Top 5 Biotech Companies To Watch For 2015


Volcano (NASDAQ: VOLC) shares dropped 15.89% to $20.49 in pre-market trading after the company reported Q3 revenue. JP Morgan downgraded the stock from Overweight to Neutral and lowered the price target from $29.00 to $24.00.

Eagle Rock Energy Partners LP (NASDAQ: EROC) dipped 17.55% to $6.06 in the pre-market session after the company lowered its quarterly distribution to $0.15 from $0.22 per unit.

American Capital Agency (NASDAQ: AGNC) shares fell 4.48% to $22.80 in the pre-market trading after the company reported Q3 comprehensive income of $0.45 per common share and net book value of $25.27 per common share.


United States Steel (NYSE: X) dipped 2.22% to $22.90 after the company posted a Q3 loss of $1.79 billion.

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Top 5 Biotech Companies 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.

Top 5 Biotech Companies To Watch For 2015: Foundation Medicine Inc (FMI)


Foundation Medicine, Inc., incorporated on November 12, 2009, is a commercial-stage company. The Company is focused on fundamentally changing the way patients with cancer are treated. The Company’s platform includes methods and algorithms for analyzing tumor tissue samples across all types of cancer, as well as information aggregation and concise reporting capabilities. Its products provide genomic information about each patient’s individual cancer, enabling physicians to optimize treatments in clinical practice and enabling biopharmaceutical companies to develop targeted oncology therapies more effectively.


FoundationOne, its first clinical product, is, to its knowledge, the only commercially available comprehensive molecular information product designed for use in the routine care of patients with cancer. In addition, the Company is considered a non-contracting provider by commercial third-party payors because it has not entered into specific contracts to provide FoundationOne to their covered patients, and as a result it takes on primary responsibility for obtaining reimbursement on behalf of patients.

Advisors’ Opinion:

  • [By James E. Brumley]

    It wouldn’t be fair to say there’s nothing like it “out there”, because there is. A company called Foundation Medicine Inc. (NASDAQ:FMI) has developed a similar/comparable app. The CLRX version of the solution appears superior in most ways, however, if for no other reason than because of the projected revenue growth the company is apt to see.

  • [By Bryan Murphy]

    Eat your heart out Foundation Medicine Inc. (NASDAQ:FMI). And WebMD Health Corp. (NASDAQ:WBMD)? Don’t even bother trying. CollabRx Inc. (NASDAQ:CLRX) has built a better mousetrap, and if yesterday’s announcement is a sign of things to come, CLRX could prove to be a very compelling investment.

  • [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.

Top 5 Biotech Companies To Watch For 2015: Mast Therapeutics Inc (MSTX)

Mast Therapeutics, Inc., formerly ADVENTRX Pharmaceuticals, Inc., incorporated in December 1995, is a development-stage company biopharmaceutical company focused on developing product candidates. The Company’s product candidate is ANX-188, a rheologic, antithrombotic and cytoprotective agent that improves microvascular blood flow and has application in treating a range of diseases and conditions, such as complications arising from sickle cell disease. As of December 31, 2011, the Company also is developing ANX-514, a detergent-free formulation of the chemotherapy drug docetaxel. The Company offers ANX-188 (purified poloxamer 188), ANX-514 (docetaxel for injectable emulsion) and Exelbine (vinorelbine injectable emulsion). In April 2011, the Company acquired SynthRx, Inc. In February 2014, Mast Therapeutics Inc completed its acquisition of Aires Pharmaceuticals, Inc. Aires became a wholly-owned subsidiary of Mast Therapeutics.


ANX-188 (purified poloxamer 188)

ANX-188 is an aqueous solution of a purified form of poloxamer 188. Poloxamer 188 (P1880, is a nonionic, block copolymer that has been found to improve microvascular blood flow by reducing viscosity, particularly under low shear conditions, and by reducing adhesive frictional forces. The Company’s purified form of P188 (purified P188), which is the active ingredient in ANX-188, was designed to eliminate certain low molecular weight substances present in P188 (non-purified), which is primarily responsible for the moderate to moderately severe elevations in serum creatinine levels (acute renal dysfunction) observed in prior clinical studies of P188 (non-purified). Purified P188 has been evaluated in multiple clinical studies by a prior sponsor, including a 255-patient, phase III study.


ANX-514 (docetaxel for injectable emulsion)

ANX-514 is a detergent-free emulsion formulation of docetaxel, an intravenously-injected chemotherapy drug c ommonly used to treat solid tumors. Taxotere, a branded form! ulation of docetaxel, is approved to treat breast, non-small cell lung, prostate, gastric, and head and neck cancers. ANX-514 was designed to have clinically comparable release of docetaxel relative to Taxotere while eliminating the presence of polysorbate 80 and ethanol, both of which are used to solubilize docetaxel in the Taxotere formulation. The ANX-514 formulation solubilizes docetaxel using oil droplets consists of a combination of non-toxic excipients. Docetaxel is contained within these oil droplets and can be administered intravenously without using detergents as pharmaceutical vehicles. Once in central circulation, the emulsion is metabolized rapidly, leaving chemically-identical active ingredient to exert its cytotoxic effect. ANX-514 may reduce the incidence and severity of hypersensitivity reactions and delay the onset of fluid retention.


Exelbine (vinorelbine injectable emulsion)

Exelbine is an emulsion formulation of the chemother apy drug vinorelbine. Navelbine, a branded formulation of vinorelbine, is approved in the United States to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin, and approved in the European Union to treat non-small cell lung cancer and advanced or metastatic breast cancer.

In August 2011, the Company received a complete response letter from the Food and Drug Administration (FDA) stating that it could not approve the Exelbine Non Disclosure Agreement (NDA) in its present form and that the bioequivalence study would need to be repeated because the authenticity of the drug products used in the bioequivalence trial could not be verified in accordance with FDA standards. However, the Company elected to discontinue independent development of Exelbine and as of December 31, 2011, the Company was seeking a partner or outside investor for the program to complete the necessary bioequivalence study.


The Company compete s with GlaxoSmithKline, Provenge and Pfizer.

Advisors’ Opinion:

  • [By John Udovich]

    The start of 2014 shows that biotech is still a hot area with the sector along with small cap biotech stocks like AMAG Pharmaceuticals, Inc (NASDAQ: AMAG), Mast Therapeutics Inc (NYSEMKT: MSTX), Cell Therapeutics Inc (NASDAQ: CTIC), Imprimis Pharmaceuticals Inc (NASDAQ: IMMY) and TNI BioTech (OTCMKTS: TNIB) producing news or returns plus Auspex Pharmaceuticals (NASDAQ: ASPX), Cara Therapeutics (NASDAQ: CARA), Egalet (NASDAQ: EGLT), Flexion Therapeutics (NASDAQ: FLXN) and Ultragenyx Pharmaceutical (NASDAQ: RARE) are among the (many…) planned biotech IPOs that have recently been announced publicly:

  • [By Lauren Pollock]

    Mast Therapeutics Inc.(MSTX) said the U.S. Food and Drug Administration gave orphan-drug designation to its MST-188 drug for the treatment of acute limb ischemia, providing a boost for the biopharmaceutical firm. Shares surged.

  • [By James E. Brumley]

    A little over a month ago, owning Mast Therapeutics, Inc. (NYSE: MSTX) was nothing but pure misery. Shares plunged from $0.63 to $0.43 in one day, when details of a dilutive public offering were unveiled. As is so often the case though, the market may have overshot with the selling effort that KO’s MSTX. Though putting more shares ‘out there’ mathematically meant existing shareholders would have to share more of the company’s upside with newcomers, what’s slowly coming to light is that the inflow of new cash is still more advantageous to those prior shareholders; the company would progress little without it.

Top 5 Biotech Companies To Watch For 2015: IsoRay Inc (ISR)


IsoRay, Inc. (IsoRay), incorporated on June 15, 2004, develops, manufactures and sells isotope-based medical products and devices for the treatment of cancer and other malignant diseases. IsoRay International LLC (International) is a wholly owned subsidiary of the Company. IsoRay obtained clearance from the Food and Drug Association (FDA) for treatment for all solid tumor applications using Cesium-131. Such applications include prostate cancer; ocular melanoma; head, neck and lung tumors; breast cancer; liver cancer; brain cancer; colorectal cancer; gynecological cancer; esophageal cancer, and pancreatic cancer. The seed may be used in surface, interstitial and intracavity applications for tumors with known radio sensitivity. The Company has an existing distribution agreement with UralDial LLC (UralDial) that allows UralDial to distribute Proxcelan Cs-131 brachytherapy seeds in Russia. The Company, through UralDial, has regulatory approval to sell Cs-131 seeds in Russia. < /p>


IsoRay markets the Proxcelan Cesium-131 brachytherapy seed for the treatment of prostate cancer; lung cancer; ocular melanoma; head and neck cancers; colorectal cancer, brain cancer; and gynecological cancer. The Company focuses to market Cesium-131 for the treatment of other malignant disease, such as breast cancer, in the near future through the use of existing technologies that have received FDA-clearance. Cesium-131 is a radioactive isotope that can be produced by the neutron bombardment of Barium-130 (Ba-130). When placed into a nuclear reactor and exposed to a flux of neutrons, Ba-130 becomes Ba-131, the radioactive material that is the parent isotope of Cesium-131. The radioactive isotope Cesium-131 is normally produced by placing a quantity of stable non-radioactive barium (ideally barium enriched in isotope Ba-130) into the neutron flux of a nuclear reactor. The irradiation process converts a small fraction of this material into a radioactive form of ba rium (Ba-131). The Ba-131 decays by electron capture to the ! radioactive isotope of interest (Cesium-131).


As of June 30, 2011, IsoRay had agreements with several independent radiopharmacies to assay, preload, and sterilize loose seeds. During the fiscal year ended June 30, 2011, the Company loaded approximately 90% of Mick cartridges in the Company’s own facility, which accounted for approximately 61% of seeds sold. Approximately 33% of seeds sold are strand configurations, including strands preloaded in needles and the remaining 6% of seeds are sold as loose seeds.

Advisors’ Opinion:

  • [By James E. Brumley]

    Ugh. It’s fun to be right about a stock, but it’s exhausting to be too right, too fast. Case in Point? IsoRay, Inc. (NYSE: ISR). Yours truly posted some bullish comments on ISR just a couple of days ago, explaining how that day’s move above a key ceiling meant a new bull trend was underway, and more gains from that price would be far easier to muster. Well, good news for those who heeded the advice – IsoRay shares are up 44% today.

  • [By Vanina Egea]

    Strengthening portfolio and business stability is to be reinforced by the introduction of new products. Last December, Textron announced the successful first flight of the Scorpion Intelligence, Surveillance and Reconnaissance (ISR)/Strike aircraft. “The Scorpion compares very favorably to more costly aircraft currently used for low-threat missions,” pilot Dan Hinson said. The new product is expected to accommodate the budget constraints and shifting mission requirements of the US Department of Defense. The same department has granted the firm an additional contract worth $22.5 million to “deprocess” Mobile Strike Force vehicles and train the Afghan Army.

  • [By James E. Brumley]

    I hate to be the one to say I told you so, but, I told you so. Back on February 26th I suggested IsoRay, Inc. (NYSEMKT:ISR) shares were a budding breakout play. The 48% rally that’s played out for ISR in the meantime unfurled right on cue. While overbought in the very short run, this small cap stock looks like it’s earning the right to be compared to the likes of bigger brothers in the cancer-treatment space… names like Roche Holding Ltd. (OTCMKTS:RHHBY) or Theragenics Corporation (NYSE:TGX).

Top 5 Biotech Companies To Watch For 2015: Biodel Inc (BIOD)


Biodel Inc. (Biodel), incorporated on December 3, 2003, is a development-stage speciality biopharmaceutical company focused on the development and commercialization of treatments for diabetes. The Company develops its product candidates by applying its formulation technologies to existing drugs. Its advanced program involves developing formulations of injectable recombinant human insulin (RHI). In addition to its ultra-rapid-acting insulin formulations, the Company has developed prototype formulations of a liquid glucagon, a basal insulin and a glucose responsive insulin, in each case for use by patients with diabetes. RHI-based formulation known as Linjeta was the subject of a New Drug Application (NDA).


The Company has two pivotal Phase III clinical trials with its preferred commercial formulation of Linjeta prior to re-submitting the NDA. In August 2011, it completed patient visits and analyzed top-line data from the first Phase 1 clinical trial of two RHI- based formulations. The trial was a single-center, randomized, double-blind, three-period crossover trial in 18 subjects with Type 1 diabetes. The purpose of the trial was to evaluate the pharmacokinetic and pharmacodynamic characteristics and injection site toleration of BIOD-105 and BIOD-107, as compared to the insulin analog marketed as Humalog. The Company conducted Phase I, Phase II and Phase III clinical trials comparing the performance of its Linjeta formulation of RHI to either Humulin, which is a branded formulation of RHI or Humalog. Its pivotal Phase III clinical trials were open-label, parallel group, randomized trials conducted at centers in the United States, Germany and India.

The Company competes with Eli Lilly, Novo Nordisk, Sanofi-Aventis, Halozyme Therapeutics, Inc. and MannKind Corporation.

Advisors’ Opinion:

  • [By Monica Gerson]

    Biodel (NASDAQ: BIOD) is expected to post a Q1 loss at $0.24 per share.

    First Majestic Silver (NYSE: AG) is estimated to post its Q1 earnings at $0.10 per share on revenue of $63.35 million.

  • [By Roberto Pedone]

    One under-$10 specialty biopharmaceutical player that’s starting to trend within range of triggering a big breakout trade is Biodel (BIOD), which is focused on the development and commercialization of innovative treatments for diabetes. This stock has been hit hard by the bears over the last three months, with shares down by 24%.

    If you take a look at the chart for Biodel, you’ll notice that this stock is ripping higher here right off its 50-day moving average of $2.32 a share with strong upside volume. Volume on Thursday has so far registered over 750,000 shares, which is well above its three-month average action of 445,084 shares. This move is quickly pushing shares of BIOD within range of triggering a big breakout trade.

    Traders should now look for long-biased trades in BIOD if it manages to break out above some near-term overhead resistance levels at $2.52 to $2.60 a share with high volume. Look for a sustained move or close above those levels with volume that hits near or above its three-month average action of 445,084 shares. If that breakout triggers soon, then BIOD will set up to re-test or possibly take out its next major overhead resistance levels $3 to its 200-day moving average of $3.39 a share. Any high-volume move above $3.39 will then give BIOD a chance to tag $4 a share.

    Traders can look to buy BIOD off weakness to anticipate that breakout and simply use a stop that sits right below some key near-term support at $2.10 a share. One can also buy BIOD off strength once it starts to clear those breakout levels with volume and then simply use a stop that sits a comfortable percentage from your entry point.