Tuesday, November 11, 2014

Top 10 Biotech Companies To Own For 2014

From the impact of Obamacare to cutting-edge research, biotech buyouts to FDA decisions, the Motley Fool's health-care team sits down each week�to discuss the most fascinating developments in health care and their implications for long-term investors. In this week's edition, the team talks about the coming trend of penalizing unhealthy employees, the importance of drug branding, the avian flu outbreak, one stock investors need to watch, and more.

In the following segment, health-care analyst David Williamson discusses the week's biggest movers and shakers, including a trio of stocks receiving the FDA's new "breakthrough" designation. Watch and find out what it means for investors.

What macro trend was Warren Buffett referring to when he said "this is the tapeworm that's eating at American competitiveness"? Find out in our free report: "What's Really Eating at America's Competitiveness." You'll also discover an idea to profit as companies work to eradicate this efficiency-sucking tapeworm. Just click here for free, immediate access.

Best Defensive Stocks To Own Right Now: OncoSec Medical Inc (ONCS)

OncoSec Medical Incorporated, incorporated on February 8, 2008, is an emerging drug-medical device company. The Company focused on designing, developing and commercializing medical approaches for the treatment of solid cancers. In March 2011, the Company acquired from Inovio Pharmaceuticals, Inc. (Inovio) certain assets related to the use of drug-medical device combination products for the treatment of different cancers.

The Company�� acquired assets relate to certain non-deoxyribonucleic acid (DNA) vaccine technology and property relating to selective tumor ablation technologies, which it refers to as the OncoSec Medical System (OMS), a therapy which uses an electroporation device to facilitate delivery of chemotherapy agents, or nucleic acids encoding cytokines, into tumors and/or surrounding tissue for the treatment and diagnosis of various cancers. As of January 24, 2012, the Company had not generated any revenue from operations.

Advisors' Opinion:
  • [By John Udovich]

    Small cap biotech stocks AVEO Pharmaceuticals, Inc (NASDAQ: AVEO), OncoSec Medical Inc (OTCMKTS: ONCS) and MetaStat Inc (OTCBB: MTST) are focused on or are developing treatments or diagnostic technologies for metastatic cancers. In case you aren�� familiar with the term metastasis or metastatic, it�� the�spread of cancer from its primary site to other places in the body as cancer cells break away from a primary tumor, penetrate into lymphatic and blood vessels, circulate through the bloodstream and then grow in a new focus (metastasize) in normal tissues elsewhere in the body. In other words, it�� a dangerous form of cancer, but there are some small cap biotech stocks targeting it for diagnostics or treatment:

Top 10 Biotech Companies To Own For 2014: PTC Therapeutics Inc (PTCT)

PTC Therapeutics, Inc., incorporated on March 31, 1998 , is a biopharmaceutical company focused on the discovery and development of orally administered, small-molecule drugs that target post-transcriptional control processes. The Company�� lead product candidate includes ataluren, which is used for the treatment of patients with genetic disorders that arise from a type of genetic mutation known as a nonsense mutation. Ataluren is in late stage clinical development for the treatment of Duchenne muscular dystrophy caused by nonsense mutations (nmDMD) and cystic fibrosis caused by nonsense mutations (nmCF).

Ataluren is orally administered small-molecule compound that targets nonsense mutations. The Company is engaged in the development of ataluren for the treatment of genetic disorders in, which a nonsense mutation is the cause of the disease. Genetic tests are available for many genetic disorders, including Duchenne muscular dystrophy and cystic fibrosis, to determine if the underlying cause is a nonsense mutation. The EMA has designated ataluren as an orphan medicinal product for the treatment of nmDMD and nmCF. During the year ended December 31, 2012, the Phase III clinical trial completed. The Company�� Ataluren clinical trials in patients with nonsense mutation genetic disorders include Ataluren for nmDMD: Phase 2b clinical trial complete; Confirmatory Phase III clinical trial initiated, and Ataluren for nmCF: Phase III trial completed.

Advisors' Opinion:
  • [By WWW.DAILYFINANCE.COM]

    Records fell on Wall Street Friday as another solid report on housing lifted the market for the second day in a row. There's a three-day weekend coming up -- something that often prompts investor caution -- but the gains were broad-based even though volume was fairly light. The VIX, which measures volatility, fell to its lowest level this year. The Dow Jones industrial average (^DJI) gained 63 points, the Nasdaq composite (^IXIC) rose 31, and the Standard & Poor's 500 index (^GPSC) added 8, topping the record high set last week. The Dow Transportation average also raced to an all-time high, lifted by airline stocks. United (UAL) soared more than 4 percent; Delta (DAL) gained more than 1 percent and Southwest (LUV) gained 2 percent. Southwest is at an all-time high, up 79 percent from a year ago. New home sales bounced back with a better than expected 6.4 percent increase last month. Lennar (LEN) and D.R. Horton (DHI) both rose 4 percent. Pulte (PHM), Beazer (BZH) and Hovnanian (HOV) also solid posted gains. Earnings continue to drive retail stocks. Gap (GPS) edged higher even though net fell. Foot Locker (FL) gained 1½ percent after topping expectations. GameStop (GME) rose 4 percent. Its net rose, helped by the rollout last year of new Xbox and PlayStation consoles. Zumiez (ZUMZ) rose 5½ percent on an earnings beat. But Aeropostale (ARO) tumbled 24 percent. Its loss widened and sales declined. The retailer continues to struggle with teen fashion trends. Also on the earnings front, TiVo (TIVO) rose 2 percent as it swung to a profit from a year ago loss. It also reported an increase in the number of subscribers. Hewlett-Packard (HPQ) rose 6 percent on news the company plans to eliminate up to 16,000 additional workers in an effort to cut costs. And several stocks extended big moves from yesterday. Best Buy (BBY) rose more than 3 percent for the second straight day after earnings beat expectations. Isis Pharmaceuticals (ISIS) jumped
  • [By John Kell]

    PTC Therapeutics Inc.(PTCT) said the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a negative opinion on the biopharmaceutical company’s marketing authorization application for its muscular dystrophy treatment. Shares slumped 21% to $20.60 in premarket trading.

Top 10 Biotech Companies To Own For 2014: Rexahn Pharmaceuticals Inc (RNN)

Rexahn Pharmaceuticals, Inc. (Rexahn) is a development-stage biopharmaceutical company. The Company focuses on the development of cures for cancer to patients worldwide. The Company�� pipeline features one drug candidate in Phase II clinical trials. The Company also has several other drug candidates in pre-clinical development. In addition, the Company has two renal cell carcinoma (CNS) candidates, Serdaxin, CNS Disorders drug for depression and neurodegenerative diseases and Zoraxel, which is a erectile dysfunction (ED) and sexual dysfunction drug that are in clinical stages and the Company is are exploring options for further development . The Company�� drug candidate, Archexin is an anticancer Akt inhibitor.

Archexin

Archexin is potent inhibitor of the Akt protein kinase (Akt) in cancer cells. Archexin has FDA orphan drug designations for five cancers (RCC, glioblastoma, and cancers of the ovary, stomach and pancreas). Multiple indications for other solid tumors can also be pursued. Archexin inhibit both activated and inactivated forms of Akt, and to reverse the drug resistance observed with the protein kinase inhibitors. Archexin is an antisense oligonucleotide (ASO) compound that is complementary to Akt mRNA, and selective for inhibiting mRNA expression and production of Akt protein. As of December 31, 2011, Archexin was in Phase II clinical trials for the treatment of pancreatic cancer with enrollment completed in September, 2011.

Serdaxin

Serdaxin is an extended release formulation of clavulanic acid, which is an ingredient present in antibiotics approved by the FDA. The Company had been developing Serdaxin for the treatment of depression and neurodegenerative disorders. From January to September, 2011, the Company conducted a randomized, double-blind, placebo-controlled study compared two doses of Serdaxin, 0.5 milligram and 5 milligram, to placebo over an eight-week treatment period for major depressive disorder (MDD) patients. As of Dec! ember 31, 2011, the Company had not made a determination of Serdaxin�� future paths or resource allocations to further develop Serdaxin to treat MDD.

Zoraxel

Zoraxel is an orally administered, on-demand tablet to treat sexual dysfunction. Zoraxel is a dual enhancer of neurotransmitters in the brain that play a key role in sexual activity phases of motivation and arousal, erection and release, and may be the ED drug to affect all three of these phases of sexual activity. As of December 31, 2011, the Company was evaluating how to proceed with the Phase IIb study of Zoraxel.

The Company�� Pre-clinical Pipeline Drug Candidates includes RX-1792, which is a small molecule anticancer EGFR inhibitor; RX-5902, which is a small molecule anticancer ribonucleic acid (RNA) helicase regulator; RX-3117, which is a Small molecule anticancer deoxyribonucleic acid (DNA) synthesis Inhibitor; RX-8243, which is a small molecule anticancer aurora kinase inhibitor; RX-0201-Nano, which is a nanoliposomal anticancer Akt inhibitor; RX-0047-Nano, which is an nanoliposomal anticancer HIF-1 alpha inhibitor and RX-21101, which is a nano-polymer Anticancer.

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

    At first glance, Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN) doesn't look like anything particularly trade-worthy. The stock's now where it was in late October, and where it was in late September, and even where it was in late June. In other words, though RNN has been much higher and much lower than its current price of $0.46 over the course of the past several months, it doesn't look like it's going anywhere - on a net basis - anytime.

  • [By James E. Brumley]

    With just a quick glance at a chart of Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN), it would be easy to conclude it's nothing but a volatile mess. When you take a step back and look at a long-term weekly chart of RNN, however, it starts to become clear that this small cap biopharma name is on the verge of a monster-sized breakout. First things first, however.

  • [By James E. Brumley]

    If you were lucky enough to step into Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN) when your truly suggested it was a budding buy back on December 23rd, then congratulations - you're now up a little more than 60% (assuming you bought into RNN after the break above a key resistance line on the 27th). Now get out. Instead, use your profits from the Rexahn to take on a stake in GTx, Inc. (NASDAQ:GTXI). No, GTXI may not look like much at first, but when you take a step back and look at a chart of GTx, Inc. through a longer-term lens, the upside potential becomes clear.

Top 10 Biotech Companies To Own For 2014: StemCells Inc (STEM)

StemCells, Inc. (StemCells), incorporated in August 1988, is engaged in the research, development, and commercialization of stem cell therapeutics and related tools and technologies for academia and industry. The Company is focused on developing and commercializing stem and progenitor cells as the basis for therapeutics and therapies, and cells and related tools and technologies to enable stem cell-based research and drug discovery and development. The Company�� primary research and development efforts are focused on identifying and developing stem and progenitor cells as potential therapeutic agents. The Company has two therapeutic product development programs, including its CNS Program, which is developing applications for HuCNS-SC cells, its human neural stem cell product candidate, and its Liver Program, which is characterizing the Company�� human liver cells as a therapeutic product.

CNS Program

The Company in its CNS Program, is in clinical development with its HuCNS-SC cells for a range of disorders of the central nervous system. The CNS includes the brain, spinal cord and eye. In February 2012, the Company had completed a Phase I clinical trial in Pelizeaus-Merzbacher Disease (PMD), a fatal myelination disorder in the brain.

The Company�� CNS Program is focused on developing clinical applications, in which transplanting HuCNS-SC cells protect or restore organ function of the patient before such function is irreversibly damaged or lost due to disease progression. The Company�� initial target indications are PMD, and more generally, diseases in which deficient myelination plays a central role, such as cerebral palsy or multiple sclerosis; spinal cord injury, disorders in which retinal degeneration plays a central role, such as age-related macular degeneration or retinitis pigmentosa. The Company�� product candidate, HuCNS-SC cells, is a purified and expanded composition of normal human neural stem cells. Its HuCNS-SC cells can be directly transp! lanted.

Liver Program

Liver stem or progenitor cells offer an alternative treatment for liver diseases. A liver cellular therapy or cell-based therapeutic provide or support liver function in patients with liver disease. The Company held a portfolio of issued and allowed patents in the liver field, which cover the isolation and use of both hLEC cells and the isolated subset, as well as the composition of the cells themselves.

The Company�� range of cell culture products, which are sold under the SC Proven brand, includes iSTEM, GS1-R, GS2-M, RHB-A, RHB-Basal, NDiff N2, and NDiff N2B27. Its iSTEM is a serum-free, feeder-free medium that maintains mouse embryonic stem cells in their pluripotent ground state by using selective small molecule inhibitors to block the pathways, which induce differentiation. RHB-A is a defined, serum-free culture medium for the selective culture of human and mouse neural stem cells and their maintenance and expansion as adherent cell populations. RHB-Basal is a defined, serum-free basal medium. When supplemented with specific growth factors, this media is formulated for the propagation and differentiation of adherent neural stem cells. RHB-Basal can also be tailored to specific-cell type requirements by the addition of customer preferred supplements.

The Company�� NDiff N2 is a defined serum-free scell culture supplement for the derivation, maintenance, expansion and/or differentiation of human and mouse embryonic stem (ES) cells and tissue-derived neural stem cells supplement. Its NDiff N2-AF is a serum-free and animal component-free version of NDiff N2. Its NDiff N2B27 is a defined, serum-free medium for the differentiation of mouse embryonic stem cells to neural cell types. NDiff N27-AF is a serum-free and animal component-free version of NDiff N27. Its GS1-R is a serum-free media formulation shown to enable the derivation and long-term maintenance of true, germline competent rat embryonic stem cells without the add! ition of ! cytokines or growth factors. Its GS2-M is a defined, serum- and feeder-free medium for the derivation and long-term maintenance of true, germline competent mouse iPS cells.

The Company also markets a number of antibody reagents for use in cell detection, isolation and characterization. These reagents are also under the SC Proven brand and it includes STEM24, STEM101, STEM121 and STEM123. Its STEM24 is a human antibody that recognizes human CD24, also known as heat stable antigen (HSA), a glycoprotein expressed on the surface of many human cell types, including immature human hematopoietic cells, peripheral blood lymphocytes, erythrocytes and many human carcinomas. Its CD24 is also a marker of human neural differentiation. Its STEM101 is a human-specific mouse antibody that recognizes the Ku80 protein found in human nuclei. Its STEM121 is a human-specific mouse antibody that recognizes a cytoplasmic protein of human cells. Its STEM123 is a human-specific mouse antibody that recognizes human glial fibrillary acidic protein (GFAP).

The Company�� Other products marketed under SC Proven include total cell genomic DNA (gDNA), RNA and protein lysate reagents purified from homogenous stem cell populations for intra-comparative studies, such as Epigenetic fingerprinting, Southern, Western and Northern blots, PCR, RT-PCR and microarrays. This range of purified stem cell line lysates includes mouse embryonic stem (ES) cells propagated in SC Proven 2i inhibitor-based GS2-M media and mouse ES cell-derived and fetal tissue-derived neural stem (NS) cells propagated in SC Proven RHB-A media.

Advisors' Opinion:
  • [By John Udovich]

    The results of a recent Pew Center Poll regarding attitudes towards abortion and various forms of stem cell research could be a good sign for the stem cell industry along with small cap stem cell stocks like StemCells Inc (NASDAQ: STEM), NeoStem Inc (NASDAQ: NBS), Neuralstem, Inc (NYSEMKT: CUR),�International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX). Basically, Americans think that having an abortion is a moral issue with 49% of American adults believing abortion is morally wrong, 23%�view it not as a moral issue and and 15% view it as morally acceptable. However and when Americans were asked about issues surrounding�human embryos, such as stem cell research or in vitro fertilization, as a matter of morality, their views were different.

  • [By James E. Brumley]

    When an investor thinks of spinal-related stem cell stocks, usually a name like Neuralstem, Inc (NYSEMKT: CUR) or StemCells Inc (NASDAQ: STEM) comes to mind. And well they should. STEM has logged some amazing breakthroughs in the field of spinal cord repair, while CUR has done the same. Not all back problems are spinal cord related though. In fact, most back problems - and therefore the most opportunity - are bone and disc related problems. That's where a young gun like BioRestorative Therapies (OTCBB: BRTX) can step in and make stem cell waves. BRTX has developed an approach to rejuvenate and revive failing spinal discs, potentially ending pain for millions of back-pain sufferers, and circumventing expensive spinal surgeries that are in increasing burden on insurance companies.

  • [By Garrett Cook]

    Healthcare shares gained 0.81 percent in the US market on Friday. Top gainers in the sector included Shire plc (NASDAQ: SHPG), StemCells (NASDAQ: STEM), and Flamel Technologies SA (NASDAQ: FLML).

  • [By Garrett Cook]

    Healthcare shares gained 0.81 percent in the US market on Friday. Top gainers in the sector included Shire plc (NASDAQ: SHPG), StemCells (NASDAQ: STEM), and Flamel Technologies SA (NASDAQ: FLML).

Top 10 Biotech Companies To Own For 2014: Intellicell Biosciences Inc (SVFC)

Intellicell Biosciences, Inc., formerly Media Exchange Group, Inc., incorporated on March 8, 1999, is engaged in regenerative medicine company focused on the expanding regenerative medical markets using a process to separate adult autologous vascular cells (AAVC's) from blood vessels in adult adipose (fat) tissue. The Company is also exploring and undertaking, either on its own or in collaboration with a third party, providing a service for the collection, processing and storage of autologous cells for future use. As of December 31, 2011, the Company has developed technologies that allow reproducible separation of stromal vascular fraction (IntelliCell) containing adipose stem cells that can be performed in tissue processing centers and in doctors��offices. On June 3, 2011, the Company completed the acquisition of Intellicell Biosciences, Inc. The Company formed a wholly-owned subsidiary, ICBS Research, Inc.

The Company's process involves the application of ultrasonic cavitation (sound waves) to the extracted adipose tissue, which results in the separation AAVC's from the blood vessels in adult adipose (fat) tissue. This AAVC, or stromal vascular fraction (IntelliCells), are removed from the patient at the point of care, and separated at the point of care under the supervision of its certified technicians following current good manufacturing practices (cGMPs) and current good tissue practices (cGTPs), and the cells are then returned to the medical professionals at the point of care for use a patient's own body (autologous treatment), by way of a same-day clinical procedure for homologous use of these cells.

Intellicell Biosciences, Inc., formerly Media Exchange Group, Inc., incorporated on March 8, 1999, is engaged in regenerative medicine company focused on the expanding regenerative medical markets using a process to separate adult autologous vascular cells (AAVC's) from blood vessels in adult adipose (fat) tissue. The Company is also exploring and undertaking, either on ! its own or in collaboration with a third party, providing a service for the collection, processing and storage of autologous cells for future use. As of December 31, 2011, the Company has developed technologies that allow reproducible separation of stromal vascular fraction (IntelliCell) containing adipose stem cells that can be performed in tissue processing centers and in doctors��offices. On June 3, 2011, the Company completed the acquisition of Intellicell Biosciences, Inc. The Company formed a wholly-owned subsidiary, ICBS Research, Inc.

The Company's process involves the application of ultrasonic cavitation (sound waves) to the extracted adipose tissue, which results in the separation AAVC's from the blood vessels in adult adipose (fat) tissue. This AAVC, or stromal vascular fraction (IntelliCells), are removed from the patient at the point of care, and separated at the point of care under the supervision of its certified technicians following current good manufacturing practices (cGMPs) and current good tissue practices (cGTPs), and the cells are then returned to the medical professionals at the point of care for use a patient's own body (autologous treatment), by way of a same-day clinical procedure for homologous use of these cells.

The Company competes with Cytori Therapeutics, Stem Cell Assurance, Inc., Osiris, Aastrom Biosciences, Aldagen, BioTime, Baxter International, Celgene, Geron, Harvest Technologies, Mesoblast, Regenexx, NeoStem, X-Cell Center, Stem Cells, Athersys, and Tissue Genesis, Life Technologies, Asterand, pacific biosciences of california inc. and AllCells, LLC.

Advisors' Opinion:
  • [By Bryan Murphy]

    To say that shares of IntelliCell BioSciences, Inc. (OTCMKTS:SVFC) has been disappointing since 2011 would be an understatement. SVFC has been an outright disaster since 2011, falling from a peak of $19.00 to a low of, well, just a few pennies as of late last year. In fact, there are those who are understandably wondering how the company is still alive, only producing about a half a million dollars in revenue in 2012, and then dialing that figure back down to nothing for the last few quarters. Yet, there's just something about a company that refuses to go away.... something compelling now.

Top 10 Biotech Companies To Own For 2014: Lpath Inc (LPTN)

Lpath, Inc. (Lpath), incorporated on September 18, 2002, is a biotechnology company focused on the discovery and development of bio-active lipid-targeted monoclonal antibody (mAb) therapeutics. The Company has three product candidates, iSONEP, ASONEP and Lpathomab. The Company's program, iSONEP, is a mAb against Sphingosine-1-Phosphate (S1P). As of December 31, 2012, it was in phase-II clinical trials for wet Age-Related Macular Degeneration. The Company is also advancing ASONEP, the systemic formulation of the mAb to S1P. ASONEP has completed a phase-I clinical trial and is entering phase-II clinical trials in Renal Cell Carcinoma.

Lpath's third product candidate, Lpathomab, is a mAb to the bioactive lipid, Lysophosphatidic Acid (LPA). The Company also applies its technology platform, ImmuneY2, to discovering mAbs to new bioactive lipid targets.

Advisors' Opinion:
  • [By Lauren Pollock]

    Lpath Inc.(LPTN) said it is no longer actively seeking to reacquire exclusive rights to its leading product candidate from Pfizer Inc.(PFE), saying the pharmaceutical giant informed the company that its offers weren’t competitive. The biotechnology company in October had warned that Pfizer might may divest itself of its exclusive option to co-develop the smaller firm’s leading product candidate–known as iSONEP.

  • [By Lauren Pollock]

    Biotechnology company Lpath Inc.(LPTN) warned Pfizer Inc.(PFE) may divest itself of its exclusive option to co-develop the smaller firm’s leading product candidate. Lpath’s stock fell.

Top 10 Biotech Companies To Own For 2014: Clovis Oncology Inc (CLVS)

Clovis Oncology, Inc. (Clovis) incorporated on April 20, 2009, is a Development-stage Company. The Company is a Biopharmaceutical Company. The Company focuses on acquiring, developing and commercializing anti-cancer agents in the United States, Europe and additional international markets. The Company also focuses on the treatment of specific subsets of cancer populations. During the year ended December 31, 2010, the Company was in the process of developing three product candidates for which it holds global marketing rights: CO-101, a lipid-conjugated form of the anti-cancer drug gemcitabine; CO-1686, an oral epidermal growth factor receptor (EGFR) mutant-selective inhibitor and CO-338, a poly ADP (Adenosine Diphosphate)-ribose polymerase (PARP) inhibitor. Effective November 19, 2013, Clovis Oncology Inc acquired the entire share capital of Ethical Oncology Science SpA.

CO-101 - a Lipid-Conjugated Form of the Anti-Cancer Drug Gemcitabine

CO-101 is designed to treat patients with pancreatic cancer whose tumors express low amounts of a membrane transporter protein on the surface of the cancer cell known as hENT1 and are thus expected to be resistant to standard gemcitabine-based therapy. Based on the published results of multiple studies assessing the correlation of hENT1 expression to survival outcomes in pancreatic cancer patients treated with gemcitabine, the Company estimates that approximately 40% to 50% of pancreatic patients express low levels of hENT1, and thus derive little or no benefit from gemcitabine therapy. CO-101 is in an international, randomized and controlled 360-patient study for the first-line treatment of metastatic pancreatic cancer. This open-label study compares CO-101 to gemcitabine as a first-line therapy in patients with metastatic pancreatic cancer. Clovis is partnered with Ventana Medical Systems for the development and commercialization of a companion diagnostic for the assessment of hENT1 levels.

CO-1686-an Oral EGFR Mutant-Selective ! Inhibitor

CO-1686 is an orally available, small molecule covalent inhibitor of the cancer-causing mutant forms of EGFR for the treatment of non-small cell lung cancer (NSCLC). CO-1686 targets both the initial activating EGFR mutations as well as the primary resistance mutation, T790M, it treats both first- and second-line NSCLC patients with EGFR mutations. Such initiating activating mutations occur in approximately 10% to 15% of NSCLC cases in Caucasian patients and approximately 30% to 35% of NSCLC cases in East Asian patients. Following treatment with approved NSCLC therapies, Tarceva (erlotinib) or Iressa (gefitinib), both known as tyrosine kinase inhibitors (TKIs), approximately half of these patients develop the T790M mutation.

The Company focuses on the development of CO-1686 as both a second-line therapy for EGFR-mutated NSCLC patients who become resistant to TKIs due to the emergence of the T790M secondary mutation and as a first-line treatment for EGFR-mutated NSCLC. Clovis is partnered with Roche Molecular Systems for the development and commercialization of a companion diagnostic for identification of EGFR mutations.

CO-338-a PARP Inhibitor

CO-338 is a small molecule PARP inhibitor that the Company focuses to develop as both monotherapy and in combination with chemotherapeutic agents for the treatment of selected cancer patients. CO-338 is in a Phase I clinical trial to determine the maximum tolerated dose of oral CO-338 that can be combined with intravenous, or IV, platinum chemotherapy in the treatment of solid tumors. This program is supplemented by two ongoing investigator-initiated trials, using the IV formulation of CO-338: a Phase I/II study in germ-line BRCA mutant breast and ovarian cancer and a Phase II study in the adjuvant treatment of germ-line BRCA mutant and triple-negative breast cancer. The Company also focuses on initiating a Phase I monotherapy study of the oral formulation, to determine an appropriate dose and schedule.!

The Company competes with Eli Lilly, Teva Pharmaceutical Industries, APP Pharmaceuticals, AB Science SA, Amgen Inc., Astellas Pharma, BioSante Pharmaceuticals, Inc., Celgene Corporation, Immunomedics, Inc., Lorus Therapeutics, Threshold Pharmaceuticals, Inc., Boehringer Ingelheim, Pfizer, Sanofi-Aventis, Astra Zeneca, Abbott, Merck, Eisai, Cephalon and Biomarin.

Advisors' Opinion:
  • [By Lauren Pollock]

    Biotech company Clovis Oncology Inc.(CLVS), which was considering a sale, didn’t enter any deal talks and is no longer seeking bids, Bloomberg News reported, citing a person with knowledge of the matter. Shares dropped 14% to $63.51 premarket.

  • [By Sean Williams]

    What: Shares of Clovis Oncology (NASDAQ: CLVS  ) , a biopharmaceutical company that's developing anti-cancer therapies, vaulted higher by as much as 136% (that's not a typo!) after reporting positive data on two early stage experimental treatments -- CO-1686 in EGFR-mutant non-small cell lung cancer (NSCLC) and Rucaparib in a monotherapy study of solid tumors -- at the American Society of Clinical Oncology's annual meeting.

  • [By Sean Williams]

    Clovis Oncology (NASDAQ: CLVS  )
    Welcome to fantasyland; population: Clovis shareholders! As my Foolish colleague and health care analyst David Williamson pointed out this week, shareholders enjoyed the best possible perk of biotech ownership Monday based on ASCO data -- a daily double. Clovis shares exploded higher as both its Rucaparib study of solid tumors, and CO-1686 for EGFR-mutant non-small-cell lung cancer, demonstrated strong early-stage results.

  • [By John Udovich]

    Biotech stocks and especially anything related to cancer has been a hot sector this year with plenty of good news with small cap cancer stocks like Clovis Oncology Inc (NASDAQ: CLVS), Celldex Therapeutics, Inc.(NASDAQ: CLDX) and MetaStat Inc (OTCBB: MTST). also recently reporting their share of good news. I should point out that one reason biotech or rather cancer is a hot area right now is because�big pharma companies who are loosing their�patent protection are looking for acquisitions with cancer in particular being a hot area. In addition and�thanks to a series of breakthroughs that have helped researchers understand the genetic basis of the disease, more investment or R&D dollars are flowing into cancer therapies or small cap biotechs in the cancer space.�With that in mind, here is the latest news about cancer or the cancer stocks or drug companies involved with finding new cancer treatments:

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