Saturday, August 2, 2014

10 Best Biotech Stocks To Own Right Now

Biotech bubble talk, news�about Veeva Systems Inc (NYSE: VEEV) and TNI BioTech (OTCMKTS: TNIB), and�recent biotech IPO filings by Ruthigen (NASDAQ: RTGN), Aerie Pharmaceuticals (NASDAQ: AERI) and Egalet (NASDAQ: EGLT) are dominating the latest biotech industry headlines:�

No End in Sight for Biotech ��ubble��(or Bubble Talk). Steve Syre has written an article for the Boston Globe entitled, No end in sight for biotech bubble, which is well worth reading before you put new money into the biotech sector. In the article, Steve wrote that the gains in 2013 have pushed the valuation of many companies deep into bubble territory. Steve also noted that�Fidelity Select Biotechnology Portfolio manager Rajiv Kaul, who is optimistic about many companies over the next decade, has also conceded that investors should think hard about what has happened to biotech stocks this year and that:�

Hot Small Cap Companies To Buy Right Now: Pain Therapeutics Inc (PTIE)

Pain Therapeutics, Inc., incorporated in May 1998, is a biopharmaceutical company that develops drugs. The Company has four drug candidates in clinical programs, including REMOXY, abuse-resistant hydromorphone, abuse-resistant hydrocodone and a radio-labeled monoclonal antibody to treat metastatic melanoma. It is also working on a new treatment for patients with hemophilia. The Company�� lead drug candidate is REMOXY, which is a painkiller. It has collaboration agreement with King Pharmaceuticals, Inc. (King) develops and commercializes REMOXY and other opioid painkillers. The Company and King jointly managed a Phase III clinical program and New Drug Application (NDA) submission for REMOXY. It is also developing a pipeline of drug candidates in the area of oncology and hematology. It owns all commercial rights to its pipeline of drug candidates in oncology and hematology. As of December 31, 2010, the Company leased approximately 30,700 square feet of space in San Mateo, California and all of its operations are located in San Mateo.

REMOXY

REMOXY is a controlled-release oral capsule form of oxycodone in a highly viscous liquid formulation matrix that includes excipients. It is formulated to help address issues of abuse and misuse of time-release oxycodone tablets. REMOXY�� capsule dosage form provides therapeutic drug levels of oxycodone on a twice-daily dosing schedule, while resisting the rapid increases in plasma levels of oxycodone associated with common methods of abuse and misuse. Its formulation also resists delivery by unapproved routes of administration, such as injection, snorting or inhalation.

Metastatic Melanoma

The Company is developing a drug candidate called PTI-188 to treat metastatic melanoma, a form of skin cancer. PTI-188 is a monoclonal antibody linked to a radioisotope, intended to deliver doses of radiation lethal to melanoma tumors without harming normal tissue. In March 2010, the Company announced data from two open-label! , dose-escalating Phase I studies conducted in Israel to assess the safety, pharmacokinetics, dosimetry and anti-tumor activity of PTI-188. During the year ended December 31, 2010, the second study was completed. The technology used in this program was developed at the Albert Einstein College of Medicine (AECOM). It had licensed worldwide commercial rights to this technology from AECOM.

Hemophilia

The Company has a gene transfer program, initially developed at Stanford University, focused at correcting a genetic disorder in which patients are unable to stop bleeding. During 2010, it conducted a variety of pre-clinical studies with this technology. The Company has licensed worldwide commercial rights to the technology used in this program from Poetic Genetics, LLC (Poetic).

Other product candidates

The Company�� alliance with King includes development of three other abuse-resistant opioid product candidates: hydromorphone, hydrocodone and oxymorphone. Its abuse-resistant formulations of hydromorphone and hydrocodone have completed Phase I clinical trials. In January 2011, the Company announced that the Food and Drug Administration (FDA) had accepted its investigational IND, for abuse-resistant oxymorphone.

The Company competes with Roxane Laboratories, Purdue Pharma, King Pharmaceuticals, Inc., Abbott Laboratories, Cephalon, Endo Pharmaceuticals, Teva Pharmaceuticals, Elkins-Sinn, Watson Laboratories, Ortho-McNeil Pharmaceutical and Forest Pharmaceuticals.

Advisors' Opinion:
  • [By Jessica Alling]

    Elsewhere, Pfizer is evaluating its continued partnership on an experimental oxycodone capsule, Remoxy. The drug is an extended-release formula that is targeted at reducing abuse of the painkiller. After years of setbacks and postponements for FDA approval, Pfizer is weighing its options. Its partners for the drug, Pain Therapeutics (NASDAQ: PTIE  ) and Durect, have both fallen heavily due to the news, with Pain Therapeutics falling more than 50% -- its largest decline ever.

  • [By Sean Williams]

    However, all isn't well when it comes to the future of abuse-resistant painkiller Remoxy, which was developed by Pain Therapeutics (NASDAQ: PTIE  ) , using Durect's�special technology-based gel capsule to prevent abuse, and is licensed by Pfizer (NYSE: PFE  ) . Remoxy has been rejected twice by the FDA -- the most recent coming in mid-2011 -- and Pfizer commented this morning that if it were to seek reapproval for the drug it wouldn't be for at least two more years. Given Pfizer's extensive product pipeline, losing Remoxy wouldn't be a big deal. For micro-cap clinical-stage companies like Pain Therapeutics and Durect, it'd be a gigantic blow. Fittingly, Pain Therapeutics and Durect shares imploded by 50% and 34%, respectively, on Friday.

10 Best Biotech Stocks To Own Right Now: Oramed Pharmaceuticals Inc (ORMP)

Oramed Pharmaceuticals Inc., incorporated on March 10, 2011, is a development-stage pharmaceutical company. The Company is engaged in the research and development of pharmaceutical solutions, including an orally ingestible insulin capsule or tablet to be used for the treatment of individuals with diabetes, use of orally ingestible capsules, tablets or pills for delivery of other polypeptides. The Company owns oral dosage form drug portfolio, it is, on an on-going basis, considering in-licensing and other means of obtaining additional technologies to complement and/or expand the product portfolio. The Company�� products include ORMD-0801 - Oral Insulin Capsule and ORMD-0901 - Oral Exenatide.

The Company focuses to conduct research and development on the technology covered by the patent application Methods and Composition for Oral Administration of Proteins. Through its research and development efforts, it focuses to develop an oral dosage form that will withstand the chemical environment of the stomach and intestines and will be effective in delivering active insulin for the treatment of diabetes. It intends to conduct the clinical trials to file an Investigational New Drug (IND), application with the United States Food and Drug Administration (FDA). It also focuses to conduct research and development by deploying its drug delivery technology for the delivery of other polypeptides in addition to insulin, and to develop other pharmaceutical products.

Advisors' Opinion:
  • [By Lisa Levin]

    Oramed Pharmaceuticals (NASDAQ: ORMP) shares moved up 21.26% to $14.20. The volume of Oramed Pharmaceuticals shares traded was 621% higher than normal. Oramed shares have jumped 187.01% over the past 52 weeks, while the S&P 500 index has gained 28.75% in the same period.

  • [By Ben Levisohn]

    Oramed Pharmaceuticals (ORMP) has dropped 19% to $12.11 after the company said it would sell nearly 1.6 million shares of stock for $10 a share.

    BP plc (BP) has fallen 0.7% to $47.24 after a U.S. judge refused its request to revise the way damages from the Deepwater Horizon oil spill are calculated.

  • [By Lisa Levin]

    Oramed Pharmaceuticals (NASDAQ: ORMP) shares moved up 15.68% to $17.85. The volume of Oramed Pharmaceuticals shares traded was 971% higher than normal. Oramed received patent allowance in Israel, Australia for platform technology in oral delivery of proteins.

10 Best Biotech Stocks To Own Right Now: Organovo Holdings Inc (ONVO)

Organovo Holdings, Inc. (Organovo), formerly Real Estate Restoration & Rental, Inc., incorporated in 2007, is a development-stage company. The Company has developed and is commercializing a platform technology for the generation of three-dimensional (3D) human tissues that can be employed in drug discovery and development, biological research, and as therapeutic implants for the treatment of damaged or degenerating tissues and organs. On December 28, 2011, Real Estate Restoration and Rental, Inc.�� (RERR) entered into an Agreement and Plan of Merger, pursuant to which RERR merged with its, wholly owned subsidiary, Organovo (Merger Sub). On February 8, 2012, the Company merged with and into Organovo Acquisition Corp. (Acquisition Corp.), a wholly owned subsidiary of Organovo, with the Company surviving the merger as a wholly owned subsidiary of Organovo Holdings (the Merger). As a result of the Merger, Organovo acquired the business of Organovo, Inc.

The Company has collaborative research agreements with Pfizer, Inc. (Pfizer) and United Therapeutic Corporation (Unither). As of March 31, 2012, it has five federal grants, including Small Business Innovation Research grants and developed the NovoGen MMX Bioprinter (its first-generation 3D bioprinter). The Company is engaged in the development of specific 3D human tissues to aid Pfizer in discovery of therapies in two areas of interest. In addition, in October 2011, it entered into a research agreement with Unither to establish and conduct a research program to discover treatments for pulmonary hypertension using its NovoGen MMX Bioprinter technology. Additionally, under the research agreement with Unither, the Company granted Unither an option to acquire from the Company a worldwide, royalty-bearing license in certain intellectual property created under the research agreement solely for use in the treatment or prevention of pulmonary hypertension and all other lung diseases.

The Company�� NovoGen MMX Bioprinter is an automate! d device that enables the fabrication of three-dimensional (3D) living tissues comprised of mammalian cells. A custom graphic user interface (GUI) facilitates the 3D design and execution of scripts that direct precision movement of the dispensing heads to deposit cellular building blocks (bio-ink) or supporting hydrogel. The Company is using a third party manufacturer, Invetech Pty., of Melbourne, Australia, to manufacture its NovoGen MMX Bioprinter. Its bioprinting technology and surrounding intellectual property and commercial rights serve as a platform for product generation across multiple markets that employ cell- and tissue-based products and services.

The Company competes with Organogenesis, Advanced BioHealing, Tengion, Genzyme, HumaCyte and Cytograft Tissue Engineering.

Advisors' Opinion:
  • [By Jake L'Ecuyer]

    Organovo Holdings (NYSE: ONVO) was also up, gaining 2.54 percent to $9.28. The rise in the shares may be attributed to Thursday's Computerworld Article on 3D printed liver coming in 2014.

10 Best Biotech Stocks To Own Right Now: bluebird bio Inc (BLUE)

bluebird bio, Inc., incorporated on April 16, 1992, is a clinical-stage biotechnology company, the Company is focused on transforming the lives of patients with severe genetic and orphan diseases using gene therapy. Gene therapy seeks to introduce a functional copy of the defective gene into a patient�� own cells, a process called gene transfer. Through gene transfer, a functional copy of the mutated gene is delivered to the patient�� cells, thereby correcting the underlying genetic defect that causes aberrant gene expression. As of December 31, 2012, the Company is conducting a Phase I/II clinical study in France evaluating an earlier generation of its LentiGlobin vector for the treatment of �-thalassemia major and SCD. Initial proof-of-concept data from this study were published in Nature. During the year ended December 31, 2013, the Company plans to initiate an extension of this study under a revised protocol for LentiGlobin, which the Company refers to as the HGB-205 Study. The Company also plans o initiate a second Phase I/II clinical program in the United States for LentiGlobin, which the Company refers to as the HGB-204 Study, for �-thalassemia major. In March 2013, the Company entered into a strategic collaboration with Celgene Corporation, or Celgene, to discover, develop and commercialize, disease-altering gene therapies in oncology.

Its gene therapy platform is based on viral vectors that utilize a modified, non-replicating version of the Human Immunodeficiency Virus Type 1 (HIV-1) virus, that has been stripped of all of the components required for it to self-replicate and infect additional cells. The HIV-1 virus is part of the lentivirus family of viruses, as a result of which the Company refer to its vectors as lentiviral vectors. Its lentiviral vectors are used to introduce a functional copy of a gene to the patient�� own isolated blood stem cells, called hematopoietic stem cells (HSCs), which reside in a patient�� bone marrow and are capable of differentiating int! o a wide range of cell types. HSCs are dividing cells, thus its approach allows for sustained expression of the modified gene as the Company is able to take advantage of a lifetime of replication of the gene-modified HSCs. Additionally, the Company has developed a cell-based vector manufacturing process that is both reproducible and scalable.

Adrenoleukodystrophy

Adrenoleukodystrophy is a rare X-linked, inherited, neurological disorder that is often fatal. ALD is caused by mutations in the ABCD1 gene which encodes for a protein called the ALD protein (ALDP), which plays a critical role in the breakdown and metabolism of long-chain fatty acids (VLCFA). Without functional ALDP, VLCFA accumulate in cells including neural cells in which they cause damage to the myelin sheath, a protective and insulating membrane that surrounds nerve cells in the brain. This damage can result in decreased motor coordination and function, visual and hearing disturbances, the loss of cognitive function, dementia, seizures, adrenal dysfunction and other complications, including death. ALD is divided into various sub-segments with three main phenotypes that impact brain function: CCALD (Childhood cerebral adrenoleukodystrophy, AMN (Adrenomyeloneuropathy) and ACALD (Adult Cerebral ALD).

�-thalassemia

�-thalassemia is a rare hereditary blood disorder caused by a genetic abnormality of the �-globin gene resulting in defective red blood cells (RBCs). Genetic mutations cause the absence or reduced production of the beta chains of hemoglobin, or �-globin, thereby preventing the proper formation of hemoglobin A, which normally accounts for greater than 95% of the hemoglobin in the blood of adults. Hemoglobin is an iron-containing protein in the blood that carries oxygen from the respiratory organs to the rest of the body. Hemoglobin A consists of four chains-two chains each of a-globin and �-globin. Normally existing at an approximate 1:1 ratio, genetic mutations that impair t! he produc! tion of �-globin can lead to a relative excess of a-globin, premature death of red blood cells. The clinical implications of the a-globin/�-globin imbalance are two-fold: first, patients lack sufficient RBCs and hemoglobin to effectively transport oxygen throughout the body and can become severely anemic; and second, the shortened life span and ineffective production of RBCs can lead to other complications such as splenomegaly, marrow expansion, bone deformities, and iron overload in organs.

Sickle cell disease

Sickle cell disease (SCD) is a hereditary blood disorder resulting from a mutation in the �-globin gene that causes polymerization of hemoglobin proteins and abnormal red blood cell function. The disease is characterized by anemia, vaso-occlusive pain crisis (a common complication of SCD in which there is severe pain due to obstructed blood flow in the bones, joints, lungs, liver, spleen, kidney, eye, or central nervous system), infections, stroke, overall poor life and early death in a subset of patients. Under low-oxygen conditions, which are exacerbated by the red blood cell abnormalities, the mutant hemoglobin aggregates causing the RBCs to take on a sickle shape (sickle cells), which causes them to aggregate and obstruct small blood vessels, thereby restricting blood flow to organs resulting in pain, cell death and organ damage. If oxygen levels are restored, the hemoglobin can disaggregate and the RBCs return to their normal shape, but over time, the sickling damages the cell membrane and the cells fail to return to the normal shape even in high-oxygen conditions.

Advisors' Opinion:
  • [By David Williamson]

    In this video, health-care analyst David Williamson takes a look at the tremendous success of the�Bluebird Bio (NASDAQ: BLUE  ) �IPO. The company increased the size of its initial public offering, and priced shares at $17 -- above the top end of its range -- but that still couldn't contain investor appetite for this stock. Shares shot up 50% on the opening day of trading, and have remained there.

10 Best Biotech Stocks To Own Right Now: TESARO Inc (TSRO)

TESARO, Inc. (TESARO), incorporated in March 2010, is a development-stage, oncology-focused biopharmaceutical company for cancer patients. The Company focuses on rolapitant and TSR-011 product. The Company�� marketed products and product candidates in development treat cancer through non-specific damage to cellular components or alter cell metabolism or internal repair mechanisms to the demise of cancer cells.

Rolapitant

Rolapitant is a potent and long-acting neurokinin-1, or NK-1, receptor antagonist is in Phase III clinical trials for the prevention of chemotherapy induced nausea and vomiting (CINV). It is in Phase III clinical trials. CINV, if not prevented by prophylaxis, has the potential to afflict up to 90% or more of cancer patients undergoing chemotherapy, depending upon the type of chemotherapy administered the dosing schedule of the chemotherapy, and the patients' age and gender, among other predisposing factors. Prolonged nausea and vomiting may result in unwanted weight loss, dehydration and malnutrition, as well as hospitalization. The Company has in-licensed the rights to rolapitant from OPKO Health, Inc.

TSR-011

TSR-011 is an orally available ALK inhibitor in preclinical development. ALK is known to be involved in certain types of cancers, including subsets of NSCLC, neuroblastoma and lymphoma. For patients in these subsets, the ALK gene is fused to an activating partner or contains point mutations, resulting in constitutive activation of ALK and the growth of cancer cells and tumor development. Inhibition of ALK in these cancer cells results in cell death and tumor growth inhibition or regression. In August 2011, the United States Food and Drug Administration approved the first ALK inhibitor, developed by Pfizer Inc., Xalkori (crizotinib), which was approved for the treatment of patients with locally advanced or metastatic NSCLC that are ALK positive.

The Company competes with GlaxoSmithKline plc, Roche Holding Ltd! . and Sanofi S.A.

Advisors' Opinion:
  • [By Brian Pacampara]

    Based on the aggregated intelligence of 180,000-plus investors participating in Motley Fool CAPS, the Fool's free investing community, biopharmaceutical company TESARO (NASDAQ: TSRO  ) has received the dreaded one-star ranking.

10 Best Biotech Stocks To Own Right Now: Prosensa Holding NV (RNA)

Prosensa Holding N.V., formerly Prosensa Holding B.V., is a biotechnology company engaged in the discovery and development of ribonucleic acid-modulating (RNA)-modulating, therapeutics for the treatment of genetic disorders. The Company�� primary focus is on rare neuromuscular and neurodegenerative disorders with a large unmet medical need, including Duchenne muscular dystrophy, myotonic dystrophy and Huntington�� disease. The Company�� clinical portfolio of RNA-based product candidates is focused on the treatment of Duchenne muscular dystrophy (DMD). The Company�� platform technology allows the development of RNA-modulating therapeutics that either interferes with splicing (exon skipping, exon inclusion, or splice mutation correction), remove mutant RNA, or block RNA expression, for different indications.

DMD is a rare, severe muscle wasting disease that occurs in up to 1 in 3,500 male births. It is commonly diagnosed between the ages of three to five, when boys begin to show signs of impaired motor development. PRO044, the Company�� product candidate, addresses a separate sub-population of DMD patients. The Company developed PRO044 using its exon-skipping technology to generate a product candidate with the same mechanism of action that is used by drisapersen.

Advisors' Opinion:
  • [By Keith Speights]

    An "alley-oop" from the opponent
    Prosensa (NASDAQ: RNA  ) shares made something of a slam dunk this week, jumping more than 16%. That dunk was made with what amounts to an "alley-oop" from its primary rival, Sarepta Therapeutics (NASDAQ: SRPT  ) .

  • [By Bryan Murphy]

    Anybody who knows at least something about Prosensa Holding NV (NASDAQ:RNA) will at least know the stock turned into a disaster a few weeks ago, plunging from a close of $24.00 on September 19th to a close of $7.14 on September 20th, thanks to the failure of its MS drug drisapersen, which was jointly developed with GlaxoSmithKline plc (NYSE:GSK). Such is the life of a company with only one drug anywhere close to being approved; drisapersen was in Phase 3 trials - RNA shares could have just as easily gained 70% rather than lost 70% had the drug worked.

  • [By Keith Speights]

    Successful launch
    You couldn't even buy stock in Prosensa (NASDAQ: RNA  ) just a few weeks ago. The biotech launched its IPO on June 28. To say that launch has gone successfully is an understatement. Shares are now more than double the IPO price and climbed 41% this week.

10 Best Biotech Stocks To Own Right Now: 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 Paul Ausick]

    Stocks on the Move: NQ Mobile Inc. (NYSE: NQ) is up 26% at $11.09 as the company fights back against a short-seller report. Celsion Corp. (NASDAQ: CLSN) is up 339.3% at $5.14 following a reverse 1:4.5 stock split. Micron Technology Inc. (NASDAQ: MU) is up 4.7% at $17.50.

  • [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:

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