Thursday, January 8, 2015

Best Biotech Stocks For 2014

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Four specialty retail stocks are moving up in their overall rating this week, according to the Portfolio Grader database. Every one of these is graded an “A” (“strong buy”) or “B” overall (“buy”).

Hot Tech Stocks To Watch For 2015: Elite Pharmaceuticals Inc (ELTP)

Elite Pharmaceuticals, Inc. (Elite), incorporated on October 1, 1997, is a specialty pharmaceutical company principally engaged in the development and manufactures of oral, controlled-release products, using technology and the development and manufacture of generic pharmaceuticals. Elite has four products: Phentermine 37.5 milligram tablets, Methadone 10 milligram tablets, Lodrane D Immediate Release capsules and Hydromorphone Hydrochloride 8 milligram tablets. During the fiscal years ended March 31, 2012 (Fiscal 2011), the Company manufactured and sold Lodrane 24 and Lodrane 24D (the Lodrane Extended Release Products).

The Company has a pipeline of additional generic drug candidates under active development, including, without limitation, ELI-154, a once-a-day oxycodone product and ELI-216, an abuse resistant oxycodone product which utilizes the Company�� propriety formulation for abuse resistant products utilizing the pharmacological approach (Elite�� Abuse Resistant Technology). ECR Pharmaceuticals (ECR), a wholly owned subsidiary of Hi-Tech Pharmacal, Inc. and the owner and marketer of the Lodrane Extended Release Products. Elite also purchased from Mikah Pharma LLC, an approved Abbreviated New Drug Application (ANDA) for Naltrexone 50 milligram tablets.

For ELI-154, Elite has developed a once-daily oxycodone formulation using its technology. An investigational new drug application (IND) has been filed and Elite has completed two pharmacokinetic studies in healthy subjects that compared blood levels of oxycodone from dosing ELI-154 and the twice-a-day product that is on the market, OxyContin marketed in the United States by Purdue Pharma LP. ELI-216 utilizes the Company's abuse-deterrent technology that is based on a pharmacological approach. ELI-216 is a combination of a narcotic agonist, oxycodone hydrochloride, in a sustained-release formulation intended for use in patients with moderate to severe chronic pain, and an antagonist, naltrexone hydrochloride, formulat! ed to deter abuse of the drug. Products utilizing the pharmacological approach to deter abuse such as Suboxone, a product marketed in the United States by Reckitt Benckiser Pharmaceuticals, Inc., and Embeda, a product marketed in the United States by Pfizer, have been approved by the United States Food & Drug Administration (FDA). ELI-216 demonstrates a euphoria-blocking effect when the product is crushed. Elite has developed ELI-154 and ELI-216 and retains the rights to these products.

The Company competes with Collegium Pharmaceuticals, Inc., Purdue Pharma LP, Acura Pharmaceuticals, Inc., Durect Corporation, Mylan Laboratories, Inc., Par Pharmaceuticals, Inc., Alkermes, Inc., Teva Pharmaceuticals Industries Ltd., Aptalis Pharma, Impax Laboratories, Inc., and Watson Pharmaceuticals.

Advisors' Opinion:
  • [By James E. Brumley]

    Judging from the company it's keeping Green Automotive Co. (OTCMKTS:GACR) may have just made its way into the upper echelon of small cap stock opportunities. The electric car company joins Elite Pharmaceuticals Inc. (OTCBB:ELTP), Amarantus Bioscience Holdings, Inc. (OTCBB:AMBS), and only three other companies as Wall-Street.com's "Best 6 Stocks" for January of 2014. As one of the top information resources for investors - particularly in terms of information regarding small and micro cap stocks - being named among the site's top pick is an accolade for AMBS, ELTP, and GACR. Even more impressive is that Green Automotive Co. was the only consumer-goods name among those six. Amarantus Bioscience Holdings and Elite Pharmaceuticals are biotechnology names... an industry that can and often does attract a lot of attention just by the nature of the business. The other three names making the "Best 6" list were an energy explorer, a power-management technology manufacturer, and prescription/medical food producer. For an electric car manufacturer to make the list speaks quite highly of GACR.

  • [By James E. Brumley]

    Exactly one month ago today I penned some bullish thoughts on Elite Pharmaceuticals Inc. (OTCBB:ELTP). If you're familiar with the company - or a regular reader of this site - then you may know why that sounds a little "off." See, at the time, ELTP shares were falling rather quickly, giving up all the gains they had made just a few days before. Almost needless to say, my premise was not a well received one. Let's just say I received some "colorful disagreements" by being optimistic about the biopharma company.

Best Biotech Stocks For 2014: Brainstorm Cell Therapuetics Inc (BCLI)

Brainstorm Cell Therapeutics Inc. (Brainstorm), incorporated on November 15, 2006, is a biotechnology company developing adult stem cell therapies for debilitating neurodegenerative disorders, such as Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig's disease), Multiple Sclerosis (MS), and Parkinson�� disease (PD). These diseases have limited treatment options and as such represent unmet medical needs. The Company�� NurOwn technology is based on a differentiation protocol, which induces differentiation of the bone marrow-derived mesenchymal stem cells into neuron-supporting cells, MSC-NTF cells, capable of releasing several neurotrophic factors, including Glial-derived neurotrophic factor (GDNF) and Brain-derived neurotrophic factor (BDNF), Vascular endothelial growth factor (VEGF) and Hepatocyte growth factor (HGF), which are critical for the growth, survival and differentiation of developing neurons.

The Company�� approach to treatment of neurodegenerative diseases with autologous adult stem cells includes a multi-step process beginning with harvesting of undifferentiated stem cells from the patient's own bone marrow, and concluding with transplantation of differentiated, neurotrophic factor-secreting mesenchymal stem cells (MSC-NTF) into the same patient-intrathecally and/or intramuscularly. Intrathecal (injection into the cerebrospinal fluid) transplantation consists of injection with a standard lumbar puncture; there is no need for a laminectomy -an invasive, orthopedic spine operation to remove a portion of the vertebral bone, as required by other technologies. Intramuscular (injection directly into muscle) transplantation is performed via a standard injection procedure as well. Its production process for induction of differentiation of human bone marrow derived mesenchymal stem cells into differentiated cells that produce NTF (MSC-NTF) for clinical use is conducted in full compliance with current Good Manufacturing Practice (cGMP).

Advisors' Opinion:
  • [By John Udovich]

    Small cap ALS and stem cell stock�Brainstorm Cell Therapeutics Inc (NASDAQ: BCLI) surged 22.68%�ahead if its Monday ice bucket challenge when they will release the final results from�a phase 2a clinical trial���meaning its worth taking a closer look at the stock along with the performance of stem cell stocks or ALS stocks like Cytokinetics, Inc (NASDAQ: CYTK), Neuralstem, Inc (NYSEMKT: CUR) and NeoStem Inc (NASDAQ: NBS). However, Brainstorm Cell Therapeutics does have a history of being the subject of paid promotions and/or investor relations activities when it was trading on the OTC.

Best Biotech Stocks For 2014: Furiex Pharmaceuticals Inc (FURX)

Furiex Pharmaceuticals, Inc. is a drug development collaboration company. The Company�� product pipeline includes two marketed products and three programs in development, including late-stage compounds, in multiple therapeutic areas. Its programs include Priligy, Alogliptin Nesina, Alogliptin/Actose Combination, Alogliptin/Metformin Combination, Fluoroquinolone, Mu Delta and PPD 10558. In November 2011, it acquired full exclusive license rights to develop and commercialize the compound MuDelta under its existing development and license agreement with Janssen Pharmaceutica N.V.

Priligy (dapoxetine) is a drug developed for the on-demand treatment of premature ejaculation (PE). Dapoxetine is a short-acting, selective serotonin reuptake inhibitor (SSRI) designed to be taken only when needed one to three hours before sexual intercourse is anticipated rather than every day. Nesina (alogliptin) is a drug for the oral treatment of type 2 diabetes (T2D). Alogliptin is a DPP-4 inhibitor that slows the inactivation of incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP).

Fluoroquinolone drug candidate is a Phase II-ready novel fluoroquinolone antibiotic that is being developed by the Company for the treatment of complicated skin and skin structure infections, such as abscesses that occur deep in the skin layers and respiratory infections. This antibiotic has a spectrum of activity and is able to treat methicillin-resistant staphylococcus aureus (MRSA) infections. The Company is developing both oral and intravenous (IV) formulations. The Company is developing Mu Delta for treatment of diarrheal predominant irritable bowel syndrome (d-IBS). The Company is conducting a Phase II study on an oral formulation of Mu Delta.

The Company is developing PPD 10558 for the treatment of dyslipidemia. PPD 10558 has shown muscle safety in preclinical studies by minimizing the delivery of the drug to the muscle. The Company has filed an inve! stigational new drug (IND) application with the United States Food and Drug Association and completed five clinical studies.

Advisors' Opinion:
  • [By Lisa Levin]

    Furiex Pharmaceuticals (NASDAQ: FURX) shares moved up 28.41% to $102.92. The volume of Furiex Pharmaceuticals shares traded was 2285% higher than normal. Forest Labs (NYSE: FRX) announced its plans to buy Furiex Pharma for up to $1.46 billion.

  • [By Jake L'Ecuyer]

    Top Headline
    Forest Laboratories (NYSE: FRX) announced its plans to buy Furiex Pharmaceuticals (NASDAQ: FURX) for up to $1.46 billion. Forest will pay around $95 per share, or around $1.1 billion in cash. Forest Labs will also pay up to $30 per share, or around $360 million in a contingent value right. The deal is projected to close in the second or third quarter of 2014.

  • [By Lauren Pollock var popups = dojo.query(".socialByline .popC"); popups.forEach]

    Forest Laboratories Inc.(FRX) agreed to acquire Furiex Pharmaceuticals(FURX) in a deal worth up to $1.33 billion that expands Forest Labs’ presence in gastroenterology. Furiex surged 28% to $102.21 premarket.

Best Biotech Stocks For 2014: Tonix Pharmaceuticals Holding Corp (TNXP)

Tonix Pharmaceuticals Holding Corp., incorporated on November 16, 2011, is a specialty pharmaceutical company focused on developing novel pharmaceutical products for disorders of the central nervous system (CNS). The Company develops TNX-102 sublingual tablet, or TNX-102 SL. TNX-102 SL is a novel dose and formulation of cyclobenzaprine (CBP), the active pharmaceutical ingredient of two prescribed muscle relaxant products, Flexeril and Amrix. TNX-102 SL is also intended for chronic use. It develops TNX-102 SL for the treatment of FM under a United States Investigational New Drug application (IND), and under three clinical trial applications (CTAs), filed in Canada. It also develops TNX-102 SL for the treatment of post-traumatic stress disorder (PTSD). As of January 25, 2013, the Company focuses on product development, and had not generated any revenues.

The Company searches for potential therapeutic solutions among known pharmaceutical agents that lack regulatory approval for the indications it seeks, but may be approved for use in other indications. It seeks to create new dose and formulation options that are tailored to the therapeutic uses to which it applies these agents. TNX-102 SL is a small, rapidly disintegrating tablet containing CBP for sublingual administration at bedtime. The Company designed TNX-102 SL for delivery of CBP to the systemic circulation through sublingual transmucosal absorption and to avoid first-pass liver metabolism.

CBP is the active pharmaceutical ingredient in its lead product candidate, TNX-102 SL. In addition to CBP, TNX-102 SL contains inactive ingredients, called excipients, which are approved for pharmaceutical use. In addition to TNX-102 SL, it develops other formulations of CBP, including TNX-102 promicellar gelatin capsule, or TNX-102 gelcap. It developed TNX-102 gelcap under an agreement with Lipocine, Inc. (Lipocine), a contract formulation developer and small-scale manufacturer. In addition it has other pipeline of other product cand! idates, including TNX-201 and TNX-301. TNX-201 is based on isometheptene mucate and is under development as a treatment for certain types of headaches.

Advisors' Opinion:
  • [By John Kell]

    Tonix Pharmaceuticals Holding Corp.(TNXP) is planning to offer some shares to raise money to fund clinical trials and the continued development of the specialty pharmaceutical company’s treatments. Shares edged up 2.1% to $16.75 premarket.

Best Biotech Stocks For 2014: 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 Brian Orelli]

    Investors should also watch Johnson & Johnson's hepatitis C drug Incivo that the health-care giant sells abroad for Vertex Pharmaceuticals (NASDAQ: VRTX  ) . Even though it has to ship some of the profits to Vertex, Incivo is a moneymaker because doctors in Europe haven't started cutting back on prescribing the drug while they wait for next-generation hepatitis C drugs as they have in the U.S., where it's called Incivek.

  • [By Sean Williams]

    Then along came Vertex Pharmaceuticals (NASDAQ: VRTX  ) with its oral medication, Incivek, which drastically changed the treatment landscape. Although still given in combination with interferon and a ribavirin, Incivek greatly improved patients' sustained virologic response (the level at which no detectable levels of the HCV virus can be found) after 24 weeks by 20% to 45% over the previous standard of treatment depending on the trial. Not surprisingly, Incivek became the quickest drug to ever reach $1 billion in sales (less than eight months), but also lost the majority of its revenue nearly as fast as it ceded ground to up-and-coming treatments.�

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