10 Best Biotech Stocks To Watch For 2015

U.S. stocks were mixed as investors continue to follow the standoff in Ukraine and digested February’s jobs report which indicated that harsh winter weather could be the culprit behind weakness seen in recent economic data reports.

The S&P 500 trading at new all time highs at 1,883.57 but finished the day virtually unchanged.

The Dow gained 0.19 percent, closing at 16,452.72.

The S&P 500 gained 0.05 percent, closing at 1,878.04. The Nasdaq lost 0.37 percent, closing at 4,336.22. Gold lost 0.86 percent, trading at $1,340.50 an ounce. Oil gained 1.00 percent, trading at $102.58 a barrel. Silver lost 3.05 percent, trading at $20.92 an ounce.

10 Best Biotech Stocks To Watch For 2015: 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’s 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’s 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 te sting.

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’s 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’s subsidiary, A thelos 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’s 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 Roberto Pedone]

    Another under-$10 biopharmaceutical player that’s starting to trend within range of triggering a big breakout trade is Neostem (NBS), engages in the development of proprietary cell therapy products. This stock has been hit hard by the sellers during the last three months, with shares off by 22%.

    If you take a look at the chart for Neostem, you’ll notice that this stock has recently spiked higher back above both its 50-day moving average at $6.41 and its 200-day moving average of $6.60 a share. This move has also pushed shares of NBS back above some near-term overhead resistance levels at $6.57 to $6.98 a share. That move is quickly pushing NBS within range of triggering another breakout trade above some key near-term overhead resistance.

    Market players should now look for long-biased trades in NBS if it manages to break out above some near-term overhead resistance at $7.22 a share with high volume. Look for a sustained move or close above that level with volume that hits near or above its three-month average action 327,514 shares. If that breakout triggers soon, then NBS will set up to re-fill some of its previous gap down zone from October that started just above $8 a share. If that that gap gets filled with volume, then NBS could easily tag its next major overhead resistance levels at $9 to $9.50 a share, or even its 52-week high at $9.89 a share.

    Traders can look to buy NBS off weakness to anticipate that breakout and simply use a stop that sits right below its 50-day moving average of $6.41 a share, or near more support at $6 a share. One can also buy NBS off strength once it takes out $7.22 a share with volume and then simply use a stop that sits a comfortable percentage from your entry point.

  • [By Monica Gerson]

    NeoStem (NYSE: NBS) priced an underwritten public offering of 5,000,000 shares of common stock at an offering price of $7.00 per share. NeoStem shares dipped 9.44% to $7.10 in after-hours trading.

  • [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:

  • [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.

10 Best Biotech Stocks To Watch For 2015: International Stem Cell Corp (ISCO)

International Stem Cell Corporation, incorporated on June 7, 2005 is a developmental-stage biotechnology company. The Company focused on therapeutic and biomedical product development. The Company’s wholly owned subsidiary Lifeline Cell Technology, LLC (LCT) develops, manufactures and commercializes over 130 human cell culture products, including frozen human primary cells and the reagents (media) needed to grow, maintain and differentiate the cells, in order to address this market opportunity. The Company’s scientists have used a technology called basal medium optimization to systematically produce optimized products designed to culture specific human cell types and to elicit specific cellular behaviors. The Company’s wholly owned subsidiary Lifeline Skin Care, Inc. (LSC) develops, manufactures and markets cosmetic skin care products using an extract derived from its pluripotent stem cells.

Therapeutic Product Candidates

Using the Company ‘s technologies and know-how, the Company is exploring and creating a range of cell types that is useful in therapeutic treatments, which include Liver cells (hepatocytes) that may be used to treat a range of congenital and acquired liver diseases. Neuronal cells for potential treatment of Parkinson’s disease and other central nervous system disorders, such as traumatic brain injury, stroke and Alzheimer’s disease. Three-dimensional eye structures to treat degenerative retinal diseases, corneal blindness, and to accelerate corneal healing.

Skin Care Products

The Company’s research scientists developed two skin care products, Defensive Day Serum and Recovery Night Serum, using an extract derived from human parthenogenic stem cells. Defensive Serum contains sunscreen, along with stem cell-derived ingredients. The day serum not only protects the skin from the aging effects of harsh light, but it continues to nurture the skin’s collagen and fibro blasts to give noticeably firmer, smoother, younger-looking ! skin. The Recovery Night Serum is a nighttime therapy that complements the Defensive Day Serum. The night serum nurtures the skin’s collagen and elastin and contains ingredients to defend against damaging free radicals, to help build firmer, smoother, younger and healthier-looking skin.

Research Products

The Company’s Lifeline subsidiary produces and sells over 250 human cell culture products. These products include frozen human cells and stem cells and the reagents needed to grow, maintain and differentiate the cells. These human cell-based products are used domestically and internationally by research scientists in pharmaceutical, academic and government research organizations to study human disease and basic cell biology.

The Company competes with Genzyme Corporation, StemCell, Advanced Cell Technology Inc., Aastrom Biosciences, ViaCyte, Obagi, SkinCeuticals, SkinMedica, Murad, Lonza, Chemicon, Life Technologies, StemCell Techno logies, Merck, BioTime and Specialty Media.

Advisors’ Opinion:

  • [By Peter Graham]

    Small cap stocks Greenfield Farms Food Inc (OTCMKTS: GRAS), International Stem Cell Corp (OTCMKTS: ISCO) and Redpoint Bio Corporation (OTCMKTS: RPBC) have all been getting some extra attention lately in various investment newsletters. However, none of these small cap stocks appear to have been the subject or paid promotions or investor relations activities. So does that make any of them good bets for traders and investors alike? Here is a quick look and a reality check:

  • [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:

  • [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 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:

10 Best Biotech Stocks To Watch For 2015: Cannabis Science Inc (CBIS)

Cannabis Science, Inc., incorporated on May 4, 2007, is a development-stage company. The Company is engaged in the creation of cannabis-based medicines, both with and without psychoactive properties, to treats disease and the symptoms of disease, as well as for general health maintenance. On February 9, 2012, the Company acquired GGECO University, Inc. (GGECO). On March 21, 2012, the Company acquired Cannabis Consulting Inc. (CCI Group).

The Company is engaged in medical marijuana research and development. The Company works with world authorities on phytocannabinoid science targeting critical illnesses, and adheres to scientific methodologies to develop, produce, and commercialize phytocannabinoid-based pharmaceutical products.

Advisors’ Opinion:

  • [By Dan Burrows]

    But it doesn’t end there. Investors should run away from all OTC marijuana stocks, including Medical Marijuana (MJNA), Cannabis Science (CBIS), CannaVest (CANV), MediSwipe (MWIP) and GreenGro Technologies (GRNH). As the SEC warns:

  • [By John Udovich]

    The SEC has halted trading of small cap marijuana stock Growlife Inc (OTCMKTS: PHOT) after a relatively brief trading halt for Advanced Cannabis Solutions, Inc (OTCMKTS: CANN), but Tranzbyte Corp (OTCMKTS: ERBB), Cannabis Science Inc (OTCMKTS: CBIS) and Medical Marijuana Inc (OTCMKTS: MJNA) are still very much alive. However and as I have noted (repeatedly) in the past (see here), Medical Marijuana Inc has a former CEO who has been indicted for a multi-state mortgage fraud scam/ponzi scheme while Medbox Inc (OTCMKTS: MDBX) is another marijuana stock with some “issues” that were summed up nicely in a Southern Investigative Reporting Foundation article cleverly entitled: Tinkerer, Lawyer, Hustler, Lies: One Man’s Path to a Dope Fortune. Obviously, investing in marijuana stocks is not for conservative. Nevertheless, there is still plenty of good or bad news for investors in the marijuana sector to inhale, including the following:

10 Best Biotech Stocks To Watch For 2015: Synageva BioPharma Corp (GEVA)

Synageva BioPharma Corp., incorporated in 1993, is a clinical-stage biopharmaceutical company. The Company is focused on the discovery, development and commercialization of therapeutic products. It has several protein therapeutics in development, including two enzyme replacement therapies for lysosomal storage disorders and two programs for life-threatening genetic conditions. Its lead program, SBC-102, recombinant human lysosomal acid lipase (LAL), is its advanced pipeline program in clinical development for LAL Deficiency. This enzyme is responsible for the metabolism of cholesteryl esters and triglycerides that are delivered to lysosomes by a variety of routes, including low-density lipoprotein receptor mediated endocytosis. On November 2, 2012, Trimeris, Inc. merged with Synageva BioPharma Corp.

SBC-102 is produced by recombinant deoxyribonucleic acid (DNA) technology in egg white using its protein manufacturing platform. The Company has initiated natural history studies in approximately 20 countries. In addition to SBC-102, it is progressing protein therapeutic programs for other rare diseases, which are at different stages of preclinical development. These include two enzyme replacement therapies for other lysosomal storage disorders and two programs for other rare life-threatening conditions. As of December 31, 2011, its product candidate pipeline included SBC-102, SBC-103, SBC-104, SBC-105 and SBC-106.

SBC-104 is an extracellular protein that targets a severe, rare genetic condition. SBC-105 is an enzyme replacement therapy being developed to treat a severe, rare metabolic disorder. SBC-106 is a protein therapy that targets a severe and rare genetic condition.

Advisors’ Opinion:

  • [By Ben Levisohn]

    Somaiya and team named Gilead and Neurocrine Biosciences (NBIX) their top picks, hile putting Buy ratings on Celgene, Biogen Idec, Alexion (ALXN), Incyte (INCY), Pharmacyclics (PCYC) and Synageva (GEVA). BioMarin (BMRN), Infinity Pharmaceuticals (INFI) and Amgen (AMGN) earned Neutral ratings.

10 Best Biotech Stocks To Watch For 2015: bluebird bio Inc (BLUE)

bluebird bio, Inc., incorporated on April 16, 1992, is a clinical-stage biotechnology company, the Company is focused on transforming the lives of patients with severe genetic and orphan diseases using gene therapy. Gene therapy seeks to introduce a functional copy of the defective gene into a patient’s own cells, a process called gene transfer. Through gene transfer, a functional copy of the mutated gene is delivered to the patient’s cells, thereby correcting the underlying genetic defect that causes aberrant gene expression. As of December 31, 2012, the Company is conducting a Phase I/II clinical study in France evaluating an earlier generation of its LentiGlobin vector for the treatment of ß-thalassemia major and SCD. Initial proof-of-concept data from this study were published in Nature. During the year ended December 31, 2013, the Company plans to initiate an extension of this study under a revised protocol for LentiGlobin, which the Company refers to as the HGB- 205 Study. The Company also plans o initiate a second Phase I/II clinical program in the United States for LentiGlobin, which the Company refers to as the HGB-204 Study, for ß-thalassemia major. In March 2013, the Company entered into a strategic collaboration with Celgene Corporation, or Celgene, to discover, develop and commercialize, disease-altering gene therapies in oncology.

Its gene therapy platform is based on viral vectors that utilize a modified, non-replicating version of the Human Immunodeficiency Virus Type 1 (HIV-1) virus, that has been stripped of all of the components required for it to self-replicate and infect additional cells. The HIV-1 virus is part of the lentivirus family of viruses, as a result of which the Company refer to its vectors as lentiviral vectors. Its lentiviral vectors are used to introduce a functional copy of a gene to the patient’s own isolated blood stem cells, called hematopoietic stem cells (HSCs), which reside in a pa tient’s bone marrow and are capable of differentiating int! o a wide range of cell types. HSCs are dividing cells, thus its approach allows for sustained expression of the modified gene as the Company is able to take advantage of a lifetime of replication of the gene-modified HSCs. Additionally, the Company has developed a cell-based vector manufacturing process that is both reproducible and scalable.

Adrenoleukodystrophy

Adrenoleukodystrophy is a rare X-linked, inherited, neurological disorder that is often fatal. ALD is caused by mutations in the ABCD1 gene which encodes for a protein called the ALD protein (ALDP), which plays a critical role in the breakdown and metabolism of long-chain fatty acids (VLCFA). Without functional ALDP, VLCFA accumulate in cells including neural cells in which they cause damage to the myelin sheath, a protective and insulating membrane that surrounds nerve cells in the brain. This damage can result in decreased motor coordination and function, visual and hearing disturbances, the loss of cognitive function, dementia, seizures, adrenal dysfunction and other complications, including death. ALD is divided into various sub-segments with three main phenotypes that impact brain function: CCALD (Childhood cerebral adrenoleukodystrophy, AMN (Adrenomyeloneuropathy) and ACALD (Adult Cerebral ALD).

ß-thalassemia

ß-thalassemia is a rare hereditary blood disorder caused by a genetic abnormality of the ß-globin gene resulting in defective red blood cells (RBCs). Genetic mutations cause the absence or reduced production of the beta chains of hemoglobin, or ß-globin, thereby preventing the proper formation of hemoglobin A, which normally accounts for greater than 95% of the hemoglobin in the blood of adults. Hemoglobin is an iron-containing protein in the blood that carries oxygen from the respiratory organs to the rest of the body. Hemoglobin A consists of four chains-two chains each of a-globin and ß-globin. Normally existing at an approximate 1:1 ratio, genetic mutations that impair t! he produc! tion of ß-globin can lead to a relative excess of a-globin, premature death of red blood cells. The clinical implications of the a-globin/ß-globin imbalance are two-fold: first, patients lack sufficient RBCs and hemoglobin to effectively transport oxygen throughout the body and can become severely anemic; and second, the shortened life span and ineffective production of RBCs can lead to other complications such as splenomegaly, marrow expansion, bone deformities, and iron overload in organs.

Sickle cell disease

Sickle cell disease (SCD) is a hereditary blood disorder resulting from a mutation in the ß-globin gene that causes polymerization of hemoglobin proteins and abnormal red blood cell function. The disease is characterized by anemia, vaso-occlusive pain crisis (a common complication of SCD in which there is severe pain due to obstructed blood flow in the bones, joints, lungs, liver, spleen, kidney, eye, or central nervous system), infections , stroke, overall poor life and early death in a subset of patients. Under low-oxygen conditions, which are exacerbated by the red blood cell abnormalities, the mutant hemoglobin aggregates causing the RBCs to take on a sickle shape (sickle cells), which causes them to aggregate and obstruct small blood vessels, thereby restricting blood flow to organs resulting in pain, cell death and organ damage. If oxygen levels are restored, the hemoglobin can disaggregate and the RBCs return to their normal shape, but over time, the sickling damages the cell membrane and the cells fail to return to the normal shape even in high-oxygen conditions.

Advisors’ Opinion:

  • [By Jay Silverman]

    Some of the biggest leaders in that field, and there have been dozens in fields, if not more this year, such as Bluebird (BLUE) and Stemline Therapeutics (STML) and have all pulled back to significantly lower levels; even below, in Bluebird’s case, the price that had actually opened up as an IPO, even though it’s above its IPO price.

  • [By David Williamson]

    In this video, health-care analyst David Williamson takes a look at the tremendous success of the Bluebird Bio (NASDAQ: BLUE  )  IPO. The company increased the size of its initial public offering, and priced shares at $17 — above the top end of its range — but that still couldn’t contain investor appetite for this stock. Shares shot up 50% on the opening day of trading, and have remained there.

10 Best Biotech Stocks To Watch For 2015: Galectin Therapeutics Inc (GALT)

Galectin Therapeutics Inc., formerly Pro-Pharmaceuticals, Inc., incorporated on January 26, 2001, is a development-stage company. The Company is engaged in drug development to create therapies for cancer and fibrotic disease. As of December 31, 2011, the Company has two compounds in development, one is to be used in cancer therapy and the other intended to be used in the treatment of liver fibrosis and fatty liver disease. These two compounds are produced from different natural starting materials, both possessing the property, which lends itself to binding to and inhibiting galectin proteins. GM-CT-01, the Company’s product candidate for cancer therapy, is a linear polysaccharide polymer consisted of mannose and galactose that has a defined chemical structure and is derived from a plant source. GR-MD-02, the Company’s product for treatment of liver fibrosis and fatty liver disease with inflammation and fibrosis, is a polysaccharide polymer possessing both linear and globul ar structures, which also is derived from a plant source.

GM-CT-01 has in development for the therapy of colorectal cancer and is in a Phase I/II clinical trial as a combination therapy with a tumor vaccine in patients with advanced melanoma. Based on the completed Phase I and partially completed Phase II clinical trials, the Company is exploring two additional potential indicia for the use of GM-CT-01 in combination with cancer chemotherapy. There are two additional pathways for the development of GM-CT-01 for use in treatment of cancer. GM-CT-01 was found to be generally safe when studied in a Phase I clinical trial in end-stage cancer patients with multiple tumor types alone and in combination with 5-Fluorouracil (5-FU), which is an Food and Drug Administration (FDA)-approved chemotherapy used for treatment of various types of cancer.

Advisors’ Opinion:

  • [By Roberto Pedone]

     

    Galectin Therapeutics (GALT) offers drug research and development to create new therapies for fibrotic disease and cancer. This stock closed up 9.6% to $12.06 in Monday’s trading session.

     

    Monday’s Volume: 674,000

    Three-Month Average Volume: 222,171

    Volume % Change: 149%

     

    Shares of GALT jumped higher on Monday after Ascendiant initiated coverage on the stock with a buy recommendation.

     

     

    From a technical perspective, GALT spiked sharply higher here with strong upside volume. This stock has been uptrending for the last three months, with shares ripping higher from its low of $3.95 to its recent high of $13.21. During that move, shares of GALT have been making mostly higher lows and higher highs, which is bullish technical price action. That move has now pushed shares of GALT within range of triggering a near-term breakout trade. That trade will hit if GALT manages to take out Monday’s high of $12.44 and then once it clears its 52-week high at $13.21 with high volume.

     

    Traders should now look for long-biased trades in GALT as long as it’s trending above some near-term support levels at $11 or at $10 and then once it sustains a move or close above those breakout levels with volume that hits near or above 222,171 shares. If that breakout hits soon, then GALT will set up to enter new 52-week-high territory above $13.21, which is bullish technical price action. Some possible upside targets off that breakout are $15 to $16.

     

10 Best Biotech Stocks To Watch For 2015: Enanta Pharmaceuticals Inc (ENTA)

Enanta Pharmaceuticals, Inc., incorporated on July 25, 1995, is a research and development-focused biotechnology company. The Company uses its chemistry-driven approach and drug discovery capabilities to create small molecule drugs in the infectious disease field. The Company is discovering and developing novel inhibitors designed for use against the hepatitis C virus (HCV). These inhibitors include members of the direct acting antiviral (DAA) inhibitor classes-protease (partnered with AbbVie, the former research-based pharmaceutical business of Abbott Laboratories), NS5A (partnered with Novartis) and nucleotide polymerase, as well as a host targeted antiviral (HTA) inhibitor class targeted against cyclophilin. ABT-450, discovered through its collaboration with AbbVie, is a protease inhibitor that has demonstrated in vitro potency against known resistant HCV mutants.

In Phase I studies, ABT-450 co-administered with ritonavir, a commonly used boosting agent to increase the blood concentrations of many protease inhibitors, was shown to be safe and well tolerated. Co-administration of ABT-450 with ritonavir, which it refers to together as ABT-450/r, has enabled once-daily dosing of ABT-450. Phase II studies have demonstrated the efficacy of ABT-450/r in patients with chronic HCV, and other interferon-free Phase II studies of ABT-450-containing regimens continue. AbbVie is developing a next-generation protease inhibitor discovered within the Enanta-AbbVie collaboration. EDP-239 is the NS5A inhibitor discovered by the Company. The Company also has a program to develop nucleotide inhibitors to HCV NS5B polymerase, which is another DAA mechanism considered to have a barrier to resistance. The Company’s Bicyclolide antibiotic product candidate is EDP-788, which it is developing for use as an intravenous drug in the hospital setting and for oral dosing in the home setting. EDP-788 is a prodrug, which means that it is inactive until it is converted in the body into an active compound. EDP-788 is! a water-soluble molecule which, when administered in preclinical models, is cleanly and rapidly converted into the active compound.

Advisors’ Opinion:

  • [By George Budwell]

    Normally, such strong efficacy results would be hailed as a major achievement. However, these results are actually less impressive than those by competing drug’s developed by AbbVie (NYSE: ABBV  ) , Enanta Pharmaceuticals (NASDAQ: ENTA  ) and Gilead. Bristol-Myers’ therapy also has a treatment duration double that of Gilead’s drug Sovaldi for genotype 1 patients. So, while these results are impressive in their own right, the therapy’s commercial prospects may be limited due to the presence of superior competitors in the market. 

  • [By Sean Williams]

    The next big thing in treating hepatitis-C
    The other currently experimental therapy very likely to make it onto the FDA’s desk before the midpoint of 2014 is AbbVie’s (NYSE: ABBV  ) direct-acting antiviral combo drug. In similar fashion to Sovaldi, this DAA-combo therapy, which includes ABT-450 from Enanta Pharmaceuticals (NASDAQ: ENTA  ) , is running six confirmatory late-stage trials on various genotypes. There are, however, two primary differences between AbbVie’s DAA-combo therapy and Sovaldi.

10 Best Biotech Stocks To Watch 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’s 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 bul k 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 cancer s, 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 follo wing 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 Jay Silverman]

    Some of the biggest leaders in that field, and there have been dozens in fields, if not more this year, such as Bluebird (BLUE) and Stemline Therapeutics (STML) and have all pulled back to significantly lower levels; even below, in Bluebird’s case, the price that had actually opened up as an IPO, even though it’s above its IPO price.

  • [By David Zeiler]

    3. Stemline Therapeutics Inc. (Nasdaq: STML): This biotech develops drugs that target cancer stem cells and tumors. Stemline went public January 29 at $10 a share and rose just 11.78% on its first day. But STML has climbed steadily since, and currently trades at $37.46, up 274.6% from its IPO price.

10 Best Biotech Stocks To Watch For 2015: 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’s product candidates treat orphan and more prevalent liver diseases for which there are limited therapeutic solutions. The Company’s 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, 20 12, the Company completed enrollment of the POISE trial with 217 patients.

The Company’s 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]

    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]

    In what’s turned into a bad day for biotech stocks, Intercept Pharmaceuticals (ICPT) is among the worst performers.

    REUTERS

    Shares of Intercept Pharmaceuticals have dropped 8.3% to $295, lagging the 3.3% drop in the iShares Nasdaq Biotechnology ETF (IBB) and the 4.7% decline in the SPDR S&P Biotech ETF (XBI). Gilead Sciences (GILD) has fallen 2.1% to $72.44 and Amgen (AMGN) is off just 1.8% at $121.88.

    Blame SAC’s decision to drastically cut its position and a secondary offering for Intercept’s decline.

    Wedbush’s Liana Moussatos explains the purpose of the secondary offering:

    Intercept raised approximately $183.3MM in a follow-on offering of 600,000 shares at $320/share. We project runway into Q3 2016 from Q3 2015, which covers major milestones, including regulatory review and potential approval of OCA in PBC in 2015…

    Reiterate OUTPERFORM rating and acquisition value of $493. Our acquisition value is calculated by applying a 30% annual discount to our net peak WW revenues for each drug/indication and applying a 1-10x multiple depending on stage of development to reflect risk. Each combination is added in a sum-of-parts to calculate an acquisition value for [Intercept Pharmaceuticals] and projected to the end of 2015 to include the time frame we see for potential acquisition.

    Just expect a heck of a lot of volatility before then.

10 Best Biotech Stocks To Watch For 2015: Medivation Inc.(MDVN)

Medivation, Inc., a biopharmaceutical company, focuses on the development of small molecule drugs for the treatment of castration-resistant prostate cancer, Alzheimer?s disease, and Huntington disease. The company?s product candidates under clinical development include MDV3100, which is in Phase 3 development for the treatment of castration-resistant prostate cancer; and dimebon, which is in Phase 3 clinical trial for the treatment of Alzheimer?s disease and Huntington disease. It has collaboration agreements with Pfizer Inc. to develop and commercialize dimebon; and Astellas Pharma Inc. to develop and commercialize MDV3100. The company was founded in 2003 and is based in San Francisco, California.

Advisors’ Opinion:

  • [By Leo Sun]

    To make matters worse, two major competing treatments — Johnson & Johnson’s (NYSE: JNJ  ) Zytiga and Astellas/Medivation’s (NASDAQ: MDVN  ) Xtandi — were later approved in the U.S. and Europe. Both drugs quickly gained favor over Provenge, since both drugs were orally administered in contrast to Provenge’s intravenous injections, and both drugs demonstrated higher efficacy rates during clinical trials. Compared to a placebo, Zytiga and Xtandi respectively demonstrated median extensions of life of 4.6 and 4.8 months, compared to 4.1 months for Provenge.

  • [By Michael Cintolo]

    Medivation (MDVN) continues to be a thorn in the side of several big-name competitors in the treatment of prostate cancer.

    Its Xtandi, which was developed in partnership with Astellas, has seen strong and steady sales growth, with revenue rising 32% in the third quarter to $108 million.

  • [By Jake L’Ecuyer]

    Equities Trading UP
    Medivation (NASDAQ: MDVN) shot up 9.84 percent to $83.26 after the company and Astellas reported final results from the Phase 3 PREVAIL trial of Enzalutamide. Credit Suisse lifted the price target on the stock from $80.00 to $95.00.

  • [By Sean Williams]

    Friday brought equally good news for Medivation (NASDAQ: MDVN  ) and its advanced prostate cancer drug Xtandi, which also received a positive opinion from the EMA’s advisory panel. This really shouldn’t come as a surprise as Medivation’s oral prostate cancer treatment won FDA approval months early in the U.S., and the 4.8 months of extended median survival it delivered compared to the placebo is remarkable for such an advanced stage disease.