5 Best Biotech Stocks To Own For 2014

Japanese shares fell, with the Topix (TPX) Index dropping after posting its biggest monthly advance since 1999, as earnings reports from Alps Electric Co. to Tokyo Electron Ltd. disappointed investors.

Alps Electric, a car audio maker, slumped 8.9 percent and semiconductor manufacturer Tokyo Electron dropped 4.1 percent after forecasting profit that missed analyst estimates. Tokyo Electric Power Co., operator of the stricken Fukushima nuclear power plant, slid 3 percent after reporting a loss six times bigger than its forecast. Tokuyama Corp., a chemicals maker, advanced the most on the Nikkei 225 Stock Average after forecasting a return to profit.

The Topix lost 0.6 percent to 1,158.37 at the close of trading in Tokyo, with about nine stocks falling for every seven that rose on the 1,711-member gauge. The measure yesterday capped a 13 percent advance for the month, its best gain since March 1999. The Nikkei 225 slid 0.4 percent to 13,799.35 today.

“With Japanese shares rising this far, there’s going to be some profit taking going on,” said Takashi Aoki, a Tokyo-based fund manager at Mizuho Asset Management Co., which oversees about $34 billion. “With earnings, it’s becoming clearer that there are some companies that cannot be saved just by the weaker yen.”

5 Best Biotech Stocks To Own For 2014: TESARO Inc (TSRO)

TESARO, Inc. (TESARO), incorporated in March 2010, is a development-stage, oncology-focused biopharmaceutical company for cancer patients. The Company focuses on rolapitant and TSR-011 product. The Company’s marketed products and product candidates in development treat cancer through non-specific damage to cellular components or alter cell metabolism or internal repair mechanisms to the demise of cancer cells.

Rolapitant

Rolapitant is a potent and long-acting neurokinin-1, or NK-1, receptor antagonist is in Phase III clinical trials for the prevention of chemotherapy induced nausea and vomiting (CINV). It is in Phase III clinical trials. CINV, if not prevented by prophylaxis, has the potential to afflict up to 90% or more of cancer patients undergoing chemotherapy, depending upon the type of chemotherapy administered the dosing schedule of the chemotherapy, and the patients’ age and gender, among other predisposing factors. Prolonged nausea an d vomiting may result in unwanted weight loss, dehydration and malnutrition, as well as hospitalization. The Company has in-licensed the rights to rolapitant from OPKO Health, Inc.

TSR-011

TSR-011 is an orally available ALK inhibitor in preclinical development. ALK is known to be involved in certain types of cancers, including subsets of NSCLC, neuroblastoma and lymphoma. For patients in these subsets, the ALK gene is fused to an activating partner or contains point mutations, resulting in constitutive activation of ALK and the growth of cancer cells and tumor development. Inhibition of ALK in these cancer cells results in cell death and tumor growth inhibition or regression. In August 2011, the United States Food and Drug Administration approved the first ALK inhibitor, developed by Pfizer Inc., Xalkori (crizotinib), which was approved for the treatment of patients with locally advanced or metastatic NSCLC that are ALK positive.

The Company competes with GlaxoSmithKline plc, Roche Holding Ltd! . and Sanofi S.A.

Advisors’ Opinion:

  • [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 Brian Orelli]

    Tesaro (NASDAQ: TSRO  ) is also up today after announcing that it established a partnership with clinicians to run the phase 3 development of its PARP inhibitor, niraparib. The trial will enroll about 300 breast cancer patients with BRCA mutations, comparing niraparib to investigators’ choice of other breast cancer treatments.

  • [By Keith Speights]

    Positive response
    Clovis wasn’t the only company to bring good news about an ovarian cancer drug to ASCO. TESARO  (NASDAQ: TSRO  ) announced phase 1 results for niraparib. Shares of the biotech jumped 16% for the week.

5 Best Biotech Stocks To Own For 2014: CEL-SCI Corp (CVM)

CEL-SCI Corporation (CEL-SCI), incorporated on March 22, 1983, is engaged in the business of Multikine cancer therapy; New cold fill manufacturing service to the pharmaceutical industry, and ligand epitope antigen presentation System (LEAPS) technology, with two products, hemagglutinin type 1 and neuraminidase type 1 (H1N1) swine flu treatment for H1N1 hospitalized patients and CEL-2000, a rheumatoid arthritis treatment vaccine.

Multikine

CEL-SCI’s Multikine, is being developed for the treatment of cancer. It is a cancer immunotherapy drugs called Combination Immunotherapy because it combines active and passive immunity in one product. It is the only cancer immunotherapy that both kills cancer cells and activates the general immune system to destroy the cancer. Multikine target the tumor micro-metastases for treatment failure. Multikine is also applicable in many other solid tumors.

New Manufacturing Facility

CEL-SCI’s facility manufactures Multikine for CEL-SCI’s Phase III clinical trial. CEL-SCI offers the use of the facility as a service to pharmaceutical companies and others, particularly those that need to fill and finish their drugs in a cold environment. Fill and finish is the process of filling injectable drugs in a sterile manner.

LEAPS

CEL-SCI’s patented T-cell Modulation Process uses heteroconjugates to direct the body to choose a specific immune response. The heteroconjugate technology, referred to as LEAPS, is intended to stimulate the human immune system to fight bacterial, viral and parasitic infections, as well as autoimmune, allergies, transplantation rejection and cancer. Administered like vaccines, LEAPS combines T-cell binding ligands with small, disease associated and peptide antigens.

Using the LEAPS technology, CEL-SCI has created a peptide treatment for H1N1 (swine flu) hospitalized patients. This LEAPS flu treatment is designe d to focus on the conserved, non-changing epitopes of the di! fferent strains of Type A Influenza viruses, including swine, avian or bird, and Spanish Influenza. CEL-SCI’s LEAPS flu treatment contains epitopes.

Advisors’ Opinion:

  • [By James E. Brumley]

    Little TNI Biotech Inc. (OTCMKTS:TNIB) just gave bigger immunology players like Amgen, Inc. (NASDAQ:AMGN) or CEL-SCI Corporation (NYSEMKT:CVM) a new reason to worry. Though CVM and AMGN aren’t exactly sweating bullets yet, TNIB has taken not a big step forward in terms biotechnological progress, but rather, has widened its net with a lateral expansion.

  • [By Bryan Murphy]

    It may not have blazed a trail into the young, immunology segment of the biotech industry the way Dendreon Corporation (NASDAQ:DNDN) did back in 2010 with the debut of Provenge. It may not have the same immunology pipeline (and company size) that ImmunoGen, Inc. (NASDAQ:IMGN) boasts. One thing is pretty certain about cancer-immunotherapy developer CEL-SCI Corporation (NYSEMKT:CVM) right now, however – its stock may be poised to dole out a much bigger foreseeable-future reward than DNDN or IMGN are.

  • [By Bryan Murphy]

    Look out AbbVie Inc. (NYSE:ABBV), and Gilead Sciences, Inc. (NASDAQ:GILD), you may want to look over your shoulder as well. There’s a new immunology player coming to town, and its name is CEL-SCI Corporation (NYSEMKT:CVM). Yes, AbbVie may be the name behind blockbuster drug Humira – with nearly $10 billion in sales in 2012 – while Gilead Sciences is saving HIV patients’ lives with immunological therapies Stribild and Complera. But, small cap company CEL-SCI may be closer to launching its own immunology drug sooner than most investors realize.

  • [By Bryan Murphy]

    Names like Amgen, Inc. (NASDAQ:AMGN) and CEL-SCI Corporation (NYSEMKT:CVM) may have pioneered and even mainstreamed the idea of cancer immunology, but the nature of the branch of biotechnology means any company could send CEL-SCI or Amgen back-pedaling. See, it’s not about size or deep pockets in the world of biotech anymore. It’s about know-how and an idea, which can just as easily be discovered and developed by a small company as they can be a large company. That’s why AMGN and CVM at least need to keep a close eye on budding immunology competitor TNI Biotech Inc. (OTCMKTS:TNIB).

5 Best Biotech Stocks To Own For 2014: ImmunoCellular Therapeutics Ltd (IMUC)

ImmunoCellular Therapeutics, Ltd., incorporated on March 20, 1987, is a clinical-stage biotechnology company. The Company is engaged in developing immune-based therapies for the treatment of cancers, such as brain, ovarian and other solid tumors. Immunotherapy is an approach to treat cancer in which a patient’s own immune system is stimulated to target tumor antigens, which are molecular signals that the immune system uses to identify foreign bodies. The Company’s products include ICT-107, ICT-140, ICT-120, ICT-109 and DIAAD. ICT-107, the pipeline product, is a Phase II therapeutic dendritic cell (DC) vaccine for the treatment of glioblastoma multiforme (GBM), the common and lethal type of brain cancer. ICT-107 is designed to activate a patient’s immune system to target six different tumor-associated antigens. In February 2012, it acquired a world-wide license from the University of Pennsylvania and The John Hopkins University (JHU).

The Company in addit ion to ICT-107, is also developing other therapeutic DC vaccines: ICT-140 for ovarian cancer and ICT-121 for recurrent GBM. ICT-140 targets seven tumor-associated antigens expressed on ovarian cancer cells. ICT-107 is a DC vaccine that targets six different tumor-associated antigens that are found on patients’ tumor cells; four of the six antigens are expressed on CSCs. The therapeutic vaccine is used subsequent to conventional therapy or concomitantly with chemotherapy in patients with newly diagnosed GBM. ICT-140 is a DC vaccine that targets seven different ovarian cancer antigens. ICT-121 is a DC vaccine that targets CD133 antigens; it has the potential to be a universal cancer vaccine because CD133 is widely expressed on CSCs from a majority of cancers. Data from this small study demonstrated that ICT-109 had a statistically ability to discriminate between cancerous and non-cancerous samples, suggesting the potential to detect pancreatic and lung cancer in plasma and s erum study sets. The DIAAD (differential immunization for an! tigen and antibody discovery) platform it acquired from Molecular Discoveries utilizes immunological tolerization to accelerate the discovery of the molecular differences between diseased cells and their normal counterparts. The monoclonal antibodies produced by DIAAD provide the basis for the discovery and development of its potential diagnostic and therapeutic products.

The Company competes with Dendreon, Oncothyreon, Galena, Bavarian Nordic and Immunovaccine, Northwest Biotherapeutics, Prima Biomed, DCPrime, Roche/Genentech, Seattle Genetics, Bristol-Myers Squibb and Immunogen.

Advisors’ Opinion:

  • [By Monica Gerson]

    ImmunoCellular Therapeutics (NYSE: IMUC) dropped 11.05% to $1.3699. ImmunoCellular’s trailing-twelve-month ROE is -59.80%.

    Posted-In: market losersNews Movers & Shakers Intraday Update Markets

  • [By Wallace Witkowski]

    Shares of ImmunoCellular (IMUC)  jumped after the drug developer said data on a mid-stage brain cancer drug study were looking encouraging.

  • [By Lauren Pollock]

    ImmunoCellular Therapeutics Ltd.(IMUC) said its leading product candidate, a dendritic cell-based vaccine for brain cancer, didn’t show a statistically significant advantage in overall survival in a Phase II study. In a research note, Maxim Group said it is pushing its EU approval date target to 2019 and lowered its estimate on the stock to $12 a share from $18 a share. The stock plunged 62% to $1.04 premarket.

  • [By Smith On Stocks]

    Using my assumptions, the common of Agenus might be worth about $7.00 per share in early 2014 based on the royalties from the Glaxo vaccines and the net operating loss carry forward even if every other asset in the company were valued at zero. However, there may be substantial value in Agenus’ internal vaccine programs in recurrent and newly diagnosed glioblastoma and the genital herpes vaccine. Based on a comparison to peer companies like Northwest Biotherapeutics (NWBO) and ImmunoCellular Therapeutics (IMUC), I believe that the internal programs at Agenus currently may be worth $150 million or $4.45 per share. Adding this to the value of the MAGE A-3 vaccine could produce a stock price of $11.00 in early 2014.

5 Best Biotech Stocks To Own For 2014: NanoViricides Inc (NNVC)

NanoViricides, Inc., incorporated on April 1, 2005, is a development-stage company. The Company is a nano-biopharmaceutical (nanomedicine) company whose business goals are to discover, develop and commercialize therapeutics to advance the care of patients suffering from life-threatening viral infections. The Company has several drugs in various stages of early development. The Company’s drugs are based on several patents, patent applications, provisional patent applications, and other property held by TheraCour Pharma, Inc. (TheraCou), to which the Company has exclusive licenses in perpetuity for the treatment of human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Influenza including Asian Bird Flu Virus (INF), Herpes Simplex Virus (HSV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), and Rabies. As of June 30, 2012, the Company had six drug development programs: Oral FluCideTM, against all Influenzas; a Piggy-back version of Flucide for hospitalized patien ts; nanoviricide eye drops against adenoviral EKC and herpes keratitis; HIVCide – I against HIV/AIDS; HerpeCide – I skin cream formulation for herpes cold sores and genital warts, and DengueCide, a broad spectrum nanoviricide designed to attack all types of dengue viruses and expected to be effective in the Severe Dengue Disease syndromes including Dengue Hemorrhagic Fever (DHS) and Dengue Shock Syndrome (DSS). As of June 30, 2012, it had engaged in organizational activities, sourcing compounds and materials, developing novel compounds and nanomaterials, and experimentation with studies on cell cultures and animals. In September 2011, NanoViricides Inc’s Inno-Haven LLC acquired a light industrial building.

The Company’s product development programs are divided into three sectors: commercially important diseases, neglected tropical diseases (NTD’s) and biosecurity/biodefense, and advanced technologies. The Company has collaborations with KARD Scientific, Inc., MA. and Southern Research Institute, AL for influenza viruse! s; National (Central) Institute of Hygiene and Epidemiology (NIHE) (Vietnam), for H5N1 avian flu; The Long Island Jewish Medical System, Feinstein Institute of Medical Research (LIJMS), NY and TheVac, LLC. for viral diseases of the eye (adenoviruses, herpesviruses – epidemic kerato-conjunctivitis (EKC), Herpes Keratitis); TheVac, LLC and Northeastern Ohio Medical University (NEOMED) for herpes virus infections; University of California at Berkeley for dengue hemorrhagic fever viruses; Center for Disease Control and Prevention (CDC) and National (Central) Institute of Hygiene and Epidemiology for rabies virus. The Company has developed lead drug candidates against a number of viral diseases.

The Company had consolidated all of its influenza drug programs into a single pan-influenza FluCide program. It is developing a single drug for all influenzas, whether pandemic, epidemic, seasonal, novel, emerging, human, swine, or avian. It is developing a nanoviricide agai nst adenoviral EKC. The nanoviricide eye drug candidate is formulated as simple eye drops. It is developing an anti-HSV nanoviricide skin cream formulation for direct application to the lesions. It has designed the anti-HIV nanoviricides using rational drug design principles. The ligands it has designed in the case of HIV-1 are thought to be broadly neutralizing. In-silico modeling indicates that its ligands dock to the conserved CD4 binding site of gp120 of HIV-1. The Company is working on developing anti-Dengue therapeutics. Dengue is an important NTD. Its RabiCide program has resulted in candidates that have enabled survival of 20% to 30% of infected animals after disease has set in, using a particular animal model.

The Company competes with Roche, Glaxo SmithKline, BioCryst Pharmaceuticals, Inc., Gilead, Bristol-Myers Squibb Company (BMS), Roche, Boehringer Ingelheim, Merck & Co., Inc. (Merck), Valeant, Schering, Pharmassett, Vertex, Intermune, Achillion and Novartis.

Advisors’ Opinion:

  • [By Roberto Pedone]

    One under-$10 nano-biopharmaceutical player that’s starting to trend within range of triggering a big breakout trade is Nanoviricides (NNVC), which engages in the discovery, development and commercialization of anti-viral therapeutics primarily in the U.S. This stock has been ripping to the upside so far in 2013, with share up big by 198%.

    If you take a look at the chart for Nanoviricides, you’ll notice that this stock has recently formed a double bottom chart pattern at $4.55 to $4.52 a share. Following that bottom, shares of NNVC have now started to uptrend and move within range of triggering a big breakout trade. That trade will hit if NNVC manages to take out the upper-end of its recent sideways trading chart pattern, which has seen NNVC trend between $4.55 and $5.74 a share.

    Traders should now look for long-biased trades in NNVC if it manages to break out above some near-term overhead resistance levels at Friday’s high of $4.94 a share to its 50-day moving average of $5.28 a share, and then once it takes out some more key overhead resistance levels at $5.72 to $5.74 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 volume of 234,994 shares. If that breakout triggers soon, then NNVC will set up to re-test or possibly take out its next major overhead resistance levels at $6.50 to its 52-week high at $7.59 a share.

    Traders can look to buy NNVC off weakness to anticipate that breakout and simply use a stop that sits right below some key near-term support levels at $4.55 to $4.52 a share. One can also buy NNVC off strength once it starts to clear those breakout levels with volume and then simply use a stop that sits a comfortable percentage from your entry point.

5 Best Biotech Stocks To Own For 2014: Pain Therapeutics Inc (PTIE)

Pain Therapeutics, Inc., incorporated in May 1998, is a biopharmaceutical company that develops drugs. The Company has four drug candidates in clinical programs, including REMOXY, abuse-resistant hydromorphone, abuse-resistant hydrocodone and a radio-labeled monoclonal antibody to treat metastatic melanoma. It is also working on a new treatment for patients with hemophilia. The Company’s lead drug candidate is REMOXY, which is a painkiller. It has collaboration agreement with King Pharmaceuticals, Inc (King) develops and commercializes REMOXY and other opioid painkillers. The Company and King jointly managed a Phase III clinical program and New Drug Application (NDA) submission for REMOXY. It is also developing a pipeline of drug candidates in the area of oncology and hematology. It owns all commercial rights to its pipeline of drug candidates in oncology and hematology. As of December 31, 2010, the Company leased approximately 30,700 square feet of space in San Mateo, California and all of its operations are located in San Mateo.

REMOXY

REMOXY is a controlled-release oral capsule form of oxycodone in a highly viscous liquid formulation matrix that includes excipients. It is formulated to help address issues of abuse and misuse of time-release oxycodone tablets. REMOXY’s capsule dosage form provides therapeutic drug levels of oxycodone on a twice-daily dosing schedule, while resisting the rapid increases in plasma levels of oxycodone associated with common methods of abuse and misuse. Its formulation also resists delivery by unapproved routes of administration, such as injection, snorting or inhalation.

Metastatic Melanoma

The Company is developing a drug candidate called PTI-188 to treat metastatic melanoma, a form of skin cancer. PTI-188 is a monoclonal antibody linked to a radioisotope, intended to deliver doses of radiation lethal to melanoma tumors without harming normal tissue. I n March 2010, the Company announced data from two open-label! , dose-escalating Phase I studies conducted in Israel to assess the safety, pharmacokinetics, dosimetry and anti-tumor activity of PTI-188. During the year ended December 31, 2010, the second study was completed. The technology used in this program was developed at the Albert Einstein College of Medicine (AECOM). It had licensed worldwide commercial rights to this technology from AECOM.

Hemophilia

The Company has a gene transfer program, initially developed at Stanford University, focused at correcting a genetic disorder in which patients are unable to stop bleeding. During 2010, it conducted a variety of pre-clinical studies with this technology. The Company has licensed worldwide commercial rights to the technology used in this program from Poetic Genetics, LLC (Poetic).

Other product candidates

The Company’s alliance with King includes development of three other abuse-resistant opioid product candidates: hydromorphone , hydrocodone and oxymorphone. Its abuse-resistant formulations of hydromorphone and hydrocodone have completed Phase I clinical trials. In January 2011, the Company announced that the Food and Drug Administration (FDA) had accepted its investigational IND, for abuse-resistant oxymorphone.

The Company competes with Roxane Laboratories, Purdue Pharma, King Pharmaceuticals, Inc., Abbott Laboratories, Cephalon, Endo Pharmaceuticals, Teva Pharmaceuticals, Elkins-Sinn, Watson Laboratories, Ortho-McNeil Pharmaceutical and Forest Pharmaceuticals.

Advisors’ Opinion:

  • [By Sean Williams]

    However, all isn’t well when it comes to the future of abuse-resistant painkiller Remoxy, which was developed by Pain Therapeutics (NASDAQ: PTIE  ) , using Durect’s special technology-based gel capsule to prevent abuse, and is licensed by Pfizer (NYSE: PFE  ) . Remoxy has been rejected twice by the FDA — the most recent coming in mid-2011 — and Pfizer commented this morning that if it were to seek reapproval for the drug it wouldn’t be for at least two more years. Given Pfizer’s extensive product pipeline, losing Remoxy wouldn’t be a big deal. For micro-cap clinical-stage companies like Pain Therapeutics and Durect, it’d be a gigantic blow. Fittingly, Pain Therapeutics and Durect shares imploded by 50% and 34%, respectively, on Friday.

  • [By Jessica Alling]

    Elsewhere, Pfizer is evaluating its continued partnership on an experimental oxycodone capsule, Remoxy. The drug is an extended-release formula that is targeted at reducing abuse of the painkiller. After years of setbacks and postponements for FDA approval, Pfizer is weighing its options. Its partners for the drug, Pain Therapeutics (NASDAQ: PTIE  ) and Durect, have both fallen heavily due to the news, with Pain Therapeutics falling more than 50% — its largest decline ever.