Saturday, September 13, 2014

Top 5 Biotech Stocks To Watch Right Now

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This week, these five stocks have the best ratings in Sales Growth, one of the eight Fundamental Categories on Portfolio Grader.

Top 10 Managed Healthcare Companies To Own In Right Now: Cellular Dynamics International Inc (ICEL)

Cellular Dynamics International, Inc., incorporated on November 16, 2007, develops and manufactures fully functioning human cells in industrial quantities to precise specifications. The Company�� iCell Operating System (iCell O/S) includes true human cells in multiple cell types (iCell products), human induced pluripotent stem cells (iPSCs) and custom iPSCs and iCell products (MyCell products). Customers use its iCell O/S products, among other purposes, for drug discovery and screening; to test the safety and efficacy of their small molecule and biologic drug candidates; for stem cell banking; and in researching cellular therapeutics. The Company�� iCell product line includes four different cell types: cardiomyocytes, neurons, hepatocytes and endothelial cells. The Company is actively developing an additional seven different cell types. iCell products are a consumable designed to be used once and then reordered.

The Company manufactures its iCell products from its iPSCs. An iPSC is a cell that has the ability both to replicate indefinitely and to be transformed into any cell type in the human body. The Company�� iCell O/S consists of six products, which include iCell Cardiomyocytes, iCell Neurons, iCell Endothelial Cells, iCell Hepatocytes and MyCell.

Advisors' Opinion:
  • [By John Udovich]

    Stem cells may not be in the news much�as the sector has moved beyond the use of embryotic�ones, but small cap stem cell stocks Cellular Dynamics International Inc (NASDAQ: ICEL), International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX) have been fairly active over the past several trading days as ICEL went public, ISCO raised additional funding and BRTX grabbed more attention:

Top 5 Biotech Stocks To Watch Right Now: 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 Stephen Simpson, CFA]

    If there's a downside to Lexicon's partnering opportunities, it's that there aren't many obvious partners left. Unless one of the existing companies in the SGLT space chose to abandon an existing partnership, Novo Nordisk, Roche (RHHBY.OB), and Takeda may be the best candidates to partner with Lexicon, and that's the sort of limited pool that can lead to hard bargaining. Sanofi (SNY) may also belong in this pool as well, though. While the company did reach a licensing agreement with Chugai for an SGLT2 inhibitor in Japan, that agreement was limited in scope and the drug does not appear on Sanofi's August 2013 pipeline chart.

  • [By Brian Orelli]

    The technology has taken awhile to develop; Isis had to figure out a way to keep the oligonucleotides that bind to mRNA from getting degraded before they could do their job. But it's finally succeeded with Kynamro, a cholesterol-lowering drug it developed with Sanofi (NYSE: SNY  ) .

  • [By Michael Douglass and David Williamson]

    There's also another option: a dengue vaccine. Several companies are developing vaccines, chief among them best-in-class European big pharma�Sanofi� (NYSE: SNY  ) . Sanofi has already completed a late-stage trial for its dengue vaccine, and the data look good (although we're still waiting to receive more data from another late-stage trial). And helping defeat this scourge could be big money for Sanofi, with its vaccine having the potential (if approved) to be a blockbuster drug.

Top 5 Biotech Stocks To Watch Right Now: Galectin Therapeutics Inc (GALT)

Galectin Therapeutics Inc., formerly Pro-Pharmaceuticals, Inc., incorporated on January 26, 2001, is a development-stage company. The Company is engaged in drug development to create therapies for cancer and fibrotic disease. As of December 31, 2011, the Company has two compounds in development, one is to be used in cancer therapy and the other intended to be used in the treatment of liver fibrosis and fatty liver disease. These two compounds are produced from different natural starting materials, both possessing the property, which lends itself to binding to and inhibiting galectin proteins. GM-CT-01, the Company's product candidate for cancer therapy, is a linear polysaccharide polymer consisted of mannose and galactose that has a defined chemical structure and is derived from a plant source. GR-MD-02, the Company's product for treatment of liver fibrosis and fatty liver disease with inflammation and fibrosis, is a polysaccharide polymer possessing both linear and globular structures, which also is derived from a plant source.

GM-CT-01 has in development for the therapy of colorectal cancer and is in a Phase I/II clinical trial as a combination therapy with a tumor vaccine in patients with advanced melanoma. Based on the completed Phase I and partially completed Phase II clinical trials, the Company is exploring two additional potential indicia for the use of GM-CT-01 in combination with cancer chemotherapy. There are two additional pathways for the development of GM-CT-01 for use in treatment of cancer. GM-CT-01 was found to be generally safe when studied in a Phase I clinical trial in end-stage cancer patients with multiple tumor types alone and in combination with 5-Fluorouracil (5-FU), which is an Food and Drug Administration (FDA)-approved chemotherapy used for treatment of various types of cancer.

Advisors' Opinion:
  • [By Roberto Pedone]

     

    Galectin Therapeutics (GALT) offers drug research and development to create new therapies for fibrotic disease and cancer. This stock closed up 9.6% to $12.06 in Monday's trading session.

     

    Monday's Volume: 674,000

    Three-Month Average Volume: 222,171

    Volume % Change: 149%

     

    Shares of GALT jumped higher on Monday after Ascendiant initiated coverage on the stock with a buy recommendation.

     

     

    From a technical perspective, GALT spiked sharply higher here with strong upside volume. This stock has been uptrending for the last three months, with shares ripping higher from its low of $3.95 to its recent high of $13.21. During that move, shares of GALT have been making mostly higher lows and higher highs, which is bullish technical price action. That move has now pushed shares of GALT within range of triggering a near-term breakout trade. That trade will hit if GALT manages to take out Monday's high of $12.44 and then once it clears its 52-week high at $13.21 with high volume.

     

    Traders should now look for long-biased trades in GALT as long as it's trending above some near-term support levels at $11 or at $10 and then once it sustains a move or close above those breakout levels with volume that hits near or above 222,171 shares. If that breakout hits soon, then GALT will set up to enter new 52-week-high territory above $13.21, which is bullish technical price action. Some possible upside targets off that breakout are $15 to $16.

     

Top 5 Biotech Stocks To Watch Right Now: 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�� 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, the 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�� 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�� lymphoma (NHL) subtypes. CLL, mantle cell lymphoma (MCL), follicular lymphoma (FL), diffuse large B cell lymphoma (DLBCL) and multiple myeloma (MM) are specific indications 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�� 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 multicenter 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 Phase 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 Jon C. Ogg]

    Pharmacyclics Inc. (NASDAQ: PCYC) was started as Overweight with a $142 price target at J.P. Morgan. Deutsche Bank also started it with a Buy rating and a $170 price target.

  • [By Sean Williams]

    What's perhaps more remarkable is the fact that Pharmacyclics (NASDAQ: PCYC  ) has three of those 23 approved breakthrough therapy designations for its lead experimental drug, ibrutinib. Ibrutinib, which is also licensed to Johnson & Johnson (NYSE: JNJ  ) subsidiary Janssen Pharmaceuticals, was designated as a breakthrough therapy for patients with chronic lymphocytic leukemia, mantle cell lymphoma, and Waldenstrom's macroglobulinemia. The big potential indication here is CLL, which is the most common adulthood leukemia and occurs in 113,000 people in the U.S. By comparison, MCL diagnoses number about 5,000 each year.

  • [By Jay Silverman]

    Over the past year, including the end of this year, we've had new blockbuster drugs for hepatitis C, which is Gilead's (GILD) drug, and also for B-cell lymphomas, which is Pharmacyclics' (PCYC) drug. Those are looking to be two of the biggest drugs ever.

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