Sunday, July 6, 2014

Top Biotech Stocks For 2014

Thanks to certain areas of financials and health care (especially brokers and biotech, respectively), more value-oriented funds have held a performance lead over ��rowthier��offerings ��meaning those with tech.

Top 5 Recreation Stocks To Own For 2015: IsoRay Inc (ISR)

IsoRay, Inc. (IsoRay), incorporated on June 15, 2004, develops, manufactures and sells isotope-based medical products and devices for the treatment of cancer and other malignant diseases. IsoRay International LLC (International) is a wholly owned subsidiary of the Company. IsoRay obtained clearance from the Food and Drug Association (FDA) for treatment for all solid tumor applications using Cesium-131. Such applications include prostate cancer; ocular melanoma; head, neck and lung tumors; breast cancer; liver cancer; brain cancer; colorectal cancer; gynecological cancer; esophageal cancer, and pancreatic cancer. The seed may be used in surface, interstitial and intracavity applications for tumors with known radio sensitivity. The Company has an existing distribution agreement with UralDial LLC (UralDial) that allows UralDial to distribute Proxcelan Cs-131 brachytherapy seeds in Russia. The Company, through UralDial, has regulatory approval to sell Cs-131 seeds in Russia.

IsoRay markets the Proxcelan Cesium-131 brachytherapy seed for the treatment of prostate cancer; lung cancer; ocular melanoma; head and neck cancers; colorectal cancer, brain cancer; and gynecological cancer. The Company focuses to market Cesium-131 for the treatment of other malignant disease, such as breast cancer, in the near future through the use of existing technologies that have received FDA-clearance. Cesium-131 is a radioactive isotope that can be produced by the neutron bombardment of Barium-130 (Ba-130). When placed into a nuclear reactor and exposed to a flux of neutrons, Ba-130 becomes Ba-131, the radioactive material that is the parent isotope of Cesium-131. The radioactive isotope Cesium-131 is normally produced by placing a quantity of stable non-radioactive barium (ideally barium enriched in isotope Ba-130) into the neutron flux of a nuclear reactor. The irradiation process converts a small fraction of this material into a radioactive form of barium (Ba-131). The Ba-131 decays by electron capture to the ! radioactive isotope of interest (Cesium-131).

As of June 30, 2011, IsoRay had agreements with several independent radiopharmacies to assay, preload, and sterilize loose seeds. During the fiscal year ended June 30, 2011, the Company loaded approximately 90% of Mick cartridges in the Company's own facility, which accounted for approximately 61% of seeds sold. Approximately 33% of seeds sold are strand configurations, including strands preloaded in needles and the remaining 6% of seeds are sold as loose seeds.

Advisors' Opinion:
  • [By James E. Brumley]

    I hate to be the one to say I told you so, but, I told you so. Back on February 26th I suggested IsoRay, Inc. (NYSEMKT:ISR) shares were a budding breakout play. The 48% rally that's played out for ISR in the meantime unfurled right on cue. While overbought in the very short run, this small cap stock looks like it's earning the right to be compared to the likes of bigger brothers in the cancer-treatment space... names like Roche Holding Ltd. (OTCMKTS:RHHBY) or Theragenics Corporation (NYSE:TGX).

  • [By Vanina Egea]

    Strengthening portfolio and business stability is to be reinforced by the introduction of new products. Last December, Textron announced the successful first flight of the Scorpion Intelligence, Surveillance and Reconnaissance (ISR)/Strike aircraft. ��he Scorpion compares very favorably to more costly aircraft currently used for low-threat missions,��pilot Dan Hinson said. The new product is expected to accommodate the budget constraints and shifting mission requirements of the US Department of Defense. The same department has granted the firm an additional contract worth $22.5 million to "deprocess" Mobile Strike Force vehicles and train the Afghan Army.

  • [By James E. Brumley]

    Ugh. It's fun to be right about a stock, but it's exhausting to be too right, too fast. Case in Point? IsoRay, Inc. (NYSE: ISR). Yours truly posted some bullish comments on ISR just a couple of days ago, explaining how that day's move above a key ceiling meant a new bull trend was underway, and more gains from that price would be far easier to muster. Well, good news for those who heeded the advice - IsoRay shares are up 44% today.

Top Biotech Stocks For 2014: Insys Therapeutics Inc (INSY)

Insys Therapeutics, Inc., incorporated on June 15, 1990, is a pharmaceutical company that develops and seeks to commercialize pharmaceutical products that target the unmet needs of cancer patients, with an initial focus on cancer-supportive care. The Company�� pharmaceuticals portfolio consists of one approved product and a number of product candidates targeting cancer-supportive care and cancer therapy. The Company�� product candidate includes Subsys, Dronabinol SG Capsule, Dronabinol RT Capsule, Dronabinol Oral Solution, Dronabinol Inhalation Device, and Dronabinol IV Solution. The Company is also developing cancer therapeutics, which is LEP-ETU, a formulation of paclitaxel, the active ingredient in the cancer drugs Taxol and Abraxane. On August 19, 2011, the Food & Drug Administration (FDA) approved its Dronabinol SG Capsule product, a generic equivalent to Marinol, for the treatment of chemotherapy induced nausea and vomiting (CINV), and anorexia associated with weight loss in patients with acquired immune deficiency syndrome (AIDS).

Subsys

The Company's Subsys is a single-use product that delivers fentanyl, an opioid analgesic, in seconds for transmucosal absorption underneath the tongue. Subsys is a transmucosal product to show pain relief when measuring the sum of pain intensity difference at five minutes in a Phase 3 breakthrough cancer pain (BTCP) clinical trial using fentanyl.

Dronabinol Product Family

The Company has an approved dronabinol product and is developing several dronabinol product candidates for the treatment of CINV and appetite stimulation in patients with AIDS, as well as other indications where dronabinol could have potential therapeutic benefits. Dronabinol, the active ingredient in Marinol, is a synthetic cannabinoid whose chemical name is delta-9-tetrahydrocannabinol (THC). Its portfolio consists of its Dronabinol SG Capsule product and Dronabinol RT Capsule product candidate, which are intended to be generic equi! valents to Marinol, in addition to three formulations, including Dronabinol Oral Solution. Dronabinol SG Capsule is a dronabinol soft gelatin capsule intended to be a generic equivalent to Marinol. Dronabinol RT Capsule is a dronabinol soft gel capsule that is stable at room temperature. Dronabinol Oral Solution is a ynthetic THC in an oral liquid formulation.

Cancer Therapeutics

In addition to its cancer-supportive care products, the Company intends to develop cancer therapeutics targeting limitations of existing commercial products. LEP-ETU, it advanced cancer therapeutic, is a NeoLipid liposomal, or microscopic membrane-like structure created from lipids, formulation that incorporates paclitaxel. LEP-ETU completed a Phase 2 clinical trial of 70 patients with metastatic breast cancer.

The Company competes with Cephalon, Inc., BioDelivery Sciences International, Inc., ProStrakan Group plc, Nycomed International Management GmbH, Archimedes Pharma Ltd., TEVA Pharmaceuticals USA, Watson Pharmaceuticals, Inc., AcelRx Pharmaceuticals, Inc., Akela Pharma Inc., Abbott Laboratories, Pharmaceutical International, Inc., Par Pharmaceutical Companies Inc., sanofi-aventis, Eisai Inc., Helsinn Group, Roche Holding AG, Par Pharmaceutical Companies Inc., GlaxoSmithKline plc, ProStrakan Group plc, Merck & Co, GW Pharmaceutical, A.P. Pharma, Inc., Aphios Corp., Roche Holding, Tesaro, Inc., Cornerstone Pharmaceutical, Inc., Bristol-Myers Squibb, Celgene Corporation, Laboratories, Amgen Inc., AstraZeneca PLC., Bayer AG, Biogen Idec Inc., Eisai Co., Ltd., F. Hoffmann- LaRoche Ltd., Johnson and Johnson, Merck and Co., Inc., Novartis AG, Onyx Pharmaceuticals Inc., Pfizer Inc., and Takeda Pharmaceutical Co. Ltd.

Advisors' Opinion:
  • [By Monica Gerson]

    INSYS Therapeutics (NASDAQ: INSY) is projected to report its Q1 earnings at $0.28 per share on revenue of $45.63 million.

    Posted-In: Earnings scheduleEarnings News Pre-Market Outlook Markets

  • [By Roberto Pedone]

    One specialty pharmaceutical player that's quickly moving within range of triggering a big breakout trade is Insys Therapeutics (INSY), which develops and commercialize supportive care products that target the unmet needs of cancer patients, with an initial focus on cancer-supportive care. This stock is off to a monster start in 2013, with shares up a whopping 434%.

    >>5 Stocks Insiders Love Right Now

    If you take a look at the chart for Insys Therapeutics, you'll notice that this stock has been uptrending strong for the last six months, with shares soaring higher from its low of $9.30 to its recent high of $53.64 a share. During that uptrend, shares of INSY have been making mostly higher lows and higher highs, which is bullish technical price action. Shares of INSY have recently pulled back to its 50-day moving average and the stock has now started to spike higher off that level. That spike is starting to push shares of INSY within range of triggering a big breakout trade.

    Traders should now look for long-biased trades in INSY if it manages to break out above some near-term overhead resistance levels at $43.50 to $44.52 a share with high volume. Look for a sustained move or close above those levels with volume that hits near or above its three-month average action of 235,266 shares. If that breakout hits soon, then INSY will set up to re-test or possibly take out its next major overhead resistance levels at $47.25 to its all-time high at $53.64 a share.

    Traders can look to buy INSY off any weakness to anticipate that breakout and simply use a stop that sits right below some near-term support at $38.75 a share or near its 50-day at $36.73 a share. One can also buy INSY off strength once it takes out those breakout levels with volume and then simply use a stop that sits a comfortable percentage from your entry point.

Top Biotech Stocks For 2014: AMAG Pharmaceuticals Inc.(AMAG)

AMAG Pharmaceuticals, Inc., a biopharmaceutical company, engages in the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia (IDA). Its principal product includes Feraheme (ferumoxytol) injection for intravenous (IV) use, which was approved for marketing in the United States in June 2009 by the U.S. Food and Drug Administration, for use as an IV iron replacement therapy for the treatment of IDA in adult patients with chronic kidney disease (CKD). The company is pursuing marketing applications in the European Union, Canada, and Switzerland for Feraheme for the treatment of IDA in CKD patients. AMAG Pharmaceuticals was founded in 1981 and is based in Lexington, Massachusetts.

Advisors' Opinion:
  • [By John Udovich]

    The start of 2014 shows that biotech is still a hot area with the sector along with small cap biotech stocks like AMAG Pharmaceuticals, Inc (NASDAQ: AMAG), Mast Therapeutics Inc (NYSEMKT: MSTX), Cell Therapeutics Inc (NASDAQ: CTIC), Imprimis Pharmaceuticals Inc (NASDAQ: IMMY) and TNI BioTech (OTCMKTS: TNIB) producing news or returns�plus Auspex Pharmaceuticals (NASDAQ: ASPX), Cara Therapeutics (NASDAQ: CARA), Egalet (NASDAQ: EGLT), Flexion Therapeutics (NASDAQ: FLXN) and Ultragenyx Pharmaceutical (NASDAQ: RARE) are among the (many�� planned biotech IPOs that have recently been announced publicly:

  • [By Monica Gerson]

    AMAG Pharmaceuticals (NASDAQ: AMAG) shares fell 16% to $18.38 in the pre-market trading after the company received a CRL from the FDA for the supplemental NDA for Feraheme for broader IDA indication.

Top Biotech Stocks For 2014: Receptos Inc (RCPT)

Receptos, Inc. (Receptos), incorporated on June 9, 2008, is a biopharmaceutical company. The Company is focused on discovering, developing and commercializing therapeutics for immune disorders. The Company�� product candidates span three specialty disease areas. The Company�� lead asset, RPC1063, is being developed as an oral therapy for the treatment of relapsing multiple sclerosis (RMS) and inflammatory bowel disease (IBD). Its second asset, RPC4046, is being developed for the treatment of an allergic/immune-mediated disorder, eosinophilic esophagitis (EoE), which is an orphan disease. RPC1063 is an oral, once daily, selective and potent sphingosine 1-phosphate 1 receptor (S1P1R) modulator. RPC4046 is a monoclonal antibody selective to interleukin-13 (IL-13) and produced by recombinant deoxyribonucleic acid (DNA) technology.

As of December 31, 2012, RPC1063 was being tested in the Phase II portion of an accelerated design, randomized Phase II/III study for the treatment of RMS. In addition, Receptos has obtained special protocol assessment (SPA) agreement from the United States food and drug administration (FDA) on its clinical trial design for the planned Phase III portion of the Phase II/III study, as well as a second planned RMS Phase III study. RPC1063 is also being tested in a randomized Phase II study for the treatment of ulcerative colitis (UC), a gastrointestinal (GI) disea se.

As of December 31, 2012, the Company was enrolling a randomized Phase II study evaluating the ability of RPC1063 to induce clinical remission in patients with moderately-to-severely active UC called TOUCHSTONE. The Company�� second asset, RPC4046 for the treatment of EoE, builds upon its competencies in immunology and GI diseases. In-licensed from AbbVie Bahamas Ltd. and AbbVie Inc. (AbbVie) RPC4046 is a monoclonal antibody directed against the IL-13 target, which has been validated in Asthma, a predominantly allergic/immune-mediated disorder.

Advisors' Opinion:
  • [By Roberto Pedone]

    Receptos (RCPT) is a biopharmaceutical company engaged in discovering, developing and commercializing therapeutics for immune disorders. This stock closed up 5% at $23.19 in Monday's trading session.

    Monday's Volume: 69,000

    Three-Month Average Volume: 55,356

    Volume % Change: 50%

    From a technical perspective, RCPT ripped higher here right above some key near-term support at $21 with decent upside volume. This move is quickly pushing shares of RCPT within range of triggering a major breakout trade. That trade will hit if RCPT manages to take out its all-time high at $25 with high volume.

    Traders should now look for long-biased trades in RCPT as long as it's trending above support at $21 and then once it sustains a move or close above its all-time high at $25 with volume that's near or above 55,356 shares. If that breakout hits soon, then RCPT will set up to enter new all-time-high territory, which is bullish technical price action. Some possible upside targets off that breakout are $30 to $35.

  • [By John Udovich]

    Small cap �biopharmaceutical stock Receptos Inc (NASDAQ: RCPT) was one of the many hot biotech IPOs of last year and its also up 72.4% since the start of this year alone, meaning its time to take a closer look at this small cap stock with potential treatments for Relapsing Multiple Sclerosis (RMS) and Inflammatory Bowel Disease (IBD) along with the performance of biotech ETF benchmarks like the iShares NASDAQ Biotechnology Index ETF (NASDAQ: IBB) and SPDR S&P Biotech ETF (NYSEARCA: XBI).

  • [By RichardCox]

    For those willing to take on some added volatility (and potential for increased risk based on less diversification), investors can look at Receptos Inc. (RCPT), to play this year's momentum in IPO entries. Enhanced expectations for the company's IPO drove the company to raise its initial share offering to 5.2 million shares. Receptos has reached late-stage development for its oral treatment for multiple sclerosis (MS). MS treatments are dominated by industry heavyweights but MS pills are expected to surge in the next few years because oral treatments are becoming more efficient than injected therapies, and can cater to a broader consumer base. Being a new company, the Receptos chart only offers limited incite, and will not be included here.

Top Biotech Stocks For 2014: Sanofi(SNY)

sanofi-aventis engages in the discovery, development, and distribution of therapeutic solutions to improve the lives of everyone. The company offers a range of healthcare assets, including a broad-based product portfolio in prescription drugs, OTC/OTX, generics, vaccines, and animal health. It has a strategic alliance with Regulus Therapeutics Inc. to discover, develop, and commercialize micro-RNA therapeutics, initially in fibrosis. The company was founded in 1970 and is headquartered in Paris, France.

Advisors' Opinion:
  • [By Keith Speights]

    Monitoring closely
    I suspect that several companies were carefully monitoring what Keryx had to say this week. Sanofi (NYSE: SNY  ) could be one of them. Zerenex will compete head-to-head against�its (NYSE: SNY  ) Renvela. The French company's drug requires more intravenous iron and erythropoiesis-stimulating agents than Zerenex, so that could give a leg up to Keryx in the marketplace.

  • [By Sean Williams]

    In addition to these hot new medications are Johnson & Johnson's (NYSE: JNJ  ) Zytiga and Sanofi's (NYSE: SNY  ) Jevtana. In December, the FDA expanded Zytiga's indications to treat late-stage prostate cancer before chemotherapy. In trials, it helped add better than five months to the median overall survival relative to the placebo. Sanofi's Jevtana -- which ironically also got FDA approval three months early in 2010 -- was approved in combination with prednisone and extended overall survival by nearly three months.

  • [By Rich Smith]

    The Securities and Exchange Commission filed civil complaints against two brothers on Tuesday, alleging that Andrew W. Jacobs and his brother Leslie J. Jacobs II traded on inside information about a tender offer made by French pharmaceutical company Sanofi (NYSE: SNY  ) to buy OTC health-care manufacturer Chattem in 2010.

  • [By Brian Orelli]

    Sanofi (NYSE: SNY  ) tried to do the opposite and block the receptor, thus controlling appetite. While Sanofi's obesity drug, Acomplia, was fairly good at helping patients shed the pounds, it had psychiatric side effects including depression. The FDA never approved the drug, and Sanofi had to remove it from the market in Europe in 2008.

Top Biotech Stocks For 2014: StemCells Inc (STEM)

StemCells, Inc. (StemCells), incorporated in August 1988, is engaged in the research, development, and commercialization of stem cell therapeutics and related tools and technologies for academia and industry. The Company is focused on developing and commercializing stem and progenitor cells as the basis for therapeutics and therapies, and cells and related tools and technologies to enable stem cell-based research and drug discovery and development. The Company�� primary research and development efforts are focused on identifying and developing stem and progenitor cells as potential therapeutic agents. The Company has two therapeutic product development programs, including its CNS Program, which is developing applications for HuCNS-SC cells, its human neural stem cell product candidate, and its Liver Program, which is characterizing the Company�� human liver cells as a therapeutic product.

CNS Program

The Company in its CNS Program, is in clinical development with its HuCNS-SC cells for a range of disorders of the central nervous system. The CNS includes the brain, spinal cord and eye. In February 2012, the Company had completed a Phase I clinical trial in Pelizeaus-Merzbacher Disease (PMD), a fatal myelination disorder in the brain.

The Company�� CNS Program is focused on developing clinical applications, in which transplanting HuCNS-SC cells protect or restore organ function of the patient before such function is irreversibly damaged or lost due to disease progression. The Company�� initial target indications are PMD, and more generally, diseases in which deficient myelination plays a central role, such as cerebral palsy or multiple sclerosis; spinal cord injury, disorders in which retinal degeneration plays a central role, such as age-related macular degeneration or retinitis pigmentosa. The Company�� product candidate, HuCNS-SC cells, is a purified and expanded composition of normal human neural stem cells. Its HuCNS-SC cells can be directly transp! lanted.

Liver Program

Liver stem or progenitor cells offer an alternative treatment for liver diseases. A liver cellular therapy or cell-based therapeutic provide or support liver function in patients with liver disease. The Company held a portfolio of issued and allowed patents in the liver field, which cover the isolation and use of both hLEC cells and the isolated subset, as well as the composition of the cells themselves.

The Company�� range of cell culture products, which are sold under the SC Proven brand, includes iSTEM, GS1-R, GS2-M, RHB-A, RHB-Basal, NDiff N2, and NDiff N2B27. Its iSTEM is a serum-free, feeder-free medium that maintains mouse embryonic stem cells in their pluripotent ground state by using selective small molecule inhibitors to block the pathways, which induce differentiation. RHB-A is a defined, serum-free culture medium for the selective culture of human and mouse neural stem cells and their maintenance and expansion as adherent cell populations. RHB-Basal is a defined, serum-free basal medium. When supplemented with specific growth factors, this media is formulated for the propagation and differentiation of adherent neural stem cells. RHB-Basal can also be tailored to specific-cell type requirements by the addition of customer preferred supplements.

The Company�� NDiff N2 is a defined serum-free scell culture supplement for the derivation, maintenance, expansion and/or differentiation of human and mouse embryonic stem (ES) cells and tissue-derived neural stem cells supplement. Its NDiff N2-AF is a serum-free and animal component-free version of NDiff N2. Its NDiff N2B27 is a defined, serum-free medium for the differentiation of mouse embryonic stem cells to neural cell types. NDiff N27-AF is a serum-free and animal component-free version of NDiff N27. Its GS1-R is a serum-free media formulation shown to enable the derivation and long-term maintenance of true, germline competent rat embryonic stem cells without the add! ition of ! cytokines or growth factors. Its GS2-M is a defined, serum- and feeder-free medium for the derivation and long-term maintenance of true, germline competent mouse iPS cells.

The Company also markets a number of antibody reagents for use in cell detection, isolation and characterization. These reagents are also under the SC Proven brand and it includes STEM24, STEM101, STEM121 and STEM123. Its STEM24 is a human antibody that recognizes human CD24, also known as heat stable antigen (HSA), a glycoprotein expressed on the surface of many human cell types, including immature human hematopoietic cells, peripheral blood lymphocytes, erythrocytes and many human carcinomas. Its CD24 is also a marker of human neural differentiation. Its STEM101 is a human-specific mouse antibody that recognizes the Ku80 protein found in human nuclei. Its STEM121 is a human-specific mouse antibody that recognizes a cytoplasmic protein of human cells. Its STEM123 is a human-specific mouse antibody that recognizes human glial fibrillary acidic protein (GFAP).

The Company�� Other products marketed under SC Proven include total cell genomic DNA (gDNA), RNA and protein lysate reagents purified from homogenous stem cell populations for intra-comparative studies, such as Epigenetic fingerprinting, Southern, Western and Northern blots, PCR, RT-PCR and microarrays. This range of purified stem cell line lysates includes mouse embryonic stem (ES) cells propagated in SC Proven 2i inhibitor-based GS2-M media and mouse ES cell-derived and fetal tissue-derived neural stem (NS) cells propagated in SC Proven RHB-A media.

Advisors' Opinion:
  • [By John Udovich]

    The results of a recent Pew Center Poll regarding attitudes towards abortion and various forms of stem cell research could be a good sign for the stem cell industry along with small cap stem cell stocks like StemCells Inc (NASDAQ: STEM), NeoStem Inc (NASDAQ: NBS), Neuralstem, Inc (NYSEMKT: CUR),�International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX). Basically, Americans think that having an abortion is a moral issue with 49% of American adults believing abortion is morally wrong, 23%�view it not as a moral issue and and 15% view it as morally acceptable. However and when Americans were asked about issues surrounding�human embryos, such as stem cell research or in vitro fertilization, as a matter of morality, their views were different.

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