Biotech stocks are hot. Real hot. Smoking.
General stock-market weakness may weigh on the sector, however, which means investors should seek out the relative safety of large-cap biotechs, according to UBS.
REUTERSAnalysts Matthew Roden and Matthew Harrison explain:
Yesterday, the UBS Global Equity Strategy team downgraded the US to Neutral relative to Europe (which was upgraded to Overweight), highlighting near term headline risks that included potential fiscal drag into 2014 (secondary to budget and debt ceiling debates), potential changes to monetary policy, and geopolitical risks. However, our strategy team maintains a bullish view on equities in general. Under these conditions, we favor large cap biotech over smid biotechs, considering positioning in the S&P500 (still only 2%), a premium to the market that is on the lower bound of normal, and a solid catalyst path and growth outlook. In our view, potential market headline risks suggest the smid biotech group may see somewhat greater risk to performance (especially given relative outperformance YTD), although the solid fundamental markets outlook suggests this may be a buying opportunity looking into 2014…
Best Cheap Companies For 2015: Stemline Therapeutics Inc (STML)
Stemline Therapeutics, Inc. (Stemline), incorporated on August 8, 2003, is a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics that target both cancer stem cells (CSCs) and tumor bulk. The Company is developing two clinical-stage product candidates, SL-401 and SL-701, for which it holds global marketing rights. The indication for SL-401, a biologic-drug conjugate, is acute myeloid leukemia (AML). The indications for SL-701, a synthetic peptide vaccine, are pediatric and adult brain cancer. It has a platform, StemScreen, for the discovery of CSC-targeted compounds, from which it has discovered or validated several of its clinical and preclinical product candidates. Stemline�� StemScreen consists of StemScreen-1 and StemScreen-2 for the identification of CSC-directed compounds.
SL-301 is a small molecule gamma-secretase inhibitor that inhibits Notch, a pathway expressed by CSCs and tumor bulk of multiple cancer types. SL-101 is a monoclonal antibody-based (mAb -based) compound that targets CD123 and has shown in vitro activity against certain hematologic cancers. SL-201 is a small molecule active against certain hematologic and solid tumor types. SL-601 is a mAb-based compound that targets a cell surface marker on bladder CSCs, which is also expressed on a variety of other solid tumor types. It has also in-licensed certain intellectual property directed to mAb-based therapeutics to validated oncology targets, including Glypican-3, Tie-1, CD133, Frizzled, Smoothened and Patched.
SL-401 - An IL-3R-Directed Compound Targeting Cancer Stem Cells and Tumor Bulk
SL-401 is a clinically active biologic-drug conjugate consisting of human interleukin-3 (IL-3) genetically linked to a truncated version of diphtheria toxin. SL-401 targets the IL-3 receptor (IL-3R), which is overexpressed on both the CSCs and tumor bulk of multiple hematologic cancers, including AML. SL-401 has demonstrated preclinical in vit! ro and in vivo activity against both leukemia blasts (which includes tumor bulk) and CSCs of a range of human leukemia cell lines and primary leukemia cells from patients.
SL-701
SL-701 is a clinically active synthetic peptide vaccine that targets several epitopes on CSCs and tumor bulk of brain cancer. In two completed Phase 1/2 clinical trials, SL-701 demonstrated single agent anti-tumor activity in pediatric patients with newly diagnosed brainstem glioma (BSG) and other high-grade gliomas (HGGs) and in adult patients with refractory or recurrent GBM, and other HGGs.
StemScreen-1
StemScreen-1 is a drug discovery platform designed to identify CSC-targeted compounds based on the isolation of CSCs and evaluation of CSC gene expression profiles. CSCs are isolated from primary tumor tissue or cell lines, and then subjected to gene expression analysis using a variety of technologies, including microarray. A control tissue, such as normal bone marrow is analyzed as a comparator against the gene expression profile of the isolated CSCs. These data are then interfaced with an information base of compounds and their mechanisms of action (that is which gene products and pathways they impact). It has utilized StemScreen-1 to discover a number of its preclinical drug candidates. These include SL-201, SL-301, and SL-601. In addition, SL-401 demonstrated activity against CSCs as determined by both an in vitro colony formation and in vivo animal implantation assay, thereby validating certain StemScreen-1 anti-CSC assays.
StemScreen-2
StemScreen-2 is a high throughput drug discovery platform it is developing to discover anti-CSC compounds. StemScreen-2 utilizes a cell-based assay that can track and follow CSCs in their natural state during high throughput screening. In particular, StemScreen-2 utilizes a CSC-specific promoter linked to a reporter as a method for identifying and following CSCs in their native environment of surrounding tumor b! ulk. In t! his way, StemScreen-2 enables the identification of compound hits, in a high throughput manner, with anti-CSC activity.
The Company competes with Boston Biomedical, Inc., Eclipse Therapeutics, Inc., OncoMed Pharmaceuticals, Inc., Verastem, Inc., Astellas Pharma US, Inc., Boehringer Ingelheim GmbH, Dainippon Sumitomo Pharma Co. Ltd., Geron Corp., GlaxoSmithKline plc, ImmunoCellular Therapeutics, Ltd, Macrogenics Inc., Amgen, Inc., Pfizer Inc., Roche Holding AG, Sanofi U.S. LLC., Cyclacel Pharmaceuticals, Inc., Sunesis Pharmaceuticals Inc., Clavis Pharma ASA, Ambit Biosciences Corporation, Celgene Corporation, Eisai Co. Ltd., Celator Pharmaceuticals, Inc., Merck & Co., Inc., Eisai Co., Inc., Roche Holding AG, Novartis AG and Celldex Therapeutics, Inc.
Advisors' Opinion:- [By Keith Speights]
Best-performing biotech IPO
Stemline Therapeutics� (NASDAQ: STML ) has only traded publicly this year, but what a year it's been. The stock's performance ranks Stemline as the best-performing biotech IPO so far in 2013. This week has been pretty good also, with shares moving up by 28%.
5 Best Biotech Stocks To Own For 2014: Genomic Health Inc (GHDX)
Genomic Health, Inc. (Genomic Health), incorporated in August 2000, is a molecular diagnostics company focused on the global development and commercialization of genomic-based clinical laboratory services that analyze the underlying biology of cancer allowing physicians and patients to make individualized treatment decisions. Its Oncotype DX platform utilizes quantitative genomic analysis known as reverse transcription polymerase chain reaction (RT-PCR), in standard tumor pathology specimens to provide tumor-specific information, or the oncotype of a tumor. As of February 2012, Oncotype DX was evaluated in invasive breast cancer in 13 clinical studies involving more than 4,000 breast cancer patients worldwide. Genomic Health offers its Oncotype DX tests as a clinical service, where it analyzes the expression levels of genes in tumor tissue samples and provide physicians with a quantitative gene expression profile expressed as a single quantitative score, which it calls a Recurrence Score, for invasive breast cancer and colon cancer and a DCIS Score for DCIS. Its Oncotype DX breast cancer test analyzes the expression levels of 21 genes and Oncotype DX colon cancer test analyzes the expression levels of 12 genes. In March 2012, the Company established a wholly owned subsidiary, InVitae Corporation.
Oncotype DX Platform
The Company�� Oncotype DX platform uses its RT-PCR approach to improve cancer treatment decisions. Its diagnostic approach correlates gene expression to clinical outcomes and provides an individualized analysis of each patient's tumor. The Company has built a diagnostic infrastructure that allows it to move from research into development through to processing actual patient samples in its clinical reference laboratory. The Company offers Oncotype DX tests as clinical laboratory services. Its technology allows the Company to analyze tumor tissue samples in its clinical reference laboratory and provide physicians with genomic information specific to the patient'! s tumor. It analyzes tissues that are handled, processed and stored under routine clinical pathology laboratory practices.
Oncotype DX Breast Cancer Test
To develop its Oncotype DX breast cancer test, the Company evaluated 250 genes in three independent clinical studies, which identified a 21-gene panel whose composite gene expression profile can be represented by a breast cancer Recurrence Score. The Company conducted studies of its Oncotype DX breast cancer test with clinical samples from postmenopausal women with invasive breast cancer who were treated with aromatase inhibitors. In March 2010, the Journal of Clinical Oncology published results from a European study using its test to analyze tumor samples from over 1,200 patients in the ATAC (Arimedix, Tamoxifen, Alone or in Combination) trial, which established the use of aromatase inhibitors for adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer. The study demonstrated that, along with other standard measures, such as tumor size, its Oncotype DX breast cancer test contributes independently to provide a more complete picture of prognosis for N- and N+ patients treated with aromatase inhibitors.
In December 2011, the Company presented positive results from the ECOG E5194 DCIS clinical validation study at SABCS. The study met its primary endpoint by demonstrating that a pre-specified Oncotype DX DCIS Score can predict the risk of local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast. In December 2011, the Company made Oncotype DX available for patients with ductal carcinoma in situ (DCIS), of the breast, a pre-invasive form of breast cancer. The launch of Oncotype DX for DCIS patients was based on positive results presented from a clinical validation study of Oncotype DX breast cancer test in patients with DCIS, conducted by the Eastern Cooperative Oncology Group (ECOG), a clinical trials cooperative! group su! pported by the National Cancer Institute.
Oncotype DX Colon Cancer Test
The Company developed its gene panel by identifying 761 cancer-related genes through review of existing research literature and computer analysis of genomic databases. The 761 candidate genes were also examined to determine whether they would be useful beyond other key variables including tumor stage, tumor grade, lymph nodes examined and MMR/MSI. It selected a final set of 12 genes, which were then independently evaluated in a validation study of over 1,400 stage II colon cancer patients from the Quick and Simple and Reliable (QUASAR), randomized study of adjuvant chemotherapy in the United Kingdom. This international, multi-center randomized trial examined the recurrence risk and the benefit associated with 5-fluorouracil/leucovorin, or 5FU/LV, adjuvant chemotherapy. Gene expression was quantified by RT-PCR from manually microdissected FPE primary colon cancer tissue, and recurrence-free interval, disease-free survival and overall survival were analyzed. In January 2012, the Company presented positive results of the first clinical decision making study of the Oncotype DX colon cancer test that shows that Recurrence Score result has a significant impact on treatment recommendations for stage II colon cancer patients.
The Company competes with General Electric Company, Hologic, Inc., Novartis AG, Myriad Genetics, Inc., Qiagen N.V., Response Genetics, Inc., Laboratory Corporation of America Holdings, Quest Diagnostics Incorporated, Roche Holding, Ltd, Siemens AG and Johnson & Johnson.
Advisors' Opinion:- [By John Udovich]
Small cap cancer diagnostic stock�Myriad Genetics, Inc (NASDAQ: MYGN) jumped to a five year high on Wednesday�thanks to good�news that the�government will be paying a heftier reimbursement for its main test than previously feared, meaning its worth taking a closer look at the stock along with small cap cancer diagnostic stocks like Rosetta Genomics Ltd (NASDAQ: ROSG) and�Genomic Health, Inc (NASDAQ: GHDX) plus mid cap diagnostic stock Quest Diagnostics Inc (NYSE: DGX). I should also mention that Myriad Genetics has been in our SmallCap Network Elite Opportunity (SCN EO) portfolio since early February and we are now up some 32.5% since then ��thanks in part to the shorts being put in a short squeeze.
- [By Keith Speights]
Genetic testing stands out as one current example of how scientific advances can help reduce medical costs. Genomic Health (NASDAQ: GHDX ) makes genetic diagnostic tests for�breast, colon, and prostate cancer. Half of the patients diagnosed with prostate cancer each year actually have a very low risk of the cancer progressing. However, 90% of these low-risk patients still undergo surgery or radiation -- at a cost of tens of thousands of dollars per patient. Genomic Health's genetic test helps identify which patients really need more extensive treatment and holds the potential to reduce overall costs.
5 Best Biotech Stocks To Own 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�� 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-VEGF 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.
Advisors' Opinion:- [By Jake L'Ecuyer]
Shares of Ophthotech (NASDAQ: OPHT) got a boost, shooting up 25.78 percent to $39.54 after the company reported that it has entered into an ex-US licensing and commercialization deal with Novartis Pharmaceuticals.
5 Best Biotech Stocks To Own For 2014: NeoStem Inc (NBS)
NeoStem, Inc., incorporated on September 18, 1980, operates in cellular therapy industry. Cellular therapy addresses the process by which new cells are introduced into a tissue to prevent or treat disease, or regenerate damaged or aged tissue, and consists of a separate therapeutic technology platform in addition to pharmaceuticals, biologics and medical devices. The Company�� business model includes the development of novel cell therapy products, as well as operating a contract development and manufacturing organization (CDMO) providing services to others in the regenerative medicine industry. Progenitor Cell Therapy, LLC, the Company�� wholly owned subsidiary (PCT), is a CDMO in the cellular therapy industry. PCT has provided pre-clinical and clinical current Good Manufacturing Practice (cGMP) development and manufacturing services to over 100 clients advancing regenerative medicine product candidates through rigorous quality standards all the way through to human testing.
PCT has two cGMP, cell therapy research, development, and manufacturing facilities in New Jersey and California, serving the cell therapy community with integrated and regulatory compliant distribution capabilities. Its core competencies in the cellular therapy industry include manufacturing of cell therapy-based products, product and process development, cell and tissue processing, regulatory support, storage, distribution and delivery and consulting services. The Company�� wholly-owned subsidiary, Amorcyte, LLC (Amorcyte) is developing its own cell therapy, AMR-001, for the treatment of cardiovascular disease. AMR-001 represents its clinically advanced therapeutic product candidate and enrollment for its Phase II PreSERVE clinical trial to investigate AMR-001's safety and efficacy in preserving heart function after a heart attack in a particular type of post Acute Myocardial Infarction (AMI) patients.
Through the Company�� subsidiary, Athelos Corporation (Athelos), the Company is collaborating w! ith Becton-Dickinson in early stage clinical development of a therapy utilizing T-cells, collaborating for autoimmune and inflammatory conditions, including but not limited to, graft vs. host disease, type 1 diabetes, steroid resistant asthma, lupus, multiple sclerosis and solid organ transplant rejection. The Company�� pre-clinical assets include its Very Small Embryonic Like (VSEL) Technology platform. The Company has basic research and development capabilities, manufacturing facilities on both the east and west coast of the United States.
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.
- [By Stock Investor]
Back in April in my article titled, "Regenerative Medicine's Time Has Come", I covered two very interesting companies focused on this field: NeoStem Inc. (NBS) and Neuralstem Inc. (CUR).
- [By John Udovich]
From stem cell burgers to earnings reports, the stem cell industry and small cap players in it like NeoStem Inc (NASDAQ: NBS), International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX) have been producing some news lately that has probably been overlooked by investors and traders alike given its August. Nevertheless, you might want to pay attention to the following stem cell news:
- [By John Udovich]
Summer and the slow news for the market that usually comes with it�is over with and both stem cell researchers or small� cap stem cell stocks like Advanced Cell Technology, Inc (OTCBB: ACTC), Neuralstem, Inc (NYSEMKT: CUR), NeoStem Inc (NASDAQ: NBS), International Stem Cell Corp (OTCMKTS: ISCO)�and BioRestorative Therapies (OTCBB: BRTX) having news for investors and traders alike. Consider the following:
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