Wednesday, October 15, 2014

Top 5 Biotech Stocks For 2014

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The grades of six semiconductor stocks are on the rise this week on Portfolio Grader. Each of these stocks is rated an “A” (“strong buy”) or “B” overall (“buy”).

Hot Solar Stocks To Buy Right Now: Medivation Inc.(MDVN)

Medivation, Inc., a biopharmaceutical company, focuses on the development of small molecule drugs for the treatment of castration-resistant prostate cancer, Alzheimer?s disease, and Huntington disease. The company?s product candidates under clinical development include MDV3100, which is in Phase 3 development for the treatment of castration-resistant prostate cancer; and dimebon, which is in Phase 3 clinical trial for the treatment of Alzheimer?s disease and Huntington disease. It has collaboration agreements with Pfizer Inc. to develop and commercialize dimebon; and Astellas Pharma Inc. to develop and commercialize MDV3100. The company was founded in 2003 and is based in San Francisco, California.

Advisors' Opinion:
  • [By Sean Williams]

    What: Shares of biopharmaceutical company Medivation (NASDAQ: MDVN  ) sank as much as 11% after rival Johnson & Johnson (NYSE: JNJ  ) announced it was purchasing Aragon Pharmaceuticals to get ahold of its experimental advanced prostate cancer drug, ARN-509.

  • [By Ben Levisohn]

    Werber and Eckhard’s favorites include Gilead (GILD) and Celgene (CELG), and they find the “risk/reward…compelling” in Medivation (MDVN) and Tesaro (TSRO).

  • [By Todd Campbell]

    That leads me to Medivation (NASDAQ: MDVN  ) , Ophthotech (NASDAQ: OPHT  ) , and Portola (NASDAQ: PTLA  ) , three companies with important therapies that may very well be destined to become top sellers.

  • [By Ben Levisohn]

    Shares of Medivation (MDVN) were halted at 2:48 p.m. today while up 2.7% at $96.89. The reason for the halt: Medivation’s Xtandi was approved for use in “pre-chemo metastatic castration-resistant prostate cancer” by the FDA.

    Citigroup’s Yaron Werber explains the significance:

    Overall the updated Xtandi label is in-line with expectations and is now better than the Zytiga label. The new indication is for the treatment of patients with metastatic castration-resistant prostate cancer which is the same as the Zytiga indication and encompasses the pre-chemo and post-chemo segments. In the clinical section of the label the statistically significant improvement in overall survival from PREVAIL is included, compared to the Zytiga label which states the analysis of overall survival did not meet statistical significance.

    We Continue To Like Stock Into TERRAIN and Breast Cancer Data��The risk/reward is positive for TERRAIN with data at YE:14 or early ��5. Recall, there was no interim analysis and the study enrolled M1 patients so PFS should be roughly similar to the 16 months that was in PREVAIL (also an M1 population). In addition, breast cancer is upside to expectations in our view and we expect ph2a Xtandi data in AR+ TNBC at SABCS in December.

    Shares of Medivation have gained 1.6% to $98.46 at 5:07 p.m. in after-hours trading.

Top 5 Biotech Stocks For 2014: Inovio Pharmaceuticals Inc (INO)

Inovio Pharmaceuticals, Inc., incorporated on June 29, 1983, is engaged in the development of a new generation of vaccines, called synthetic vaccines, focused on cancers and infectious diseases. The Company's SynCon technology enables the design of universal vaccines capable of providing cross-protection against existing or changing strains of pathogens, such as influenza and human immunodeficiency virus (HIV). The Company's electroporation delivery technology uses brief, controlled electrical pulses to increase cellular uptake of the vaccine. Its clinical programs include cervical dysplasia (therapeutic), avian influenza (preventive), prostate cancer (therapeutic), leukemia (therapeutic), hepatitis C virus (HCV) and HIV vaccines. It is advancing preclinical research and clinical development for a universal seasonal/pandemic influenza vaccine, as well as preclinical work for other products, including malaria and prostate cancer vaccines. Its partners and collaborators include University of Pennsylvania, Drexel University, National Microbiology Laboratory of the Public Health Agency of Canada, Program for Appropriate Technology in Health/Malaria Vaccine Initiative (PATH/MVI), National Institute of Allergy and Infectious Diseases (NIAID), Merck, ChronTech, University of Southampton, United States Military HIV Research Program (USMHRP), the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and HIV Vaccines Trial Network (HVTN). As of December 31, 2011 it owned 16.1% interest in VGX Int��.

Inovio�� Solution

The Company�� synthetic vaccine platform consists of its SynCon vaccine design process and electroporation delivery technology. It has developed a preclinical and clinical stage pipeline of vaccines. The Company�� synthetic vaccines are designed to prevent a disease (prophylactic vaccines) or treat an existing disease (therapeutic vaccines). Its synthetic vaccine consists of a deoxyribonucleic acid (DNA) plasmid encoding a selected antigen! (s), which is introduced into cells of humans or animals with the purpose of evoking an immune response to the encoded antigen. The Company�� synthetic vaccines are designed to generate specific antibody and/or T-cell responses.

The Company�� SynCon technology provides processes that employ bioinformatics, which combine extensive genetic data and sophisticated algorithms. Its design process uses the genetic make-up of a common antigen(s) from multiple strains of a virus within a viral sub-type or taxonomic group (family) of pathogens, such as HIV, hepatitis C virus (HCV), human papillomavirus (HPV), influenza and other diseases to synthetically create a new antigen for the desired pathogen target that does not exist in nature. Its synthetic vaccine candidates are being delivered into cells of the body using its electroporation (EP) DNA delivery technology.

Cancer Synthetic Vaccines

The Company has two broad types of cancer vaccines: preventive (or prophylactic) vaccines, which are intended to prevent cancer from developing in healthy people, and treatment (or therapeutic) vaccines, which are intended to treat an existing cancer by strengthening the body�� natural defenses against the cancer. Two types of cancer preventive vaccines are available in the United States. The United States Food and Drug Administration (the FDA) has approved two vaccines, Gardasil and Cervarix that protect against infection by the two types of HPV-types 16 and 18-that cause approximately 70% of all cases of cervical cancer worldwide. In addition, Gardasil protects against infection by two additional HPV types, 6 and 11, which are responsible for about 90% of all cases of genital warts in males and females but do not cause cervical cancer.

Cervarix manufactured by GlaxoSmithKline, is composed of virus-like particles (VLPs) made with proteins from HPV types 16 and 18. Cervarix is approved for use in females��ages 10 to 25 for the prevention of cervical cancer caused by! HPV type! s 16 and 18. Gardasil manufactured by Merck, is approved for use in females for the prevention of cervical cancer, and some vulvar and vaginal cancers, caused by HPV types 16 and 18 and for use in males and females for the prevention of genital warts caused by HPV types 6 and 11. The vaccine is approved for these uses in females and males ages 9 to 26. The FDA has also approved a cancer preventive vaccine that protects against hepatitis B virus (HBV) infection.

Inovio�� VGX-3100 is designed to raise immune responses against the E6 and E7 genes of HPV types 16 and 18 that are present in both pre-cancerous and cancerous cells transformed by these HPV types. E6 and E7 are oncogenes that play an integral role in transforming HPV-infected cells into cancerous cells. In March 2011, it initiated a randomized, double-blind Phase II study of VGX-3100 delivered using the CELLECTRA intramuscular electroporation device in women with HPV Type 16 or 18 and diagnosed with, but not yet treated for, cervical intraepithelial neoplasia (CIN) 2/3. The study is designed to enroll 148 subjects. In January 2011, it announced the publication of a scientific paper in the journal Human Vaccines detailing potent immune responses in a preclinical study of its SynCon vaccine for prostate cancer targeting two antigens, prostate specific antigen (PSA) and prostate specific membrane antigen (PSMA).

In January 2011, the Company announced the regulatory approval of a Phase II clinical trial (WIN Trial) to treat leukemia utilizing its new ELGEN 1000 automated vaccine delivery device. The single dose level, Phase II study, called WT1 immunity via DNA fusion gene vaccination in haematological malignancies by intramuscular injection followed by intramuscular electroporation. Cancer Vaccines encodes for hTERT, an antigen related to non-small cell lung, breast and prostate cancers. The vaccine is delivered using its electroporation delivery technology.

Infectious Disease Synthetic Vaccines

In Marc! h 2011, the Company announced the initiation of a follow-on open label, single dose Phase II clinical study in collaboration with ChronTech of the ChronVac-C HCV DNA vaccine delivered using its electroporation technology in treatment naive HCV infected individuals. Its HIV vaccines consist of candidates for HIV prevention, as well as therapy or treatment. PENNVAX-B is designed to target HIV clade B (most commonly found in the United States, North America, Australia and the European Union (EU). PENNVAX-G is designed to target HIV clades A, C and D, which are more commonly found in Asia, Africa, Russia and South America. This Phase I clinical study of PENNVAX-B (HVTN-080) vaccinated 48 healthy, HIV-negative volunteers to assess safety and levels of immune responses generated by Inovio�� PENNVAX-B vaccine delivered with its CELLECTRA electroporation device. PENNVAX-B is a SynCon vaccine that targets HIV gag, pol, and env proteins.

The Company�� VGX-3400X targets H5N1. The vaccine consists of three distinct DNA plasmids coded for a consensus hemagglutinin (HA) antigen derived from different H5N1 virus strains; a consensus neuraminidase (NA) antigen derived from different N1 sequences; and a consensus nucleoprotein (NP) fused to a small portion of the m2 protein (m2E) based on a broader cross-section of influenza viruses in addition to H5N1 and H1N1. Conventional vaccines are strain-specific and have limited ability to protect against genetic shifts in the influenza strains they target. They are therefore modified annually in anticipation of the next flu season�� new strain(s). It is focused on developing DNA-based influenza vaccines able to provide broad protection against known as well as newly emerging, unknown seasonal and pandemic influenza strains.

Animal Health/Veterinary

VGX Animal Health, Inc. (VGX AH), a majority-owned subsidiary, has licensed LifeTide, a plasmid-based growth hormone releasing hormone (GHRH) technology for swine. LifeTide is one of onl! y four DN! A-based treatments approved for use in animals and is the only DNA-based agent delivered using electroporation that has been granted marketing approval (Australia). VGX AH is also developing a GHRH-based treatment for cancer and anemia in dogs and cats. It is developing a synthetic vaccine for foot-and-mouth disease (FMD) administered by its vaccine delivery technology. The FMD virus is one of the most infectious diseases affecting farm animals, including cattle, swine, sheep and goats, and is a serious threat to global food safety.

The Company competes with Crucell N.V, Sanofi-Aventis, Novartis, Inc., GlaxoSmithKline plc, Merck, Pfizer, AstraZeneca, Inc., Novartis, Inc., MedImmune and CSL.

Advisors' Opinion:
  • [By George Budwell]

    Inovio Pharmaceuticals (NYSEMKT: INO  ) develops DNA-based vaccines and delivers them using a proprietary electroporation technique. Shares of Inovio have been a roller coaster all year long, and have certainly been the playground of day traders. Last week, Inovio shares lost more than 10% of their value on heavy volume, suggesting the stock may continue to experience downward pressure. This rapid move downward is surprising because the company recently signed a licensing deal with Roche (NASDAQOTH: RHHBY  ) to commercialize Inovio's multi-antigen DNA immunotherapies for prostate cancer and hepatitis B. As part of the deal, Inovio received $10 million upfront, and milestone payments could go as high as $412 million.

  • [By Roberto Pedone]

    Another biotechnology player that insiders are jumping into here is Inovio Pharmaceuticals (INO), which discovers, develops, and develops synthetic vaccines and immune therapies focusing on cancers and infectious diseases. Insiders are buying this stock into notable weakness, since shares are off by 17.4% so far in 2014.

    Inovio Pharmaceuticals has a market cap of $578 million and an enterprise value of $415 million. This stock trades at a premium valuation, with a price-to-sales of 30.15 and a price-to-book of 4.30. Its estimated growth rate for this year is 56.9%, and for next year it's pegged at -43.5%. This is a cash-rich company, since the total cash position on its balance sheet is $108.86 million and its total debt is zero.

    The CEO just bought 250,000 shares, or about $2.26 million worth of stock, at $9.05 per share.

    From a technical perspective, INO is currently trending below both its 50-day and 200-day moving averages, which is bearish. This stock has been downtrending badly for the last few weeks, with shares moving lower from its high of $14.20 to its recent low of $8.60 a share. During that downtrend, shares of INO have been consistently making lower highs and lower lows, which is bearish technical price action. Shares of INO have now started to explode higher off that $8.60 low and it's quickly approaching a big breakout trade.

    If you're in the bull camp on INO, then I would look for long-biased trades as long as this stock is trending above Wednesday's intraday low of $8.92 or above that recent low of $8.60 and then once it breaks out above both its 50-day at $10.11 and its 200-day at $10.24 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 1.87 million shares. If that breakout hits soon, then INO will set up to re-test or possibly take out its next major overhead resistance levels at $11 to $11.50, or even $12 to $12.5

  • [By MONEYMORNING]

    Inovio Zooms: We recommended biotech Inovio Inc. (NYSE: INO) at 71 cents a share back on Feb. 1, 2013, and have re-recommended it a number of times since. With their 15.2% gain yesterday, the shares are now at $3.71, up 414% from where we first told you about them - and we believe there's more to come. In fact, we'll be bringing you an interesting update on this company very soon. Inovio is one of 24 recommendations that have doubled or better since we launched Private Briefing back in August 2011.

  • [By Sean Williams]

    On the clinical data front, Alnylam Pharmaceuticals (NASDAQ: ALNY  ) and Inovio Pharmaceuticals (NYSEMKT: INO  ) both put investors in their happy place.

Top 5 Biotech Stocks For 2014: Exelixis Inc.(EXEL)

Exelixis, Inc., a biotechnology company, develops small molecule therapies for the treatment of cancer. It focuses on developing Cabozantinib, an inhibitor of tumor growth, metastasis, and angiogenesis that target MET, VEGFR2, and RET, which are key kinases involved in the development and progression of various cancers. The cabozantinib is in Phase III clinical trial for the treatment for medullary thyroid cancer. The company also engages in various clinical programs for cabozantinib focused on the treatment of metastatic castration-resistant prostate cancer, ovarian cancer, breast cancer, renal cell carcinoma, non-small cell lung cancer, hepatocellular cancer, and melanoma. In addition, Exelixis, Inc. involves in developing a portfolio of other novel compounds to address serious unmet medical needs through collaborations with various pharmaceutical and biotechnology companies, including Bristol-Myers Squibb Company, sanofi-aventis, Genentech, Inc., Boehringer Ingelheim Gm bH, and GlaxoSmithKline and Daiichi Sankyo Company Limited. Its products under development through collaborations include XL475, XL281, XL139, and XL413 inhibitors; ROR antagonists; therapies targeted against LXR, a nuclear hormone receptor implicated in various cardiovascular and metabolic disorders; XL147, XL765, and isoform-selective PI3K inhibitors; XL518, a small-molecule inhibitor of MEK; sphingosine-1-phosphate type 1 receptor; XL880 inhibitor; and therapies targeted against the mineralocorticoid receptor, a nuclear hormone receptor implicated in various cardiovascular and metabolic diseases. The company was formerly known as Exelixis Pharmaceuticals, Inc. and changed its name to Exelixis, Inc. in February 2000. Exelixis, Inc. was founded in 1994 and is headquartered in South San Francisco, California.

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

    Shares of Exelixis (NASDAQ: EXEL) were down 37.89 percent to $4.00 after the company issued an update on ongoing COMET-1 phase 3 pivotal trial in men with metastatic castration-resistant prostate cancer. Stifel Nicolaus lowered the price target on the stock from $11.00 to $9.00.

Top 5 Biotech Stocks For 2014: 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 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.

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