Monday, September 8, 2014

Hot Biotech Stocks To Watch Right Now

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The overall ratings of three diversified telecommunication services stocks are down on Portfolio Grader this week. Each of these rates a “D” (“sell”) or “F” overall (“strong sell”).

Top 10 Low Price Companies To Buy For 2015: 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 Bio-Wire]

    Another company that has benefitted from Inovio�� newfound attention is OncoSec Medical (OTC: ONCS) ��a newer ��ffshoot�� company that uses a similar but distinctly different electroporation device known as the OncoSec Medical System (OMS) that is based on Inovio�� technology. The specific amplitude and frequency of the OMS electroporation is calibrated such that plasmid delivery into solid tumor masses is fully optimized, while CELLECTRA electroporation is less specialized and focus more on the vaccination of skin cells. The cross-license agreement made between Inovio and Oncosec also covers the two devices for their distinctly different applications.

  • [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:

  • [By James E. Brumley]

    How does the old saying go? Beggars can't be choosers? Two weeks ago, yours truly penned some bullish comments regarding OncoSec Medical Inc. (OTCMKTS:ONCS). The long and short of it was, if ONCS could clear a technical ceiling around $0.36, then life would get much easier for the bulls.

  • [By James E. Brumley]

    If you're looking for the next big biotech breakout stock, then OncoSec Medical Inc. (OTCMKTS:ONCS) deserves a place on your watchlist. This volatile cancer play has been down more than up 2011, but if you look closely at a long-term chart of ONCS, you may find it's already wiggled its way into a new uptrend. And, it may be only a matter of time before the bullish fireworks start to go off.

Hot Biotech Stocks To Watch 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 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.�

  • [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.

Hot Biotech Stocks To Watch Right Now: Epizyme Inc (EPZM)

Epizyme, Inc., incorporated on November 1, 2007, is a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize personalized therapeutics for patients with genetically defined cancers. The Company systematically identify the genetic alterations that create cancer causing genes, called oncogenes, select patients in whom the identified genetic alteration is found and then design small molecule therapeutics to inhibit the oncogene. The clinical development plan for each of its product candidates is directed towards patients with a particular genetically defined cancer.The Company is conducting a Phase I clinical trial of its advanced product candidate, EPZ-5676, an inhibitor targeting the DOT1L HMT, for the treatment of mixed lineage leukemia (MLL-r). The Company has identified its two lead product candidates using its product platform.

EPZ-5676-DOT1L Inhibitor

EPZ-5676 is an intravenously administered small molecule inhibitor of DOT1L. The Company is developing EPZ-5676 for the treatment of MLL-r, an aggressive subtype of the two most common forms of acute leukemia, ALL and AML. Patients with MLL-r are routinely diagnosed with existing technologies that are commonly used in clinical setting. The Company�� Phase 1 clinical trial of EPZ-5676 is an open label, multicenter trial that has two phases.

EPZ-6438-EZH2 Inhibitor

The Company is developing EPZ-6438 as an orally available small molecule inhibitor of EZH2 for the treatment of non-Hodgkin lymphoma patients who have an oncogenic point mutation in EZH2. EZH2 is an HMT that can become oncogenic and cause non-Hodgkin lymphoma and a range of other solid tumors. Two types of non-Hodgkin lymphoma, diffuse large B-cell lymphoma of germinal-center origin, or DLBCL, and follicular lymphoma, or FL, are particularly associated with an EZH2 point mutation. There are no therapies approved specifically for the treatment of cancer associated with an EZH2 point mutation.

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

    Epizyme (NASDAQ: EPZM) shot up 54.63 percent to $31.70 after the company reported two major milestone achievements. It announced the achievement of a proof of concept milestone in the EPZ-5676 DOT1L inhibitor clinical program.

Hot Biotech Stocks To Watch Right Now: Biodel Inc (BIOD)

Biodel Inc. (Biodel), incorporated on December 3, 2003, is a development-stage speciality biopharmaceutical company focused on the development and commercialization of treatments for diabetes. The Company develops its product candidates by applying its formulation technologies to existing drugs. Its advanced program involves developing formulations of injectable recombinant human insulin (RHI). In addition to its ultra-rapid-acting insulin formulations, the Company has developed prototype formulations of a liquid glucagon, a basal insulin and a glucose responsive insulin, in each case for use by patients with diabetes. RHI-based formulation known as Linjeta was the subject of a New Drug Application (NDA).

The Company has two pivotal Phase III clinical trials with its preferred commercial formulation of Linjeta prior to re-submitting the NDA. In August 2011, it completed patient visits and analyzed top-line data from the first Phase 1 clinical trial of two RHI-based formulations. The trial was a single-center, randomized, double-blind, three-period crossover trial in 18 subjects with Type 1 diabetes. The purpose of the trial was to evaluate the pharmacokinetic and pharmacodynamic characteristics and injection site toleration of BIOD-105 and BIOD-107, as compared to the insulin analog marketed as Humalog. The Company conducted Phase I, Phase II and Phase III clinical trials comparing the performance of its Linjeta formulation of RHI to either Humulin, which is a branded formulation of RHI or Humalog. Its pivotal Phase III clinical trials were open-label, parallel group, randomized trials conducted at centers in the United States, Germany and India.

The Company competes with Eli Lilly, Novo Nordisk, Sanofi-Aventis, Halozyme Therapeutics, Inc. and MannKind Corporation.

Advisors' Opinion:
  • [By Monica Gerson]

    Biodel (NASDAQ: BIOD) is expected to post a Q1 loss at $0.24 per share.

    First Majestic Silver (NYSE: AG) is estimated to post its Q1 earnings at $0.10 per share on revenue of $63.35 million.

  • [By Roberto Pedone]

    One under-$10 specialty biopharmaceutical player that's starting to trend within range of triggering a big breakout trade is Biodel (BIOD), which is focused on the development and commercialization of innovative treatments for diabetes. This stock has been hit hard by the bears over the last three months, with shares down by 24%.

    If you take a look at the chart for Biodel, you'll notice that this stock is ripping higher here right off its 50-day moving average of $2.32 a share with strong upside volume. Volume on Thursday has so far registered over 750,000 shares, which is well above its three-month average action of 445,084 shares. This move is quickly pushing shares of BIOD within range of triggering a big breakout trade.

    Traders should now look for long-biased trades in BIOD if it manages to break out above some near-term overhead resistance levels at $2.52 to $2.60 a share with high volume. Look for a sustained move or close above those levels with volume that hits near or above its three-month average action of 445,084 shares. If that breakout triggers soon, then BIOD will set up to re-test or possibly take out its next major overhead resistance levels $3 to its 200-day moving average of $3.39 a share. Any high-volume move above $3.39 will then give BIOD a chance to tag $4 a share.

    Traders can look to buy BIOD off weakness to anticipate that breakout and simply use a stop that sits right below some key near-term support at $2.10 a share. One can also buy BIOD off strength once it starts to clear those breakout levels with volume and then simply use a stop that sits a comfortable percentage from your entry point.

Hot Biotech Stocks To Watch Right Now: Biota Pharmaceuticals Inc (BOTA)

Biota Pharmaceuticals, Inc., formerly Nabi Biopharmaceuticals, incorporated on March 14, 1969, is an anti-infective drug development company, with key expertise in respiratory diseases, particularly influenza. Biota developed the neuraminidase inhibitor, zanamivir, subsequently marketed by GlaxoSmithKline as Relenza. The Company�� researches include a series of candidate drugs aimed at treatment of respiratory syncytial virus (RSV) disease and Hepatitis C (HCV) virus infections. In addition, Biota and Daiichi Sankyo co-own a range of second generation influenza anti-virals, of which the lead product lnavir, is approved for marketing in Japan.

The Company�� products include Zanamivir, Inavi, Phoslyra, BioStar OIA FLU and BioStar OIA FLU A/B. Zanamivir is a neuraminidase inhibitor for the treatment and prophylaxis of influenza marketed as Relenza by GlaxoSmithKline. Inavi (laninamivir) is a neuraminidase inhibitor marketed by Daiichi Sankyo in Japan. Phoslyra is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). BioStar OIA FLU and BioStar OIA FLU A/B are influenza diagnostic tests, which are marketed by Inverness Medical as part of their BioStar product range.

Relenza is delivered directly to the primary site of infection on the lungs, using a Disk Inhaler device. Relenza is approved in over 50 countries for the treatment of influenza, including in the United States, the European Union, Japan and Australia. Relenza is also approved for use as a preventative (prophylactic) treatment against influenza. Inavir is approved for sale in Japan for the treatment of influenza in adults and children. Daiichi Sankyo has applied to sell Inavir in Japan for the prevention of influenza.

PhosLo and Phoslyra are different dose forms of calcium acetate; a phosphate binder approved in multiple countries for the control of hyperphosphatemia (high serum phosphate) in patients with end stage renal disease (ESRD). PhosLo and Pho! slyra were sold to Fresnius Medical Care. Biota, together with its Japanese based partner, Daiichi Sankyo, have developed an inhaled antiviral compounds for influenza, called long acting inhaled neuraminidase inhibitors (LANI). Biota's human rhinovirus (HRV) drug for the prevention and treatment of the causes of the common cold, BTA798, has completed Phase I, Phase IIa and Phase IIb clinical trials.

Advisors' Opinion:
  • [By gurujx]

    Biota Pharmaceuticals Inc (BOTA) Reached the 3-year Low of $2.42

    The prices of Biota Pharmaceuticals Inc (BOTA) shares have declined to close to the 3-year low of $2.42, which is 93.3% off the 3-year high of $34.92.

Hot Biotech Stocks To Watch Right Now: KYTHERA Biopharmaceuticals Inc (KYTH)

KYTHERA Biopharmaceuticals, Inc., incorporated in June 2004, is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of prescription products for the aesthetic medicine market. The Company�� initial focus is on the facial aesthetics market. The Company�� product candidate, ATX-101, is a injectable drug in Phase III clinical development for the reduction of submental fat, which commonly presents as an undesirable double chin. Based on clinical trials conducted, ATX-101 has exhibited results in the reduction of submental fat. ATX-101 contains a synthetic form of sodium deoxycholate. In the United States and Canada, the Company is conducting two pivotal Phase III trials of ATX-101 for the reduction of submental fat. The Company initiated this pivotal Phase III clinical program, with planned enrollment of 1,000 patients, in March 2012.

In Europe, Bayer, its collaborator outside the United States and Canada, recently completed two pivotal Phase III trials of ATX-101 for the reduction of submental fat. In these multi-center, randomized, double-blind, placebo-controlled pivotal trials involving 723 patients, ATX-101 resulted in a reduction in submental fat, as assessed by a validated clinician scale and a patient satisfaction scale.

ATX-101 contains a synthetic form of sodium deoxycholate. ATX-101 is designed to be a locally-injected drug that causes proximal, preferential destruction of adipocytes, or fat cells, with minimal effect on surrounding tissue. Upon subcutaneous injection under the skin, ATX-101 disrupts cell membranes in protein-poor tissues, such as fat, while being attenuated by interactions with protein-rich tissue, such as skin, muscle and blood vessels. This attenuation by protein-rich tissue results in the preferential destruction of adipocytes by ATX-101. The destruction of adipocytes, or adipocytolysis, elicits a natural response, in which macrophages are attracted to remove cellular debris and fat particles t! hrough the lymphatic system. The macrophages also emit low levels of chemical messengers, known as cytokines, which attract fibroblasts, another cell type, to the area. Fibroblasts produce collagen, and it is believed that new collagen production, or neocollagenesis, promotes retraction of the skin in the areas of fat reduction. The fat removal process with ATX-101 is incremental with each treatment, thereby allowing for control of the aesthetic outcome.

Advisors' Opinion:
  • [By Monica Gerson]

    Kythera Biopharmaceuticals (NASDAQ: KYTH) shares jumped 28.69% to $43.15 in pre-market trading after the company reported positive ATX-101 top line phase III trial results for the reduction of submental fat.

  • [By Lisa Levin]

    Kythera Biopharmaceuticals (NASDAQ: KYTH) shares moved up 24.01% to $41.58. The volume of Kythera Biopharmaceuticals shares traded was 6431% higher than normal. Kythera reported positive ATX-101 top line phase III trial results for the reduction of submental fat.

  • [By Roberto Pedone]

    Kythera Biopharmaceuticals (KYTH) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. This stock closed up 12.2% to $31.99 in Monday's trading session.

    Monday's Volume: 221,000

    Three-Month Average Volume: 72,572

    Volume % Change: 220%

    From a technical perspective, KYTH ripped sharply higher here right above its 50-day moving average of $26.92 with heavy upside volume. This move pushed shares of KYTH into new all-time-high territory above its previous all-time high at $31.93, which is bullish technical price action.

    Traders should now look for long-biased trades in KYTH as long as it's trending above Monday's low of $28.28 and then once it sustains a move or close above its new all-time high at $32 with volume that hits near or above 72,572 shares. If we get that move soon, then KYTH will set up to enter new all-time-high territory, which is bullish price action. Some possible upside targets off that move are $35 to $37.

  • [By Lisa Levin]

    Kythera Biopharmaceuticals (NASDAQ: KYTH) shares surged 24.40% to touch a new 52-week high of $41.71 after the company reported positive ATX-101 top line phase III trial results for the reduction of submental fat.

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