Wednesday, July 30, 2014

Hot Biotech Companies To Buy For 2014

Major market indexes set record highs again this week, but not everyone joined in the celebration. Here are three party-poopers for the week from the world of health care.

Hard to say goodbye
Synta Pharmaceuticals (NASDAQ: SNTA  ) found out how hard it can be to say goodbye. The company's head of research and development left abruptly this week. Shares of the biotech sank 18% on the news.

The other negative for Synta came from the analyst community. BMO Capital downgraded the stock from outperform to market perform. However, this action stemmed from the departure of Synta's R&D president, Sumant Ramachandra.

Ramachandra left suddenly after less than two months heading up Synta's R&D group. The company stated that he resigned "for personal reasons." A BMO analyst suggested that the surprise departure hinted at a "less than amicable separation," although no further details were provided by Synta.

A penny costs a lot these days
Isis Pharmaceuticals (NASDAQ: ISIS  ) reported its first quarter results on Tuesday, missing analysts' earnings estimate by $0.01 per share. Isis shares fell 15% for the week. Is a penny worth that much these days? Not really.

Top Oil Companies To Invest In Right Now: Conatus Pharmaceuticals Inc (CNAT)

Conatus Pharmaceuticals Inc., incorporated on July 13, 2005, is a biotechnology company focused on the development and commercialization of medicines to treat liver disease. The Company is developing its lead compound, emricasan, for the treatment of patients in orphan populations with chronic liver disease and acute exacerbations of chronic liver disease. The Company has designed a clinical program to demonstrate the therapeutic benefit of emricasan across the spectrum of fibrotic liver disease. The Company�� initial development strategy targets indications for emricasan with high unmet clinical need in orphan patient populations, such as patients with acute-on-chronic liver failure (ACLF), chronic liver failure (CLF), and patients who have developed liver fibrosis post-orthotopic liver transplant due to Hepatitis C virus infection (HCV-POLT).

The Company has completed two placebo-controlled Phase II trials in patients with liver disease showing reductions in ALT levels that occur rapidly, within as little as one day after initiation of therapy, and are maintained throughout the treatment period. In the Company�� 204-patient Phase 2b trial, it also measured cCK18, an important biomarker of apoptosis and disease severity. Emricasan has been generally well-tolerated in all of the clinical studies. As of July 23, 2013, the Company had not generated any revenue.

Advisors' Opinion:
  • [By Lauren Pollock]

    Conatus Pharmaceuticals Inc.'s(CNAT) shares jumped 26% to $7.75 premarket after the biotechnology firm said its treatment for chronic liver disease has been granted a status that could mean quicker approval.

  • [By John Udovich]

    While Intercept Pharmaceuticals Inc (NASDAQ: ICPT) surged earlier this year and Achillion Pharmaceuticals, Inc (NASDAQ: ACHN) has surged this week after Merck & Co. Inc (NYSE: MRK) agreed to purchase hepatitis stock�Idenix Pharmaceuticals Inc (NASDAQ: IDIX) at a 239% premium, it seems the herd has realized that small cap Conatus Pharmaceuticals Inc (NASDAQ: CNAT) is also a liver disease stock as shares suddenly surged 56.69% on no apparent company news. But just what is�Conatus Pharmaceuticals and is it worth taking a chance on?

Hot Biotech Companies To Buy For 2014: Horizon Pharma Inc (HZNP)

Horizon Pharma, Inc. (Horizon), incorporated on March 23, 2010, is a biopharmaceutical company that develops and commercializes medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases. On April 23, 2011, the United States Food and Drug Administration, approved DUEXIS (formerly HZT-501), a tablet formulation containing a fixed-dose combination of ibuprofen and famotidine in a single pill. The Company�� other product, LODOTRA (NP-01), is a programmed release formulation of low-dose prednisone that is marketed in Europe by the Company�� distribution partner, Mundipharma International Corporation Limited (Mundipharma). As of December 31, 2010, Horizon completed multiple Phase III clinical trials of LODOTRA. In addition to these product candidates, the Company has a pipeline of earlier-stage product candidates to treat pain-related diseases and chronic inflammation. On April 1, 2010, Horizon effected a recapitalization and acquisition pursuant to which Horizon Pharma, Inc. became a holding company, that operates through its wholly owned subsidiaries, Horizon Pharma USA, Inc. (formerly Horizon Therapeutics, Inc.) and Horizon Pharma AG (formerly Nitec Pharma AG (Nitec)).

DUEXIS

DUEXIS is a combination of 800 milligram ibuprofen and 26.6 milligram famotidine in a single pill and is indicated for the relief of signs and symptoms of rheumatoid arthritis (RA), and osteoarthritis (OA), and to decrease the risk of developing upper gastrointestinal (GI), ulcers in patients who are taking ibuprofen for those indications. The Company has completed two Phase III clinical trials in a total of over 1,500 patients with mild to moderate pain or arthritis that demonstrated a significant reduction in the incidence of non-steroidal anti-inflammatory drugs (NSAID)-induced upper GI ulcers when treated with DUEXIS versus ibuprofen alone.

LODOTRA

LODOTRA is a programmed release formulation of low-dose prednisone, a well-established drug use! d to inhibit the production of various pro-inflammatory cytokines, which are proteins associated with joint inflammation in RA. LODOTRA has received regulatory approval in Europe for the treatment of moderate to severe, active RA in adults when accompanied by morning stiffness. As of December 31, 2010, the Company had completed two pivotal Phase III clinical trials of LODOTRA in a total of over 600 patients with RA. The first pivotal Phase III trial supported the approval of LODOTRA in Europe in March 2009, where it is approved for marketing in 14 European countries. LODOTRA achieved significant results and met the primary endpoint in each of the two pivotal Phase III clinical trials. Its LODOTRA product was developed and is owned by Horizon Pharma AG. As of December 31, 2010, the Company markets LODOTRA in Europe through three separate agreements. Pursuant to two separate agreements, it granted Merck Serono GmbH and Merck GesmbH, an affiliate of Merck Serono, the rights to distribute and market LODOTRA in each of Germany and Austria, respectively, and pursuant to the third agreement, it granted Mundipharma rights to distribute and market LODOTRA in the rest of Europe. The Company also has a manufacturing and supply agreement with Jagotec AG under which Jagotec or its affiliates manufacture and supply LODOTRA to the Company as bulk tablets.

The Company competes with Pfizer Inc., Pozen Inc., Abbott Laboratories and Amgen Inc.

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

    Top losers in the sector included Horizon Pharma (NASDAQ: HZNP), off 9.5 percent, and Anacor Pharmaceuticals (NASDAQ: ANAC), down 8.2 percent.

    Top Headline
    The Greenbrier Companies (NYSE: GBX) reported a 13% gain in its fiscal second-quarter earnings. Greenbrier's quarterly profit surged to $15.6 million, or $0.50 per share, versus a year-ago profit of $13.8 million, or $0.45 per share. Excluding one-time items, it earned $0.51 per share. Its revenue climbed 88% to $502.2 million. However, analysts were expecting earnings of $0.60 per share on revenue of $508.69 million.

Hot Biotech Companies To Buy For 2014: Biota Pharmaceuticals Inc (BOTA)

Biota Pharmaceuticals, Inc., formerly Nabi Biopharmaceuticals, incorporated on March 14, 1969, is an anti-infective drug development company, with key expertise in respiratory diseases, particularly influenza. Biota developed the neuraminidase inhibitor, zanamivir, subsequently marketed by GlaxoSmithKline as Relenza. The Company�� researches include a series of candidate drugs aimed at treatment of respiratory syncytial virus (RSV) disease and Hepatitis C (HCV) virus infections. In addition, Biota and Daiichi Sankyo co-own a range of second generation influenza anti-virals, of which the lead product lnavir, is approved for marketing in Japan.

The Company�� products include Zanamivir, Inavi, Phoslyra, BioStar OIA FLU and BioStar OIA FLU A/B. Zanamivir is a neuraminidase inhibitor for the treatment and prophylaxis of influenza marketed as Relenza by GlaxoSmithKline. Inavi (laninamivir) is a neuraminidase inhibitor marketed by Daiichi Sankyo in Japan. Phoslyra is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). BioStar OIA FLU and BioStar OIA FLU A/B are influenza diagnostic tests, which are marketed by Inverness Medical as part of their BioStar product range.

Relenza is delivered directly to the primary site of infection on the lungs, using a Disk Inhaler device. Relenza is approved in over 50 countries for the treatment of influenza, including in the United States, the European Union, Japan and Australia. Relenza is also approved for use as a preventative (prophylactic) treatment against influenza. Inavir is approved for sale in Japan for the treatment of influenza in adults and children. Daiichi Sankyo has applied to sell Inavir in Japan for the prevention of influenza.

PhosLo and Phoslyra are different dose forms of calcium acetate; a phosphate binder approved in multiple countries for the control of hyperphosphatemia (high serum phosphate) in patients with end stage renal disease (ESRD). PhosLo and Pho! slyra were sold to Fresnius Medical Care. Biota, together with its Japanese based partner, Daiichi Sankyo, have developed an inhaled antiviral compounds for influenza, called long acting inhaled neuraminidase inhibitors (LANI). Biota's human rhinovirus (HRV) drug for the prevention and treatment of the causes of the common cold, BTA798, has completed Phase I, Phase IIa and Phase IIb clinical trials.

Advisors' Opinion:
  • [By gurujx]

    Biota Pharmaceuticals Inc (BOTA) Reached the 3-year Low of $2.42

    The prices of Biota Pharmaceuticals Inc (BOTA) shares have declined to close to the 3-year low of $2.42, which is 93.3% off the 3-year high of $34.92.

Hot Biotech Companies To Buy For 2014: Foundation Medicine Inc (FMI)

Foundation Medicine, Inc., incorporated on November 12, 2009, is a commercial-stage company. The Company is focused on fundamentally changing the way patients with cancer are treated. The Company�� platform includes methods and algorithms for analyzing tumor tissue samples across all types of cancer, as well as information aggregation and concise reporting capabilities. Its products provide genomic information about each patient�� individual cancer, enabling physicians to optimize treatments in clinical practice and enabling biopharmaceutical companies to develop targeted oncology therapies more effectively.

FoundationOne, its first clinical product, is, to its knowledge, the only commercially available comprehensive molecular information product designed for use in the routine care of patients with cancer. In addition, the Company is considered a non-contracting provider by commercial third-party payors because it has not entered into specific contracts to provide FoundationOne to their covered patients, and as a result it takes on primary responsibility for obtaining reimbursement on behalf of patients.

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

    It wouldn't be fair to say there's nothing like it "out there", because there is. A company called Foundation Medicine Inc. (NASDAQ:FMI) has developed a similar/comparable app. The CLRX version of the solution appears superior in most ways, however, if for no other reason than because of the projected revenue growth the company is apt to see.

  • [By RedChip]

    According to Walter Isaacson�� biography, Steve Jobs paid a reported $100,000 to learn the DNA sequence of his cancer. This work, completed at MIT and Harvard, led to the launch of Foundation Medicine (NASDAQ: FMI). Foundation Medicine has grabbed headlines over the past couple of weeks as it entered the capital markets with a high-profile IPO led by Goldman Sachs.

  • [By Bryan Murphy]

    Eat your heart out Foundation Medicine Inc. (NASDAQ:FMI). And WebMD Health Corp. (NASDAQ:WBMD)? Don't even bother trying. CollabRx Inc. (NASDAQ:CLRX) has built a better mousetrap, and if yesterday's announcement is a sign of things to come, CLRX could prove to be a very compelling investment.

Hot Biotech Companies To Buy For 2014: Biodel Inc (BIOD)

Biodel Inc. (Biodel), incorporated on December 3, 2003, is a development-stage speciality biopharmaceutical company focused on the development and commercialization of treatments for diabetes. The Company develops its product candidates by applying its formulation technologies to existing drugs. Its advanced program involves developing formulations of injectable recombinant human insulin (RHI). In addition to its ultra-rapid-acting insulin formulations, the Company has developed prototype formulations of a liquid glucagon, a basal insulin and a glucose responsive insulin, in each case for use by patients with diabetes. RHI-based formulation known as Linjeta was the subject of a New Drug Application (NDA).

The Company has two pivotal Phase III clinical trials with its preferred commercial formulation of Linjeta prior to re-submitting the NDA. In August 2011, it completed patient visits and analyzed top-line data from the first Phase 1 clinical trial of two RHI-based formulations. The trial was a single-center, randomized, double-blind, three-period crossover trial in 18 subjects with Type 1 diabetes. The purpose of the trial was to evaluate the pharmacokinetic and pharmacodynamic characteristics and injection site toleration of BIOD-105 and BIOD-107, as compared to the insulin analog marketed as Humalog. The Company conducted Phase I, Phase II and Phase III clinical trials comparing the performance of its Linjeta formulation of RHI to either Humulin, which is a branded formulation of RHI or Humalog. Its pivotal Phase III clinical trials were open-label, parallel group, randomized trials conducted at centers in the United States, Germany and India.

The Company competes with Eli Lilly, Novo Nordisk, Sanofi-Aventis, Halozyme Therapeutics, Inc. and MannKind Corporation.

Advisors' Opinion:
  • [By Monica Gerson]

    Biodel (NASDAQ: BIOD) is expected to post a Q1 loss at $0.24 per share.

    First Majestic Silver (NYSE: AG) is estimated to post its Q1 earnings at $0.10 per share on revenue of $63.35 million.

  • [By Roberto Pedone]

    One under-$10 specialty biopharmaceutical player that's starting to trend within range of triggering a big breakout trade is Biodel (BIOD), which is focused on the development and commercialization of innovative treatments for diabetes. This stock has been hit hard by the bears over the last three months, with shares down by 24%.

    If you take a look at the chart for Biodel, you'll notice that this stock is ripping higher here right off its 50-day moving average of $2.32 a share with strong upside volume. Volume on Thursday has so far registered over 750,000 shares, which is well above its three-month average action of 445,084 shares. This move is quickly pushing shares of BIOD within range of triggering a big breakout trade.

    Traders should now look for long-biased trades in BIOD if it manages to break out above some near-term overhead resistance levels at $2.52 to $2.60 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 445,084 shares. If that breakout triggers soon, then BIOD will set up to re-test or possibly take out its next major overhead resistance levels $3 to its 200-day moving average of $3.39 a share. Any high-volume move above $3.39 will then give BIOD a chance to tag $4 a share.

    Traders can look to buy BIOD off weakness to anticipate that breakout and simply use a stop that sits right below some key near-term support at $2.10 a share. One can also buy BIOD 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.

Hot Biotech Companies To Buy 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�� own immune system is stimulated to target tumor antigens, which are molecular signals that the immune system uses to identify foreign bodies. The Company�� 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�� 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 addition 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 serum 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 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 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 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 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.

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