Top 10 Biotech Companies To Invest In 2015


Airbus vs. Boeing Fundamental Analysis

To paraphrase from John Denver, Japan Airline Co. (TOKYO:9201) better known as JAL has packed its bags and is ready to fly Airbus. Following consolidation of the industry in the early 2000s and an additional sale of stock from BAE Systems (LONDON:BA), Airbus is now a subsidiary of European Aeronautic Defence & Space NV (EURONEXT PARIS:EAD). Earlier this year, EAD announced that it would change its name to the Airbus Group, a process that will be completed by the second half of 2014 (hence our interchangeable use of EAD and Airbus in this article). The JAL deal, valued at over $9billion, signals a new phase in the Airbus vs. Boeing rivalry and is a setback for The Boeing Company (NYSE: BA) which has been supplying jets to JAL for over fifty years.


According to a 2013 report from Deloitte, commercial aerospace sector revenues continued double digit growth in 2012. Though revenues as well as earnings in the defense related aerospace sector decreased, the commercial segment saw an 18.3% increase in revenues with 13.2% increase in earnings. Today, we look at Airbus vs. Boeing to see what fundamental analysis on these companies reveals. CapitalCube uses peer-based analysis for its reports; our full peer-set used for this article is listed at the end of this post.

Top 10 Biotech Companies To Invest In 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 Ben Levisohn]

    Shares of Medivation (MDVN) were halted at 2:48 p.m. today while up 2.7% at $96.89. The reason for the halt: Medivation’s Xtandi was approved for use in “pre-chemo metastatic castration-resistant prostate cancer” by the FDA.

    Citigroup’s Yaron Werber explains the significance:

    Overall the updated Xtandi label is in-line with expectations and is now better than the Zytiga label. The new indication is for the treatment of patients with metastatic castration-resistant prostate cancer which is the same as the Zytiga indication and encompasses the pre-chemo and post-chemo segments. In the clinical section of the label the statistically significant improvement in overall survival from PREVAIL is included, compared to the Zytiga label which states the analysis of overall survival did not meet statistical significance.


    We Continue To Like Stock Into TERRAIN and Breast Cancer Data─ The risk/reward is positive for TERRAIN with data at YE:14 or early ’15. Recall, there was no interim analysis and the study enrolled M1 patients so PFS should be roughly similar to the 16 months that was in PREVAIL (also an M1 population). In addition, breast cancer is upside to expectations in our view and we expect ph2a Xtandi data in AR+ TNBC at SABCS in December.

    Shares of Medivation have gained 1.6% to $98.46 at 5:07 p.m. in after-hours trading.

  • [By Todd Campbell]

    That leads me to Medivation (NASDAQ: MDVN  ) , Ophthotech (NASDAQ: OPHT  ) , and Portola (NASDAQ: PTLA  ) , three companies with important therapies that may very well be destined to become top sellers.

Top 10 Biotech Companies To Invest In 2015: Pain Therapeutics Inc (PTIE)

Pain Therapeutics, Inc., incorporated in May 1998, is a biopharmaceutical company that develops drugs. The Company has four drug candidates in clinical programs, including REMOXY, abuse-resistant hydromorphone, abuse-resistant hydrocodone and a radio-labeled monoclonal antibody to treat metastatic melanoma. It is also working on a new treatment for patients with hemophilia. The Company’s lead drug candidate is REMOXY, which is a painkiller. It has collaboration agreement with King Pharmaceuticals, Inc (King) develops and commercializes REMOXY and other opioid painkillers. The Company and King jointly managed a Phase III clinical program and New Drug Application (NDA) submission for REMOXY. It is also developing a pipeline of drug candidates in the area of oncology and hematology. It owns all commercial rights to its pipeline of drug candidates in oncology and hematology. As of December 31, 2010, the Company leased approximately 30,700 square feet of space in San Mateo, California and all of its operations are located in San Mateo.


REMOXY

REMOXY is a controlled-release oral capsule form of oxycodone in a highly viscous liquid formulation matrix that includes excipients. It is formulated to help address issues of abuse and misuse of time-release oxycodone tablets. REMOXY’s capsule dosage form provides therapeutic drug levels of oxycodone on a twice-daily dosing schedule, while resisting the rapid increases in plasma levels of oxycodone associated with common methods of abuse and misuse. Its formulation also resists delivery by unapproved routes of administration, such as injection, snorting or inhalation.


Metastatic Melanoma

The Company is developing a drug candidate called PTI-188 to treat metastatic melanoma, a form of skin cancer. PTI-188 is a monoclonal antibody linked to a radioisotope, intended to deliver doses of radiation lethal to melanoma tumors without harming normal tissue. I n March 2010, the Company announced data from two open-label! , dose-escalating Phase I studies conducted in Israel to assess the safety, pharmacokinetics, dosimetry and anti-tumor activity of PTI-188. During the year ended December 31, 2010, the second study was completed. The technology used in this program was developed at the Albert Einstein College of Medicine (AECOM). It had licensed worldwide commercial rights to this technology from AECOM.


Hemophilia

The Company has a gene transfer program, initially developed at Stanford University, focused at correcting a genetic disorder in which patients are unable to stop bleeding. During 2010, it conducted a variety of pre-clinical studies with this technology. The Company has licensed worldwide commercial rights to the technology used in this program from Poetic Genetics, LLC (Poetic).

Other product candidates

The Company’s alliance with King includes development of three other abuse-resistant opioid product candidates: hydromorphone , hydrocodone and oxymorphone. Its abuse-resistant formulations of hydromorphone and hydrocodone have completed Phase I clinical trials. In January 2011, the Company announced that the Food and Drug Administration (FDA) had accepted its investigational IND, for abuse-resistant oxymorphone.


The Company competes with Roxane Laboratories, Purdue Pharma, King Pharmaceuticals, Inc., Abbott Laboratories, Cephalon, Endo Pharmaceuticals, Teva Pharmaceuticals, Elkins-Sinn, Watson Laboratories, Ortho-McNeil Pharmaceutical and Forest Pharmaceuticals.

Advisors’ Opinion:

  • [By Sean Williams]

    However, all isn’t well when it comes to the future of abuse-resistant painkiller Remoxy, which was developed by Pain Therapeutics (NASDAQ: PTIE  ) , using Durect’s special technology-based gel capsule to prevent abuse, and is licensed by Pfizer (NYSE: PFE  ) . Remoxy has been rejected twice by the FDA — the most recent coming in mid-2011 — and Pfizer commented this morning that if it were to seek reapproval for the drug it wouldn’t be for at least two more years. Given Pfizer’s extensive product pipeline, losing Remoxy wouldn’t be a big deal. For micro-cap clinical-stage companies like Pain Therapeutics and Durect, it’d be a gigantic blow. Fittingly, Pain Therapeutics and Durect shares imploded by 50% and 34%, respectively, on Friday.

  • [By Jessica Alling]

    Elsewhere, Pfizer is evaluating its continued partnership on an experimental oxycodone capsule, Remoxy. The drug is an extended-release formula that is targeted at reducing abuse of the painkiller. After years of setbacks and postponements for FDA approval, Pfizer is weighing its options. Its partners for the drug, Pain Therapeutics (NASDAQ: PTIE  ) and Durect, have both fallen heavily due to the news, with Pain Therapeutics falling more than 50% — its largest decline ever.

Top 10 Biotech Companies To Invest In 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.

  • [By Keith Speights]

    Best-performing biotech IPO
    Stemline Therapeutics  (NASDAQ: STML  ) has only traded publicly this year, but what a year it’s been. The stock’s performance ranks Stemline as the best-performing biotech IPO so far in 2013. This week has been pretty good also, with shares moving up by 28%.

Top 10 Biotech Companies To Invest In 2015: Lpath Inc (LPTN)

Lpath, Inc. (Lpath), incorporated on September 18, 2002, is a biotechnology company focused on the discovery and development of bio-active lipid-targeted monoclonal antibody (mAb) therapeutics. The Company has three product candidates, iSONEP, ASONEP and Lpathomab. The Company’s program, iSONEP, is a mAb against Sphingosine-1-Phosphate (S1P). As of December 31, 2012, it was in phase-II clinical trials for wet Age-Related Macular Degeneration. The Company is also advancing ASONEP, the systemic formulation of the mAb to S1P. ASONEP has completed a phase-I clinical trial and is entering phase-II clinical trials in Renal Cell Carcinoma.


Lpath’s third product candidate, Lpathomab, is a mAb to the bioactive lipid, Lysophosphatidic Acid (LPA). The Company also applies its technology platform, ImmuneY2, to discovering mAbs to new bioactive lipid targets.

Advisors’ Opinion:

  • [By Lauren Pollock]

    Lpath Inc.(LPTN) said it is no longer actively seeking to reacquire exclusive rights to its leading product candidate from Pfizer Inc.(PFE), saying the pharmaceutical giant informed the company that its offers weren’t competitive. The biotechnology company in October had warned that Pfizer might may divest itself of its exclusive option to co-develop the smaller firm’s leading product candidate–known as iSONEP.

  • [By Lauren Pollock]

    Biotechnology company Lpath Inc.(LPTN) warned Pfizer Inc.(PFE) may divest itself of its exclusive option to co-develop the smaller firm’s leading product candidate. Lpath’s stock fell.

Top 10 Biotech Companies To Invest In 2015: 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 Erin McCarthy]

    Navidea Biopharmaceuticals Inc.(NAVB) said Chief Executive Mark Pykett would leave that post around the end of this month as the company restructures its biopharmaceutical product pipeline.

  • [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)

  • [By Sean Williams]

    Diagnostics can also play an important role in early and late-stage breast cancer diagnoses. Navidea Biopharmaceuticals (NYSEMKT: NAVB  ) had Lymphoseek, its external lymph-node imaging and intra-operative lymphatic mapping diagnostic device, approved by the Food and Drug Administration earlier this year to help doctors stage cancer. Discovering whether breast cancer has invaded adjacent lymph nodes has never been easier or safer thanks to Lymphoseek, and it can dramatically aid physicians in determining the best course of action for breast cancer patients.

Top 10 Biotech Companies To Invest In 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 10 Biotech Companies To Invest In 2015: Rexahn Pharmaceuticals Inc (RNN)


Rexahn Pharmaceuticals, Inc. (Rexahn) is a development-stage biopharmaceutical company. The Company focuses on the development of cures for cancer to patients worldwide. The Company’s pipeline features one drug candidate in Phase II clinical trials. The Company also has several other drug candidates in pre-clinical development. In addition, the Company has two renal cell carcinoma (CNS) candidates, Serdaxin, CNS Disorders drug for depression and neurodegenerative diseases and Zoraxel, which is a erectile dysfunction (ED) and sexual dysfunction drug that are in clinical stages and the Company is are exploring options for further development . The Company’s drug candidate, Archexin is an anticancer Akt inhibitor.


Archexin

Archexin is potent inhibitor of the Akt protein kinase (Akt) in cancer cells. Archexin has FDA orphan drug designations for five cancers (RCC, glioblastoma, and cancers of the ovary, stomach and pancreas). Multiple indications for other solid tumors can also be pursued. Archexin inhibit both activated and inactivated forms of Akt, and to reverse the drug resistance observed with the protein kinase inhibitors. Archexin is an antisense oligonucleotide (ASO) compound that is complementary to Akt mRNA, and selective for inhibiting mRNA expression and production of Akt protein. As of December 31, 2011, Archexin was in Phase II clinical trials for the treatment of pancreatic cancer with enrollment completed in September, 2011.


Serdaxin

Serdaxin is an extended release formulation of clavulanic acid, which is an ingredient present in antibiotics approved by the FDA. The Company had been developing Serdaxin for the treatment of depression and neurodegenerative disorders. From January to September, 2011, the Company conducted a randomized, double-blind, placebo-controlled study compared two doses of Serdaxin, 0.5 milligram and 5 milligram, to placebo over an eight-week treatment pe riod for major depressive disorder (MDD) patients. As of Dec! ember 31, 2011, the Company had not made a determination of Serdaxin’s future paths or resource allocations to further develop Serdaxin to treat MDD.


Zoraxel

Zoraxel is an orally administered, on-demand tablet to treat sexual dysfunction. Zoraxel is a dual enhancer of neurotransmitters in the brain that play a key role in sexual activity phases of motivation and arousal, erection and release, and may be the ED drug to affect all three of these phases of sexual activity. As of December 31, 2011, the Company was evaluating how to proceed with the Phase IIb study of Zoraxel.

The Company’s Pre-clinical Pipeline Drug Candidates includes RX-1792, which is a small molecule anticancer EGFR inhibitor; RX-5902, which is a small molecule anticancer ribonucleic acid (RNA) helicase regulator; RX-3117, which is a Small molecule anticancer deoxyribonucleic acid (DNA) synthesis Inhibitor; RX-8243, which is a small molecule anticancer aurora kinase inhibitor; RX-0201-Nano, which is a nanoliposomal anticancer Akt inhibitor; RX-0047-Nano, which is an nanoliposomal anticancer HIF-1 alpha inhibitor and RX-21101, which is a nano-polymer Anticancer.


Advisors’ Opinion:

  • [By John Udovich]

    So far this year, Rexahn Pharmaceuticals, Inc (NYSEMKT: RNN), Imprimis Pharmaceuticals Inc (NASDAQ: IMMY) and Arrowhead Research Corp (NASDAQ: ARWR) are up 186.3%, 157.2% and 142.5%, respectively, since the start of the year – making them the best performing small cap biotech stocks for 2014. But given their lackluster performance over the past few years, what is the secret behind their phenomenal 2014 rise and will they keep rising? For starters, none of these small caps have really produced anything in the way of blockbuster news:

  • [By James E. Brumley]

    If you were lucky enough to step into Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN) when your truly suggested it was a budding buy back on December 23rd, then congratulations – you’re now up a little more than 60% (assuming you bought into RNN after the break above a key resistance line on the 27th). Now get out. Instead, use your profits from the Rexahn to take on a stake in GTx, Inc. (NASDAQ:GTXI). No, GTXI may not look like much at first, but when you take a step back and look at a chart of GTx, Inc. through a longer-term lens, the upside potential becomes clear.

  • [By James E. Brumley]

    At first glance, Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN) doesn’t look like anything particularly trade-worthy. The stock’s now where it was in late October, and where it was in late September, and even where it was in late June. In other words, though RNN has been much higher and much lower than its current price of $0.46 over the course of the past several months, it doesn’t look like it’s going anywhere – on a net basis – anytime.

Top 10 Biotech Companies To Invest In 2015: Biogen Idec Inc(BIIB)

Biogen Idec Inc. discovers, develops, manufactures, and markets therapies for the treatment of neurodegenerative diseases, hemophilia, and autoimmune disorders in the United States and internationally. Its marketed products include the AVONEX for the treatment of relapsing multiple sclerosis (MS); RITUXAN for treating relapsed or refractory, CD20-positive, and B-cell Non-Hodgkin?s lymphoma (NHL); TYSABRI to treat relapsing MS; FUMADERM for the treatment of severe plaque psoriasis in adult patients; and FAMPYRA, an oral compound for the improvement of walking in adult patients with MS with walking disability. Biogen Idec Inc.?s products under Phase III consist of PEGylated interferon beta-1a designed to prolong the effects and reduce the dosing frequency of interferon beta-1a; BG-12 for the treatment of MS; Daclizumab, a monoclonal antibody in relapsing MS; Long-lasting factor IX and VIII fusion protein for the treatment of hemophilia B; GA101, a monoclonal antibody for t h e treatment of chronic lymphocytic leukemia and NHL; and Dexpramipexole, an orally administered small molecule for the treatment of amyotrophic lateral sclerosis. The company?s Phase I clinical trial products include Anti-LINGO for use in multiple sclerosis, Neublastin for use in neuropathic pain, CD40L for use in systemic lupus erythematosus, ANTI-TWAEK humanized monoclonal antibody for TWEAK, and BIIB037 for use in Alzheimer’s disease; and Phase II clinical trial product comprises OCRELIZUMAB, a humanized monoclonal antibody for treating CD20. It has collaboration agreements with Genentech, Inc.; Elan Pharma International, Ltd; Acorda Therapeutics, Inc.; Portola Pharmaceuticals, Inc.; Swedish Orphan Biovitrum AB; Abbott Biotherapeutics Corp; and Vernalis plc. The company was formerly known as IDEC Pharmaceuticals Corporation and changed its name to Biogen Idec Inc. in November 2003. Biogen Idec Inc. was founded in 1985 and is headquartered in Weston, Massachusetts.


Advisors’ Opinion:

  • [By Chad Fraser]

    Big Moves Are Reshaping Baxter

    Baxter shares have risen 6.8% year-to-date, below the S&P 500’s 7.6% gain. But even though the stock hasn’t caused a lot of buzz with investors, management has made a number of important moves in the past two years.

    The first came in late 2012, when the company acquired Gambro AB for US$4.0 billion, marking the biggest acquisition in its 83-year history. Sweden-based Gambro makes dialysis products for patients with acute and chronic kidney disease. The company is the world’s second-largest manufacturer of dialysis machines, after Germany’s Fresenius.


    Baxter already had a presence in the dialysis market but mainly focused on in-home equipment, while Gambro’s products are mostly used in clinics.

    This is a large and growing market for the company: according to the Baxter, approximately two million people worldwide are on some form of dialysis, and that number is growing by more than 5% annually due to ri sing rates of diabetes and hypertension.

    Another major move came in March, when Baxter announced that it would break itself into two separate firms along the lines of its current divisions; it aims to complete the split in mid-2015.


    “The breakup makes sense because the two units have separate profiles, with the medical devices business being more defensive, while the biopharmaceuticals unit grows faster, albeit with greater risk,” wrote Springer.

    One of those risks is rising competition. For example, Biogen Idec’s (NasdaqGS: BIIB) Eloctate hemophilia A therapy received FDA approval in June. Eloctate could become a significant competitor to Baxter’s Advate treatment, which controls about 35% of the market. But Advate has the advantage of being well established: it was approved more than a decade ago and is now used in 64 countries.


    Eloctate is expected to cost roughly the same as Advate, but it requires fewer injections. Baxter is currently developing a longer-

  • [By Ben Levisohn]

    On a quiet day for big biotech, shares of Celgene have fallen 0.2% to $94.73 at 10:58 a.m., while Amgen (AMGN) has gained 0.1% to $138.69, Gilead Sciences (GILD) has dipped 0.1% to $109.33, Biogen Idec (BIIB) has dropped 0.7% to $34167 and Regeneron (REGN) is off 0.9% at $358.76.

  • [By Ben Levisohn]

    If the big-five biotechs were the Rat Pack, Celgene (CELG) would be Joey Bishop, to Amgen’s (AMGN) Frank Sinatra, Biogen’s (BIIB) Dean Martin and Gilead Sciences (GILD) Sammy Davis Jr. (Which, I suppose makes Regenron (REGN) Peter Lawford. These analogies only go so far.)

Top 10 Biotech Companies To Invest In 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:

  • [By Bryan Murphy]

    Much like Nuvilex, Cannabis Science Inc. (OTCMKTS:CBIS) appears to simply be another conventional biotech outfit. And, truth be told, that’s what CBIS is. It just happens to be developing two drugs based on cannabinoids… one to reat HIV/AIDS, and the other to treat cancer. Both drugs are in preclinical trials right now, so an actual marketable product is still years down the road for Cannabis Science Inc. But, as a legitimate biotechnology that isn’t aiming to simply fuel tokers’ needs, it’s not going to hit any regulatory or law-enforcement roadblocks.

Top 10 Biotech Companies To Invest In 2015: CEL-SCI Corp (CVM)

CEL-SCI Corporation (CEL-SCI), incorporated on March 22, 1983, is engaged in the business of Multikine cancer therapy; New cold fill manufacturing service to the pharmaceutical industry, and ligand epitope antigen presentation System (LEAPS) technology, with two products, hemagglutinin type 1 and neuraminidase type 1 (H1N1) swine flu treatment for H1N1 hospitalized patients and CEL-2000, a rheumatoid arthritis treatment vaccine.

Multikine

CEL-SCI’s Multikine, is being developed for the treatment of cancer. It is a cancer immunotherapy drugs called Combination Immunotherapy because it combines active and passive immunity in one product. It is the only cancer immunotherapy that both kills cancer cells and activates the general immune system to destroy the cancer. Multikine target the tumor micro-metastases for treatment failure. Multikine is also applicable in many other solid tumors.

New Manufacturing Facility

CEL-SCI’s facility manufactures Multikine for CEL-SCI’s Phase III clinical trial. CEL-SCI offers the use of the facility as a service to pharmaceutical companies and others, particularly those that need to fill and finish their drugs in a cold environment. Fill and finish is the process of filling injectable drugs in a sterile manner.

LEAPS

CEL-SCI’s patented T-cell Modulation Process uses heteroconjugates to direct the body to choose a specific immune response. The heteroconjugate technology, referred to as LEAPS, is intended to stimulate the human immune system to fight bacterial, viral and parasitic infections, as well as autoimmune, allergies, transplantation rejection and cancer. Administered like vaccines, LEAPS combines T-cell binding ligands with small, disease associated and peptide antigens.

Using the LEAPS technology, CEL-SCI has created a peptide treatment for H1N1 (swine flu) hospitalized patients. This LEAPS flu treatment is designe d to focus on the conserved, non-changing epitopes of the di! fferent strains of Type A Influenza viruses, including swine, avian or bird, and Spanish Influenza. CEL-SCI’s LEAPS flu treatment contains epitopes.

Advisors’ Opinion:

  • [By James E. Brumley]

    Little TNI Biotech Inc. (OTCMKTS:TNIB) just gave bigger immunology players like Amgen, Inc. (NASDAQ:AMGN) or CEL-SCI Corporation (NYSEMKT:CVM) a new reason to worry. Though CVM and AMGN aren’t exactly sweating bullets yet, TNIB has taken not a big step forward in terms biotechnological progress, but rather, has widened its net with a lateral expansion.

  • [By Bryan Murphy]

    It may not have blazed a trail into the young, immunology segment of the biotech industry the way Dendreon Corporation (NASDAQ:DNDN) did back in 2010 with the debut of Provenge. It may not have the same immunology pipeline (and company size) that ImmunoGen, Inc. (NASDAQ:IMGN) boasts. One thing is pretty certain about cancer-immunotherapy developer CEL-SCI Corporation (NYSEMKT:CVM) right now, however – its stock may be poised to dole out a much bigger foreseeable-future reward than DNDN or IMGN are.

  • [By Bryan Murphy]

    Look out AbbVie Inc. (NYSE:ABBV), and Gilead Sciences, Inc. (NASDAQ:GILD), you may want to look over your shoulder as well. There’s a new immunology player coming to town, and its name is CEL-SCI Corporation (NYSEMKT:CVM). Yes, AbbVie may be the name behind blockbuster drug Humira – with nearly $10 billion in sales in 2012 – while Gilead Sciences is saving HIV patients’ lives with immunological therapies Stribild and Complera. But, small cap company CEL-SCI may be closer to launching its own immunology drug sooner than most investors realize.