This week, 12 stocks get F’s (“strong sell”) in Portfolio Grader‘s three main grading categories, Total Grade, Overall Fundamental Grade, and Quantitative Grade.
These are the worst of the worst in the entire Portfolio Grader database. This week, there are 4,253 stocks and only these 12 get failing marks in all categories to make the dreaded “Triple F” stocks list. Here they are:
Top 10 Biotech Companies To Watch For 2014: Vertex Pharmaceuticals Incorporated(VRTX)
Vertex Pharmaceuticals Incorporated engages in discovering, developing, manufacturing, and commercializing small molecule drugs for the treatment of serious diseases worldwide. Its products include telaprevir, a prescription medicine used for the treatment of patients with genotype 1 hepatitis C virus (HCV) infection; and Ivacaftor, a prescription medicine used for the treatment of cystic fibrosis. The company markets its products under the INCIVEK brand name in the United States and Canada; INCIVO brand in the United Kingdom, Germany, France, Sweden, Austria, Finland, Denmark, Switzerland, and Norway; KALYDECO brand in the United States; and TELAVIC brand in Japan. Its drug candidates comprise VX-222, a Phase II clinical trial drug candidate, and ALS-2200 and ALS-2158, a Phase I clinical trial drug candidates that are designed to inhibit the replication of HCV; VX-809 and VX-661, a Phase II clinical trial drug candidates that improve the function of defective cystic fibro sis; VX-509, a Phase II clinical trial drug candidate for the treatment of patients with rheumatoid arthritis and other immune-mediated inflammatory diseases; VX-765, a Phase II clinical trial drug for the treatment of epilepsy; and VX-787, an investigational drug candidate for the treatment of influenza A. The company was founded in 1989 and is headquartered in Cambridge, Massachusetts.
Advisors' Opinion:- [By Ben Levisohn]
Textron (TXT) rose 19% to $37.29 this week after it agreed to buy Beechcraft for $1.4 billion. Allergan (AGN) advanced 12% to $107.73 after Restatis was protected from generic competition, and�Vertex Pharmaceuticals�(VRTX) finished up� 10% at $71.83 after a clinical study didn’t show what the biotech company had hoped it would but left open the possibility of future success. 3M (MMM) jumped 8.1% to $136.72 after increasing its dividend, share buyback and guidance–and it was upgraded by JPMorgan to boot.
- [By Sue Chang and Saumya Vaishampayan]
Vertex Pharmaceuticals Inc. (VRTX) �shares gained 3.9%. Geoff Meacham, an analyst at J.P. Morgan, said last week that he rates the drug maker�� stock at overweight due to opportunities for the company in the cystic fibrosis area.
- [By Sean Williams]
Then along came Vertex Pharmaceuticals (NASDAQ: VRTX ) with its oral medication, Incivek, which drastically changed the treatment landscape. Although still given in combination with interferon and a ribavirin, Incivek greatly improved patients' sustained virologic response (the level at which no detectable levels of the HCV virus can be found) after 24 weeks by 20% to 45% over the previous standard of treatment depending on the trial. Not surprisingly, Incivek became the quickest drug to ever reach $1 billion in sales (less than eight months), but also lost the majority of its revenue nearly as fast as it ceded ground to up-and-coming treatments.�
Top 10 Biotech Companies To Watch For 2014: Telik Inc (TELK)
Telik, Inc. (Telik), incorporated in 1988, is a clinical-stage drug development company focused on discovering and developing small molecule drugs to treat cancer. The Company discovers its product candidates using the Company�� drug discovery technology, Target-Related Affinity Profiling (TRAP). TELINTRA, its principal drug product candidate in clinical development, is a small molecule glutathione analog inhibitor of the enzyme glutathione S-transferase P1-1 (GST P1-1). TELCYTA, its other product candidate, is a small molecule cancer drug product candidate designed to be activated in cancer cells.
Clinical Product Development
TELINTRA is the Company�� lead small molecule product candidate in clinical development for the treatment of blood disorders, including cancer. It has a mechanism of action and acts by inhibiting GST P1-1, an enzyme that is involved in the control of cellular growth and differentiation. Inhibition of GST P1-1 results in the activation of the signaling molecule Jun kinase, a regulator of the function of blood precursor cells. Preclinical tests show that TELINTRA is capable of causing the death or apoptosis of leukemic or malignant blood cells, while stimulating the growth and development of normal blood precursor cells. TELINTRA has been studied in Myelodysplastic Syndrome (MDS) using two formulations. A liposomal formulation was developed for intravenous administration of TELINTRA and was used in Phase I and Phase II studies in MDS patients. The results from the Phase II intravenous liposomal TELINTRA clinical trials demonstrated that TELINTRA treatment was associated with improvement in all three types of blood cell levels in patients with all types of MDS, including those in intermediate and high-risk groups. An oral dosage formulation (tablet) was subsequently developed and results from a Phase I study with TELINTRA tablets showed clinical activity and the formulation to be well tolerated. In June 2011, the Company initiated a Phase II clinical ! trial to evaluate TELINTRA tablets. In October 2011, the Company initiated an additional Phase IIb clinical trial to evaluate TELINTRA tablets. '
The activity and safety profile of tablet formulation allowed the Company to complete a Phase II trial of TELINTRA tablets in MDS. The primary objective of the Phase II TELINTRA tablet study was to determine the efficacy of TELINTRA. A multivariate logistic regression analysis was conducted to identify MDS disease prognostic factors associated with erythroid improvement response rates, including prior MDS treatment, age, gender, the international prognostic scoring system (IPSS), risk, Eastern Cooperative Group performance status, years from MDS diagnosis, MDS World Health Organization subtypes, anemia only versus anemia plus other cytopenias, dose schedule and starting dose. Results from this study show that TELINTRA is the first GSTP1-1 enzyme inhibitor shown to cause clinically reductions in red blood cell transfusions, including transfusion independence in low to intermediate-1 risk MDS patients, as well as improvement in platelet count and white blood cell levels in certain patients. TELINTRA, administered orally twice daily, appeared to be convenient and flexible for chronic treatment administration.
TELCYTA is a small molecule drug product candidate that the Company is developed for the treatment of cancer. TELCYTA binds to GST. TELCYTA has been evaluated in multiple Phase II and Phase III clinical trials, including trials using TELCYTA as monotherapy and in combination regimens in ovarian, non-small cell lung, breast and colorectal cancer. Results from these clinical trials indicate that TELCYTA monotherapy was generally well-tolerated, with mostly mild to moderate side effects, particularly when compared to the side effects and toxicities of standard chemotherapeutic drugs. When TELCYTA was evaluated in combination with standard chemotherapeutic drugs, the tolerability of the combinations was similar to that expected of each! drug alo! ne.
Clinical activity including objective tumor responses and/or disease stabilization was reported in the TELCYTA Phase II trials; however, TELCYTA did not meet its primary endpoints in the Phase III studies. Positive results from a Phase I-IIa multicenter, dose-ranging study of TELCYTA in combination with carboplatin and paclitaxel as first-line therapy for patients with non-small cell lung cancer, or NSCLC, were published in a peer reviewed publication. Clinical data demonstrated positive results of TELCYTA in combination with carboplatin and paclitaxel in the treatment of first-line lung cancer followed by TELCYTA maintenance therapy. As of December 31, 2011, the Company had an on-going investigator-led study at a single site of TELCYTA in patients with refractory or relapsed mantle cell lymphoma, diffuse B cell lymphoma, and multiple myeloma.
Preclinical Drug Product Development
The Company has a small molecule compound, TLK60404, in preclinical development that inhibits both Aurora kinase and VEGFR kinase. Aurora kinase is a signaling enzyme whose function is required for cancer cell division, while VEGF plays a key role in tumor blood vessel formation, ensuring an adequate supply of nutrients to support tumor growth. These lead compounds prevented tumor growth in preclinical models of human colon cancer and human leukemia by inhibiting both Aurora kinase and VEGFR kinase. A development drug product candidate, TLK60404, has been selected.
The Company, using its TRAP technology has discovered TLK60357, a novel, potent small molecule inhibitor of cell division. TLK60357 inhibits the formation of microtubules that are necessary for cancer cell growth leading to persistent G2/M cancer cell cycle block and subsequent cell death. This compound demonstrates potent broad-spectrum anticancer activity against a number of human cancer cells. This compound also displays oral efficacy in multiple, standard preclinical models of cancer. TLK60596, a potent VG! FR kinase! inhibitor, blocks the formation of new blood vessels in tumors. Oral administration of TLK60596 to animal models of human colon cancer reduced tumor growth.
Top 5 Value Stocks To Buy Right Now: Dyadic International Inc (DYAI)
Dyadic International, Inc. (Dyadic), incorporated in September 2002, is a holding company. The Company is a global biotechnology company. The Company has operations at the United States and the Netherlands. Dyadic uses its technologies to conduct research and development (R&D) and commercial activities for the discovery, development, manufacture and sale of enzymes and proteins for the bioenergy, industrial enzyme, and biopharmaceutical industries. The Company derives all of its revenues from the licensing of its technologies, the sale of its enzymes and conducting research and development (R&D) activities for third parties. The Company operates in two segments: the United States operations and The Netherlands operations. The United States segment includes a subsidiary in Poland.
The United States operating segment is a developer, manufacturer and distributor of enzyme products, proteins, peptides and other bio-molecules derived from genes and a collaborative licensor of enabling technologies for the development and manufacturing of biological products and use in R&D. The Netherlands operating segment is also a researcher and developer of enzyme products, proteins, peptides and other bio-molecules derived from genes and, to date, has mainly invested in R&D activities.
Dyadic�� R&D activities focus on its fungal strains and associated technologies. Dyadic uses its Trichoderma and C1 fungal strains in the production of its industrial enzymes. Dyadic manufactures and sells liquid and dry enzyme products to global customers for use within the animal feed, pulp and paper, starch and alcohol, food and brewing, textiles, and biofuels industries.
Dyadic also utilizes a technology platform based on its patented and C1 fungus (the C1 Platform Technology), which enables the development and manufacture of proteins and enzymes for diverse market opportunities. The C1 Platform Technology can also be used to screen for the discovery of novel genes and proteins. The C1 Platf! orm Technology also has the potential of developing and producing other biological products such as antibodies, vaccines, proteins and polypeptides for the biopharmaceutical industry.
Top 10 Biotech Companies To Watch For 2014: Sanofi(SNY)
sanofi-aventis engages in the discovery, development, and distribution of therapeutic solutions to improve the lives of everyone. The company offers a range of healthcare assets, including a broad-based product portfolio in prescription drugs, OTC/OTX, generics, vaccines, and animal health. It has a strategic alliance with Regulus Therapeutics Inc. to discover, develop, and commercialize micro-RNA therapeutics, initially in fibrosis. The company was founded in 1970 and is headquartered in Paris, France.
Advisors' Opinion:- [By Charles Rice, Associate Editor - November 6, 2013 Money Morning]
By acquiring Brazil's Medley Pharmaceuticals in 2009, Sanofi SA (NYSE ADR: SNY) became the largest generic pharmaceutical manufacturer in Latin America. The company holds a 12% market share in Brazil and reported annual revenue for its generics business of around $2.4 billion, a 5% increase over 2011 in constant exchange rates. Sanofi reported 2012 earnings of approximately $46 billion.
- [By Stephen Simpson, CFA]
If there's a downside to Lexicon's partnering opportunities, it's that there aren't many obvious partners left. Unless one of the existing companies in the SGLT space chose to abandon an existing partnership, Novo Nordisk, Roche (RHHBY.OB), and Takeda may be the best candidates to partner with Lexicon, and that's the sort of limited pool that can lead to hard bargaining. Sanofi (SNY) may also belong in this pool as well, though. While the company did reach a licensing agreement with Chugai for an SGLT2 inhibitor in Japan, that agreement was limited in scope and the drug does not appear on Sanofi's August 2013 pipeline chart.
Top 10 Biotech Companies To Watch For 2014: ArQule Inc.(ARQL)
ArQule, Inc., a clinical-stage biotechnology company, engages in the research and development of cancer therapeutics directed toward molecular targets and biological processes. Its lead product ARQ 197 is non-adenosine triphosphate competitive inhibitor of the c-Met receptor tyrosine kinase, which is being evaluated as monotherapy and in combination therapy in a Phase II clinical development program that includes trials in non-small cell lung cancer, c-Met-associated soft tissue sarcomas, pancreatic adenocarcinoma, hepatocellular carcinoma, germ cell tumors, and colorectal cancer. The company is also developing ARQ 621, a Phase I program focused on inhibition of the Eg5 kinesin spindle protein. Its clinical stage products include ARQ 501, ARQ 761, and ARQ 171, which are designed to kill cancer cells selectively while sparing normal cells through the direct activation of DNA damage response/checkpoint pathways. In addition, the company involves in pre-clinical development o f B-RAF and AKIP Kinase inhibitors. The company has collaborations with Kyowa Hakko Kirin Co., Ltd. and Daiichi Sankyo Co., Ltd. ArQule, Inc. was founded in 1993 and is headquartered in Woburn, Massachusetts.
Top 10 Biotech Companies To Watch For 2014: Cellular Dynamics International Inc (ICEL)
Cellular Dynamics International, Inc., incorporated on November 16, 2007, develops and manufactures fully functioning human cells in industrial quantities to precise specifications. The Company�� iCell Operating System (iCell O/S) includes true human cells in multiple cell types (iCell products), human induced pluripotent stem cells (iPSCs) and custom iPSCs and iCell products (MyCell products). Customers use its iCell O/S products, among other purposes, for drug discovery and screening; to test the safety and efficacy of their small molecule and biologic drug candidates; for stem cell banking; and in researching cellular therapeutics. The Company�� iCell product line includes four different cell types: cardiomyocytes, neurons, hepatocytes and endothelial cells. The Company is actively developing an additional seven different cell types. iCell products are a consumable designed to be used once and then reordered.
The Company manufactures its iCell products from its iPSCs. An iPSC is a cell that has the ability both to replicate indefinitely and to be transformed into any cell type in the human body. The Company�� iCell O/S consists of six products, which include iCell Cardiomyocytes, iCell Neurons, iCell Endothelial Cells, iCell Hepatocytes and MyCell.
Advisors' Opinion:- [By John Udovich]
Stem cells may not be in the news much�as the sector has moved beyond the use of embryotic�ones, but small cap stem cell stocks Cellular Dynamics International Inc (NASDAQ: ICEL), International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX) have been fairly active over the past several trading days as ICEL went public, ISCO raised additional funding and BRTX grabbed more attention:
Top 10 Biotech Companies To Watch 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.
Top 10 Biotech Companies To Watch For 2014: Gentium SpA(GENT)
Gentium S.p.A., a biopharmaceutical company, focuses on the development and manufacture of its primary product candidate, defibrotide, an investigational drug based on a mixture of single-stranded and double-stranded DNA extracted from pig intestines. It develops defibrotide for the treatment and prevention of hepatic veno-occlusive disease (VOD), a condition that occurs when veins in the liver are blocked as a result of cancer treatments, such as chemotherapy or radiation, that are administered prior to stem cell transplantation. The company has completed a Phase III clinical trial of defibrotide for the treatment of severe VOD in the United States, Canada, and Israel; and a Phase II/III pediatric trial in Europe for the prevention of VOD. It also offers sulglicotide that is developed from swine duodenum, and has ulcer healing and gastrointestinal protective properties in South Korea; and urokinase, which is made from human urine to treat various vascular disorders, such as deep vein thrombosis and pulmonary embolisms. The company was formerly known as Pharma Research S.r.L. and changed its name to Gentium S.p.A. in July 2001. Gentium S.p.A. was founded in 1993 and is headquartered in Villa Guardia, Italy.
Advisors' Opinion:- [By Jake L'Ecuyer]
Shares of Jazz Pharmaceuticals Public Limited Company (NASDAQ: JAZZ) got a boost, shooting up 7.77 percent to $123.65 after the company announced its plans to buy Gentium SpA (NASDAQ: GENT) for around $1 billion.
- [By James Oberweis]
Gentium Spa (GENT) is focused on the development and commercialization of its leading product, defibrotide, to treat certain complications arising from chemotherapy, and bone marrow and stem cell transplantation therapy.
Top 10 Biotech Companies To Watch For 2014: InterMune Inc.(ITMN)
InterMune, Inc., a biopharmaceutical company, engages in the research, development, and commercialization of therapies in pulmonology and fibrotic diseases. In pulmonology, the company focuses on therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. It markets pirfenidone, an orally active drug that inhibits the synthesis of TGF-beta under the Esbriet name in the European Union, as well as in a Phase III clinical trial in the United States. Pirfenidone is also approved for the treatment of IPF in Japan, where it is marketed by Shionogi & Co. Ltd. under the Pirespa trade name. The company?s research programs focus on the discovery of small-molecule therapeutics and biomarkers to treat and monitor serious pulmonary and fibrotic diseases. InterMune, Inc. was founded in 1998 and is headquartered in Brisbane, California.
Advisors' Opinion:- [By Rich Smith]
On Thursday, the Securities and Exchange Commission charged a former vice president of finance, accounting officer, and controller of InterMune (NASDAQ: ITMN ) with insider trading.
- [By Ben Levisohn]
Markey rates the stock a Buy with an $11 price target. Shares of MannKind have jumped 14% to $7.85 today. The SPDR Biotech ETF (XBI) has gained 0.7% to $119.85 today, while Alnylam Pharmaceuticals (ALNY) has gained 1% to $49.05, NPS Pharmaceuticals (NPSP) has fallen 4.1% to $23.56, and InterMune (ITMN) has risen 2.6% to $14.89.
- [By Brian Pacampara]
What: Shares of biotechnology company Intermune (NASDAQ: ITMN ) surged 13% today after its quarterly results and outlook topped Wall Street expectations.
Top 10 Biotech Companies To Watch For 2014: Transition Therapeutics Inc.(TTHI)
Transition Therapeutics Inc., a biopharmaceutical company, develops novel therapeutics for various disease indications primarily in Canada. Its lead products include ELND005 (AZD-103), a Phase II clinical trial product for the treatment of Alzheimer?s disease; TT-301 and TT-302, which are Phase I clinical trial products, for the treatment of rheumatoid arthritis, Alzheimer?s disease, traumatic brain injury, and intracerebral hemorrhage; and TT401/402, a preclinical stage product to treat diabetes. The company also has an emerging pipeline of preclinical and clinical drug candidates for the treatment of anti-inflammatory and metabolic indications. It has strategic collaborations with Elan Pharma International Limited to develop and commercialize ELND005 (AZD-103); and a licensing and collaboration agreement with Eli Lilly and Company to develop and commercialize gastrin based therapies, and the preclinical compound TT401/402. The company was formerly known as Transition T herapeutics and Diagnostics Inc. and changed its name to Transition Therapeutics Inc. on December 2000. Transition Therapeutics Inc. was founded in 1987 and is headquartered in Toronto, Canada.
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