Geneos Wealth Management announced Tuesday that Ryan Diachok has been named president of the Denver-based independent broker-dealer; Russ Diachok will give up the presidency but remain CEO of the firm, which has 275 producing reps.
Ryan Diachok, 35, is the nephew of Russ Diachok, 56, who with his father, George Diachok, founded Geneos in 2003 after selling the IBD Multi Financial to ING (Multi is now part of Cetera).
In an interview, Russ Diachock said the promotion was a “natural progression for family-run firms” and reflected the “fantastic job” that Ryan Diachok has done in his 15 years at the firm, especially working with advisors, in recruiting and serving as liaison with Geneos’ product and strategic partners.
“Ryan started at the bottom — I stuck him the mailroom — but he was one of my strategic partners early on,” Russ Diachok said. “Ryan will continue to oversee what he’s been doing,” notably in recruiting, “while I’ll be spending a little less time in the office.”
Top 10 Biotech Stocks To Buy For 2014: Ophthotech Corp (OPHT)
Ophthotech Corporation, incorporated on January 05, 2007, is a biopharmaceutical company specializing in the development of therapeutics to treat diseases of the eye. The Company’s advanced product candidate is Fovista, which the Company is developing for use in combination with anti-VEGF drugs that represent the current standard of care for the treatment of wet age-related macular degeneration (wet AMD). Wet AMD is a serious disease of the central portion of the retina, known as the macula, which is responsible for detailed central vision and color perception. It is characterized by abnormal new blood vessel formation and growth, referred to as neovascularization, which results in blood vessel leakage, retinal distortion and scar formation. If untreated, the progressive retinal damage results in rapid, irreversible and severe vision loss. Wet AMD is the cause of blindness in patients over the age of 55 in the United States and the European Union.
The anti-V EGF market for the treatment of wet AMD consists predominantly of two drugs that are approved for marketing and primarily prescribed for the treatment of wet AMD, Lucentis and Eylea, and off-label use of the cancer therapy Avastin. The use of anti-VEGF drugs has significantly improved visual outcomes for patients with wet AMD who have been treated with these drugs as compared to untreated patients.
- [By John Udovich]
Yesterday, small cap biotech Acceleron Pharma Inc (NASDAQ: XLRN) rose 9.76% plus shares are up 183.6% for retail investors since its September IPO, meaning its worth taking a closer look at the stock along with the performance of other biotech IPOs like BIND Therapeutics Inc (NASDAQ: BIND), Ophthotech Corp (NASDAQ: OPHT) and Foundation Medicine Inc (NASDAQ: FMI) which also debuted at the same time.
- [By John Udovich]
The biotech sector has been pretty exciting this year with small cap biotech stocks Prana Biotechnology Limited (NASDAQ: PRAN) and TNI BioTech (OTCMKTS: TNIB) having recently produced noteworthy news for investors while Acceleron Pharma, Inc (NASDAQ: XLRN), Ophthotech (NASDAQ: OPHT) and BIND Therapeutics (NASDAQ: BIND) have just set term sheets for their upcoming IPOs. Just consider all of the following recent news:
- [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 10 Biotech Stocks To Buy For 2014: 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.
- [By Selena Maranjian]
Companies that stand a good chance of surging in coming years are also good Roth candidates. Exelixis (NASDAQ: EXEL ) , for example, is a smallish biotech company tackling various cancers. It even has an approved thyroid cancer drug on the market, and the formula may end up approved to treat other conditions, as well. The downside, though, is that the drug is expensive, and the segment of thyroid-cancer patients who might take it is very small.
- [By Sean Williams]
Where investment dollars are headed
Thyroid cancer is treated in nearly every case with a full or partial thyroid removal since the majority of thyroid cancers aren’t aggressive. However, in those rare cases where surgery isn’t an option or the disease has metastasized to other parts of the body, there are two drugs approved by the Food and Drug Administration to choose from.
Caprelsa: AstraZeneca’s (NYSE: AZN ) Caprelsa was approved to treat unresectable, locally advanced, or metastatic medullary thyroid cancer in April 2011. In trials, AstraZeneca’s pill increased progression-free survival over the placebo and delivered an overall response rate of 44%, compared with just 1% for the placebo — although it should be noted that all responses were partial. However, Caprelsa also comes with a laundry list of side effects that range from something as simple as rash, nausea, and hypertension, to having resulted in death from respiratory arrest and cardiac failure with arrhythmia. Cometriq: Exelixis’ (NASDAQ: EXEL ) Cometriq was approved last November to treat progressive metastatic medullary thyroid cancer. The capsules work by inhibiting multiple tyrosine kinases, which are crucial to blood vessel growth in solid and metastasizing tumors. In late-stage trials, patients receiving Cometriq demonstrated an astounding 11.2 months of progression-free survival compared with just four months for the placebo. Further, the objective response rate was 27% in the Cometriq arm and a goose egg for the placebo arm. Similar to AstraZeneca’s Caprelsa, severe adverse reactions tended to increase for Cometriq users relative to the placebo.
Just as we’ve witnessed with every previous cancer in this series, not every drug trial proves successful. Pfizer’s (NYSE: PFE ) Sutent, for instance, is a very successful treatment for kidney cancer, gastrointestinal stromal tumors, and pancreatic endocrine tumors, but it didn’t fare as wel
Top 10 Biotech Stocks To Buy For 2014: Prosensa Holding NV (RNA)
Prosensa Holding N.V., formerly Prosensa Holding B.V., is a biotechnology company engaged in the discovery and development of ribonucleic acid-modulating (RNA)-modulating, therapeutics for the treatment of genetic disorders. The Company’s primary focus is on rare neuromuscular and neurodegenerative disorders with a large unmet medical need, including Duchenne muscular dystrophy, myotonic dystrophy and Huntington’s disease. The Company’s clinical portfolio of RNA-based product candidates is focused on the treatment of Duchenne muscular dystrophy (DMD). The Company’s platform technology allows the development of RNA-modulating therapeutics that either interferes with splicing (exon skipping, exon inclusion, or splice mutation correction), remove mutant RNA, or block RNA expression, for different indications.
DMD is a rare, severe muscle wasting disease that occurs in up to 1 in 3,500 male births. It is commonly diagnosed between the ages of three to five , when boys begin to show signs of impaired motor development. PRO044, the Company’s product candidate, addresses a separate sub-population of DMD patients. The Company developed PRO044 using its exon-skipping technology to generate a product candidate with the same mechanism of action that is used by drisapersen.
- [By Leo Sun]
However, these three biotech stocks — Amarin (NASDAQ: AMRN ) , Dendreon (NASDAQ: DNDN ) , Prosensa (NASDAQ: RNA ) — don’t fit that category at all. Read on to understand why these dogs of the sector should never be mistaken as underdogs.
- [By Sean Williams]
Shares of Sarepta climbed to a 52-week high of $55.61 in September shortly after an experimental rival drug, drisapersen, developed by Prosensa (NASDAQ: RNA ) and GlaxoSmithKline (NYSE: GSK ) , missed its primary end point by a mile in late-stage trials. However, Sarepta also tanked just weeks later after the Food and Drug Administration decided against supporting an accelerated drug approval for eteplirsen; the agency would not make the connection that increased dystrophin production led to its remarkable trial results. Also, given the recent failure of drisapersen in a phase 3 study, the FDA felt it pertinent that Sarepta engage in a broader study. Shares ultimately dipped as low as $12.12.
- [By John Udovich]
It should also be mentioned that earlier in the week, GlaxoSmithKline plc (NYSE: GSK) returned full rights of Duchenne muscular dystrophy drug drisapersen to their partner Prosensa Holding NV (NASDAQ: RNA) and that news sent shares down 12.48% on Monday. Moreover, Prosensa Holding also sank some 70% last fall when Drisapersen failed a phase 3 trial by missing a primary endpoint measuring for how far patients could walk over the course of six minutes (the improvement wasn’t significantly better than the placebo). However, Prosensa Holding also rose 24.37% yesterday after announcing initial findings from further analyses from the aggregate data for drisapersen, with the CEO saying:
Top 10 Biotech Stocks To Buy 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’s 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’s human liver cells as a therapeutic product.
The Company in its CNS Program, is in cli nical 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’s 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’s 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’s 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 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’s 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 a nd 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’s 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 an tibody that recognizes human glial fibrillary acidic protein (GFAP).
The Company’s 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.
- [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.
Top 10 Biotech Stocks To Buy For 2014: Prima BioMed Ltd (PBMD)
Prima BioMed Ltd is a biotechnology company is engaged in the development and commercialization of medical therapies with a focus on oncology. Its product candidates in development include Cvac, an autologous dendritic cell vaccine for ovarian cancer, monoclonal antibodies for multiple tumour types, and an oral formulation for the human papilloma virus (HPV), vaccine. Its product candidate Cvac is a dendritic cell therapy, for which it is conducting a Phase IIb trial for the treatment of ovarian cancer. Cvac is designed to target the tumour antigen mucin-1, which is expressed at high levels on different tumour types. It also has two preclinical product development programs. In May 2011, Prima BioMed GmbH, a 100 % owned subsidiary of Prima BioMed Ltd, was incorporated in Germany. In May 2011, Prima BioMed Middle East FZLLC, a 100 % owned subsidiary of Prima BioMed Ltd, was incorporated in the United Arab Emirates. Advisors’ Opinion:
- [By Bryan Murphy]
Were it the first time, or even the second time, it happened, it might be dismissible. A third time though? As they say, the third time is the charm. If the old saying applies in the worlds of small cap stocks (and it usually does), then Prima Biomed Ltd. (NASDAQ:PBMD) just kick-started what could be a trade-worthy rally.
- [By Monica Gerson]
Prima Biomed (NASDAQ: PBMD) shares dipped 38.59% to touch a new 52-week low of $1.44 after the company reported top-line analysis of CVac Phase 2 trial.
Top 10 Biotech Stocks To Buy For 2014: Johnson & Johnson(JNJ)
Johnson & Johnson engages in the research and development, manufacture, and sale of various products in the health care field worldwide. The company operates in three segments: Consumer, Pharmaceutical, and Medical Devices and Diagnostics. The Consumer segment provides products used in baby care, skin care, oral care, wound care, and women?s health care fields, as well as nutritional, over-the-counter pharmaceutical products, and wellness and prevention platforms under the brands of JOHNSON?S, AVEENO, CLEAN & CLEAR, JOHNSON?S Adult, NEUTROGENA, RoC, LUBRIDERM, DABAO, LISTERINE, REACH, BAND-AID, CAREFREE, STAYFREE, SPLENDA, TYLENOL, SUDAFED, ZYRTEC, MOTRIN IB, and PEPCID AC. The Pharmaceutical segment offers products in various therapeutic areas, such as anti-infective, antipsychotic, contraceptive, dermatology, gastrointestinal, hematology, immunology, neurology, oncology, pain management, and virology. Its principal products include REMICADE for the treatment of immune me diated inflammatory diseases; STELARA for the treatment of moderate to severe plaque psoriasis; SIMPONI, a treatment for adults with moderate to severe rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis; VELCADE for the treatment of multiple myeloma; PREZISTA and INTELENCE for treating HIV/AIDS patients; NUCYNTA for moderate to severe acute pain; INVEGA SUSTENNAtm for the acute and maintenance treatment of schizophrenia in adults; RISPERDAL CONSTA for the management of bipolar I disorder and schizophrenia; and PROCRIT to stimulate red blood cell production. The Medical Devices and Diagnostics segment primarily offers circulatory disease management products; orthopaedic joint reconstruction, spinal care, and sports medicine products; surgical care, aesthetics, and women?s health products; blood glucose monitoring and insulin delivery products; professional diagnostic products; and disposable contact lenses. The company was founded in 1886 and is based in N e w Brunswick, New Jersey.
- [By Patricio Kehoe]
Johnson & Johnson (JNJ) comes in next, the fund owning over 235,000 shares, worth $21.5 million. The company operates in a highly competitive industry, including companies such as Novartis AG (NVS) and Pfizer Inc. (PFE). The company reported earnings per share increased by 32.5% compared to the same quarter one year prior, and has demonstrated a pattern of positive earnings per share growth over the past two years. The company returns cash to investors, and its current dividend yield is 2.83%, which is considered quite enough to protect the purchasing power.
- [By Vanina Egea]
In Johnson & Johnson (JNJ) Blackhill disclosed ownership of over 206,560 shares, worth $18.9 million. The company reported earnings per share increased by 32.5% compared to the same quarter one year prior, and has demonstrated a pattern of positive earnings per share growth over the past two years. The company returns cash to investors: Its current dividend yield is 2.83%, which is considered quite enough to protect the purchasing power.
Top 10 Biotech Stocks To Buy For 2014: Oramed Pharmaceuticals Inc (ORMP)
Oramed Pharmaceuticals Inc., incorporated on March 10, 2011, is a development-stage pharmaceutical company. The Company is engaged in the research and development of pharmaceutical solutions, including an orally ingestible insulin capsule or tablet to be used for the treatment of individuals with diabetes, use of orally ingestible capsules, tablets or pills for delivery of other polypeptides. The Company owns oral dosage form drug portfolio, it is, on an on-going basis, considering in-licensing and other means of obtaining additional technologies to complement and/or expand the product portfolio. The Company’s products include ORMD-0801 – Oral Insulin Capsule and ORMD-0901 – Oral Exenatide.
The Company focuses to conduct research and development on the technology covered by the patent application Methods and Composition for Oral Administration of Proteins. Through its research and development efforts, it focuses to develop an oral dosage form that will with stand the chemical environment of the stomach and intestines and will be effective in delivering active insulin for the treatment of diabetes. It intends to conduct the clinical trials to file an Investigational New Drug (IND), application with the United States Food and Drug Administration (FDA). It also focuses to conduct research and development by deploying its drug delivery technology for the delivery of other polypeptides in addition to insulin, and to develop other pharmaceutical products.
- [By Lisa Levin]
Oramed Pharmaceuticals (NASDAQ: ORMP) shares moved up 15.68% to $17.85. The volume of Oramed Pharmaceuticals shares traded was 971% higher than normal. Oramed received patent allowance in Israel, Australia for platform technology in oral delivery of proteins.
- [By Ben Levisohn]
Oramed Pharmaceuticals (ORMP) has dropped 19% to $12.11 after the company said it would sell nearly 1.6 million shares of stock for $10 a share.
BP plc (BP) has fallen 0.7% to $47.24 after a U.S. judge refused its request to revise the way damages from the Deepwater Horizon oil spill are calculated.
Top 10 Biotech Stocks To Buy For 2014: Celgene Corp (CELG)
Celgene Corporation is a global biopharmaceutical company primarily engaged in the discovery, development and commercialization of therapies designed to treat cancer and immune-inflammatory related diseases. The Company is engaged in the research and development, which is designed to bring new therapies to market, and is engaged in research in several scientific areas that may deliver therapies, focusing areas, such as intracellular signaling pathways in cancer and immune cells, immunomodulation in cancer and autoimmune diseases, and therapeutic application of cell therapies. The Company’s primary commercial stage products include REVLIMID, VIDAZA, THALOMID, ABRAXANE and ISTODAX. Additional sources of revenue include a licensing agreement with Novartis, which entitles it to royalties on FOCALIN XR and the entire RITALIN family of drugs, the sale of services through its Cellular Therapeutics subsidiary and other miscellaneous licensing agreements. In March 2012, it acquir ed Avila Therapeutics.
The Company invests in research and development, and the drug candidates in its pipeline at various stages of preclinical and clinical development. These candidates include pomalidomide and apremilast, its oral anti-cancer and anti-inflammatory agents, PDA-001, its cellular therapy, oral azacitidine, CC-223 and CC-115 for hematological and solid tumor malignancies, CC-122, its anti-cancer pleiotropic pathway modifier, and ACE-011 and ACE-536 biological products for anemia in several clinical settings of unmet need. Celgene product candidates include Pomalidomide (CC-4047), Oral Anti-Inflammatory: Apremilast (CC-10004), CC-11050, Kinase Inhibitors:Tanzisertib (CC-930), Cellular Therapies: PDA-001, Activin Biology: Sotatercept (ACE-011) ACE-536, and Anti-tumor Agents: CC-22, CC-115, CC-122 and Oral Azacitidine. It owns and operates a manufacturing facility in Zofingen, Switzerland. The Company also owns and operates a drug product manufactur ing facility in Boudry, Switzerland.
Commercial! Stage Products
REVLIMID (lenalidomide) is an oral immunomodulatory drug marketed in the United States and many international markets, in combination with dexamethasone, for treatment of patients with multiple myeloma who have received at least one prior therapy. It is also marketed in the United States and certain international markets for the treatment of transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID is distributed in the United States through contracted pharmacies under the RevAssist program, which is a risk-management distribution program. Internationally, REVLIMID is distributed under mandatory risk-management distribution programs.
REVLIMID continues to be evaluated in numerous clinical trials worldwide either alone or in combination with one or more other therapies in the treatm ent of a range of hematological malignancies, including multiple myeloma (MDS) various lymphomas, chronic lymphocytic leukemia (CLL) other cancers and other diseases. VIDAZA (azacitidine for injection) is a pyrimidine nucleoside. VIDAZA is a Category 1 recommended treatment for patients with intermediate-2 and high-risk MDS and is marketed in the United States for the treatment of all subtypes of MDS. In Europe, VIDAZA is marketed for the treatment of intermediate-2 and high-risk MDS, as well as acute myeloid leukemia (AML) with 30% blasts and has been granted orphan drug designation for the treatment of MDS and AML.
THALOMID (thalidomide) is marketed for patients with newly diagnosed multiple myeloma and for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) an inflammatory complication of leprosy and as maintenance therapy for prevention and suppression of the cutaneous manifestation of ENL recurrence. THA LOMID is distributed in the United States under its System f! or Thalid! omide Education and Prescribing Safety (S.T.E.P.S.) program. Internationally, THALOMID is also distributed under mandatory risk-management distribution programs. ABRAXANE (paclitaxel albumin-bound particles for injectable suspension) is a solvent-free chemotherapy treatment option for metastatic breast cancer, which was developed using its nab technology platform. This protein-bound chemotherapy agent combines paclitaxel with albumin. As of December 31, 2011, ABRAXANE was in various stages of investigation for the treatment of expanded applications for metastatic breast; non-small cell lung; malignant melanoma; pancreatic; bladder and ovarian.
ISTODAX (romidepsin) has received orphan drug designation for the treatment of non-Hodgkin’s T-cell lymphomas, which includes CTCL and PTCL. The Company has licensed the worldwide rights (excluding Canada) regarding certain chirally pure forms of methylphenidate for FOCALIN and FOCALIN XR to Novartis. It also licensed to N ovartis the rights related to long-acting formulations of methylphenidate and dex-methylphenidate products which are used in FOCALIN XR and RITALIN LA.
Preclinical and Clinical-Stage Pipeline
The product candidates in the Company’s pipeline are at various stages of preclinical and clinical development. Pomalidomide is a small molecule that is orally available and modulates the immune system and other biologically important targets. Pomalidomide is being evaluated in a phase III clinical trial for the treatment of myelofibrosis and a phase III clinical trial evaluating pomalidomide as a treatment for patients with relapsed/refractory multiple myeloma is accruing patients.
The Company is developing a product, ORAL ANTI-INFLAMMATORY AGENTS, which is orally available small molecules that target PDE4, an intracellular enzyme that modulates the production of multiple pro-inflammatory and anti-inflammatory mediators, including interleukin-2 (IL-2), IL-10, IL-12, IL-23, INF-gamma, TNF-a, leukotrienes,! and nitr! ic oxide synthase. Its investigational drug, apremilast (CC-10004), is used for the treatment of moderate to severe psoriasis and active psoriatic arthritis and is being evaluated in a phase II trial for rheumatoid arthritis and six phase III multi-center international clinical trials. In addition, it is investigating its oral PDE4 inhibitor, CC-11050, which is an anti-inflammatory compound that treat a variety of chronic inflammatory conditions, such as Cutaneous Lupus Erythematosus (CLE).
The Company’s oral kinase inhibitor platform includes inhibitors of the c-Jun N-terminal kinase (JNK) mTOR kinase, spleen tyrosine kinase (Syk) c-fms tyrosine kinase (c-FMS) and DNA-dependent protein kinase (DNAPK). Its oral Syk, c-FMS and DNAPK kinase inhibitors are being investigated in pre-clinical studies. The Company’s new second generation JNK inhibitor, tanzisertib (CC-930), is being evaluated in a phase II trial for the treatment of idiopathic pulmonary fibrosis a nd a phase II trial for the treatment of discoid lupus is accruing patients. Amrubicin is a third-generation fully synthetic anthracycline molecule with potent topoisomerase II inhibition.
At Celgene Cellular Therapeutics (CCT), it is researching stem cells derived from the human placenta, as well as from the umbilical cord. CCT is the Company’s research and development division. Stem cell based therapies provide disease-modifying outcomes for serious diseases, which lack adequate therapy. It has developed technology for collecting, processing and storing placental stem cells with broad therapeutic applications in cancer, auto-immune diseases, including Crohn’s disease, multiple sclerosis, neurological disorders, including stroke and amyotrophic lateral sclerosis (ALS), graft-versus-host disease, and other immunological / anti-inflammatory, rheumatologic and bone disorders.
The Company has collaborated with Acceleron Pharma, Inc. (Acceleron) to de velop sotatercept. Two phase I clinical studies have been co! mpleted. ! An additional phase II clinical study has been initiated and is ongoing related to treatments for end-stage renal anemia and to evaluate effects on red blood cell mass and plasma volume.
The Company competes with Abbott Laboratories, Amgen Inc. (Amgen), AstraZeneca PLC., Biogen Idec Inc., Bristol-Myers Squibb Co., Eisai Co., Ltd., F. Hoffmann-LaRoche Ltd., Johnson and Johnson, Merck and Co., Inc., Novartis AG, Pfizer, Sanofi and Takeda Pharmaceutical Co. Ltd. (Takeda).
- [By DailyFinance Staff]
Stocks bounced in and out of the plus column before picking a direction on Friday. Unfortunately, the path chosen was down again, though not far. The Dow Jones industrial average (^DJI) extended its losing streak to five days, dropping another 43 points. The Standard & Poor’s 500 (^GSPC) fell 5 and the Nasdaq composite (^IXIC) lost 15 points. In all, each of the major averages lost in the neighborhood of a quarter of a percent Friday, and all lost ground for the week. Meanwhile, another once-popular teen retailer took a tumble. Shares of Aeropostale (ARO) tumbled 20 percent after the retailer posted a wider than expected quarterly loss. The stock is now down 60 percent over the past year. But investors were buying some other retailers. Zumiez (ZUMZ), also geared toward teens, rose 2½ percent despite forecasting a loss in the current quarter. A couple of chains geared toward women did well. Ulta Salon (ULTA) gained nearly 6½ percent as earnings topped expectations. Ann (ANN), best known for its Ann Taylor stores, rose 7½ percent. And Coach (COH) gained 2 percent. Other gainers today: Green Mountain (GMCR), maker of Keurig, was up 7 percent, after expanding its deal with Starbucks. Liberty Media (LSTZA) ended its deal to buy those shares of Sirius XM (SIRI) it doesn’t already own. Both stocks gained on the news; Liberty up 7 percent, Sirius up 2 percent. And Castlight Health (CSLT) soared nearly 150 percent above its $16 a share IPO price. The company, which helps workers choose healthcare benefits, stands to gain from Obamacare. On the downside: Tesla (TSLA) lost another 3 percent on reports that New York could become the fifth state to block the company from selling direct to consumers. Still, Tesla has a pretty good track record. It’s stock has soared more than 500 percent over the past year. Biotechs continued to lose ground. Celgene (CELG) fell 4 percent on a double dose of bad news. British regulators reportedly plan to rejec
- [By Ben Levisohn]
Shares of Gilead (GILD) and Celgene (CELG) have tumbled today after both companies revealed that they were facing patent pressures.
For Gilead, Idenix Pharmaceuticals (IDIX) filed a patent-infringement lawsuit that appears to target Gilead’s Sovaldi (someone please correct me if I’m wrong). For Celgene, it was the decision of a New Jersey court to schedule a hearing on a patent case for April 29, earlier than expected. It hasn’t helped that the UK’s National Institute for Health and Care Excellence also said that Celgene’s Revlimid doesn’t work well enough to be covered for “second line treatment of multiple myeloma.”
- [By Ben Levisohn]
Shares of Gilead Sciences has dropped 1.3% to $81.52 at 10:33 a.m., while Amgen (AMGN) has fallen 0.3% to $123.78, Biogen Idec (BIIB) has gained 0.8% to $331.07 and Celgene (CELG) has risen 1.1% to $166.59. The SPDR S&P Biotech ETF (XBI) has advanced 0.6% to $153.43.
- [By Ben Levisohn]
Shares of Gilead have gained 2.4% to $80.64 at 2:31 p.m., easily outpacing Amgen (AMGN), which has risen 0.6% to $119.64, Biogen Idec (BIIB), which has advance0.5% to $317.14 and Celgene, (CELG) is off 0.1% to $156.75. The SPDR S&P Biotech ETF (XBI) has fallen jumped 2.6% to $153.43.
Top 10 Biotech Stocks To Buy For 2014: Cubist Pharmaceuticals Inc.(CBST)
Cubist Pharmaceuticals, Inc., a biopharmaceutical company, focuses on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. The company markets CUBICIN (daptomycin for injection), a once-daily, bactericidal, intravenous, antibiotic with activity against gram-positive organisms, including methicillin-resistant staphylococcus aureus. Its clinical development product pipeline consists of CXA-201, which is in the phase III clinical trial for patients with complicated urinary tract infections; and in phase II clinical trial for patients with complicated abdominal infections. The company is also developing CXA-201 for the treatment of hospital acquired pneumonia. In addition, its product under development comprises CB-183,315, an oral, bactericidal lipopeptide with in vitro bactericidal activity against C. difficile, for the treatment of clostridium difficile-associated diarrhea (CDAD). Further , the company?s pre-clinical programs include therapies to treat various bacterial infections and agents to treat acute pain. Additionally, it promotes MERREM I.V. (meropenem for injection), a carbapenem class intravenous antibiotic, in the United States under a commercial services agreement with AstraZeneca Pharmaceuticals, LP; and DIFICID as the treatment for CDAD in adults under the co-promotion agreement with Optimer Pharmaceuticals, Inc. The company also has collaborations with Forma Therapeutics, Inc. to discover and develop antibacterial compounds; an agreement with the Broad Institute to transform natural products discovery; a collaboration with Hydra Biosciences, Inc., to develop ion channel drugs; and a collaboration agreement with Alnylam Pharmaceuticals, Inc., for the development and commercialization of Alnylam’s RNAi therapeutics as a therapy for the treatment of respiratory syncytial virus. The company was founded in 1992 and is headquartered in Lexington, Ma s sachusetts.
- [By Sean Williams]
What: Shares of Cubist Pharmaceuticals (NASDAQ: CBST ) , a biopharmaceutical company devoted to developing acute care therapies, added 12% following the announcement of its second-quarter earnings results.
- [By Jake Keator]
Shares of Cubist Pharmaceuticals (NASDAQ: CBST ) exploded upward on Friday, finishing up over 9%. The company reported strong second-quarter results Thursday, beating average analyst estimates for both revenue and EPS. Total net revenues were $258.8 million, up 12.2% over Q2 2012, while non-GAAP diluted EPS was $0.42. Average analyst estimates were $254.73 million for revenue and EPS of $0.38.
Top 10 Biotech Stocks To Buy For 2014: Medizone International Inc (MZEI)
Medizone International, Inc. (Medizone), incorporated in January 31, 1986, is a development-stage company. The Company is engaged in research into the medical uses of ozone. Medizone focuses in the field of hospital sterilization. It is a research and development company engaged in developing its AsepticSure. The Company is developing an ozone-based technology (AsepticSure) for decontaminating and sterilizing hospital surgical suites, emergency rooms, and intensive care units.
The Company started hospital beta-testing of a prototype system utilizing the original technology. The first round of in-hospital beta-testing for this AsepticSure hospital disinfection system was completed at a Hotel Dieu hospital in Kingston, Ontario, Canada. In addition to the hospital disinfection system, it employs an ozone-destruct unit which is used following disinfection of the treated infrastructure to reverse the O3 gas in the space, and turn it back into O2 in a short period o f time. The Company’s subsidiaries include Medizone Canada, Ltd. (MedCan). As of December 31, 2011, the Company had not generated any revenues.
- [By CRWE]
Today, MZEI surged (+5.64%) up +0.0048 at $.0899 with 21,900 shares in play thus far (ref. google finance Delayed: 1:32PM EDT October 16, 2013).
Medizone International, Inc. previously reported that its WHO award-winning green infection control technology, AsepticSure has been Granted a patent by the United States Patent and Trademark office. (US 61/223,219) titled “Healthcare Facility Disinfecting System”. The AsepticSure infection control system has repeatedly demonstrated 100% microbial kill rates when used to decontaminate hospital rooms of the causative agents of HAI (hospital acquired infections).
“With patent protection now established in the United States, Canada and Singapore and pending applications in process for the 37 member countries of the EU as well as Korea, Japan, China, India, Brazil and Mexico, our patent momentum is clearly gaining strength,” stated Edwin Marshall, Medizone’s CEO.