside) price target by Wedbush.
- Mallinckrodt (NYSE:MNK) initiated with Buy rating and $95 (19% upside) price target by Stifel Nicolaus.
- TESARO (NASDAQ:TSRO) initiated with Outperform rating and $122 (28% upside) price target by RBC Capital.
Thu, Aug. 18, 11:00 AM
Thu, Aug. 18, 9:17 AM
Wed, Aug. 17, 5:36 PM
Tue, Aug. 9, 4:05 PM
Mon, Aug. 8, 5:35 PM
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Thu, Jun. 9, 10:18 AM
- Arrowhead Pharmaceuticals (ARWR) commences a Phase 1/2 clinical trial assessing ARC-521, an RNAi therapeutic, for the treatment of chronic hepatitis B virus (HBV) infection. The first phase will evaluate the safety, tolerability and pharmacokinetics of single doses of ARC-521 in healthy volunteers while the second phase will assess the safety, tolerability and antiviral activity of single and multiple doses in subjects with chronic HBV and negative for e antigen (HBeAg).
- The trial, ARC5211001, is currently recruiting participants at a single site in New Zealand, but will expand to other countries pending regulatory and ethics review.
- ARC-521 is designed to stop the production all HBV gene products by intervening upstream of the reverse transcription process where current nucleotide and nucleoside analogs act. It is a second-generation HBV candidate that complements ARC-520, currently in Phase 2 development.
Fri, May 20, 7:32 AM
- Arrowhead Pharmaceuticals (NASDAQ:ARWR) initiated with Buy rating and $12 (140% upside) price target by Chardan Capital.
- Amicus Therapeutics (NASDAQ:FOLD) initiated with Buy rating and $10 (45% upside) price target by Bank of America.
- Quorum Health (NYSE:QHC) initiated with Equal Weight rating and $12 (2% upside) price target by Morgan Stanley.
- TESARO (NASDAQ:TSRO) initiated with Outperform rating and $56 (30% upside) price target by Credit Suisse.
- Prothena (NASDAQ:PRTA) initiated with Overweight rating and $60 (47% upside) price target by Barclays.
- Mazor Robotics (NASDAQ:MZOR) upgraded to Outperform from Market Perform by Wells Fargo. Price target raised to $15-17 (14% upside from midpoint) from $10-13.
- Eli Lilly (NYSE:LLY) upgraded to Strong Buy with a price target of $88.67 (19% upside) by the Vetr Community.
- Haemonetics (NYSE:HAE) upgraded to Neutral from Sell by Goldman Sachs. Price target raised to $29 (5% upside) from $25.
- Nanosphere (NASDAQ:NSPH) downgraded to Neutral from Buy by Rodman & Renshaw. Price target lowered to $1.35 (2% upside) from $2.00.
- Anacor Pharmaceuticals (NASDAQ:ANAC) downgraded to Neutral from Buy by Mizuho Securities. Price target set at $99.25 (0% upside).
- Globus Medical (NYSE:GMED) downgraded to Sell from Neutral by Goldman Sachs. Price target lowered to $21 (10% downside risk) from $26.
- EPIRUS Biopharmaceuticals (NASDAQ:EPRS) downgraded to Market Perform from Outperform by Leerink Swann. Price target lowered to $0.75 (27% upside).
Tue, May 10, 4:07 PM
- Arrowhead Pharmaceuticals (NASDAQ:ARWR): FQ2 EPS of -$0.35 beats by $0.02.
- Revenue of $0.04M (flat Y/Y) misses by $0.03M.
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.
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