Wednesday, June 17, 2015

Top 10 Biotech Companies To Buy For 2015

In the health care sector, investors can tap into the full range of the risk spectrum. They can swing for the fences with bets on emerging biotechnology companies set to deliver groundbreaking new drugs, or they can make lower risk plays on “Big Pharma,” hoping these giant drug makers can stay ahead of their patent expiration curve.

Among the lowest risk plays of all in the sector are distribution companies that produce steady growth and returns on trends as simple as increasing utilization.

Henry Schein (NSDQ: HSIC) is a global distributor of health care products, including medical, dental and animal health care supplies with about 35 percent of sales outside of the US. It also offers software systems used to manage finances, educational requirements and other office functions as well as value-added services such as practice design.

Since the company went public in 1995, its sales have grown at an annual compound rate of 17 percent, rising from $616.2 million to $8.9 billion last year. Earnings per share (EPS) have experienced similar growth, up from $0.34 in 1995 to $4.44 in 2012.

Top Financial Companies To Own For 2016: Regeneron Pharmaceuticals Inc.(REGN)

Regeneron Pharmaceuticals, Inc., a biopharmaceutical company, discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions in the United States. The company?s commercial product includes ARCALYST (rilonacept) injection for subcutaneous use for the treatment of cryopyrin-associated periodic syndromes, including familial cold auto-inflammatory syndrome and muckle-wells syndrome in adults and children. Its products under Phase III clinical development stage consist of VEGF Trap-Eye, an aflibercept ophthalmic solution developed using intraocular delivery for the treatment of serious eye diseases; ARCALYST for the prevention of gout flares in patients initiating uric acid-lowering treatment; and Aflibercept (VEGF Trap), which is developed in oncology. The company?s earlier stage clinical programs include various human antibodies, such as REGN727 for low-density lipoprotein cholesterol reduction, REGN88 for rheumatoid arthritis and ankylosing spondylitis; REGN668 for atopic dermatitis and asthma; REGN421 and REGN910 for oncology; REGN475 for the treatment of pain; and REGN728 and REGN846. It also conducts preclinical research programs in the areas of oncology and angiogenesis, ophthalmology, metabolic and related diseases, muscle diseases and disorders, inflammation and immune diseases, bone and cartilage, pain, cardiovascular diseases, and infectious diseases. The company distributes its products through third party service providers. It has strategic collaboration with sanofi-aventis Group to discover, develop, and commercialize human monoclonal antibodies; and Bayer HealthCare LLC to develop and commercialize VEGF Trap. Regeneron Pharmaceuticals, Inc. was founded in 1988 and is based in Tarrytown, New York.

Advisors' Opinion:
  • [By Traders Reserve]

    Regeneron (REGN) shares could see a big jump in 2014. The big promise in the year is with respect to expansion of its eye treatment product, Eylea. Analysts expect the company to grow profits by more than 50% in 2014. At current prices shares trade for 54 times 2014 estimated earnings. That�� a rich premium, but not nosebleed compared to some momentum stocks. The real potential for growth to be even larger than expected is what turns on the momentum ground and as other rocket ships come back to earth look for this one to keep on climbing.

Top 10 Biotech Companies To Buy For 2015: Vertex Pharmaceuticals Incorporated(VRTX)

Vertex Pharmaceuticals Incorporated engages in discovering, developing, manufacturing, and commercializing small molecule drugs for the treatment of serious diseases worldwide. Its products include telaprevir, a prescription medicine used for the treatment of patients with genotype 1 hepatitis C virus (HCV) infection; and Ivacaftor, a prescription medicine used for the treatment of cystic fibrosis. The company markets its products under the INCIVEK brand name in the United States and Canada; INCIVO brand in the United Kingdom, Germany, France, Sweden, Austria, Finland, Denmark, Switzerland, and Norway; KALYDECO brand in the United States; and TELAVIC brand in Japan. Its drug candidates comprise VX-222, a Phase II clinical trial drug candidate, and ALS-2200 and ALS-2158, a Phase I clinical trial drug candidates that are designed to inhibit the replication of HCV; VX-809 and VX-661, a Phase II clinical trial drug candidates that improve the function of defective cystic fibro sis; VX-509, a Phase II clinical trial drug candidate for the treatment of patients with rheumatoid arthritis and other immune-mediated inflammatory diseases; VX-765, a Phase II clinical trial drug for the treatment of epilepsy; and VX-787, an investigational drug candidate for the treatment of influenza A. The company was founded in 1989 and is headquartered in Cambridge, Massachusetts.

Advisors' Opinion:
  • [By Ben Levisohn]

    Sovaldi selling way beyond our expectations. The initial prescription data are so massively outperforming even the biggest weeks Incivek ever had, we believe any reasonable comparison between the two drugs would indicate that U.S. sales in 2014, alone, are going to exceed $5 billion. In 4Q11, Vertex (VRTX) recognized $458 million in Incivek sales and WK reported 11,409 NRx. Sovaldi is already pacing more than 2x that volume in 1Q14. Sovaldi also has ~70% price premium over Incivek. There is almost no way barring an extreme reduction in volume over the next few weeks that Gilead won’t hit at least $1 billion in sales in 1Q14 (consensus is at $336 million), and that really only accounts for U.S. sales. While we expect a slower uptake ex-US, we note that historical Incivo sales indicate that there is likely to be an additional $1 billion in Sovaldi sales in 2014 coming from ex-U.S. territories. We believe this volume implies that next year’s sofosbuvir/ledipisvir sales are not only set to be the best launch ever, but exceed the highest single year sales of any pharmaceutical product in history…As a result of our model changes, we are raising our price target to $103 and elevating the stock to Outperform.

  • [By Northwest Trader]

    That was the case until Vertex's (VRTX) successful launch of VX-770 (Kalydeco) in January of 2012.

    Kalydeco (Ivacaftor) addresses the G551D mutation via CFTR modulation (potentiator), and is an orphan drug with a steep price tag of $294,000 per year. As CF is a chronic disease, this represents a potential gross revenue of roughly 340 million dollars per year.

  • [By Garrett Cook]

    Vertex Pharmaceuticals (NASDAQ: VRTX) shares shot up 42.73 percent to $95.07 after the company reported that its two phase 3 studies of Lumacaftor in combination with ivacaftor met the primary endpoint.

  • [By Sean Williams]

    Vertex Pharmaceuticals (NASDAQ: VRTX  ) suffered through an unpleasant week, with shares down 9% after it announced a partial clinical hold on Friday for its all-oral hepatitis-C drug, VX-135. The drug, which is currently in midstage trials, was placed on clinical hold by the FDA after it noted elevated, but reversible, liver enzyme levels in patients receiving the 400mg dose with ribavirin. To me this looks like a precautionary hold, but it will be perceived as painful, since it puts Vertex's oral hepatitis-C medication that much further behind its competition. Kalydeco is becoming the future of Vertex with regard to its potential to treat various mutations of cystic fibrosis, so I wouldn't worry too much about this minor setback with VX-135.

Top 10 Biotech Companies To Buy For 2015: Flexion Therapeutics Inc (FLXN)

Flexion Therapeutics, Inc. (Flexion Therapeutics), incorporated on November 5, 2007, is a pharmaceutical company focused on the development and commercialization of injectable pain therapies. The Company is targeting anti-inflammatory and analgesic therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis, a type of degenerative arthritis, referred to as OA. The Company�� portfolio of small molecule product candidates addresses the OA pain treatment spectrum, from moderate to severe pain. The Company�� product candidate, FX006, is an injectable intra-articular, meaning in the joint, sustained-release treatment for patients with moderate to severe OA pain. It is developing two additional product candidates, FX007 for post-operative pain and FX005 to treat end-stage OA patients. FX007 is a locally administered TrkA receptor antagonist for persistent relief of post-operative pain, including in patients who have received total joint replacement, also referred to as total joint arthroplasty (TJA). Its product candidates are designed to deliver established anti-inflammatory and analgesic effects directly to the site of disease, optimizing sustained local drug concentration to achieve a durable and clinically meaningful response. These product candidates are also designed to limit systemic exposure to the drugs and minimize systemic toxicities.

FX006 - Front Line IA Therapy for Patients with Moderate to Severe OA Pain

FX006 is a steroid, triamcinolone acetonide (TCA), formulated for sustained-release, delivered through intra-articular (IA) injection and designed to treat moderate to severe OA pain. FX006 combines commonly administered TCA with poly lactic-co-glycolic acid (PLGA), its injectable IA sustained-release technology. As of January 8, 2014, two clinical trials had been conducted to test FX006 against immediate-release TCA injection. FX006 has been studied in two clinical trials, in which a total of 196 patients received FX006! and a total of 56 patients received immediate-release TCA: Study FX006-2011-001 and Study FX006-2011-002.

FX007-For Post-Operative Pain

FX007 is a small molecule TrkA receptor antagonist that is in development for the persistent relief of post-operative pain. TrkA is the receptor for nerve growth factor, commonly known as NGF, a small peptide that is released following tissue injury. NGF binds to TrkA on the surface of pain sensing neurons and renders these cells more responsive to external stimuli.

FX005-For End-Stage OA Pain

FX005 is intended as therapy for patients with end-stage OA pain, particularly those patients awaiting TJA, as an alternative to opioids. FX005 is a p38 MAP, or mitogen-activated protein, kinase inhibitor formulated for sustained-release delivered through IA injection, which is designed to have both analgesic and anti-inflammatory benefits without the systemic side effects of oral p38 MAP kinase inhibitors. p38 MAP kinase is an enzyme in an inflammatory cascade that upregulates in response to stress and culminates in the elaboration of multiple proinflammatory cytokines, including interleukin 1 and tumor necrosis factor, as well as enzymes like matrix metalloproteinases that have the potential to destroy cartilage. In other studies, multiple oral p38 MAP kinase inhibitors have been evaluated in inflammatory diseases and pain and, while efficacy has been demonstrated, serious toxicity affecting multiple organ systems has been frequently observed. FX005 has completed a Phase-II A clinical trial, in which 70 patients were randomized to FX005 and 70 patients were randomized to placebo.

The Company competes with Fidia Farmaceutici S.p.A, Ampio Pharmaceuticals, Inc., Carbylan BioSurgery, Inc., Merck Serono and Allergan, Inc., Pacira Pharmaceuticals, Janssen Pharmaceuticals, Inc. and Johnson & Johnson.

Advisors' Opinion:
  • [By John Udovich]

    It�� a new year and the first one and a half trading weeks of 2014 has not disappointed biotech investors as the sector and mid cap or small cap biotech or�pharma stocks like Intercept Pharmaceuticals Inc (NASDAQ: ICPT), Epizyme Inc (NASDAQ: EPZM), Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) and TNI BioTech Inc (OTCQB: TNIB) either surging or producing some news plus there have been IPO filings for future listings for�Flexion Therapeutics (NASDAQ: FLXN), Aldexa Therapeutics (NASDAQ: ALDX), Retrophin (NASDAQ:�RTRX) and Dicerna Pharmaceuticals (NASDAQ: DRNA). Consider the following news so far this year:

  • [By John Udovich]

    The start of 2014 shows that biotech is still a hot area with the sector along with small cap biotech stocks like AMAG Pharmaceuticals, Inc (NASDAQ: AMAG), Mast Therapeutics Inc (NYSEMKT: MSTX), Cell Therapeutics Inc (NASDAQ: CTIC), Imprimis Pharmaceuticals Inc (NASDAQ: IMMY) and TNI BioTech (OTCMKTS: TNIB) producing news or returns�plus Auspex Pharmaceuticals (NASDAQ: ASPX), Cara Therapeutics (NASDAQ: CARA), Egalet (NASDAQ: EGLT), Flexion Therapeutics (NASDAQ: FLXN) and Ultragenyx Pharmaceutical (NASDAQ: RARE) are among the (many�� planned biotech IPOs that have recently been announced publicly:

Top 10 Biotech Companies To Buy For 2015: 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 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.

  • [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.

Top 10 Biotech Companies To Buy For 2015: ArQule Inc.(ARQL)

ArQule, Inc., a clinical-stage biotechnology company, engages in the research and development of cancer therapeutics directed toward molecular targets and biological processes. Its lead product ARQ 197 is non-adenosine triphosphate competitive inhibitor of the c-Met receptor tyrosine kinase, which is being evaluated as monotherapy and in combination therapy in a Phase II clinical development program that includes trials in non-small cell lung cancer, c-Met-associated soft tissue sarcomas, pancreatic adenocarcinoma, hepatocellular carcinoma, germ cell tumors, and colorectal cancer. The company is also developing ARQ 621, a Phase I program focused on inhibition of the Eg5 kinesin spindle protein. Its clinical stage products include ARQ 501, ARQ 761, and ARQ 171, which are designed to kill cancer cells selectively while sparing normal cells through the direct activation of DNA damage response/checkpoint pathways. In addition, the company involves in pre-clinical development o f B-RAF and AKIP Kinase inhibitors. The company has collaborations with Kyowa Hakko Kirin Co., Ltd. and Daiichi Sankyo Co., Ltd. ArQule, Inc. was founded in 1993 and is headquartered in Woburn, Massachusetts.

Advisors' Opinion:
  • [By Roberto Pedone]

     

    ArQule (ARQL), a clinical-stage biotechnology company, researches and develops cancer therapeutics. This stock closed up 3.4% to $1.49 in Thursday's trading session.

     

    Thursday's Range: $1.44-$1.54

    52-Week Range: $1.29-$2.94

    Thursday's Volume: 908,000

    Three-Month Average Volume: 567,811

     

    From a technical perspective, ARQL jumped higher here right above some near-term support at $1.40 with above-average volume. This move briefly pushed shares of ARQL back above its 50-day moving average of $1.53, before the stock closed just below that level at $1.49. This move is starting to push shares of ARQL within range of triggering a near-term breakout trade. That trade will hit if ARQL manages to take out some near-term overhead resistance levels at $1.54 to $1.60 with high volume.

     

    Traders should now look for long-biased trades in ARQL as long as it's trending above some near-term support levels at $1.40 or at $1.35 and then once it sustains a move or close above those breakout levels with volume that hits near or above 567,811 shares. If that breakout hits soon, then ARQL will set up to re-test or possibly take out its next major overhead resistance levels at $1.66 to $1.78, or even $1.90 to $2.

     

Top 10 Biotech Companies To Buy For 2015: Celsion Corporation(CLSN)

Celsion Corporation, an oncology drug development company, develops and commercializes targeted chemotherapeutic oncology drugs based on its proprietary heat-activated liposomal technology. The company is developing its lead product, ThermoDox that is in Phase III clinical trial for primary liver cancer; and in phase II clinical trial for treatment of recurrent chest wall breast cancer. It has a license agreement with Yakult Honsha to commercialize and market ThermoDox for the Japanese market. The company also has a license agreement with Duke University under which it received exclusive rights to commercialize and use Duke's thermo-liposome technology. In addition, Celsion Corporation has a joint research agreement with Royal Phillips Electronics to evaluate the combination of Phillips' high intensity focused ultrasound with its ThermoDox to determine the potential of this combination to treat a range of cancers. The company was founded in 1982 and is based in Columbia, M aryland.

Advisors' Opinion:
  • [By EquityOptionsGuru]

    The Prolieve Thermodilatation System was actually developed by the current management of Medifocus while employed at Celsion Corporation (NASDAQ:CLSN). The system was also jointly developed with Boston Scientific (NYSE:BSX) before being acquired by Medifocus in July 2012. Prolieve has already received FDA approval, is currently generating revenue, and is the only in office alternative to drug therapy. The system essentially uses microwave energy to treat Benign Prostatic Hyperplasia (BPH), which is a non-cancerous enlargement of the prostate gland that typically affects men over the age of 50. The Prolieve device works by compressing and heating prostatic tissue that may be blocking the flow of urine. This particular treatment option offers patients several benefits including the following:

Top 10 Biotech Companies To Buy For 2015: 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 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?

  • [By John Udovich]

    Recent IPO�FibroGen Inc (NASDAQ: FGEN) surged 22.96% today, reportedly after the journal Hepatology published the results of a workshop between the FDA and the American Association for the Study of Liver Disease (AASLD) which laid out criteria for a phase three study of a treatment for non-alcoholic steatohepatitis (NASH)���meaning its worth taking a closer look at the stock along with the performance of potential small cap or mid cap liver disease stock peers like Conatus Pharmaceuticals Inc (NASDAQ: CNAT), Intercept Pharmaceuticals Inc (NASDAQ: ICPT) and Raptor Pharmaceutical Corp (NASDAQ: RPTP) which rose 24.35%, 10.98% and 2.02%, respectively. According to Investors Business Daily, NASH (the more serious version of fatty liver disease) is potentially an enormous market with about 6 million�US patients but the�lack of previous treatments had left it unclear how the FDA would measure success against the disease while FibroGen Inc doesn't yet have a NASH human trial in the works, it has said it hopes to start one for its lead candidate FG-3019 (its in mid-stage trials for pulmonary fibrosis and liver fibrosis due to hepatitis B infection).

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