In the last six months Galena Biopharma, Inc. (GALE) stock has soared over 239%. Galena is a biotechnical company pursuing and developing therapeutics using peptide-based immunotherapy to treat some of the most deadly cancers of today. 2013 brought about a number of positive advancements in both the company and its treatments-- and if January�� announcements, purchases, and partnerships are any indication of where the company and its stock are headed this year, Galena should continue to not just meet, but exceed expectations.
NEUVAX IN CLINICAL TRIALS FOR BREAST AND PROSTATE CANCER
Galena�� flagship drug, the breast cancer therapy NeuVax, is currently in a number of clinical trials. Breast cancer is the most common cancer among women. In 2011 the breast cancer drug market reached $6.8 billion and is expected to rise to $10.9 billion by 2018. According the World Health Organization, there are about 1.4 million new cases diagnosed worldwide each year-- and according to the National Cancer Institute, over 230,000 of these are in the U.S. NeuVax is designed at preventing the recurrence of breast cancer in patients under remission and who are HER2-negative. NeuVax is an E75 peptide derived from HER2, which is then combined with the immune adjuvant granulocyte macrophage colony-stimulating factor (GM-CSF). What NeuVax does is stimulates the CD8+ T cells to target cells that show any level of HER2.
Best Construction Material Companies For 2015: Elan Corporation PLC (ELN)
Elan Corporation, plc (Elan), incorporated in December 1969, is a neuroscience-based biotechnology company. The Company is focused on discovering and developing advanced therapies in neurodegenerative and autoimmune diseases. Elan�� business focuses on neurodegenerative diseases, such as Alzheimer�� disease and Parkinson�� disease; autoimmune diseases, including MS and Crohn�� disease and neo-epitope based targets for treatments across a range of therapeutic indications. Tysabri is a treatment for MS and Crohn�� disease that the Company markets and distributes with Biogen Idec. On September 16, 2011, Elan sold its EDT business to Alkermes, Inc. In November 2011, Elan launched a collaboration with the University of Cambridge, England, the Cambridge-Elan Centre for Research Innovation and Drug Discovery (Cambridge-Elan Centre). On December 21, 2012, the Company completed the demerger of Prothena Corporation plc. In April 2013, it closed the TYSABRI (natalizumab) Collaboration Transaction with Biogen Idec.
Tysabri
Tysabri, which is an alpha-4 integrin inhibitor, is a therapy for MS, a neurological disorder involving central nervous system dysfunction among adults. Tysabri is approved in more than 65 countries. Tysabri is approved in the United States as a monotherapy for relapsing forms of MS, for patients who have had an inadequate response to, or are unable to tolerate, an alternative MS therapy. In the European Union, it is approved for relapsing-remitting MS (RRMS) in adult patients who have failed to respond to beta interferon or have rapidly evolving, severe RRMS. As of December 31, 2011, there were approximately 64,400 patients on Tysabri therapy worldwide.
In June 2011, the European Commission (EC) approved the inclusion of the anti-JCV antibody status as an additional factor in stratifying patients at risk for developing PML in the Summary of Product Characteristics��(SmPC) for Tysabri in the European Union. The Company has developed a two-step ! enzyme-linked immunosorbent assay (ELISA), STRATIFY JCV, with Biogen Idec. The assay detects anti-JCV antibodies in the blood of patients, and is commercially available in Europe. In January 2012, the FDA cleared the assay for commercial use in the United States. As of December 31, 2011, over 80,000 tests had been administered using the assay. Tysabri is marketed and distributed by Elan and Biogen Idec. The Company�� research group, Neotope, is focused on creating monoclonal antibodies based on neo-epitope targets for the treatment of a range of therapeutic indications.
Beta Amyloid Immunotherapies (AIP)
Beta amyloid immunotherapy includes the treatment of Alzheimer�� disease by inducing or enhancing the body�� immune response in order to clear toxic species of beta amyloid from the brain. The AIP includes bapineuzumab (intravenous and subcutaneous delivery) and ACC-001, as well as other compounds. Bapineuzumab is an experimental humanized monoclonal antibody delivered intravenously that is being studied as a treatment for mild to moderate Alzheimer�� disease. It is designed to provide antibodies to beta amyloid directly to the patient (passive immunotherapy).
ELND005, an A� Aggregation Inhibitor
The small molecule ELND005 (Scyllo-inositol) is a beta amyloid anti-aggregation agent. Preclinical data suggest that ELND005 may act through the mechanism of preventing and reversing the fibrilisation of beta amyloid (the aggregation of beta amyloid into clumps of insoluble oligomers). ELND005 may have additional applications in psychiatric indications, such as bipolar disorder. In November 2011, the Company entered into a manufacturing agreement for the supply of the active pharmaceutical ingredient for ELND005 with Lonza Group AG.
Neotope Biosciences Limited
Neotope Biosciences Limited (Neotope) is the Company�� wholly owned subsidiary that focuses on the discovery and development of antibodies to neo-epitope related targ! ets for t! he treatment of a range of indications. It includes amyloidosis, diabetes, cancer and macular degeneration. Neotope�� portfolio of targets includes alpha-synuclein for the potential treatment of synucleinopathies, such as Lewy body dementia and Parkinson�� disease, tau for Alzheimer�� disease and other tauopathies. It also has a program for type 2-diabetes.
Onclave Therapeutics Limited
Elan�� wholly owned subsidiary Onclave Therapeutics Limited (Onclave) was formed to develop assets originating from Elan that have application in oncology related diseases. Onclave�� program, NEOD001, which originated from Neotope, is being investigated for the treatment of AL amyloidosis, which is a fatal disease involving abnormal accumulation of amyloid in organs and tissue. During the year ended December 31, 2011, Onclave filed for orphan drug designation of NEOD001. Onclave�� pipeline includes additional compounds with relevance in diverse cancer indications.
The Company competes with Biogen Idec, Bayer Schering Pharma AG, Bayer Schering Pharma, Merck Serono, Pfizer, Teva Neurosciences, Inc., Sanofi-Aventis and Novartis AG.
Advisors' Opinion:- [By Sean Williams]
Elan (NYSE: ELN )
Having a lot of cash in the biotech sector doesn't mean that a company's clinical trials will translate into success. Elan's claim to fame was the development of multiple sclerosis drug Tysabri, which it licensed out to Biogen Idec (NASDAQ: BIIB ) . Sales of the drug hit $1.6 billion last year. - [By Russ Krull]
Finally, Ireland-based biotech Elan (NYSE: ELN ) issued $850 million of eight-year notes. The money is going to help pay for a royalty stake in some Theravance products. Elan expects the transaction to add to earnings starting in 2014. My Foolish colleagues Sean Williams and Brian Orelli think this might be a better deal for Theravance than for Elan.
- [By Tim Brugger]
After consulting with outside financial advisors, in conjunction with the Elan (NYSE: ELN ) board of directors and executive management team, the Ireland-based biotechnology company has determined the recent $12.50-a-share buyout offer from Royalty Pharma undervalues select Elan assets by as much as $4.3 billion, the company announced Wednesday.
- [By Brian Orelli]
Royalty Pharma announced Monday that it's willing increase the $11-per-share offer it made for Elan (NYSE: ELN ) back in February, depending on the result of Elan's buyback.
Hot Biotech Companies To Watch For 2014: Intercept Pharmaceuticals Inc (ICPT)
Intercept Pharmaceuticals, Inc., incorporated on September 4, 2002, is a biopharmaceutical company focused on the development and commercialization of therapeutics to treat chronic liver diseases utilizing its bile acid chemistry.The Company�� product candidates treat orphan and more prevalent liver diseases for which there are limited therapeutic solutions. The Company�� product candidate, obeticholic acid, or OCA, is a bile acid analog, a chemical substance that has a structure based on a naturally occurring human bile acid. It is developing OCA initially for primary biliary cirrhosis, or PBC, as a second line treatment for patients who have an inadequate response to or who are unable to tolerate standard of care therapy and therefore need additional treatment. The Company is conducting a Phase 3 clinical trial of OCA in PBC, which it calls the POISE trial, that serves as the basis for seeking regulatory approval in the United States and Europe. As of December 19, 2012, the Company completed enrollment of the POISE trial with 217 patients.
The Company�� clinical focus is on the development of OCA, orally administered, first-in-class FXR agonist that has broad liver-protective properties and may a variety of chronic insults to the liver that cause fibrosis, which can eventually lead to cirrhosis, liver transplant and death. The Company owns worldwide rights to OCA outside of Japan and China, where it has licensed the compound to Dainippon Sumitomo Pharma, or DSP, and granted it an option to license OCA in certain other Asian countries.The Company is sponsoring an independent study involving more than ten leading PBC centers in North America and Europe, or collectively the Global PBC Study Group, that are pooling their long-term patient data to evaluate the relationship between biochemical and clinical endpoints.
The Company competes with Eli Lilly, Exelixis, Inc., Phenex Pharmaceuticals AG, , Johnson & Johnson, NovImmune SA, Dr. Falk Pharma GmbH, Galmed Medical Researc! h Ltd., Immuron Ltd., Mochida Pharmaceutical Co., Ltd., NasVax Ltd. , Raptor Pharmaceutical Corp. Astellas Pharma US, Inc., AstraZeneca, Salix Pharmaceuticals, Inc. and Tioga Pharmaceuticals, Inc.
Advisors' Opinion:- [By Ben Levisohn]
Sure Intercept Pharmaceuticals (ICPT) might feel like the only biotech stock that matters today, but there are others. For instance, Incyte (INCY) and� BioMarin (BMRN) are on the move after Barclays changed its ratings on the pair.
REUTERSBut before getting into that, let’s talk about Barclays’ Ying Huang and team’s thoughts on the sector. Would you believe they echo those of Goldman Sachs in its downgrade of the sector earlier this week (and just about everyone else) by calling this a stock picker’s market?
Huang explains:
Biotech should continue to outperform in 2014, but may be a more stock-specific year: We believe biotech as a group will continue to outperform the broad market in 2014 but do not expect a repeat of 2013. In 2013, the Nasdaq Biotech Index outperformed the S&P 500 by a large margin (+65.6% vs. S&P +29.6%), driven by a combination of generalist investor interest, hunt for growth opportunities, healthy long-term outlook for the industry, and an accommodative FDA. While we expect trends to remain strong in the overall industry and for biotech to outperform the broader market in 2014, it will likely be more muted, with fewer meaningful catalysts and as investors favor larger companies with less downside risk.
Huang too falls back on the PEG ratio–Price/Earnings to Growth–while explaining away the sectors P/E of 31.4, which dwarfs the 18 P/E in U.S. pharmaceuticals. “Looking at PEG ratios, which we view as a more appropriate metric given the growth profile of biotech companies, the group has traded at a reasonable and stable 1.0x for the past decade,” Huang says.
As for Incyte and BioMarin, Huang explains why he’s bullish on the former, bearish on the latter:
After taking a closer look at [Incyte's] pipeline assets, we are increasingly bullish on its proprietary JAK1 inhibitor INCB39110 and its IDO inhibitor INCB024360 and have increased ou
- [By Ben Levisohn]
It’s hard not to think it might be. Today, Gilead Sciences (GILD), Intercept Pharmaceuticals (ICPT), Celgene (CELG), Amgen (AMGN) and Vertex Pharmaceuticals (VRTX).
- [By Ben Levisohn]
Intercept Pharmaceuticals (ICPT) has�taken investors on a wild ride this year. After more than quintupling, it’s now up “only” 235% in 2014. And Deutsche Bank thinks it’s time to buy.
Special to The ChronicleDeutsche Bank analyst Alethia Young and team explain why they see “good risk/reward” in Intercept Pharmaceuticals:
Intercept’s lead asset is obeticholic acid (OCA) for treatment of liver diseases like PBC and NASH. Our conviction is based on 1) OCA will take meaningful stake in a large NASH market, 2) full results from the FLINT trial will be supportive of further development from a regulatory & commercial perspective, and 3) we think in the long-term that OCA will be a treatment for many other liver diseases beyond PBC and NASH…
On good data, we think Intercept trades to $336-$404/sh. On bad data, we think Intercept trades to $110-$146/sh. We think shares currently reflect ~35% chance of success for NASH. We see some downside protection in the fact that if NASH fails in Ph2b, the co will likely price PBC higher. We assume $65K, but every $5K in pricing is worth about $9/sh. At 100% success for PBC & NASH, our FV is $518/sh.
Our $395 TP is based on a probability adjusted DCF analysis (-100% terminal growth rate) and 11% discount rate which is in-line with biotech peers.
Shares of Intercept Pharmaceuticals have gained 2.9% to $229.03 at 11:44 a.m. today.
Hot 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:
Hot 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.
Hot Biotech Companies To Watch For 2014: Celsion Corporation(CLSN)
Celsion Corporation, an oncology drug development company, develops and commercializes targeted chemotherapeutic oncology drugs based on its proprietary heat-activated liposomal technology. The company is developing its lead product, ThermoDox that is in Phase III clinical trial for primary liver cancer; and in phase II clinical trial for treatment of recurrent chest wall breast cancer. It has a license agreement with Yakult Honsha to commercialize and market ThermoDox for the Japanese market. The company also has a license agreement with Duke University under which it received exclusive rights to commercialize and use Duke's thermo-liposome technology. In addition, Celsion Corporation has a joint research agreement with Royal Phillips Electronics to evaluate the combination of Phillips' high intensity focused ultrasound with its ThermoDox to determine the potential of this combination to treat a range of cancers. The company was founded in 1982 and is based in Columbia, M aryland.
Advisors' Opinion:- [By EquityOptionsGuru]
The Prolieve Thermodilatation System was actually developed by the current management of Medifocus while employed at Celsion Corporation (NASDAQ:CLSN). The system was also jointly developed with Boston Scientific (NYSE:BSX) before being acquired by Medifocus in July 2012. Prolieve has already received FDA approval, is currently generating revenue, and is the only in office alternative to drug therapy. The system essentially uses microwave energy to treat Benign Prostatic Hyperplasia (BPH), which is a non-cancerous enlargement of the prostate gland that typically affects men over the age of 50. The Prolieve device works by compressing and heating prostatic tissue that may be blocking the flow of urine. This particular treatment option offers patients several benefits including the following:
- [By Paul Ausick]
Stocks on the Move: NQ Mobile Inc. (NYSE: NQ) is up 26% at $11.09 as the company fights back against a short-seller report. Celsion Corp. (NASDAQ: CLSN) is up 339.3% at $5.14 following a reverse 1:4.5 stock split. Micron Technology Inc. (NASDAQ: MU) is up 4.7% at $17.50.
Hot Biotech Companies To Watch For 2014: 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.
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