Wednesday, July 16, 2014

Top Biotech Companies To Buy Right Now

Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.

What: Shares of Cubist Pharmaceuticals (NASDAQ: CBST  ) , a biopharmaceutical company devoted to developing acute care therapies, added 12% following the announcement of its second-quarter earnings results.

So what: For the quarter, Cubist reported 12.2% revenue growth over the year-ago period, to $258.8 million, as its lead product Cubicin saw revenue jump 13.5%, to $227.1 million. Profit for the quarter decreased to $0.42 per share, from $0.56 per share last year. Still, this was certainly more than enough to excite investors, because Wall Street had been expecting just $254 million in sales and a profit of $0.40 per share. Also fueling today's gains was an update on the advancement of ceftolozane/tazobactam (previously CXA-201) in late-stage trials.

Now what: This was another solid quarter for Cubist. As always, I'm a bit leery when a biotech stock gets a massive chunk of revenue from just a single drug -- in this case, Cubicin is responsible for nearly 88% of total revenue -- as it leaves the company exposed should a sales or safety problem arise with that drug. However, I'm also seeing the beginnings of a diverse pipeline. Ceftolozane/tazobactam, should it be approved for all three tested indications, including the treatment of ventilator-associated bacterial pneumonia, could have peak sales potential of anywhere from $1 billion to $1.3 billion according to varying estimates. If I were you, I'd be adding Cubist Pharmaceuticals to your Watchlist.

Top 10 Gold Stocks To Invest In 2015: Oncolytics Biotech Inc (ONCY)

Oncolytics Biotech Inc. (Oncolytics), incorporated on April 2, 1998, is a development-stage company. The Company is focused on its research and development of REOLYSIN, which is its cancer therapeutic. REOLYSIN is developed from the reovirus. This virus has been demonstrated in tumour cells bearing an activated Ras pathway. Oncolytics is directing a clinical trial program with the focus of developing REOLYSIN as a human cancer therapeutic. The clinical program includes clinical trials, which it sponsors directly along with Third Party Clinical Trials. Third Party Clinical Trials are clinical trials that are being sponsored by other institutions. As of December 31, 2011, the United States National Cancer Institute (NCI), the University of Leeds and the Cancer Therapy & Research Center at the University of Texas Health Center in San Antonio (CTRC) were sponsoring part of its clinical trial program.

The Company�� clinical trial program has included human trials using REOLYSIN alone, and in combination with radiation and chemotherapy, and delivered via local administration and/or intravenous administration. Oncolytics uses contract toll manufacturers to produce REOLYSIN. On December 31, 2011, the Company had two wholly owned subsidiaries, Oncolytics Biotech (Barbados) Inc. (OBB) and Valens Pharma Ltd. Oncolytics Biotech (US) Inc. and Oncolytics Biotech (U.K.) are wholly owned subsidiaries of OBB.

Advisors' Opinion:
  • [By Sean Williams]

    With this in mind, I feel it'd be prudent of biotech-savvy investors to give Oncolytics Biotech (NASDAQ: ONCY  ) a closer look.

    The big risks
    I'm quite aware that there are a lot factors that'd raise a red flag with Oncolytics. Similar to Affymax, you could say that Oncolytics has put all of its eggs in one basket with its lead experimental drug, reolysin. According to Oncolytics' website, including its U.K., Canadian, and U.S. studies, reolysin as either a monotherapy or combination therapy is the basis for all 31 clinical trials! Obviously, if reolysin proves ineffective or unsafe, Oncolytics is going to be a world of hurt.

  • [By Maxx Chatsko]

    T-VEC is not your traditional biologic drug. It is actually a bioengineered form of the herpes virus that, once injected into cancerous tumors, replicates, and produces an immune-stimulating protein that puts a bulls eye on cancer cells throughout the body. Despite its promise and intriguing mechanism of action, T-VEC is not in further development at Amgen. However, Oncolytics (NASDAQ: ONCY  ) has shown promising results for its bioengineered form of reovirus called Reolysin. Initial phase 3 results showed that 86% of patients taking the drug had reduced tumor mass or growth after six weeks of treatment. �

Top Biotech Companies To Buy Right Now: Intercept Pharmaceuticals Inc (ICPT)

Intercept Pharmaceuticals, Inc., incorporated on September 4, 2002, is a biopharmaceutical company focused on the development and commercialization of therapeutics to treat chronic liver diseases utilizing its bile acid chemistry.The Company�� product candidates treat orphan and more prevalent liver diseases for which there are limited therapeutic solutions. The Company�� product candidate, obeticholic acid, or OCA, is a bile acid analog, a chemical substance that has a structure based on a naturally occurring human bile acid. It is developing OCA initially for primary biliary cirrhosis, or PBC, as a second line treatment for patients who have an inadequate response to or who are unable to tolerate standard of care therapy and therefore need additional treatment. The Company is conducting a Phase 3 clinical trial of OCA in PBC, which it calls the POISE trial, that serves as the basis for seeking regulatory approval in the United States and Europe. As of December 19, 2012, the Company completed enrollment of the POISE trial with 217 patients.

The Company�� clinical focus is on the development of OCA, orally administered, first-in-class FXR agonist that has broad liver-protective properties and may a variety of chronic insults to the liver that cause fibrosis, which can eventually lead to cirrhosis, liver transplant and death. The Company owns worldwide rights to OCA outside of Japan and China, where it has licensed the compound to Dainippon Sumitomo Pharma, or DSP, and granted it an option to license OCA in certain other Asian countries.The Company is sponsoring an independent study involving more than ten leading PBC centers in North America and Europe, or collectively the Global PBC Study Group, that are pooling their long-term patient data to evaluate the relationship between biochemical and clinical endpoints.

The Company competes with Eli Lilly, Exelixis, Inc., Phenex Pharmaceuticals AG, , Johnson & Johnson, NovImmune SA, Dr. Falk Pharma GmbH, Galmed Medical Researc! h Ltd., Immuron Ltd., Mochida Pharmaceutical Co., Ltd., NasVax Ltd. , Raptor Pharmaceutical Corp. Astellas Pharma US, Inc., AstraZeneca, Salix Pharmaceuticals, Inc. and Tioga Pharmaceuticals, Inc.

Advisors' Opinion:
  • [By Jake L'Ecuyer]

    Equities Trading UP
    Shares of Intercept Pharmaceuticals (NASDAQ: ICPT) got a boost, shooting up 62.40 percent to $452.02. Citigroup lifted the price target on the stock from $60.00 to $400.00, while Bank of America raised the price target from $81.00 to $872.00.

  • [By John Udovich]

    It�� a new year and the first one and a half trading weeks of 2014 has not disappointed biotech investors as the sector and mid cap or small cap biotech or�pharma stocks like Intercept Pharmaceuticals Inc (NASDAQ: ICPT), Epizyme Inc (NASDAQ: EPZM), Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) and TNI BioTech Inc (OTCQB: TNIB) either surging or producing some news plus there have been IPO filings for future listings for�Flexion Therapeutics (NASDAQ: FLXN), Aldexa Therapeutics (NASDAQ: ALDX), Retrophin (NASDAQ:�RTRX) and Dicerna Pharmaceuticals (NASDAQ: DRNA). Consider the following news so far this year:

Top Biotech Companies To Buy Right Now: Protalix Biotherapeutics Inc (PLX)

Protalix BioTherapeutics, Inc. is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins based on its ProCellEx protein expression system, ProCellEx. Using its ProCellEx system, the Company is developing a pipeline of biosimilar or generic versions of recombinant therapeutic proteins based on its plant cell-based expression technology, which focuses pharmaceutical markets and that rely upon known biological mechanisms of action. ProCellEx protein expression system consists of a set of technologies and capabilities for the development of recombinant proteins, including advanced genetic engineering technology and plant cell-based protein expression methods. Its ProCellEx protein expression system is built on flexible custom-designed bioreactors made of polyethylene and optimized for the development of complex proteins in plant cell cultures. In June 2010, it had completed the preliminary phase I clinical trial of PRX-105.

Taliglucerase Alfa

Taliglucerase alfa is a plant cell expressed recombinant glucocerebrosidase enzyme (GCD) for the treatment of Gaucher disease. The Company has commenced pre-clinical studies of an oral form of taliglucerase alfa. Its oral taliglucerase alfa is a plant cell expressed form of GCD that is naturally encapsulated within carrot cells genetically engineered to express the GCD enzyme. Pre-clinical studies of oral taliglucerase alfa demonstrate the stability of the enzyme in the cell and the capacity of the cell�� cellulose wall to protect the enzyme against degradation in the digestive tract in an in-vitro model of the stomach and intestines. Additionally, rats fed with lyophilized carrot cells expressing GCD have accumulated the active enzyme in the target organs; the spleen and liver. As of December 31, 2010, the Company had completed Phase III Clinical Trial.

PRX-102

The Company is developing PRX-102, its plant cell expressed modified version of the recombinant ! alpha-GAL-A protein, a therapeutic enzyme for the treatment of Fabry disease. Fabry disease is a rare, hereditary, genetic lysosomal storage disorder in humans caused by an X-lined deficiency of the alpha-GAL-A enzyme. The Company is in the animal evaluation testing phase of the development of PRX-102, which tests are based on a mouse model for Fabry disease.

Acetylcholinesterase

Protalix Ltd. is a wholly owned subsidiary of the Company is licensed the rights to certain technology under a research and license agreement with Yissum Research and Development Company (Yissum) and the Boyce Thompson Institute, Inc. Pursuant to the agreement, the Company is developing PRX-105, a plant cell-based acetylcholinesterase (AChE) and its molecular variants for the use in several therapeutic and prophylactic indications, as well as in a biodefense program and an organophosphate-based pesticide treatment program.

As of December 31, 2010, its in-vitro experiments of PRX-105 have shown that the acetylcholinesterase enzyme in its ProCellEx protein expression system demonstrates biological activity on biochemical and cellular levels. In addition, early animal studies demonstrated that the acetylcholinesterase expressed in its ProCellEx protein expression system was able to treat animals exposed to the nerve gas agent analogues, both when injected with its acetylcholinesterase product candidate immediately before exposure or when injected after exposure. In March 2010, it initiated a preliminary phase I clinical trial of PRX-105, which the Company completed in June 2010.

pr-antiTNF

pr-antiTNF is a candidate for the treatment of certain autoimmune diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing, spondylitis, psoriatic arthritis and plaque psoriasis. The Company has designed the antiTNF as pr-antiTNF. pr-antiTNF is a plant cell-expressed recombinant fusion protein made from the soluble form of the human TNF receptor (TNFR), f! used to t! he Fc component of a human antibody domain. pr-antiTNF has an identical amino acid sequence to Enbrel and its in-vitro and preclinical animal studies have demonstrated that pr-antiTNF exhibits similar activity to Enbrel. Specifically, pr-antiTNF binds TNF thereby inhibiting it from binding to cellular surface TNF receptors and protects L929 cells from TNF-induced apoptosis in a dose-dependent manner.

The Company competes with Genzyme, Actelion, Crucell N.V., Biolex, Inc., Chlorogen, Inc., Greenovation Biotech GmbH, Symbiosys, Novartis AG/Sandoz Pharmaceuticals, BioGeneriX AG, Stada Arzneimittel AG, BioPartners GmbH and Teva.

Advisors' Opinion:
  • [By Maxx Chatsko]

    Industrial biotech isn't the only industry headed to Brazil. Protalix (NYSEMKT: PLX  ) entered into a technology transfer agreement with Brazil's Ministry of Health last week that will pay the company $280 million. The deal is big news for Protalix's first product, Elelyso/Uplyso, which was developed with partner Pfizer (NYSE: PFE  ) . The treatment is approved as an enzyme replacement therapy, or ERT, for adults with type 1 Gaucher disease, and it marks a huge step forward for the future of biomanufacturing. In the following video, Fool contributor Maxx Chatsko explains what this means for the product's commercialization and the adoption of Protalix's novel plant cell-based expression system for therapeutic proteins.

  • [By Keith Speights]

    Other investors might wish that Pfizer would use some of its cash to acquire a few smaller companies. Protalix BioTherapeutics (NYSEMKT: PLX  ) has been mentioned as one possible candidate. The two companies already partner together on Gaucher disease drug Elelyso. In February, Protalix spurred rumors that Pfizer could be interested in buying the company after it announced that it had engaged Citigroup to pursue a "broad array of strategic alternatives."

Top Biotech Companies To Buy Right Now: OncoMed Pharmaceuticals Inc (OMED)

OncoMed Pharmaceuticals, Inc. (OncoMed) incorporated on July 19, 2004, is a clinical development-stage biopharmaceutical company. The Company focuses on discovering and developing monoclonal antibody therapeutics targeting cancer stem cells (CSCs). It utilizes its technologies to identify, isolate and evaluate CSCs; identify and/or validate multiple potential targets and pathways critical to CSC self-renewal and differentiation; and develop targeted antibody and other protein-based therapeutics that are designed to modulate these CSC targets and inhibit the growth of CSCs. The Company's anti-cancer therapeutics include anti-DLL4 (demcizumab, OMP-21M18), Anti-DLL4/Anti-VEGF Bispecific, and Anti-Notch2/3 (OMP-59R5), Anti-Notch1 (OMP-52M51, Anti-Fzd7, Fzd8-Fc, RSPO-LGR.

Anti-DLL4 (demcizumab, OMP-21M18) is a humanized monoclonal antibody that inhibits Delta Like Ligand 4 (DLL4) in the Notch signaling pathway. The Company has completed a single-agent Phase Ia trial in advanced solid tumor patients. The Company focuses on conducting two Phase Ib combination trials of demcizumab. Anti-DLL4/anti-VEGF bispecific is a monoclonal antibody that targets and inhibits both DLL4 and vascular endothelial growth factor ( VEGF). VEGF is the target of Avastin. Anti-Notch2/3 (OMP-59R5) is a human monoclonal antibody that targets the Notch2 and Notch3 receptors.

Anti-Notch1 OMP-52M51 is a humanized monoclonal antibody targeted to the Notch1 receptor. Anti-Fzd7 OMP-18R5 is a human monoclonal antibody identified by screening against the Frizzled7 receptor (Fzd7) that binds a conserved epitope on five Frizzled receptors and inhibits Wnt signaling. OMP-18R5 is in a Phase I single-agent trial in advanced solid tumor patients. Fzd8-Fc OMP-54F28 is a fusion protein based on a truncated form of the Frizzled8 receptor ( Fzd8). RSPO-LGR ligands signal through the LGR receptor family.

The Company utilizes several robust technologies for the discovery and optimization of its antibody and protein-bas! ed therapeutics, including multiple proprietary technologies. Its antibody technologies include Mammalian Display Technology, Bispecific Antibody Technology, Hybridoma Technology. Mammalian Display Technology utilizes flow cytometry to isolate mammalian cells expressing antibodies on the cell surface with desired characteristics from large libraries of candidate antibodies. Bispecific Antibody Technology is used to generate its anti-DLL4/anti-VEGF antibody. Hybridoma Technology is used for isolating antibodies from mice, including multiplex single-cell screening techniques.

Advisors' Opinion:
  • [By WWW.DAILYFINANCE.COM]

    Stocks ended a mini-losing streak on Friday, led by upbeat news from Intel (INTC). The Dow Jones industrial average (^DJI) rose 41 points, after sliding more than 200 over the previous two days. The Nasdaq composite (^IXIC) gained 13 and the Standard & Poor's 500 index (^GPSC) added 6 points. Those modest gains did little to trim the loss for the week. The major averages posted their biggest weekly declines in more than two months. Intel is a component of all three big indexes, and it jumped 7 percent after raising its revenue guidance for the current quarter. The company sees stronger business demand for PCs than it previously expected. Intel shares are up 23 percent over the past six months. The Intel news had a ripple effect. Computer maker Hewlett-Packard (HPQ) rose more than 5 percent and Microsoft (MSFT) gained 1½ percent. Part of the increased demand Intel points to is tied to corporate buyers who need to replace their Windows XP machines, because Microsoft has stopped providing technical support for that platform. But Apple (AAPL) lost more than 1 percent. The stock is down since its 7-for-1 stock split took effect on Monday. There were two other big stories that had some legs beyond the companies directly involved. Open Table (OPEN) agreed to be acquired by Priceline (PCLN) for $2.6 billion. Open Table, which provides restaurant reservations, jumped 48 percent. Other online service providers rode the coattails of that deal. Yelp (YELP) gained 14 percent and Groupon (GRPN) gained 4 percent. In the retail arena, Express (EXPR) jumped 21 percent after a private equity firm took a 9.9 percent stake in the teen retailer and indicated it may make a buyout offer. That gave a boost to Aeropostale (ARO) and American Eagle (AEO), which both rose more than 2 percent. Abercrombie & Fitch (ANF) gained 1½. Elsewhere, International Game Technology (IGT) gained 10½ percent on a Reuters report that a bidding war could erupt for
  • [By Maria Armental var popups = dojo.query(".socialByline .popC"); popups.forEach]

    The U.S. Food and Drug Administration on Wednesday imposed a partial clinical hold on a second cancer treatment trial by OncoMed Pharmaceuticals Inc.(OMED) The FDA’s action follows a similar hold last Friday on another treatment targeting cancer stem cells.

  • [By Lauren Pollock]

    Among the companies with shares expected to actively trade in Tuesday’s session are OncoMed Pharmaceuticals Inc.(OMED), Lexicon Pharmaceuticals Inc.(LXRX) and Krispy Kreme Doughnuts Inc.(KKD)

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