Tuesday, February 24, 2015

Top Biotech Companies To Buy For 2014

Gilead Sciences (NASDAQ: GILD  ) shares have steadily risen more than 90% over the past year. The biotech announced first-quarter results after the market closed on Thursday, though, that weren't all that impressive. Will this be a problem for Gilead? I doubt it.

By the numbers
First quarter non-GAAP earnings came in at $801.9 million, or $0.48 per diluted share. That's up from $704.4 million, or $0.45 per diluted share, during the first quarter of last year. However, the average analysts' estimate called for earnings of $0.50 per share.

Gilead reported GAAP earnings for the first quarter of $722.2 million, or $0.43 per diluted share. This represents a large gain from the $442.0 million, or $0.28 per diluted share, reported in the same period for 2012.

Revenue for the quarter totaled $2.53 billion, an 11% increase year over year. However, that figure missed the $2.58 billion in revenue expected by analysts. $2.39 billion of that revenue stemmed from product sales. This amounts to an 8% bump from the first quarter of 2012.

Top 10 Defensive Stocks To Invest In Right Now: Portola Pharmaceuticals Inc (PTLA)

Portola Pharmaceuticals, Inc. (Portola), incorporated on September 2, 2003, is a biopharmaceutical company developing product candidates that have the potential to represent advances in the fields of thrombosis and hematology. The Company is advancing its three wholly owned programs using biomarker and genetic approaches.

Betrixaban

Portola's compound, betrixaban, is an oral, once-daily Factor Xa inhibitor being evaluated in the only biomarker-based Phase-III study for hospital to home prophylaxis of venous thromboembolism (VTE) in acute medically ill patients. Betrixaban's properties particularly suited to potentially demonstrate efficacy without increasing bleeding in this patient population.

Andexanet Alfa

Portola's second development candidate, andexanet alfa (PRT4445), has the potential to be a reversal agent to directly reverse the effects of Factor Xa inhibitors in patients who suffer a bleeding episode or who require emergency surgery. Portola has entered into clinical collaboration agreements with all of the manufacturers of direct Factor Xa inhibitors, including Bristol-Myers Squibb and Pfizer (Eliquis [apixaban]), Bayer HealthCare and Janssen Pharmaceuticals (XARELTO [rivaroxaban]), and Daiichi Sankyo (Savaysa [edoxaban]), while retaining all decision-making and commercial rights to the program.

Cerdulatinib (PRT2070) and PRT2607

Portola's third wholly owned product candidate, cerdulatinib (PRT2070), is an orally available kinase inhibitor that uniquely inhibits two validated tumor proliferation pathways - spleen tyrosine kinase (Syk) and janus kinase (JAK). It is being studied in patients with leukemias or lymphomas with a focus on genetically-defined subtypes, as well as in patients who have failed therapy due to relapse or acquired mutations. Portola's fourth program is partnered with Biogen Idec and is focused on the development of PRT2607, a selective Syk inhibitor.

Advisors' Opinion:
  • [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.

Top Biotech Companies To Buy For 2014: Genomic Health Inc (GHDX)

Genomic Health, Inc. (Genomic Health), incorporated in August 2000, is a molecular diagnostics company focused on the global development and commercialization of genomic-based clinical laboratory services that analyze the underlying biology of cancer allowing physicians and patients to make individualized treatment decisions. Its Oncotype DX platform utilizes quantitative genomic analysis known as reverse transcription polymerase chain reaction (RT-PCR), in standard tumor pathology specimens to provide tumor-specific information, or the oncotype of a tumor. As of February 2012, Oncotype DX was evaluated in invasive breast cancer in 13 clinical studies involving more than 4,000 breast cancer patients worldwide. Genomic Health offers its Oncotype DX tests as a clinical service, where it analyzes the expression levels of genes in tumor tissue samples and provide physicians with a quantitative gene expression profile expressed as a single quantitative score, which it calls a Recurrence Score, for invasive breast cancer and colon cancer and a DCIS Score for DCIS. Its Oncotype DX breast cancer test analyzes the expression levels of 21 genes and Oncotype DX colon cancer test analyzes the expression levels of 12 genes. In March 2012, the Company established a wholly owned subsidiary, InVitae Corporation.

Oncotype DX Platform

The Company�� Oncotype DX platform uses its RT-PCR approach to improve cancer treatment decisions. Its diagnostic approach correlates gene expression to clinical outcomes and provides an individualized analysis of each patient's tumor. The Company has built a diagnostic infrastructure that allows it to move from research into development through to processing actual patient samples in its clinical reference laboratory. The Company offers Oncotype DX tests as clinical laboratory services. Its technology allows the Company to analyze tumor tissue samples in its clinical reference laboratory and provide physicians with genomic information specific to the patient'! s tumor. It analyzes tissues that are handled, processed and stored under routine clinical pathology laboratory practices.

Oncotype DX Breast Cancer Test

To develop its Oncotype DX breast cancer test, the Company evaluated 250 genes in three independent clinical studies, which identified a 21-gene panel whose composite gene expression profile can be represented by a breast cancer Recurrence Score. The Company conducted studies of its Oncotype DX breast cancer test with clinical samples from postmenopausal women with invasive breast cancer who were treated with aromatase inhibitors. In March 2010, the Journal of Clinical Oncology published results from a European study using its test to analyze tumor samples from over 1,200 patients in the ATAC (Arimedix, Tamoxifen, Alone or in Combination) trial, which established the use of aromatase inhibitors for adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer. The study demonstrated that, along with other standard measures, such as tumor size, its Oncotype DX breast cancer test contributes independently to provide a more complete picture of prognosis for N- and N+ patients treated with aromatase inhibitors.

In December 2011, the Company presented positive results from the ECOG E5194 DCIS clinical validation study at SABCS. The study met its primary endpoint by demonstrating that a pre-specified Oncotype DX DCIS Score can predict the risk of local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast. In December 2011, the Company made Oncotype DX available for patients with ductal carcinoma in situ (DCIS), of the breast, a pre-invasive form of breast cancer. The launch of Oncotype DX for DCIS patients was based on positive results presented from a clinical validation study of Oncotype DX breast cancer test in patients with DCIS, conducted by the Eastern Cooperative Oncology Group (ECOG), a clinical trials cooperative! group su! pported by the National Cancer Institute.

Oncotype DX Colon Cancer Test

The Company developed its gene panel by identifying 761 cancer-related genes through review of existing research literature and computer analysis of genomic databases. The 761 candidate genes were also examined to determine whether they would be useful beyond other key variables including tumor stage, tumor grade, lymph nodes examined and MMR/MSI. It selected a final set of 12 genes, which were then independently evaluated in a validation study of over 1,400 stage II colon cancer patients from the Quick and Simple and Reliable (QUASAR), randomized study of adjuvant chemotherapy in the United Kingdom. This international, multi-center randomized trial examined the recurrence risk and the benefit associated with 5-fluorouracil/leucovorin, or 5FU/LV, adjuvant chemotherapy. Gene expression was quantified by RT-PCR from manually microdissected FPE primary colon cancer tissue, and recurrence-free interval, disease-free survival and overall survival were analyzed. In January 2012, the Company presented positive results of the first clinical decision making study of the Oncotype DX colon cancer test that shows that Recurrence Score result has a significant impact on treatment recommendations for stage II colon cancer patients.

The Company competes with General Electric Company, Hologic, Inc., Novartis AG, Myriad Genetics, Inc., Qiagen N.V., Response Genetics, Inc., Laboratory Corporation of America Holdings, Quest Diagnostics Incorporated, Roche Holding, Ltd, Siemens AG and Johnson & Johnson.

Advisors' Opinion:
  • [By Keith Speights]

    Genetic testing stands out as one current example of how scientific advances can help reduce medical costs. Genomic Health (NASDAQ: GHDX  ) makes genetic diagnostic tests for�breast, colon, and prostate cancer. Half of the patients diagnosed with prostate cancer each year actually have a very low risk of the cancer progressing. However, 90% of these low-risk patients still undergo surgery or radiation -- at a cost of tens of thousands of dollars per patient. Genomic Health's genetic test helps identify which patients really need more extensive treatment and holds the potential to reduce overall costs.

  • [By John Udovich]

    Small cap cancer diagnostic stock�Myriad Genetics, Inc (NASDAQ: MYGN) jumped to a five year high on Wednesday�thanks to good�news that the�government will be paying a heftier reimbursement for its main test than previously feared, meaning its worth taking a closer look at the stock along with 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 also mention that Myriad Genetics has been in our SmallCap Network Elite Opportunity (SCN EO) portfolio since early February and we are now up some 32.5% since then ��thanks in part to the shorts being put in a short squeeze.

  • [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.

Top Biotech Companies To Buy For 2014: OncoMed Pharmaceuticals Inc (OMED)

OncoMed Pharmaceuticals, Inc. (OncoMed) incorporated on July 19, 2004, is a clinical development-stage biopharmaceutical company. The Company focuses on discovering and developing monoclonal antibody therapeutics targeting cancer stem cells (CSCs). It utilizes its technologies to identify, isolate and evaluate CSCs; identify and/or validate multiple potential targets and pathways critical to CSC self-renewal and differentiation; and develop targeted antibody and other protein-based therapeutics that are designed to modulate these CSC targets and inhibit the growth of CSCs. The Company's anti-cancer therapeutics include anti-DLL4 (demcizumab, OMP-21M18), Anti-DLL4/Anti-VEGF Bispecific, and Anti-Notch2/3 (OMP-59R5), Anti-Notch1 (OMP-52M51, Anti-Fzd7, Fzd8-Fc, RSPO-LGR.

Anti-DLL4 (demcizumab, OMP-21M18) is a humanized monoclonal antibody that inhibits Delta Like Ligand 4 (DLL4) in the Notch signaling pathway. The Company has completed a single-agent Phase Ia trial in advanced solid tumor patients. The Company focuses on conducting two Phase Ib combination trials of demcizumab. Anti-DLL4/anti-VEGF bispecific is a monoclonal antibody that targets and inhibits both DLL4 and vascular endothelial growth factor ( VEGF). VEGF is the target of Avastin. Anti-Notch2/3 (OMP-59R5) is a human monoclonal antibody that targets the Notch2 and Notch3 receptors.

Anti-Notch1 OMP-52M51 is a humanized monoclonal antibody targeted to the Notch1 receptor. Anti-Fzd7 OMP-18R5 is a human monoclonal antibody identified by screening against the Frizzled7 receptor (Fzd7) that binds a conserved epitope on five Frizzled receptors and inhibits Wnt signaling. OMP-18R5 is in a Phase I single-agent trial in advanced solid tumor patients. Fzd8-Fc OMP-54F28 is a fusion protein based on a truncated form of the Frizzled8 receptor ( Fzd8). RSPO-LGR ligands signal through the LGR receptor family.

The Company utilizes several robust technologies for the discovery and optimization of its antibody and protein-bas! ed therapeutics, including multiple proprietary technologies. Its antibody technologies include Mammalian Display Technology, Bispecific Antibody Technology, Hybridoma Technology. Mammalian Display Technology utilizes flow cytometry to isolate mammalian cells expressing antibodies on the cell surface with desired characteristics from large libraries of candidate antibodies. Bispecific Antibody Technology is used to generate its anti-DLL4/anti-VEGF antibody. Hybridoma Technology is used for isolating antibodies from mice, including multiplex single-cell screening techniques.

Advisors' Opinion:
  • [By Stephen Quickel]

    Recently, too, Celgene has formed a strategic partnership with OncoMed (OMED) to develop up to six anti-cancer stem-cell antibodies.

    Celgene itself has posted four successive quarters of revenue growth, which is expected to lift annual sales from $5.5 to $6.4 billion for calendar 2013, and to $7.5 billion in 2014. Despite its expanding size, earnings per share are projected to grow by 23.2% a year, by 28 Street analysts following its stock.

  • [By Roberto Pedone]

    OncoMed Pharmaceuticals (OMED), a clinical development-stage biotechnology company, focuses on discovering and developing monoclonal antibody therapeutics targeting cancer stem cells. This stock closed up 5.3% at $18.08 in Monday's trading session.

    Monday's Volume: 446,000

    Three-Month Average Volume: 178,792

    Volume % Change: 155%

    From a technical perspective, OMED ripped higher here right above previous support at $16.57 with above-average volume. This stock has been downtrending badly for the last four months and change, with shares moving lower from its high of $28.43 to its recent low of $16.57. During that move, shares of OMED have been making mostly lower highs and lower lows, which is bearish technical price action. That said, shares of OMED have now starting to rebound off some previous support and it's quickly moving within range of triggering a near-term breakout trade. That trade will hit if OMED manages to clear some near-term overhead resistance levels at $19.17 to its 50-day at $19.92 and then above more resistance at $20 with high volume.

    Traders should now look for long-biased trades in OMED as long as it's trending above some key near-term support at $16.57 and then once it sustains a move or close above those breakout levels with volume that hits near or above 178,792 shares. If that breakout kicks off soon, then OMED will set up to re-test or possibly take out its next major overhead resistance levels at $21.80 to $22.43, or even $24 to $24.48.

  • [By WWW.DAILYFINANCE.COM]

    Stocks ended a mini-losing streak on Friday, led by upbeat news from Intel (INTC). The Dow Jones industrial average (^DJI) rose 41 points, after sliding more than 200 over the previous two days. The Nasdaq composite (^IXIC) gained 13 and the Standard & Poor's 500 index (^GPSC) added 6 points. Those modest gains did little to trim the loss for the week. The major averages posted their biggest weekly declines in more than two months. Intel is a component of all three big indexes, and it jumped 7 percent after raising its revenue guidance for the current quarter. The company sees stronger business demand for PCs than it previously expected. Intel shares are up 23 percent over the past six months. The Intel news had a ripple effect. Computer maker Hewlett-Packard (HPQ) rose more than 5 percent and Microsoft (MSFT) gained 1½ percent. Part of the increased demand Intel points to is tied to corporate buyers who need to replace their Windows XP machines, because Microsoft has stopped providing technical support for that platform. But Apple (AAPL) lost more than 1 percent. The stock is down since its 7-for-1 stock split took effect on Monday. There were two other big stories that had some legs beyond the companies directly involved. Open Table (OPEN) agreed to be acquired by Priceline (PCLN) for $2.6 billion. Open Table, which provides restaurant reservations, jumped 48 percent. Other online service providers rode the coattails of that deal. Yelp (YELP) gained 14 percent and Groupon (GRPN) gained 4 percent. In the retail arena, Express (EXPR) jumped 21 percent after a private equity firm took a 9.9 percent stake in the teen retailer and indicated it may make a buyout offer. That gave a boost to Aeropostale (ARO) and American Eagle (AEO), which both rose more than 2 percent. Abercrombie & Fitch (ANF) gained 1½. Elsewhere, International Game Technology (IGT) gained 10½ percent on a Reuters report that a bidding war could erupt for

Top Biotech Companies To Buy For 2014: KYTHERA Biopharmaceuticals Inc (KYTH)

KYTHERA Biopharmaceuticals, Inc., incorporated in June 2004, is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of prescription products for the aesthetic medicine market. The Company�� initial focus is on the facial aesthetics market. The Company�� product candidate, ATX-101, is a injectable drug in Phase III clinical development for the reduction of submental fat, which commonly presents as an undesirable double chin. Based on clinical trials conducted, ATX-101 has exhibited results in the reduction of submental fat. ATX-101 contains a synthetic form of sodium deoxycholate. In the United States and Canada, the Company is conducting two pivotal Phase III trials of ATX-101 for the reduction of submental fat. The Company initiated this pivotal Phase III clinical program, with planned enrollment of 1,000 patients, in March 2012.

In Europe, Bayer, its collaborator outside the United States and Canada, recently completed two pivotal Phase III trials of ATX-101 for the reduction of submental fat. In these multi-center, randomized, double-blind, placebo-controlled pivotal trials involving 723 patients, ATX-101 resulted in a reduction in submental fat, as assessed by a validated clinician scale and a patient satisfaction scale.

ATX-101 contains a synthetic form of sodium deoxycholate. ATX-101 is designed to be a locally-injected drug that causes proximal, preferential destruction of adipocytes, or fat cells, with minimal effect on surrounding tissue. Upon subcutaneous injection under the skin, ATX-101 disrupts cell membranes in protein-poor tissues, such as fat, while being attenuated by interactions with protein-rich tissue, such as skin, muscle and blood vessels. This attenuation by protein-rich tissue results in the preferential destruction of adipocytes by ATX-101. The destruction of adipocytes, or adipocytolysis, elicits a natural response, in which macrophages are attracted to remove cellular debris and fat particles t! hrough the lymphatic system. The macrophages also emit low levels of chemical messengers, known as cytokines, which attract fibroblasts, another cell type, to the area. Fibroblasts produce collagen, and it is believed that new collagen production, or neocollagenesis, promotes retraction of the skin in the areas of fat reduction. The fat removal process with ATX-101 is incremental with each treatment, thereby allowing for control of the aesthetic outcome.

Advisors' Opinion:
  • [By Roberto Pedone]


    One stock that's quickly moving within range of triggering a major breakout trade is Kythera Biopharmaceuticals (KYTH), which is focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. This stock has been on a bullish run in 2013, with shares up by 48%.

    If you take a look at the chart for Kythera Biopharmaceuticals, you'll notice that this stock has been trending sideways and consolidating for the last month, with shares moving between $40.55 on the downside and $47.85 on the upside. Shares of KYTH are now starting to spike higher off some near-term support at $42.54 a share. That move is quickly pushing KYTH within range of triggering a major breakout trade above the upper-end of its recent range.

    Traders should now look for long-biased trades in KYTH if it manages to break out above some near-term overhead resistance at $47.50 to its all-time high of $47.85 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 199,029 shares. If that breakout hits soon, then KYTH will set up to enter new all-time high territory, which is bullish technical price action. Some possible upside targets off that breakout are $55 to $57, or even $60 a share.

    Traders can look to buy KYTH off any weakness to anticipate that breakout and simply use a stop that sits right below some key near-term support at $42.54 a share, or at $40.55 a share. One can also buy KYTH off strength once it takes out those breakout levels with volume and then simply use a stop that sits a comfortable percentage from your entry point.

  • [By Lisa Levin]

    Kythera Biopharmaceuticals (NASDAQ: KYTH) jumped 24.43% to $41.72 after the company reported positive ATX-101 top line phase III trial results for the reduction of submental fat.

  • [By Monica Gerson]

    Kythera Biopharmaceuticals (NASDAQ: KYTH) shares jumped 28.69% to $43.15 in pre-market trading after the company reported positive ATX-101 top line phase III trial results for the reduction of submental fat.

  • [By Lisa Levin]

    Kythera Biopharmaceuticals (NASDAQ: KYTH) shares moved up 24.01% to $41.58. The volume of Kythera Biopharmaceuticals shares traded was 6431% higher than normal. Kythera reported positive ATX-101 top line phase III trial results for the reduction of submental fat.

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