Looking for a good trade when the market isn't yielding many? Try Orbitz Worldwide, Inc. (NYSE:OWW). It's not as sexy as a budding biotech company or the creator of the next great digital gizmo, but it's reliable, and the OWW chart says the long-term as well as the short-term undertow are both pointed higher now.
You probably know the company well enough to be able to say it's an online travel agent. What widely unappreciated about Orbitz Worldwide, however, is just how complete and diversified it is. OWW can help travelers book flights, hotels, and car rentals, not to mention secure tickets to attractions and venues near their destination. Perhaps even more encouraging to investors is the willingness to license its technology and service to third parties, further diversifying (not to mention growing) its revenue streams. In fact, last year's top line of $847 was a record, and the pros say this year's projected revenue is $915 million, with $960 million in the cards for next year.
Best Gold Stocks To Invest In Right Now: Five Prime Therapeutics Inc (FPRX)
Five Prime Therapeutics, Inc., incorporated on December 20, 2001, is a clinical-stage biotechnology company focused on discovering and developing protein therapeutics. Protein therapeutics is antibodies or drugs developed from extracellular proteins or protein fragments that block disease processes, including cancer and inflammatory diseases. The Company�� advanced product candidates include FP-1039/GSK3052230 (FP-1039), FPA008 and FPA144. FP-1039 is a protein therapeutic that traps and neutralizes cancer-promoting fibroblast growth factors (FGFs), involved in cancer cell proliferation and new blood vessel formation. FPA008 is an antibody that inhibits colony stimulating factor-1 receptor (CSF1R), and is being developed to treat patients with inflammatory diseases, including rheumatoid arthritis (RA). FPA144 is an antibody that inhibits FGF receptor 2b (FGFR2b), and is being developed to treat patients with gastric cancer and potentially other solid tumors.
FP-1039
FP-1039 is a protein therapeutic, which includes the extracellular part of FGFR1. FP-1039 acts as an inhibitor of FGFs, because the FGFR1 portion of the molecule binds to FGFs and prevents them from binding to FGFR1 on tumor and blood vessel cells. Because FGF proteins circulating in the blood are called ligands, FP-1039 is called a ligand trap. FP-1039 also includes a portion of an antibody called the Fc region. In preclinical testing, it observed inhibition of tumor growth with single-agent FP-1039, particularly in tumors withFGFR1 gene amplification, including squamous NSCLC and SCLC.
FPA008
FPA008 is an antibody that inhibits CSF1R and is being developed to treat patients with RA. FPA008 also has the potential to treat patients with other inflammatory diseases, including lupus nephritis, psoriatic arthritis, ankylosing spondylitis, fibrosis, inflammatory bowel disease and multiple sclerosis. These are chronic, incurable disorders with serious medical complications and disability for ! which better therapies with novel mechanisms of action are needed. FPA008 is an anti-CSF1R antibody, which it designed to block the ability of IL-34 and CSF1 to bind to and activate CSF1R. FPA008 reduces the numbers and activity of monocytes and macrophages that cause disease, and prevents the production and release of inflammatory factors. The Company and others has demonstrated that both IL-34 and CSF1 are present at increased levels in the inflamed joints of patients with RA.
FPA144
FPA144 is a monoclonal antibody directed against a form of FGFR2, or FGFR2b. When the FGFR2 gene is amplified by cancer cells, the FGFR2b protein is expressed at abnormally high levels on the tumor�� surface. This occurs in some patients with gastric and lower esophageal cancers. The tumor cells that have too much FGFR2b protein on their surface can be identified by special staining tests performed on the tumor. Because FGFR2b is the target for FPA144, patients��tumors can be screened for this protein, helping to identify the patients most likely to respond to FPA144 treatment.
Advisors' Opinion:- [By John Kell and Tess Stynes var popups = dojo.query(".socialByline .popC"); p]
Among the companies with shares expected to actively trade in Monday’s session are Keurig Green Mountain Inc.(GMCR), JA Solar Holdings Co.(JASO) and Five Prime Therapeutics Inc.(FPRX)
- [By Monica Gerson]
Breaking news
Alcoa (NYSE: AA) is investing US$13 million to expand its wheel manufacturing plant in Europe, to meet growing demand for its lightweight, durable, low-maintenance aluminum truck wheels. To read the full news, click here. L & L Energy (NASDAQ: LLEN) announced today that its Special Independent Committee has appointed Mr. Nicholas Chen, Managing Partner at Pamir Law Group, to replace Mr. Mark Bartlett. To read the full news, click here. Five Prime Therapeutics (NASDAQ: FPRX) and Bristol-Myers Squibb (NYSE: BMY) announced today that they have signed a collaboration agreement for the discovery, development and commercialization of immuno-oncology therapies directed toward targets identified in two undisclosed immune checkpoint pathways using Five Prime's proprietary target discovery platform. To read the full news, click here. First Solar (NASDAQ: FSLR) on Sunday announced the completion of the 1.3MW(DC) solar photovoltaic (PV) power plant at Kitakyushu-shi. Powered by First Solar FS Series 3 Black PV modules, the plant will generate approximately 1,400 MWh of clean and safe solar electricity per year. To read the full news, click here.Posted-In: Credit Suisse US Stock FuturesNews Eurozone Futures Global Pre-Market Outlook Markets
Best Biotech Companies To Invest In 2014: Osiris Therapeutics Inc.(OSIR)
Osiris Therapeutics, Inc., a stem cell company, focuses on the development and marketing of therapeutic products to treat various medical conditions in the inflammatory, autoimmune, orthopedic, and cardiovascular areas. It operates in two business segments, Therapeutics and Biosurgery. The Therapeutics segment focuses on developing biologic stem cell drug candidates from a readily available and non-controversial source, adult bone marrow. The Biosurgery segment works to harness the ability of cells and novel constructs to promote the body's natural healing. This segment focuses on developing biologic products for use in surgical procedures. The company?s lead biologic drug candidate is Prochymal, which is in phase 2 and 3 clinical trails for various indications, including acute graft versus host disease (GvHD), Crohn's disease, acute myocardial infarction, type 1 diabetes, pulmonary disease, and gastrointestinal injury resulting from radiation exposure. Its biologic drug candidates also include Chondrogen, a preparation of adult mesenchymal stem cells that is in phase 2 clinical trials for osteoarthritis and cartilage protection. The company has collaboration agreements with Genzyme Corporation for the development and commercialization of Prochymal and Chondrogen in various countries except in the United States and Canada. It also has a partnership with Juvenile Diabetes Research Foundation for the development of Prochymal as a treatment for the preservation of insulin production in patients with newly diagnosed type 1 diabetes mellitus. Osiris Therapeutics, Inc. was founded in 1992 and is headquartered in Columbia, Maryland.
Advisors' Opinion:- [By Maxx Chatsko]
Additionally, stem cell therapies have remained elusive as the industry's ultimate Holy Grail. Osiris (NASDAQ: OSIR ) received Canadian approval for the world's first stem cell drug, Prochymal, for children battling acute graft-versus-host disease, or GvHD, last year. The approval meant more symbolically than to the bottom line, but it definitely put the potential of stem cells front and center for investors.
- [By Alexander Maxwell]
One of the companies attempting to develop a better treatment for chronic diabetic foot ulcers is Osiris Therapeutics� (NASDAQ: OSIR ) . Earlier this month, Osiris shares more than doubled as the company announced positive data for its CDFU drug Grafix. The study results were very impressive to say the least; the study was stopped early due to the overwhelming efficacy exhibited by the treatment. A main highlight is the fact that 62% of Grafix patients had their wound closed at 12 weeks, compared to only 21% of patients using conventional methods. Clearly, the efficacy in this endpoint was overwhelming. Grafix also achieved all of the secondary endpoints for the trial, and more importantly demonstrated a relatively benign safety record.�
- [By Lauren Pollock]
Osiris Therapeutics Inc.(OSIR) said Friday a proposed ruling from the Centers for Medicare and Medicaid Services won’t immediately affect reimbursements for its Grafix stem-cell product. The regenerative medicine company said Grafix will maintain its current reimbursement status — also called transitional pass-through status — potentially through late 2015.
Best Biotech Companies To Invest In 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.
Best Biotech Companies To Invest In 2014: Tekmira Pharmaceuticals Corp (TKMR)
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing ribonucleic acid (RNA) interference (RNAi) therapeutics and providing its lipid nanoparticle (LNP) delivery technology to pharmaceutical partners. On March 1, 2012, it announced that the Company had secured a license from Alnylam to develop TKMALDH2, an RNAi therapeutic that utilizes Tekmira's LNP for the treatment of Alcohol Dependence (AD). Its lead oncology product candidate, TKM-PLK1, targets PLK1, a protein involved in tumor cell proliferation and a validated oncology target. On February 8, 2012, it announced that Phase I clinical trial for TKM-Ebola had been initiated. The Phase 1 TKM-Ebola clinical trial is a placebo-controlled, single-blind, single-ascending dose study with additional multiple-ascending dose cohorts in healthy human volunteers. In the field of RNAi therapeutics, the Company has licensed its LNP delivery technology to Alnylam Pharmaceuticals, Inc. and Merck & Co., Inc. Advisors' Opinion:- [By Markus Aarnio]
Companies working on chemically synthesized siRNAs include Merck (MRK), through its subsidiary Sirna Therapeutics, Inc., Novartis (NVS), Takeda (TKPHF.PK), Kyowa Hakko Kirin, Marina Biotech, Inc., Arrowhead and its subsidiary, Calando, Quark, Silence Therapeutics plc, Tekmira (TKMR), Sylentis and Dicerna Pharmaceuticals, Inc.
- [By Lisa Levin]
Tekmira Pharmaceuticals (NASDAQ: TKMR) shares climbed 34.11% to $13.25. The volume of Tekmira Pharmaceuticals shares traded was 2187% higher than normal. Tekmira signed a development agreement with Monsanto (NYSE: MON) on delivery technology for agricultural applications.
Best Biotech Companies To Invest In 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�� 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 Brian Orelli]
Johnson & Johnson (NYSE: JNJ ) announced on Monday that it had received a third Breakthrough Therapy Designation for the blood cancer drug ibrutinib that it's developing with Pharmacyclics� (NASDAQ: PCYC ) . The designation covers patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have a deletion of the short arm of chromosome 17.
- [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.
- [By Sean Williams]
The other factor that makes J&J a company I wouldn't dare bet against is its top-notch pharmaceutical program. J&J has delivered incredible wins over the past couple of quarters including the approval of Invokana, the first SGLT-2 inhibitor approved in the U.S. to treat Type 2 diabetes, as well as its December 2011 licensing partnership with Pharmacyclics (NASDAQ: PCYC ) over experimental drug, ibrutinib, which has been designated as a breakthrough therapy by the Food and Drug Administration for the treatment of two rare blood cancers and could generate up to $5 billion in peak sales if approved (it's currently under review by the FDA).
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