Seattle Genetics, Inc. (NASDAQ:SGEN) is a big deal today, and Needham & Company says it could be the next big thing in the pharmaceutical space.
Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for cancer.
Its product candidate, ADCETRIS or brentuximab vedotin is approved by United States Food and Drug Administration (FDA) in two indications: the treatment of patients with Hodgkin lymphoma, and for patients with systemic anaplastic large cell lymphoma (s ALCL).
ADCETRIS is an antibody-drug conjugate, or ADC, comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing its technology.
Top 5 Cheapest Companies For 2016: 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 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 2015: 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.
Top 10 Biotech Companies To Own For 2015: Exelixis Inc.(EXEL)
Exelixis, Inc., a biotechnology company, develops small molecule therapies for the treatment of cancer. It focuses on developing Cabozantinib, an inhibitor of tumor growth, metastasis, and angiogenesis that target MET, VEGFR2, and RET, which are key kinases involved in the development and progression of various cancers. The cabozantinib is in Phase III clinical trial for the treatment for medullary thyroid cancer. The company also engages in various clinical programs for cabozantinib focused on the treatment of metastatic castration-resistant prostate cancer, ovarian cancer, breast cancer, renal cell carcinoma, non-small cell lung cancer, hepatocellular cancer, and melanoma. In addition, Exelixis, Inc. involves in developing a portfolio of other novel compounds to address serious unmet medical needs through collaborations with various pharmaceutical and biotechnology companies, including Bristol-Myers Squibb Company, sanofi-aventis, Genentech, Inc., Boehringer Ingelheim Gm bH, and GlaxoSmithKline and Daiichi Sankyo Company Limited. Its products under development through collaborations include XL475, XL281, XL139, and XL413 inhibitors; ROR antagonists; therapies targeted against LXR, a nuclear hormone receptor implicated in various cardiovascular and metabolic disorders; XL147, XL765, and isoform-selective PI3K inhibitors; XL518, a small-molecule inhibitor of MEK; sphingosine-1-phosphate type 1 receptor; XL880 inhibitor; and therapies targeted against the mineralocorticoid receptor, a nuclear hormone receptor implicated in various cardiovascular and metabolic diseases. The company was formerly known as Exelixis Pharmaceuticals, Inc. and changed its name to Exelixis, Inc. in February 2000. Exelixis, Inc. was founded in 1994 and is headquartered in South San Francisco, California.
Advisors' Opinion:- [By Jake L'Ecuyer]
Equities Trading DOWN
Shares of Exelixis (NASDAQ: EXEL) were down 36.18 percent to $4.11 after the company issued an update on ongoing COMET-1 phase 3 pivotal trial in men with metastatic castration-resistant prostate cancer. Stifel Nicolaus lowered the price target on the stock from $11.00 to $9.00.
Top 10 Biotech Companies To Own For 2015: GW Pharmaceuticals PLC (GWPRF)
GW Pharmaceuticals plc is a United Kingdom-based company. The Company is engaged in the research, development and commercialization of a range of cannabinoid prescription medicines to meet patient needs in a range of medical conditions. The Company is developing a portfolio of cannabinoid medicines, of which the main product is Sativex, an oromucosal spray for the treatment of Multiple Sclerosis (MS) symptoms, cancer pain and neuropathic pain. The Company operates in three segments: Sativex Commercial, Sativex Research and Development and Pipeline Research and Development. The Company�� wholly owned subsidiaries include GW Pharma Limited, G-Pharm Limited, Cannabinoid Research Institute Limited, Guernsey Pharmaceuticals Limited and GWP Trustee Company Limited. Advisors' Opinion:- [By Ben Levisohn]
But, as the Huffington Post points out, most of the companies that stand to benefit are very small–they make micro caps look big–trade over the counter–good bye liquidity. That includes transaction-processing company MediSwipe (MWIPD), GreenGro Technologies (GRNH) Medbox (MDBX), which makes dispenser for high-risk drugs, and GW Pharmaceuticals (GWPRF).
Top 10 Biotech Companies To Own For 2015: Puma Biotechnology Inc (PBYI)
Puma Biotechnology, Inc., incorporated in April 2007, is a development-stage biopharmaceutical company that acquires and develops products for the treatment of various forms of cancer. The Company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seeks to further develop those drug candidates for commercial use. As of December 31, 2011, the Company licensed three drug candidates: PB272 (neratinib (oral)), which the Company is developing for the treatment of advanced breasts cancer patients and gastric cancer patients; PB272 (neratinib (intravenous)), which the Company is developing for the treatment of advanced cancer patients, and PB357.
PB272 (neratinib (oral))-Breast Cancer
Neratinib is a potent irreversible tyrosine kinase inhibitor, or TKI, that blocks signal transduction through the epidermal growth factor receptors (EGFRs), HER1, HER2 and HER4. The Company's initial focus is on the development of neratinib as an oral treatment of patients with HER2 positive metastatic breast cancer.
PB272 (neratinib (intravenous))
The Company develops neratinib as an intravenously administered agent. In pre-clinical studies the intravenous version of neratinib resulted in higher exposure levels of neratinib in pre-clinical models.
PB357
PB357 is an orally administered agent that is an irreversible TKI that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2, and HER4. PB357 is structurally similar to PB272. Pfizer completed single dose Phase I trials of PB357. The Company is evaluating PB357.
The Company competes with Genentech, GlaxoSmithKline, Roche, Boehringer Ingelheim, Takeda, Array Biopharma and Ambit Biosciences.
Advisors' Opinion:- [By George Budwell]
With that being said, developmental biotechs that fall hard on news could be worth taking a look at because they may have fallen for all the wrong reasons. Puma Biotechnology (NYSE: PBYI ) , for example, plummeted by 25% about a month ago after reporting mid-stage clinical trial data for the company's flagship cancer drug PB272 (neratinib).
- [By Anna Prior]
Puma Biotechnology Inc.(PBYI) reported positive top-line data from the Phase II clinical trial of the biopharmaceutical company’s investigational drug PB272 for the neoadjuvant treatment of breast cancer.
- [By Tom Rojas and Maria Armental var popups = dojo.query(".socialByline .popC"); ]
Puma Biotechnology Inc.(PBYI) said its investigational breast-cancer treatment showed a 33% improvement in disease-free survival over a placebo in a Phase 3 study. Share surged 271% to $218 premarket.
- [By Ben Levisohn]
After big rallies by biotech stocks, the folks at Weeden wondered if the rally getting overdone.�UBS analyst Matthew Roden and team think biotech stocks like Gilead Sciences�(GILD), Celgene�(CELG),�Vertex Pharmaceuticals (VRTX),�Puma Biotechnology (PBYI) and Achillion Pharmaceuticals (ACHN) can keep running. They explain why:
Top 10 Biotech Companies To Own For 2015: 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 John Udovich]
On Tuesday, small cap biopharmaceutical company Epizyme Inc (NASDAQ: EPZM) surged 75.56% after the company announced that its�EPZ-5676, a DOT1L inhibitor for acute leukemias, had reached its proof-of-concept milestone, meaning its worth taking a closer look at the stock as well as look at the share performance of cancer stocks like large cap Celgene Corporation (NASDAQ: CELG) and small caps�Dendreon Corporation (NASDAQ: DNDN) and Geron Corporation (NASDAQ: GERN).
Top 10 Biotech Companies To Own For 2015: Tauriga Sciences Inc (TAUG)
Tauriga Sciences, Inc., formerly Immunovative, Inc., incorporated on April 18, 2001, is a development-stage company. The Company along with Constellation Diagnostics, Inc. (Constellation) focuses on establishing a joint venture partnership to develop and commercialize a imaging-based diagnostic technology for use in predictive and preventative oncology.
The Company has rights to commercialize AlloStim and AlloVax. As of March 31, 2013 the Company did not have any revenues.
Advisors' Opinion:- [By Peter Graham]
Small cap marijuana stocks IMD Companies Inc (OTCMKTS: ICBU), Tauriga Sciences Inc (OTCMKTS: TAUG), ML Capital Group Inc (OTCBB: MLCG) and Lexaria Corp (OTCMKTS: LXRP) are aiming to give investors a high with their latest news. However, only one of these small cap marijuana stocks appears to be the subject of minor paid promotion or investor relations type of activities. So will investors and traders alike get a high off of these small caps? Here is a quick reality check:
- [By Peter Graham]
Small cap health care or personal care stocks Axxess Pharma Inc (OTCMKTS: AXXE), Radiant Creations Group Inc (OTCBB: RCGP) and Tauriga Sciences Inc (OTCMKTS: TAUG) have recently been attracting attention in various investment newsletters or in investor alerts. Some of the attention may have to do with paid promotions that two of these small caps have been the subject of. So how healthy are these three small cap health care or personal care orientated stocks? Here is a checkup:
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