Top 5 Biotech Companies To Watch For 2014

WASHINGTON — Credit cards, long a target for critics of predatory financial practices, are becoming something of a poster child for how regulation can help fix things.

Thanks to reforms from the 2009 CARD Act reforms, American consumers last year saved $1.5 billion on lower late fees and $2.5 billion from new restrictions on fees charged for going over your credit limit.

Perhaps best of all, stringent requirements on credit cards for those under age 21 has resulted in the percentage of 18 to 20-year-olds with a credit card account dropping by half.

These are some of the highlights from a report released last week by the Consumer Financial Protection Bureau, a new regulatory agency created in the wake of the 2008 crisis.

Other reforms from the legislation — formally known as the Credit Card Accountability, Responsibility and Disclosure Act — included restrictions on raising interest rates, requiring payments due on the same day every month, applyi ng payments to high-interest balances first and so on.

Top 5 Biotech Companies To Watch For 2014: Pharmacyclics Inc (PCYC)

Pharmacyclics, Inc., incorporated on April 19, 1991, is a clinical-stage biopharmaceutical company focused on developing and commercializing small-molecule drugs for the treatment of cancer and immune mediated diseases. The Company’s clinical development and product candidates are small-molecule enzyme inhibitors designed to target biochemical pathways involved in human diseases. As of June 30, 2011, it had three drug candidates under clinical development and a number of preclinical lead molecules. This includes an inhibitor of Bruton’s tyrosine kinase (Btk) (PCI-32765) in Phase II studies in hematologic malignancies; a Btk inhibitor lead optimization program targeting autoimmune indications, an inhibitor of Factor VIIa (PCI-27483) in a Phase II clinical trial in pancreatic cancer, and a histone deacetylase (HDAC) inhibitor (PCI-24781) in Phase I and II clinical trials in solid tumors and hematological malignancies as of June 30, 2012.

As of June 30, 2012, t he Company developed ibrutinib, which has demonstrated clinical activity and tolerability in Phase I and Phase II clinical trials in a variety of B-cell malignancies, including chronic lymphocytic leukemia (CLL) and a number of non-Hodgkin’s lymphoma (NHL) subtypes. CLL, mantle cell lymphoma (MCL), follicular lymphoma (FL), diffuse B-cell lymphoma (DLBCL) and multiple myeloma (MM) are specific indications of its current or planned Phase Ib/II and Phase III development program. had development programs for B-cell malignancies and autoimmune diseases. For malignant indications it has developed PCI-32765, which has demonstrated clinical activity and tolerability in Phase I and Phase II clinical trials in a range of B-cell malignancies, including chronic lymphocytic leukemia (CLL) and a number of non-Hodgkin’s lymphoma (NHL) subtypes. CLL, mantle cell lymphoma (MCL), follicular lymphoma (FL), diffuse large B cell lymphoma (DLBCL) and multiple myeloma (MM) are specific indica tions of its Phase II development. It has developed an assay! to measure occupancy of Btk in PBMCs using a cell-permeable fluorescently-labeled derivative of PCI-32765.

Factor VII is an enzyme that becomes activated (FVIIa) by binding to the cell surface protein tissue factor (TF), a protein found in the body that helps to trigger the process of blood clotting in response to injury. TF is over expressed in many cancers including gastric, breast, colon, lung, prostate, ovarian and pancreatic cancers. In these tumors, the FVIIa/TF complex induces intracellular signaling pathways by activating protease activated receptor 2 (PAR-2), another cell-surface protein. This in turn increases the expression of interleukin-8 (IL-8), a protein produced by white blood cells and other immune cells in response to pathogenic stimulation, and vascular endothelial growth factor (VEGF), a signal protein produced by cells that stimulate the growth of blood vessels. Both proteins play an important role in tumor growth and metastases as well as angiogenesis (growth of new blood vessels). FVIIa/TF complex also initiates the coagulation (a process by which blood forms clots) processes implicated in the high incidence of thromboembolic (the process by which the blood clots within a blood vessel) complications seen in patients with TF-expressing cancers. Thromboembolic events are a cause of death in patients with cancer and anticoagulant treatment has been shown to improve survival in a variety of cancers (Klerk et al. JCO. 2005).

PCI-27483 Factor VIIa Inhibitor

The Company’s Factor VIIa inhibitor PCI-27483 is a first-in-human small molecule inhibitor that selectively targets FVIIa. As an inhibitor of FVIIa, PCI-27483 has two potential mechanisms of action: inhibition of intracellular signaling involved in tumor growth and metastases and inhibition of early coagulation processes associated with thromboembolism.

Factor VIIa PCI-27483 Clinical Development Update

A mu lticenter Phase I/II of PCI-27483 in patients with locally a! dvanced o! r metastatic pancreatic cancer that are either receiving or are planned to receive gemcitabine therapy has completed enrollment. The Phase II portion of the study randomized patients to receive either gemcitabine alone or gemcitabine plus PCI-27483 (1.2 mg/kg twice daily). The objectives are to assess the safety of FVIIa Inhibitor PCI-27483 at pharmacologically active dose levels, to assess potential inhibition of tumor progression and to obtain initial information of the effects on the incidence of thromboembolic events. Due to a paradigm shift away from the use of gemcitabine alone for the treatment of pancreatic cancer, enrolling patients in this randomized study has been challenging. PCYC is evaluating other alternatives for development of this agent.

A multicenter Phase I/II of PCI-27483 in patients with locally advanced or metastatic pancreatic cancer that are either receiving or are planned to receive gemcitabine therapy has completed enrollment. The Phas e II portion of the study randomized patients to receive either gemcitabine alone or gemcitabine plus PCI-27483 (1.2 mg/kg twice daily). PCI-27483 is covered by United States patents and patent applications and counterpart patents and patent applications in fourteen ex-United States territories, including Europe, Canada, Mexico, Japan, China, India, South Korea, Australia and Brazil.

Advisors’ Opinion:

  • [By MONEYMORNING]

    We saw this last year with such Private Briefing recommendations as The Boeing Co. (NYSE: BA) and Pharmacyclics Inc. (Nasdaq: PCYC), which rose more than 100% and 400%, respectively, following our recommendation.

  • [By Ben Levisohn]

    Somaiya and team named Gilead and Neurocrine Biosciences (NBIX) their top picks, hile putting Buy ratings on Celgene, Biogen Idec, Alexion (ALXN), Incyte (INCY), Pharmacyclics (PCYC) and Synageva (GEVA). BioMarin (BMRN), Infinity Pharmaceuticals (INFI) and Amgen (AMGN) earned Neutral ratings.

  • [By John McCamant]

    The company—which we consider conservative among biotech stocks—is Pharmacyclics (PCYC). Its pill is also expected to be approved for a much larger B-cell cancer market, chronic lymphocytic leukemia (CLL), by the end of February.

  • [By Anders Bylund]

    And then there’s cancer drug developer Pharmacyclics (NASDAQ: PCYC  ) . This stock had been trading like a roller coaster when the poison pill quietly got the kibosh, and continued to trade sideways for another couple of years. Then Pharmacyclics’ cancer treatments made some headway in FDA proceedings led by leukemia drug Ibrutinib, sending the stock on a rocket ride. Pharmacyclics’ returns of 2,500% since the plan change make the S&P 500’s 45% jump look like dead money. And Pharmacyclics may work together with some big partners, but remains a separate business to this day.

Top 5 Biotech Companies To Watch For 2014: Hemispherx Biopharma Inc (HEB)

Hemispherx Biopharma, Inc. (Hemispherx) is a specialty pharmaceutical company engaged in the clinical development of new drugs therapies based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders. Hemispherx focuses on two core pharmaceutical technology platforms Ampligen and Alferon N Injection.The commercial focus for Ampligen includes application as a treatment for Chronic Fatigue Syndrome (CFS) and as an influenza vaccine enhancer (adjuvant) for both therapeutic and preventative vaccine development. Alferon N Injection is a United States Food and Drug Administration (FDA) approved product with an indication for refractory or recurring genital warts. Alferon LDO (Low Dose Oral) is a formulation under development targeting influenza. It has three subsidiaries BioPro Corp., BioAegean Corp., and Core BioTech Corp. The Company’s foreign subsidiary is Hemispherx Biopharma Europe N.V./S.A.

Ampligen

Ampligen is an experimental drug, which is undergoing clinical development for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Over 1,000 patients have participated in the Ampligen clinical trials representing the administration of more than 90,000 doses of this drug. The Company is also engaged in ongoing, experimental studies assessing the efficacy of Ampligen against influenza viruses.

Alferon N Injection

Alferon N Injection is the registered trademark for the Company’s injectable formulation of natural alpha interferon. Interferons are a group of proteins produced and secreted by cells to combat diseases. The Company’s natural alpha interferon is produced from human white blood cells. Alferon N Injection [Interferon alfa-n3 (human leukocyte derived)] is a highly purified, natural-source, glycosylated, multi-species alpha interferon product.

Alferon LDO (Low Dose Oral)

Alferon LDO [Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)]! is an experimental low-dose, oral liquid formulation of Natural Alpha Interferon and like Alferon N Injection should not cause antibody formation, which is a problem with recombinant interferon. It is an experimental immunotherapeutic that works by stimulating an immune cascade response in the cells of the mouth and throat, enabling it to bolster systemic immune response through the entire body by absorption through the oral mucosa.

The Company competes with Pfizer, GlaxoSmithKline, Merck, AstraZeneca, Baxter International, Fletcher/CSI, AVANT Immunotherapeutics, AVI BioPharma and Genta.

Advisors’ Opinion:

  • [By MONEYMORNING]

    Hemispherix Biopharma Inc. (NYSE: HEB) is a specialty pharmaceutical company. It engages in the clinical development of new drug therapies based on natural immune system enhancing technologies and targets the treatment of viral and immune-based clinical disorders. The Philadelphia, Pa.-headquartered company gained widespread attention over the last several months for its work on flu research. Its flagship products include Alferon N Injection, approved by the FDA for a category of sexually transmitted disease infection. Experimental treatments include Ampligen and Oragens, in development stages for the potential treatment of global viral diseases and disorders of the immune system including human papilloma virus, human immunodeficiency virus, chronic fatigue syndrome, hepatitis, and influenza. Shares have traded as low as $0.18 and as high as $0.55 over the last year. At last check, shares were changing hands around $0.50 on volume of 2 million shares.

Top 5 Biotech Companies To Watch For 2014: Incyte Corporation(INCY)

Incyte Corporation focuses on the discovery and development of proprietary small molecule drugs for hematologic and oncology indications, and inflammatory and autoimmune diseases. Its product pipe line includes INCB18424, which is in Phase III clinical trial for myelofibrosis; Phase III trial for polycythemia vera; Phase III trial for essential thrombocythemia; Phase I/II trial to treat solid tumors/other hematologic malignancies; and Phase IIb trail for the treatment of psoriasis. The company?s portfolio also includes INCB28050, a Phase IIb clinical trial product for rheumatoid arthritis; INCB28060, a Phase I/II product for solid tumors; INCB7839, a Phase II product for breast cancer; and INCB24360, a Phase I/II product for solid tumors. It has a collaborative research and license agreements with Novartis International Pharmaceutical Ltd.; Eli Lilly and Company; and Pfizer Inc. The company was founded in 1991 and is headquartered in Wilmington, Delaware.

Advisors’ Opinion:

  • [By John McCamant]

    Incyte Pharmaceuticals (INCY) recently held their quarterly conference call. Importantly, sales for Jakafi—an advanced compound used for the treatment of patients with intermediate or high-risk myelofibrosis (MF)—met or exceeded Wall Street’s expectations.

  • [By Ben Levisohn]

    Sure Intercept Pharmaceuticals (ICPT) might feel like the only biotech stock that matters today, but there are others. For instance, Incyte (INCY) and  BioMarin (BMRN) are on the move after Barclays changed its ratings on the pair.

  • [By Ben Levisohn]

    Somaiya and team named Gilead and Neurocrine Biosciences (NBIX) their top picks, hile putting Buy ratings on Celgene, Biogen Idec, Alexion (ALXN), Incyte (INCY), Pharmacyclics (PCYC) and Synageva (GEVA). BioMarin (BMRN), Infinity Pharmaceuticals (INFI) and Amgen (AMGN) earned Neutral ratings.

  • [By Ben Levisohn]

    Vertex has dropped 6.1% to $66.97 today at 2:24 p.m. but it’s fall doesn’t seem to be having an impact on other biotech companies. Incyte (INCY) gained 2% to $39.77, Acorda Therapeutics (ACOR) has gained 0.7% to $30.83 and Regeneron Pharmaceuticals (REGN) has dropped 0.6% to $285.96.

Top 5 Biotech Companies To Watch 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’s other product, LODOTRA (NP-01), is a programmed release formulation of low-dose prednisone that is marketed in Europe by the Company’s 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 pursua nt 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 for mulation 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]

    Leading and Lagging Sectors
    Wednesday morning, the healthcare sector proved to be a source of strength for the market. Leading the sector was strength from Horizon Pharma (NASDAQ: HZNP) and Pernix Therapeutics Holdings (NASDAQ: PTX). In trading on Wednesday, telecommunications services shares were relative laggards, down on the day by about 0.39 percent. Top decliners in the sector included Shenandoah Telecommunications Co (NASDAQ: SHEN), off 3.3 percent, and CalAmp (NASDAQ: CAMP), down around 2.4 percent.

  • [By Lisa Levin]

    Horizon Pharma (NASDAQ: HZNP) shares reached a new 52-week high of $17.12 after the company announced its plans to acquire privately held Vidara Therapeutics International for around $660 million.

  • [By Lisa Levin]

    Horizon Pharma (NASDAQ: HZNP) shares gained 24.15% to $18.23 after the company announced its plans to acquire privately held Vidara Therapeutics International for around $660 million.

Top 5 Biotech Companies To Watch For 2014: Rosetta Genomics Ltd (ROSG)

Rosetta Genomics Ltd., incorporated on March 9, 2000, is seeking to develop and commercialize diagnostic tests based on discovered group of genes known as microRNAs. The Company has established a clinical laboratory improvement amendment (CLIA)-certified laboratory in Philadelphia, which enables it to develop, validate and commercialize its own diagnostic tests applying its microRNA technology. In July 2011, the Company launched its fifth product – miRview lung. As of December 31, 2011, the Company launched five tests based on its five microRNA technologies: miRview mets; miRview mets2; miRview squamous; miRview meso, and miRview lung.

Rimonim Consortium

In January 2011, the Company joined the Rimonim Consortium, which is supported by the Office of the Chief Scientist at the Ministry of Industry, Trade and Labor of the State of Israel, or the OCS. The purpose of the consortium is to develop RNA interference, or RNAi, -based therapeutics.

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Rosetta Green

Rosetta Green Ltd. is an Israeli subsidiary of the Company, which was established to leverage its capabilities into the areas of cleantech and plant biotech by using its microRNA technologies to develop plants and algae more suitable for various applications, such as feedstocks for biofuels and agriculture. Research at the Rosetta Green project has been shown to develop algal strains with oil content, to discover potential novel microRNAs from commercially-important algae and to identify drought-regulated microRNAs in plants.

The Company competes with Pathwork Diagnostics, Inc., Biotheranostics, Inc., Combimatrix Corporation, Alnylam Pharmaceuticals, Inc., Asuragen Inc., Exiqon A/S, Life Technologies Corporation, Isis Pharmaceuticals, Merck & Co., Inc., Santaris Pharma A/S, and Regulus Therapeutics.

Advisors’ Opinion:

  • [By John Udovich]

    On Tuesday, small cap cancer diagnostic stock Myriad Genetics, Inc (NASDAQ: MYGN) jumped 11.42% in one day, meaning its worth taking a closer look at the stock along with the performance of small cap cancer diagnostic stocks like Rosetta Genomics Ltd (NASDAQ: ROSG) and Genomic Health, Inc (NASDAQ: GHDX) plus mid cap diagnostic stock Quest Diagnostics Inc (NYSE: DGX). I should mention that we have had Myriad Genetics in our SmallCap Network Elite Opportunity (SCN EO) portfolio since February 5th and we are already up 18.50% – a nice return in just two weeks time.

  • [By Anthony Mirhaydari]

    For now, I continue to recommend investors maintain a cautious stance, focusing on the buying interest coming into safe-haven assets like U.S. Treasury bond and precious metals while booking profits in biotech stocks that have been red hot this month. The leveraged Direxion 3x Treasury Bond Bull (TMF) is up nearly 7% in my Edge Letter Sample Portfolio since it was added on Jan. 10. I just sold Tower Hill Mines (THM) and Rosetta Genomics (ROSG) for gains of 46% and 18% respectively.

  • [By John Udovich]

    The National Cancer Institute estimates that about ten million Americans have or have had some form of cancer with the overall costs of the disease topping $126 billion annually – meaning there is a big market for small cap cancer diagnostic stocks like Rosetta Genomics Ltd. (NASDAQ: ROSG), Genetic Technologies Limited (NASDAQ: GENE) and MetaStat Inc (OTCBB: MTST) just in the US alone without considering global cancer figures. After all, catching and doing something about cancer early on is critical to increase survival rates and bring down the cost of treatment. With that in mind, here are three small cap cancer diagnostic stocks helping to lead the fight to diagnose and stop cancer: