Top 10 Biotech Stocks To Watch For 2014

With shares of Apple (NASDAQ:AAPL) trading around $470, is AAPL an OUTPERFORM, WAIT AND SEE, or STAY AWAY? Let’s analyze the stock with the relevant sections of our CHEAT SHEET investing framework:

T = Trends for a Stock’s Movement

Apple designs, manufactures, and markets mobile communication and media devices, personal computers, portable digital music players, and a variety of related software, services, peripherals, networking solutions, third-party digital content, and applications. The company’s products and services include the iPhone, iPad, Mac, iPod, Apple TV, a portfolio of consumer and professional software applications, the iOS and OS X operating systems, iCloud, and further accessory, service, and support offerings. Apple also delivers digital content and applications through its iTunes, App, iBook, and Mac App stores.

Apple released its new lineup of iPhones on Tuesday, including a cheaper, more basic version of the iPhone called the iPhone 5C to target emerging markets. Apple said the new phones would be available in China on September 20. Apple has received a license from Chinese regulators for its iPhones to operate on China Mobile’s (NYSE:CHL) 3G and 4G networks, according to the Wall Street Journal. China Mobile is China’s largest carrier, with 700 million subscribers, representing a huge untapped market for Apple.

Top 10 Biotech Stocks To Watch For 2014: Navidea Biopharmaceuticals Inc (NAVB)

Navidea Biopharmaceuticals, Inc. (Navidea), formerly Neoprobe Corporation, incorporated in 1983, is a biopharmaceutical company focused on the development and commercialization of precision diagnostic agents. As of December 31, 2011, the Company’s radiopharmaceutical development programs included Lymphoseek (Lymphoseek, Kit for the Preparation of Technetium Tc99m for Injection), a radiopharmaceutical agent for lymph node mapping; AZD4694, an imaging agent, and RIGScan, a tumor antigen-specific targeting agent. In January 2012, the Company executed an option agreement with Alseres Pharmaceuticals, Inc. (Alseres) to license [123I]-E-IACFT Injection, also called Altropane, an Iodine-123 radiolabeled imaging agent, being developed as an aid in the diagnosis of Parkinson’s disease, movement disorders and dementia. In August 2011, the Company sold its gamma detection device line of business (the GDS Business) to Devicor Medical Products, Inc.

Lymphoseek

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Navidea’s pipeline includes clinical-stage radiopharmaceutical agents used to identify the presence and status of disease. Lymphoseek (Kit for the Preparation of Technetium Tc99m for Injection) is a lymph node targeting agent intended for use in intraoperative lymphatic mapping (ILM) procedures and lymphoscintigraphy employed in the overall diagnostic assessment of certain solid tumor cancers. The lymph system is a component of the body’s immune system. The key components of the lymph system are lymph nodes-small anatomic structures that contain disease-fighting lymphocytes, filter lymph of bacteria and cancer cells, and signal infection in response to heightened levels of pathogens. In Navidea’s Phase III clinical studies of Lymphoseek, it detected over 99% of positive nodes identified by vital blue dye (VBD). As of December 31, 2011, Navidea, in co-operation with UC, San Diego affiliate (UCSD), completed or initiated five Phase I clinical trials, one multi-cent er Phase II trial and three multi-center Phase II trials inv! olving Lymphoseek. Two Phase III studies were completed in subjects with breast cancer and melanoma. During the year ended December 31, 2011, data from NEO3-09 were released, which indicated that all primary and secondary endpoints for the study were met. As of December 31, 2011, third Phase III clinical trial for Lymphoseek in subjects with head and neck squamous cell carcinoma (NEO3-06) was in progress.

AZD4694

AZD4694 is a Fluorine-18 labeled precision radiopharmaceutical candidate for use in the imaging and evaluation of patients with signs or symptoms of cognitive impairment such as Alzheimer’s disease (AD). It binds to beta-amyloid deposits in the brain that can then be imaged in positron emission tomography (PET) scans. Amyloid plaque pathology is a required feature of AD and the presence of amyloid pathology is a supportive feature for diagnosis of probable AD. Patients who are negative for amyloid pathology do not have AD. AZD4694 has been studied in several clinical trials. Clinical studies through Phase IIa have included more than 80 patients to date, both suspected AD patients and healthy volunteers. No significant adverse events have been observed. Results suggest that AZD4694 has the ability to image patients quickly and safely with high sensitivity.

RadioImmunoGuided Surgery

As of December 31, 2011, RIGScan had been studied in a number of clinical trials, including Phase III studies. Navidea has conducted two Phase III studies, NEO2-13 and NEO2-14, of RIGScan in patients with primary and metastatic colorectal cancer, respectively. Both studies were multi-institutional involving cancer treatment institutions in the United States, Israel, and the European Union.

The Company competes with Pharmalucence, Eli Lilly, Bayer Schering, General Electric and GE Healthcare.

Advisors’ Opinion:

  • [By Lauren Pollock]

    Navidea Biopharmaceuticals Inc.(NAVB) said the U.S. Food and Drug Administration has granted a priority review for an expanded use of its Lymphoseek drug for some patients with head and neck cancer. Shares dropped 5.4% to $1.97 premarket.

  • [By Lauren Pollock]

    Among the companies with shares expected to actively trade in Tuesday’s session are Toll Brothers Inc.(TOL) and Navidea Biopharmaceuticals Inc.(NAVB)

Top 10 Biotech Stocks To Watch For 2014: TESARO Inc (TSRO)

TESARO, Inc. (TESARO), incorporated in March 2010, is a development-stage, oncology-focused biopharmaceutical company for cancer patients. The Company focuses on rolapitant and TSR-011 product. The Company’s marketed products and product candidates in development treat cancer through non-specific damage to cellular components or alter cell metabolism or internal repair mechanisms to the demise of cancer cells.

Rolapitant

Rolapitant is a potent and long-acting neurokinin-1, or NK-1, receptor antagonist is in Phase III clinical trials for the prevention of chemotherapy induced nausea and vomiting (CINV). It is in Phase III clinical trials. CINV, if not prevented by prophylaxis, has the potential to afflict up to 90% or more of cancer patients undergoing chemotherapy, depending upon the type of chemotherapy administered the dosing schedule of the chemotherapy, and the patients’ age and gender, among other predisposing factors. Prolonged nausea an d vomiting may result in unwanted weight loss, dehydration and malnutrition, as well as hospitalization. The Company has in-licensed the rights to rolapitant from OPKO Health, Inc.

TSR-011

TSR-011 is an orally available ALK inhibitor in preclinical development. ALK is known to be involved in certain types of cancers, including subsets of NSCLC, neuroblastoma and lymphoma. For patients in these subsets, the ALK gene is fused to an activating partner or contains point mutations, resulting in constitutive activation of ALK and the growth of cancer cells and tumor development. Inhibition of ALK in these cancer cells results in cell death and tumor growth inhibition or regression. In August 2011, the United States Food and Drug Administration approved the first ALK inhibitor, developed by Pfizer Inc., Xalkori (crizotinib), which was approved for the treatment of patients with locally advanced or metastatic NSCLC that are ALK positive.

The Company competes with GlaxoSmithKline plc, Roche Holding Ltd! . and Sanofi S.A.

Advisors’ Opinion:

  • [By Ben Levisohn]

    Werber and Eckhard’s favorites include Gilead (GILD) and Celgene (CELG), and they find the “risk/reward…compelling” in Medivation (MDVN) and Tesaro (TSRO).

  • [By Brian Orelli]

    Tesaro (NASDAQ: TSRO  ) is also up today after announcing that it established a partnership with clinicians to run the phase 3 development of its PARP inhibitor, niraparib. The trial will enroll about 300 breast cancer patients with BRCA mutations, comparing niraparib to investigators’ choice of other breast cancer treatments.

Top 10 Biotech Stocks To Watch 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 R ecurrence 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’s 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 Coop erative 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 rec urrence-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]

    On Tuesday, small cap cancer diagnostic stock Myriad Genetics, Inc (NASDAQ: MYGN) jumped 11.42% in one day, meaning its worth taking a closer look at the stock along with the performance of 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 mention that we have had Myriad Genetics in our SmallCap Network Elite Opportunity (SCN EO) portfolio since February 5th and we are already up 18.50% – a nice return in just two weeks time.

  • [By John Udovich]

    Large and small cap cancer stocks Gilead Sciences, Inc (NASDAQ: GILD), Celgene Corporation (NASDAQ: CELG), Veracyte (NASDAQ: VCYT), Genomic Health, Inc (NASDAQ: GHDX), Cell Therapeutics Inc (NASDAQ: CTIC) and MetaStat Inc (OTCMKTS: MTST) have all been producing a steady stream of news lately for biotech investors looking for a way to cash in on the growth in development of cancer treatments. Just consider the following news:

  • [By Sean Williams]

    What: Shares of Genomic Health (NASDAQ: GHDX  ) , a provider of genome-based clinical diagnostic tests, popped as much as 10% following the release of its first-quarter results.

Top 10 Biotech Stocks To Watch For 2014: Nektar Therapeutics(NKTR)

Nektar Therapeutics, a clinical-stage biopharmaceutical company, engages in developing a pipeline of drug candidates that utilize its PEGylation and polymer conjugate technology platforms. The company?s product pipeline consists of drug candidates across various therapeutic areas, including oncology, pain, anti-infectives, anti-viral, and immunology. Its research and development activities involve small molecule drugs, peptides, and other potential biologic drug candidates. The company?s proprietary drug candidates in clinical development comprise NKTR-118, a peripheral opioid antagonist, which has completed Phase II clinical trail for the treatment of opioid-induced constipation; BAY41-6551 that has completed Phase II clinical trail to treat gram-negative pneumonias; NKTR-102, a topoisomerase I inhibitor-polymer conjugate, which is in Phase II clinical trail for multiple cancer indications, including breast, ovarian, and colorectal; and NKTR-105 that is in Phase I clinica l trail to treat solid tumors. Its preclinical products consists of NKTR-119 (Opioid/NKTR-118 combinations) for the treatment of pain; NKTR-181 (abuse deterrent, tamper-resistant opioid) to treat pain; NKTR-194 (non-scheduled opioid) for the treatment of mild to moderate pain; NKTR-171 (tricyclic antidepressant) to treat neuropathic pain; and NKTR-140 (protease inhibitor candidate) to treat HIV. The company has collaboration with Bayer Healthcare LLC to develop BAY41-6551 (NKTR-061, Amikacin Inhale), which is an inhaled solution of amikacin, an aminoglycoside antibiotic; and a license agreement with AstraZeneca AB for the development and commercialization of Oral NKTR-118 and NKTR-119. In addition, Nektar Therapeutics has various license, manufacturing, and supply agreements for its technology with biotechnology and pharmaceutical companies, such as Affymax, Amgen, Baxter, Roche, Merck, Pfizer, and UCB Pharma. The company was founded in 1990 and is headquartered in San Fran c isco, California.

Advisors’ Opinion:

  • [By John McCamant]

    Nektar Therapeutics (NKTR) is expected to get FDA approval this year for its lead drug naloxegol, a once-a-day pill for opioid-induced constipation (OIC). The drug is licensed to AstraZeneca. NKTR will receive up to $245 million in milestone payments, plus royalties.

  • [By Jay Silverman]

    Jay Silverman: Oh, by the way, if you wanted me to throw a few of those names that might be considered, Novavax would be one of them, and Nektar (NKTR), and the Medicines Company (MDCO) and Pharmacyclics, which has been a great stock, but has come under pressure of late.

Top 10 Biotech Stocks To Watch For 2014: BIND Therapeutics Inc (BIND)

BIND Therapeutics, Inc., incorporated on May 19, 2006, is a clinical-stage nanomedicine platform company developing Accurins, its targeted and programmable therapeutics. Accurins are designed with specified physical and chemical characteristics to target specific cells or tissues and concentrate a therapeutic payload at the site of disease to enhance efficacy while minimizing adverse effects on healthy tissues. Its drug candidate, BIND-014, is in Phase II clinical trials for non-small cell lung cancer, or NSCLC, and metastatic castrate-resistant prostate cancer (mCRPC).

Accurins represent the evolution of targeted therapies and nanomedicine. Accurins are polymeric nanoparticles that incorporate a therapeutic payload and are designed to have prolonged circulation within the bloodstream, enable targeting of the diseased tissue or cells, and provide for the controlled and timely release of the therapeutic payload. The four components include Targeting ligands, St ealth and protective layer, Controlled-release polymer matrix and Therapeutic payload. The Company focuses to use its medicinal nanoengineering platform to develop Accurins in several therapeutic areas, with an initial focus on the treatment of various types of cancer. In addition, the Company entered into collaboration agreements with several biopharmaceutical companies to develop and commercialize Accurins that are based on its collaborators’ therapeutic payloads. The Company’s programs include BIND-014, solid tumor accurin and hematologic cancer accurin.

Advisors’ Opinion:

  • [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:

Top 10 Biotech Stocks To Watch For 2014: 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:

Top 10 Biotech Stocks To Watch 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).

Advisors’ Opinion:

  • [By Ben Levisohn]

    That would be Amgen (AMGN), which fell 1.4% today,  Biogen Idec (BIIB), which dropped 5.1%, Celgene (CELG), which declined 2.1%, Gilead Sciences (GILD), which dropped 4%, Regeneron Pharmaceuticals (REGN), which fell 3.8%, and Alexion Pharmaceuticals (ALXN), which finished off 1.1%.

  • [By Ben Levisohn]

    Biotech stocks have been slammed recently and Morgan Stanley believes it’s time to start differentiating between the fundamentals of companies like Amgen (AMGN), Biogen Idec (BIIB), Celgene (CELG) and Gilead Sciences (GILD).

  • [By Ben Levisohn]

    No, says Credit Suisse analyst Ravi Mehrotra and team, when contemplating the recent drops in Gilead Sciences (GILD), Biogen Idec (BIIB), Celgene (CELG) and their ilk. They explain why:

Top 10 Biotech Stocks To Watch For 2014: Redpoint Bio Corp (RPBC)

Redpoint Bio Corporation (Redpoint), incorporated in August 1995, is a development-stage biotechnology company. The Company leverages discoveries in the molecular biology of taste to discover and develop taste modulators for the food and beverage industries. Its food and beverage program has been focused on identifying flavor modifiers that improve the taste of ingredients. In June 2009, the Company announced that it had identified an all-natural sweetness enhancer, RP44. RP44 is Reb-C (rebaudioside C), a component of the stevia plant.

Sweetness Enhancer Program

Redpoint announced that it had identified RP44, an all-natural sweetness enhancer, in June 2009. In January 2010, it disclosed that RP44 is Reb-C (rebaudioside C), a component of the stevia plant. RP44 is derived from material found in the side stream of the Reb A production process. A purified component of stevia known as Reb A has received regulatory approval in the United States. Unlik e Reb A, RP44 has a low intrinsic level of sweetness and therefore is not useful as a sweetener.

Diabetes and Obesity Drug Discovery Program

The Company’s initial programs focused on the modulation of the TRPm5 ion channel, a signaling element in taste sensation, in order to discover compounds that modulate the taste of food and beverage products. Redpoint initiated a program designed to leverage the research it had already conducted on the discovery of modulators of the TRPm5 ion channel to further explore opportunities for the discovery of diabetes or obesity therapeutics. TRPm5 modulators discovered at Redpoint have been shown to elicit the secretion of hormones known to play roles in metabolism in relevant model systems.

The Company competes with International Flavors & Fragrances Inc., Givaudan SA, Symrise, Firmenich, Senomyx, PureCircle Ltd, GLG Life Tech Corporation, Eli Lilly and Company, Amylin Pharmaceuticals, Merck & Co., Inc., Metabolex, Inc., OSI Pharmaceuticals, GlaxoSmithKline! , Arena Pharmaceuticals, Inc. and Johnson & Johnson.

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:

Top 10 Biotech Stocks To Watch For 2014: Neurocrine Biosciences Inc.(NBIX)

Neurocrine Biosciences, Inc. engages in the discovery, development, and commercialization of drugs for the treatment of neurological and endocrine-related diseases and disorders in the United States. It develops drugs for endometriosis, stress-related disorders, pain, tardive dyskinesia, uterine fibroids, diabetes, insomnia, and other neurological and endocrine-related diseases and disorders. The company?s products in clinical development include Elagolix, a Phase II drug for endometriosis; Vesicular Monoamine Transporter 2 Inhibitor (VMAT2), a Phase II drug for movement disorders; CRF2 Peptide Agonist, a Phase II drug for cardiovascular diseases; CRF1 Antagonist, a Phase II drug for stress-related disorders; and Elagolix, a Phase II drug for uterine fibroids. Its research programs comprise G Protein-Coupled Receptor 119 (GPR119) for type II diabetes; VMAT2 for schizophrenia; GnRH Antagonists for men?s and women?s health, and oncology; Antiepileptic Drugs for epilepsy, ess ential tremor, and pain; and G Protein-Coupled Receptors for other conditions. The company has collaborations with GlaxoSmithKline to develop and commercialize CRF antagonists for psychiatric, neurological, and gastrointestinal diseases; Dainippon Sumitomo Pharma Co. Ltd. to develop and commercialize Indiplon in Japan; Abbott International Luxembourg S.