Sunday, March 29, 2015

Top 5 Biotech Companies To Own In Right Now

From the smallest biotech to the biggest pharmaceutical stock The Motley Fool's Market Check-Up�covers the health care sector's biggest headlines, hottest market movers, and Obamacare's ongoing rollout.

In this segment from Monday's episode, health-care analyst David Williamson discusses Shire (NASDAQ: SHPG  ) , a biopharmaceutical company focusing on rare diseases, that just beat out several rivals with its bid of $4.2 billion to acquire ViroPharma (NASDAQ: VPHM  ) . ViroPharma sells the successful hereditary angioedema drug Cinryze, which is used in prophylactic treatment of the disease. Shire sees this as an immediately complementary fit with its drug Firazyr, which is for patients already suffering from the active disease.

In the video, David discusses why the deal is good for Shire, why he doesn't see critics' concerns over the deal as anything investors should worry about, and whether he likes the stock from here.

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Top 5 Shipping Companies To Watch In Right Now: Immune Design Corp (IMDZ)

Immune Design Corp, incorporated on February 20, 2008, is a clinical-stage immunotherapy company. The Company has engineered its technologies to activate the immune system�� natural ability to create tumor-specific cytotoxic T cells (CTLs), to fight cancer. The Company is developing multiple product candidates from its two discovery platforms, DCVex and GLAAS. The Company�� product candidates, LV305, CMB305 and G100, utilize multiple immuno-oncology approaches. LV305 was developed from the DCVex platform and it is enrolling patients in a Phase I clinical trial for the treatment of five solid tumor types. CMB305 is a prime-boost approach that combines LV305 with a second agent, G305. G100 was developed from the GLAAS platform and it is enrolling patients with Merkel cell carcinoma in a Phase I clinical trial.

The Company�� immuno-oncology product candidates are being developed in two separate approaches: Specific Antigen and Endogenous Antigen. The Specific Antigen approach uses selected antigens that are also present in the patient�� tumor so that the immune system will be educated to recognize the tumor antigen and kill tumor cells expressing the antigen. The Endogenous Antigen approach, in contrast, does not require a selected antigen present in the tumor. It instead relies on treatments, such as chemotherapy or local radiation to lyse tumors and release endogenous antigens, which are then captured by neighboring GLAAS-activated dendritic cells, generating a varied immune response. The Company utilizes DCVex and GLAAS to develop product candidates that work in vivo and are designed to create and expand diverse armies of CTLs to fight tumors. DCVex is a discovery platform that uses a first-in-class vector to generate product candidates designed to create CTLs in vivo. The DCVex vector is a delivery system based on a re-engineered virus to carry the genetic information of a tumor antigen safely and selectively to dendritic cells (DCs), in the skin. The GLAAS platform also works in! vivo and is based on a small synthetic molecule called GLA, which stands for glucopyranosyl lipid A. GLA selectively binds to the TLR4 receptor and causes potent activation of the DC.

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

    www.gopro.com Now that it's nearly over, we can definitively say that 2014 has been one of the best years for initial public stock offerings in history. In terms of proceeds raised from IPOs, 2014 will challenge or even exceed the year 2000. Which is saying something: That was the height of the dot.com frenzy, when seemingly every new company with a website felt compelled to list on the stock exchange. As can be expected of a busy IPO year, some of 2014's new stock market titles have been runaway hits soaring above their issue price, while others have belly-flopped. Since we're heading into the most optimistic time of the year, we'll shine a light on the three best performers. In order of stock price appreciation, they are: GoPro (GPRO) 2014's current IPO front-runner is this company, maker of the popular action photography camera -- the one that's usually responsible for those hairy point-of-view videos posted on Facebook (FB) and other online sharing sites. GoPro's stock hit the market at the end of June priced at $24, and as if this writing it now stands at $70.72 for a muscular 195 percent total return. Although that's impressive, it should be noted that the current price is quite a bit lower than the stock's high of nearly $94, which it touched in early October. But then the camera was effectively blamed for the horrific accident that befell Formula One racing star Michael Schumacher -- although the journalist making the allegation later recanted -- and the shares cratered. The stock recovered after the company reported strong third-quarter earnings, and all seemed well again... until GoPro decided to float a secondary issue of stock. It'll sell 10.3 million fresh shares on the market, adding to the nearly 126 million currently outstanding. When secondary share issues are announced, a company's stock often takes a hit, since investors aren't too crazy about their existing stakes being diluted. Regardless, on a fundamental basis GoPro is a popular, if

Top 5 Biotech Companies To Own In Right Now: Foundation Medicine Inc (FMI)

Foundation Medicine, Inc., incorporated on November 12, 2009, is a commercial-stage company. The Company is focused on fundamentally changing the way patients with cancer are treated. The Company�� platform includes methods and algorithms for analyzing tumor tissue samples across all types of cancer, as well as information aggregation and concise reporting capabilities. Its products provide genomic information about each patient�� individual cancer, enabling physicians to optimize treatments in clinical practice and enabling biopharmaceutical companies to develop targeted oncology therapies more effectively.

FoundationOne, its first clinical product, is, to its knowledge, the only commercially available comprehensive molecular information product designed for use in the routine care of patients with cancer. In addition, the Company is considered a non-contracting provider by commercial third-party payors because it has not entered into specific contracts to provide FoundationOne to their covered patients, and as a result it takes on primary responsibility for obtaining reimbursement on behalf of patients.

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

    It wouldn't be fair to say there's nothing like it "out there", because there is. A company called Foundation Medicine Inc. (NASDAQ:FMI) has developed a similar/comparable app. The CLRX version of the solution appears superior in most ways, however, if for no other reason than because of the projected revenue growth the company is apt to see.

  • [By John Udovich]

    If you have not been watching the biotech sector lately, you should start paying attention as the sector along with small cap biotech stocks like Cell Therapeutics Inc (NASDAQ: CTIC), BIND Therapeutics Inc (NASDAQ: BIND) and TNI BioTech (OTCMKTS: TNIB) continue to produce a steady stream of good news for investors thanks to positive industry trends. Moreover, Ophthotech Corp (NASDAQ: OPHT), Foundation Medicine Inc (NASDAQ: FMI), Evoke Pharma and Fate Therapeutics Inc (NASDAQ: FATE) are this week's biotech IPOs that will no doubt be watched closely by Wall Street and industry observers in general. With that in mind, consider the following biotech news or recent articles about the industry and the small cap players in it:

Top 5 Biotech Companies To Own In Right Now: Cell Therapeutics Inc (CTIC)

Cell Therapeutics, Inc. (CTI), incorporated in 1991, develops, acquires and commercializes treatments for cancer. The Company�� research, development, acquisition and in-licensing activities concentrate on identifying and developing new ways to treat cancer. As of December 31, 2011, CTI focused its efforts on Pixuvri (pixantrone dimaleate) (Pixuvri), OPAXIO (paclitaxel poliglumex) (OPAXIO), tosedostat, brostallicin and bisplatinates. As of December 31, 2011, it developed Pixuvri, an anthracycline derivative for the treatment of hematologic malignancies and solid tumors. Another late-stage drug candidate of the Company, OPAXIO, is being studied as a potential maintenance therapy for women with advanced stage ovarian cancer, who achieve a complete remission following first-line therapy with paclitaxel and carboplatin. As of December 31, 2011, it also developed tosedostat in collaboration with Chroma Therapeutics, Ltd. (Chroma). On May 31, 2012, CTI completed its acquisition gaining worldwide rights to S*BIO Pte Ltd.'s (S*BIO) pacritinib.

Pixuvri

As of December 31, 2011, the Company developed Pixuvri, an aza-anthracenedione derivative, for the treatment of non-Hodgkin�� lymphoma (NHL), and various other hematologic malignancies, and solid tumors. Pixuvri was studied in the Company�� EXTEND, or PIX301, clinical trial, which was a phase III single-agent trial of Pixuvri for patients with relapsed, refractory aggressive NHL who received two or more prior therapies and who were sensitive to treatment with anthracyclines. On September 28, 2011, CTI announced that a second independent radiology assessment of response and progression endpoint data from its PIX301 clinical trial of Pixuvri was achieved with statistical significance. The results of the EXTEND trial met its primary endpoint and showed that patients randomized to treatment with Pixuvri achieved a significantly higher rate of confirmed and unconfirmed complete response compared to patients treated with standard chem! otherapy had a significantly increased overall response rate and experienced a statistically significant improvement in median progression free survival. Pixuvri had predictable and manageable toxicities when administered at the proposed dose and schedule in the EXTEND clinical trial in heavily pre-treated patients. In March 2011, the Company initiated the PIX-R trial to study Pixuvri in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Pixuvri has also been studied in patients with HER2-negative metastatic breast cancer who have tumor progression after at least two, but not more than three, prior chemotherapy regimens. In the second quarter of 2010, the NCCTG opened this phase II study for enrollment. The study is closed to accrual and results are expected to be reported by the NCCTG later in 2012.

OPAXIO

OPAXIO is the Company�� biologically-enhanced chemotherapeutic agent that links paclitaxel to a biodegradable polyglutamate polymer, resulting in a new chemical entity. As of December 31, 2011, the Company focused its development of OPAXIO on ovarian, brain, esophageal, head and neck cancer. OPAXIO was designed to improve the delivery of paclitaxel to tumor tissue while protecting normal tissue from toxic side effects. In November 2010, results were presented by the Brown University Oncology Group from a phase II trial of OPAXIO combined with temozolomide (TMZ), and radiotherapy in patients with newly-diagnosed, high-grade gliomas, a type of brain cancer. The trial demonstrated a high rate of complete and partial responses and a high rate of six month progression free survival (PFS). Based on these results, the Brown University Oncology Group has initiated a randomized, multicenter, phase II study of OPAXIO and standard radiotherapy versus TMZ and radiotherapy for newly diagnosed patients with glioblastoma with an active gene termed MGMT that reduces responsiveness to TMZ. A phase I/II study of OPAXIO combined with radi! otherapy ! and cisplatin was initiated by SUNY Upstate Medical University, in patients with locally advanced head and neck cancer.

Tosedostat

In March 2011, the Company entered into a co-development and license agreement with Chroma Therapeutics, Ltd. (Chroma), providing the Company with marketing and co-development rights to Chroma�� drug candidate, tosedostat, in North, Central and South America. Tosedostat is an oral, aminopeptidase inhibitor that has demonstrated anti-tumor responses in blood related cancers and solid tumors in phase I-II clinical trials. Interim results from the phase II OPAL study of tosedostat in elderly patients with relapsed or refractory acute myeloid leukemia (AML) showed that once-daily, oral doses of tosedostat had predictable and manageable toxicities and results demonstrated response rates, including a high-response rate among patients who received prior hypomethylating agents, which are used to treat myelodysplastic syndrome (MDS), a precursor of AML.

Brostallicin

As of December 31, 2011, the Company developed brostallicin through its wholly owned subsidiary, Systems Medicine LLC, which holds rights to use, develop, import and export brostallicin. Brostallicin is a synthetic deoxyribonucleic acid (DNA) minor groove binding agent that has demonstrated anti-tumor activity and a favorable safety profile in clinical trials, in which more than 230 patients have been treated as of December 31, 2011. The Company uses a genomic-based platform to guide the development of brostallicin. A phase II study of brostallicin in relapsed, refractory soft tissue sarcoma met its predefined activity and safety hurdles and resulted in a first-line phase II clinical trial study that was conducted by the European Organization for Research and Treatment of Cancer (EORTC).

The Company competes with Bristol-Myers Squibb Company, Sanofi-Aventis, Pfizer, Roche Group, Genentech, Inc., Astellas Pharma, Eli Lilly and Company, Celgene, Telik, I! nc., TEVA! Pharmaceuticals Industries Ltd. and PharmaMar.

Advisors' Opinion:
  • [By MONEYMORNING]

    Cell Therapeutics Inc. (Nasdaq: CTIC), based in Seattle, Wash., acquires, develops, and commercializes treatments for cancers, including non-Hodgkin's leukemia and ovarian, neck, and brain cancers. The company just announced it has completed patient enrollment in clinical trials for an investigational agent to be used as a maintenance therapy in ovarian cancer patients. The trial is being conducted by the Gynecologic Oncology Group, one of the National Cancer Institute's funded research groups. Roth Capital recently reiterated a "Buy" rating on the stock and raised its price target from $6 to $7. Roth believes the company's treatment for leukemia, Pacritinib, is effectively evolving. Additionally, the investment firm sees potential in CTIC's Tosedostat, which deprives tumor cells of the amino acid building blocks needed to make proteins necessary for tumor cell survival. Shares rose 2% Tuesday to $3.52 on volume of 6 million shares.

  • [By Sean Williams]

    Cell Therapeutics (NASDAQ: CTIC  )
    Certainly no discussion of companies with large accumulated deficits would be complete without discussing a biotechnology company. It's perfectly understandable to see a biotech, especially a clinical-stage one, run with an accumulated deficit, as it takes time and money to build up a drug pipeline. However, after multiple complete response letters (the equivalent of a rejection) by the Food and Drug Administration and years without an approved drug, Cell Therapeutics racked up an astounding $1.83 billion in accumulated deficits through the end of fiscal 2012. By comparison, that's nearly 56 times larger than its shareholder equity.�

Top 5 Biotech Companies To Own In Right Now: Kite Pharma Inc (KITE)

Kite Pharma, Inc., incorporated on June 1, 2009, is a clinical-stage biopharmaceutical company focused on the development and commercialization of cancer immunotherapy products designed to harness the power of a patient�� own immune system to eradicate cancer cells. The Company does this using its engineered autologous cell therapy (eACT). eACT involves the genetic engineering of T cells to express either chimeric antigen receptors (CARs, or T cell receptors, or TCRs). These modified T cells are designed to recognize and destroy cancer cells. The Company funds multiple Phase I-2a clinical trials with CAR- and TCR-based therapies that are being conducted by its collaborator, the Surgery Branch of the National Cancer Institute (NCI). The Company plans to conduct a Phase I-2 clinical trial for its lead product candidate KTE-C19, a CAR-based therapy, in patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL).

eACT involves harvesting T cells from the patient�� blood; genetically engineering T cells to express cancer-specific receptors; increasing the number of engineered T cells and infusing the functional cancer-specific T cells back into the patient. Using eACT technology, T cells can be genetically modified to express one of two classes of cancer-specific receptors: CARs or TCRs. CARs can recognize native cancer antigens that are part of an intact protein presented on the cancer cell surface. TCRs broaden the therapeutic approach by recognizing fragments on the cancer cell surface derived from intracellular proteins. By combining both CAR and TCR approaches, it has the potential to generate a portfolio of products that can target both solid and hematological tumors. It has a Cooperative Research and Development Agreement (CRADA), through which it is funding the research and development of eACT-based product candidates utilizing CARs and TCRs for the treatment of advanced solid and hematological malignancies.

The Company�� lead product candidate, KTE-C19, ! is an anti-CD19 CAR T cell therapy. CD19 is a protein expressed on the cell surface of B cell lymphomas and leukemias. The Company is an ongoing NCI Phase I-2a clinical trial utilizing anti-CD19 CAR T cell therapy that is designed to establish a dose level and appropriate conditioning regimen, as well as to assess overall safety, in patients with B cell lymphomas and leukemias that had been heavily pretreated and were relapsed/refractory (unresponsive) to chemotherapy. KTE-C19 will use the identical anti-CD19 CAR construct and viral vector that is being used in the NCI trial. The Company a license with the NIH for intellectual property relating to a TCR-based T cell therapy targeting the antigen SSX2 for the treatment of head and neck cancer, hepatocellular carcinoma, melanoma, prostate cancer and sarcoma, and a co-exclusive license to this intellectual property for the treatment of certain additional cancer types.

Advisors' Opinion:
  • [By Matt Egan]

    While the health-care sector only raised $1.8 billion during the second quarter, it led the way with 24 IPOs, up from 17 the year before. Hot drug IPOs include Zs Pharma (ZSPH), Kite Pharma (KITE) and GlobeImmune (GBIM), all of which debuted in June and are trading more than 40% above their IPO price.

  • [By John Udovich]

    Small cap cancer drug stock Kite Pharma Inc (NASDAQ: KITE) has surged after announcing a�strategic research collaboration and license agreement with Amgen, Inc (NASDAQ: AMGN)�involving Chimeric Antigen Receptors (CAR) ��meaning its worth taking a closer look at the stock, which had an IPO last June,�along with potential peers�Bellicum Pharmaceuticals Inc (NASDAQ: BLCM) and Juno Therapeutics (NASDAQ: JUNO) which are players in the CAR therapies space and had more recent IPOs.

  • [By John Udovich]

    Biotech news this week was dominated by a number of healthcare and biotech related IPOs, including Parnell Pharmaceuticals Holdings Ltd (NASDAQ: PARN), Signal Genetics Inc (NASDAQ: SGNL), ZS Pharma Inc (NASDAQ: ZSPH), Ardelyx Inc (NASDAQ: ARDX)�and Zafgen Inc (NASDAQ: ZFGN) with Kite Pharma Inc (NASDAQ: KITE), Microlin Bio Inc (NASDAQ: MCLB) and�Syndax Pharmaceuticals Inc (NASDAQ: SNDX) presumably set to debut today (Note:�See�This Week�� Biotech IPOs: Two Losers and One Winner So Far (PARN, SGNL & ZSPH)):

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