Top Biotech Stocks To Watch For 2014

With the�SPDR S&P Biotech Index�up 20% over the trailing-12-month period, it's evident that investment dollars are willingly flowing into the biotech sector. Keeping that in mind, let's have a look at some of the rulings, studies, and companies that made waves in the sector last week.

If the biotech sector was to make a movie, I'd have suggested the title be "The Good, the Bad, and the Intriguing" following this week's action.

The good
Leading to the plus column was biotech cancer drug developer Onyx Pharmaceuticals (NASDAQ: ONXX  ) which soared 57% on the week (nearly $50 a share!) after receiving a buyout bid from Amgen�for what amounted to $120 a share. Onyx quickly rebuffed the offer price as too low but did note it was actively looking for strategic alternatives that would properly value Onyx and its pipeline. Earlier in the week I took a deeper dive into Onyx and pegged its fair value at $145 a share. Although I favor the potential of its pipeline, I'm starting to see little upside left in shares at these levels.

Hot Asian Stocks To Invest In Right Now: 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�� own cells, a process called gene transfer. Through gene transfer, a functional copy of the mutated gene is delivered to the patient�� 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 �-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 �-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�� own isolated blood stem cells, called hematopoietic stem cells (HSCs), which reside in a patient�� 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).

�-thalassemia

�-thalassemia is a rare hereditary blood disorder caused by a genetic abnormality of the �-globin gene resulting in defective red blood cells (RBCs). Genetic mutations cause the absence or reduced production of the beta chains of hemoglobin, or �-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 �-globin. Normally existing at an approximate 1:1 ratio, genetic mutations that impair t! he produc! tion of �-globin can lead to a relative excess of a-globin, premature death of red blood cells. The clinical implications of the a-globin/�-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 �-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.

Top Biotech Stocks To Watch For 2014: Incyte Corporation(INCY)

Incyte Corporation focuses on the discovery and development of proprietary small molecule drugs for hematologic and oncology indications, and inflammatory and autoimmune diseases. Its product pipe line includes INCB18424, which is in Phase III clinical trial for myelofibrosis; Phase III trial for polycythemia vera; Phase III trial for essential thrombocythemia; Phase I/II trial to treat solid tumors/other hematologic malignancies; and Phase IIb trail for the treatment of psoriasis. The company?s portfolio also includes INCB28050, a Phase IIb clinical trial product for rheumatoid arthritis; INCB28060, a Phase I/II product for solid tumors; INCB7839, a Phase II product for breast cancer; and INCB24360, a Phase I/II product for solid tumors. It has a collaborative research and license agreements with Novartis International Pharmaceutical Ltd.; Eli Lilly and Company; and Pfizer Inc. The company was founded in 1991 and is headquartered in Wilmington, Delaware.

Advisors' Opinion:

• [By Maxx Chatsko]

  Incite growth into your portfolio
  Investors looking for the next high-growth biotech company should certainly spend time researching Incyte (NASDAQ: INCY  ) . The company sports a handful of the most promising JAK inhibitors, which are garnering high level interest throughout the pharmaceutical industry. The molecules have big potential in treating various cancers and inflammatory diseases such as rheumatoid arthritis and psoriasis.

• [By Ben Levisohn]

  Sure Intercept Pharmaceuticals (ICPT) might feel like the only biotech stock that matters today, but there are others. For instance, Incyte (INCY) and� BioMarin (BMRN) are on the move after Barclays changed its ratings on the pair.

• [By Maxx Chatsko]

  The best part about being a buy-and-hold investor is that when volatility strikes and analysts and pundits are panicking, you can calmly go about your business and steal great companies at bargain prices. One of the stocks on my top watchlist is Incyte (NASDAQ: INCY  ) , which is a growing biotech company focused on developing oncology and anti-inflammatory drugs. The company's shares have recently fallen below $20 for the first time since early February, which I think warrants a deeper look. In the following video, I'll break down the pros and cons of adding Incyte to your portfolio, although I think the company has a lot of potential in its pipeline.

• [By Maxx Chatsko]

  Pfizer will turn its immediate focus to Xeljanz, a novel JAK3 inhibitor, as it awaits phase 3 data from ertugliflozin several years from now. The drug class has swept the pharmaceutical industry by storm. Novartis (NYSE: NVS  ) and Eli Lilly are developing JAK1 and JAK2 inhibitors for several applications with Incyte (NASDAQ: INCY  ) , while a handful of other companies have molecules of their own. While companies have high hopes for the cancer-fighting potential of JAK inhibitors, such as Jakafi from Novartis and Incyte, the biggest opportunities may lie in the immunology market.

Top Biotech Stocks To Watch For 2014: Boston Therapeutics Inc (BTHE)

Boston Therapeutics, Inc. is a development-stage company. The Company�� business is the development, manufacture and commercialization of therapeutic drugs and dietary supplements with a focus on glyco-pathology, a specialized field involving understanding the importance of carbohydrates in biochemistry and progression of diseases. The Company is focusing on three products: IPOXYN, an injectable anti-hypoxia drug, which it is developing; PAZ320, which is a non-systemic, chewable drug candidate for reduction of blood glucose in diabetics in development and SUGARDOWN, a complex carbohydrate-based chewable dietary supplement, which it is marketing. The Company�� non-systemic compounds for prediabetes and diabetes, SUGARDOWN and PAZ320, belong to the class of carbohydrate-hydrolyzing enzyme inhibitors.

SUGARDOWN

The Company has developed SUGARDOWN, a non-systemic complex carbohydrate-based dietary supplement to moderate post-meal blood glucose using processes and technology. It has unrestricted access to both sufficient raw materials at commodity pricing and processing facilities to produce sufficient supply of SUGARDOWN to support product distribution across multiple sales channels as a dietary supplement. Its SUGARDOWN dietary supplement consists of a stabilized complex carbohydrate composition. The Company has completed development of SUGARDOWN as a dietary supplement. On January 24, 2012 the Company announced the clinical trial results in healthy volunteers performed at the University of Sydney on SUGARDOWN.

PAZ320

PAZ320 is a non-systemic, non-toxic, chewable drug candidate for prevention of diabetes and its complications. PAZ320 inhibits the enzymes, which release glucose from complex carbohydrate in foods during digestion, reducing the amount of available glucose absorbed through the intestine. PAZ320 is in development as a drug candidate. The Company�� non-systemic compounds for prediabetes and diabetes, SUGARDOWN and PAZ320, belong to the! class of carbohydrate-hydrolyzing enzyme inhibitors.

IPOXYN

The Company has developed a drug candidate product IPOXYN, a glyco-protein based therapeutic agent. Its IPOXYN anti-hypoxia drug consists of a stabilized glycoprotein composition containing oxygen-rechargeable iron, targeting both human and animal tissues and organ systems deprived of oxygen and in need of metabolic support. In addition to potential uses for human patients, it also focuses to file a registration for IPOXYN for veterinary applications under the name OXYFEX. The Company�� pharmaceutical agents are intended for intravenous administration into the circulatory system to target acute and late stage diseases.

Advisors' Opinion:

• [By CRWE]

  Today, BTHE remains (0.00%) +0.000 at $1.10 thus far (ref. google finance Delayed: 12:25PM EDT October 10, 2013).

  Boston Therapeutics has previously closed the final tranche of approximately $1.8 million to bring total gross proceeds of approximately $5.3 million from the private placement of Common Stock and warrants to existing and new accredited investors (the “Offering”).
  Proceeds of the offering will be used to fund additional clinical trials for PAZ320, a non-systemic chewable drug designed to reduce the elevation of postprandial glucose or post-meal blood sugar for treatment of patients with Type 2 diabetes, and for general corporate purposes. PAZ320 is the first compound in a new class of therapies for this disease.

Top Biotech Stocks To Watch For 2014: Galena Biopharma Inc (GALE)

Galena Biopharma, Inc. (Galena), formerly RXi Pharmaceuticals Corporation, incorporated on April 3, 2006, is a biotechnology company focused on discovering, developing and commercializing therapies addressing unmet medical needs using targeted biotherapeutics. The Company is pursuing the development of cancer therapeutics using peptide-based immunotherapy products, including its main product candidate, NeuVaxTM (E75), for the treatment of breast cancer and other tumors. NeuVax is a peptide-based immunotherapy intended to reduce the recurrence of breast cancer in low-to-intermediate HER2-positive breast cancer patients not eligible for trastuzumab (Herceptin; Genentech/Roche). On January 19, 2012, the Company initiated enrollment in its Phase 3 PRESENT clinical trial for NeuVax (E75 peptide plus GM-CSF) vaccine in low-to-intermediate HER2 1+ and 2+ breast cancer patients in the adjuvant setting to prevent recurrence (Clinicaltrials.gov identifier NCT01479244). The Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment study is a randomized, multicenter, multinational clinical trial that will enroll approximately 700 breast cancer patients. The Company�� Phase 2 trial of NeuVax achieved its primary endpoint of disease-free survival (DFS). On April 13, 2011, the Company completed its acquisition of Apthera, Inc.,(Apthera).

The Company focuses to start a Phase 2 trial comparing NeuVax in combination with trastuzumab (Herceptin) versus trastuzumab, alone, in a 300-patient, randomized study in the adjuvant breast cancer setting. The Company's second product candidate, Folate Binding Protein-E39 (FBP), is a vaccine, consisting of the peptides E39 and J65, aimed at preventing the recurrence of ovarian, endometrial, and breast cancers. On February 14, 2012, the Company announced the initiation of a Phase 1/2 clinical trial in two gynecological cancers: ovarian and endometrial adenocarcinomas. Folate binding protein has ! very limited tissue distribution and expression in non-malignant tissue and is over-expressed in more than 90% of ovarian and endometrial cancers, as well as in 20% to 50% of breast, lung, colorectal and renal cell carcinomas.

In April 2011, the Company acquired Apthera Inc and its NeuVax product candidate. The Company focuses on developing a pipeline of immunotherapy product candidates for the treatment of various cancers based on the E75 peptide, the advanced of which is NeuVax, which is targeted at preventing the recurrence of breast cancer. NeuVax has had positive Phase 1/2 clinical trial results for the prevention of breast cancer recurrence in patients who have had breast cancer and received the standard of care treatment (surgery, chemotherapy, radiotherapy and hormonal therapy as indicated). The Company had also initiated its Phase 3 PRESENT clinical trial of NeuVax for the prevention of breast cancer recurrence in early-stage low-to-intermediate HER2 breast cancer patients. NeuVax directs killer T-cells to target and destroy cancer cells that express HER2/neu, a protein associated with epithelial tumors in breast, ovarian, pancreatic, colon, bladder and prostate cancers. NeuVax is comprised of a HER2/neu-derived peptide called E75. E75 is a nine-amino acid sequence that is immunogenic (produces an immune response) and GM-CSF is a commercially available protein that acts to stimulate and activate components of the immune system such as macrophages and dendritic cells.

The Company also develops novel applications for NeuVax based on preclinical studies and phases 2 clinical trials which suggest that combining NeuVax and trastuzumab (Herceptin; Genentech/Roche) can increase antigen presentation by tumor cells by promoting receptor internalization and subsequent proteosomal degradation of the HER2 protein. The Company also is pursuing additional therapeutic indications for NeuVax that are in Phase 1/2 clinical trials. RXI-109, is a dermal anti-scarring therapy that targets! connecti! ve tissue growth factor (CTGF) and that may inhibit connective tissue formation in human fibrotic disease.

The Company competes with Roche Laboratories, Inc., Pfizer Inc., Bayer HealthCare AG, Sanofi-Aventis, US, LLC, Amgen, Inc., GlaxoSmithKline plc, Renovo Group plc, CoDa Therapeutics, Inc., Sirnaomics, Inc., FirstString Research, Inc., Merz Pharmaceuticals, LLC, Capstone Therapeutics, Halscion, Inc., Garnet Bio Therapeutics, Inc., AkPharma Inc., Promedior, Inc., Kissei Pharmaceutical Co., Ltd., Eyegene, Derma Sciences, Inc., Healthpoint Biotherapeutics, Pharmaxon, Excaliard Pharmaceuticals, Inc., Alnylam Pharmaceuticals, Inc., Marina Biotech, Inc., Tacere Therapeutics, Inc., Benitec Limited, OPKO Health, Inc., Silence Therapeutics plc, Quark Pharmaceuticals, Inc., Rosetta Genomics Ltd., Lorus Therapeutics, Inc., Tekmira Pharmaceuticals Corporation, Arrowhead Research Corporation, Regulus Therapeutics Inc. and Santaris.

Advisors' Opinion:

• [By James E. Brumley]

  The last two weeks have been absolutely fantastic ones for Galena Biopharma Inc. (NASDAQ:GALE). Shares have soared from $2.37 to the current price of $3.32 - a 40% pop - rewarding investors who had been patiently waiting through late October for the runup to take hold. Congratulations if that's you. But, if that was you, then now might be a great time to take the money and run with the trade, as GALE looks poised to make a sizeable pullback. More on that in a moment.

• [By James E. Brumley]

  It may look like little more than a choppy mess with just a quick glance at Galena Biopharma Inc. (NASDAQ:GALE). But, the more you study the chart - and the company - the more you realize there's enough long-term potential from the company's pipeline to keep spurring GALE in a generally-upward direction. In fact, the bulls look like they're on the verge of taking Galena Biopharma out of second gear and putting it into third. As such, it may not be a bad bet at this point.

• [By Sean Williams]

  The waiting game
  The tables are clearly stacked against small biotech companies developing cancer drugs. History has shown that few (if any) have successfully had the Food and Drug Administration approve a late-stage cancer drug. While mid-stage trials of Galena Biopharma's (NASDAQ: GALE  ) HER2-targeting breast cancer vaccine have been promising thus far, the chances of an approval seem a long way off.

• [By Paul Ausick]

  Stocks on the move: Galena Biopharma Inc. (NASDAQ: GALE) is down 15.4% at $1.93 after pricing a secondary offering of 17.5 million units at $2.00. Safeway Inc. (NYSE: SWY) is up 6.1% at $28.21, after an analyst�� upgrade which sent shares to a new 52-week high of $28.88 earlier. Avanir Pharmaceuticals Inc. (NASDAQ: AVNR) is down 18.2% at $4.08.