Below, we highlight a handful of ETFs across each asset class that have surged over the past three years, as well as those that have struggled to keep up with Wall Street�� quick pace (note that inverse and leveraged ETFs are excluded from this list ��data as of 7/23/13):
Equity ETFs: Biotechs and Pharma Come Out on Top, Solar StrugglesThough the Equity ETF space covers multiple industries, biotechnology-targeted funds have delivered stellar returns over the trailing 3-year period; Van Eck�� Market Vectors Biotech ETF has gained an incredible 165%. Solar Energy ETFs, however, have struggled to gain traction ��both KWT and TAN have lost around 60%.
Top Regional Bank Stocks To Own Right Now: Hemispherx Biopharma Inc (HEB)
Hemispherx Biopharma, Inc. (Hemispherx) is a specialty pharmaceutical company engaged in the clinical development of new drugs therapies based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders. Hemispherx focuses on two core pharmaceutical technology platforms Ampligen and Alferon N Injection.The commercial focus for Ampligen includes application as a treatment for Chronic Fatigue Syndrome (CFS) and as an influenza vaccine enhancer (adjuvant) for both therapeutic and preventative vaccine development. Alferon N Injection is a United States Food and Drug Administration (FDA) approved product with an indication for refractory or recurring genital warts. Alferon LDO (Low Dose Oral) is a formulation under development targeting influenza. It has three subsidiaries BioPro Corp., BioAegean Corp., and Core BioTech Corp. The Company's foreign subsidiary is Hemispherx Biopharma Europe N.V./S.A.
Ampligen
Ampligen is an experimental drug, which is undergoing clinical development for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Over 1,000 patients have participated in the Ampligen clinical trials representing the administration of more than 90,000 doses of this drug. The Company is also engaged in ongoing, experimental studies assessing the efficacy of Ampligen against influenza viruses.
Alferon N Injection
Alferon N Injection is the registered trademark for the Company's injectable formulation of natural alpha interferon. Interferons are a group of proteins produced and secreted by cells to combat diseases. The Company's natural alpha interferon is produced from human white blood cells. Alferon N Injection [Interferon alfa-n3 (human leukocyte derived)] is a highly purified, natural-source, glycosylated, multi-species alpha interferon product.
Alferon LDO (Low Dose Oral)
Alferon LDO [Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)]! is an experimental low-dose, oral liquid formulation of Natural Alpha Interferon and like Alferon N Injection should not cause antibody formation, which is a problem with recombinant interferon. It is an experimental immunotherapeutic that works by stimulating an immune cascade response in the cells of the mouth and throat, enabling it to bolster systemic immune response through the entire body by absorption through the oral mucosa.
The Company competes with Pfizer, GlaxoSmithKline, Merck, AstraZeneca, Baxter International, Fletcher/CSI, AVANT Immunotherapeutics, AVI BioPharma and Genta.
Advisors' Opinion:- [By MONEYMORNING]
Hemispherix Biopharma Inc. (NYSE: HEB) is a specialty pharmaceutical company. It engages in the clinical development of new drug therapies based on natural immune system enhancing technologies and targets the treatment of viral and immune-based clinical disorders. The Philadelphia, Pa.-headquartered company gained widespread attention over the last several months for its work on flu research. Its flagship products include Alferon N Injection, approved by the FDA for a category of sexually transmitted disease infection. Experimental treatments include Ampligen and Oragens, in development stages for the potential treatment of global viral diseases and disorders of the immune system including human papilloma virus, human immunodeficiency virus, chronic fatigue syndrome, hepatitis, and influenza. Shares have traded as low as $0.18 and as high as $0.55 over the last year. At last check, shares were changing hands around $0.50 on volume of 2 million shares.
- [By Matt Egan]
Shares of Hemispherx Biopharma (HEB) soared 11% on Wednesday amid the rising Ebola fears. Earlier this week, the company announced a series of research collaborations aimed at developing treatments to fight Ebola.
Hot Biotech Stocks To Invest In 2014: Durata Therapeutics Inc (DRTX)
Durata Therapeutics, Inc., incorporated on November 4, 2009, is a pharmaceutical company focused on the development and commercialization of therapeutics for patients with infectious diseases and acute illnesses. The Company enroll and dose patients in two global Phase III clinical trials with its product candidate, dalbavancin, for the treatment of patients with acute bacterial skin and skin structure infections (abSSSI). Dalbavancin is an intravenous antibiotic product candidate designed for once-weekly dosing. In addition to abSSSI, the Company focuses on the development of dalbavancin for additional indications, including osteomyelitis, diabetic foot infection and pneumonia.
As of December 31, 2011, Dalbavancin had already completed three Phase III clinical trials, in which more than 1,000 patients in total received dalbavancin. Dalbavancin achieved its primary efficacy endpoint of non-inferiority in each of these three completed Phase III clinical trials when compared to linezolid, cefazolin or vancomycin, three of the standard-of-care agents for uncomplicated skin and skin structure infections (uSSSI), and complicated skin and skin structure infections (cSSSI). Its two ongoing Phase III clinical trials are designed to compare dalbavancin to vancomycin, with an option to switch to oral linezolid, under the new FDA draft guidance.
The Company competes with Pfizer, Cubist Pharmaceuticals, Inc., Theravance, Inc., Forest Laboratories, Inc., Sanofi-Aventis Ltd., The Medicines Company, Trius Therapeutics, Inc., Cempra, Inc., Rib-X Pharmaceuticals, Inc., Paratek Pharmaceuticals, Inc., Nabriva Therapeutics AG, Tetraphase Pharmaceuticals, Inc. and Furiex Pharmaceuticals, Inc.
Advisors' Opinion:- [By Lisa Levin]
Durata Therapeutics (NASDAQ: DRTX) shares climbed 5.30% to $14.18. The volume of Durata Therapeutics shares traded was 861% higher than normal. The FDA Advisory Committee unanimously recommended the approval of Durata's Dalvance.
- [By Bob's Stocks]
Durata Therapeutics (DRTX) is developing Dalbavancin, a once a week, intravenous antibiotic product candidate, for the treatment of patients with acute bacterial skin and skin structure infections, or ABSSSI. The company is expected to file a NDA (New Drug Application) at any moment and MAA (Marketing Authorization Application) at the end of 2013.
Hot Biotech Stocks To Invest In 2014: Horizon Pharma Inc (HZNP)
Horizon Pharma, Inc. (Horizon), incorporated on March 23, 2010, is a biopharmaceutical company that develops and commercializes medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases. On April 23, 2011, the United States Food and Drug Administration, approved DUEXIS (formerly HZT-501), a tablet formulation containing a fixed-dose combination of ibuprofen and famotidine in a single pill. The Company�� other product, LODOTRA (NP-01), is a programmed release formulation of low-dose prednisone that is marketed in Europe by the Company�� distribution partner, Mundipharma International Corporation Limited (Mundipharma). As of December 31, 2010, Horizon completed multiple Phase III clinical trials of LODOTRA. In addition to these product candidates, the Company has a pipeline of earlier-stage product candidates to treat pain-related diseases and chronic inflammation. On April 1, 2010, Horizon effected a recapitalization and acquisition pursuant to which Horizon Pharma, Inc. became a holding company, that operates through its wholly owned subsidiaries, Horizon Pharma USA, Inc. (formerly Horizon Therapeutics, Inc.) and Horizon Pharma AG (formerly Nitec Pharma AG (Nitec)).
DUEXIS
DUEXIS is a combination of 800 milligram ibuprofen and 26.6 milligram famotidine in a single pill and is indicated for the relief of signs and symptoms of rheumatoid arthritis (RA), and osteoarthritis (OA), and to decrease the risk of developing upper gastrointestinal (GI), ulcers in patients who are taking ibuprofen for those indications. The Company has completed two Phase III clinical trials in a total of over 1,500 patients with mild to moderate pain or arthritis that demonstrated a significant reduction in the incidence of non-steroidal anti-inflammatory drugs (NSAID)-induced upper GI ulcers when treated with DUEXIS versus ibuprofen alone.
LODOTRA
LODOTRA is a programmed release formulation of low-dose prednisone, a well-established drug use! d to inhibit the production of various pro-inflammatory cytokines, which are proteins associated with joint inflammation in RA. LODOTRA has received regulatory approval in Europe for the treatment of moderate to severe, active RA in adults when accompanied by morning stiffness. As of December 31, 2010, the Company had completed two pivotal Phase III clinical trials of LODOTRA in a total of over 600 patients with RA. The first pivotal Phase III trial supported the approval of LODOTRA in Europe in March 2009, where it is approved for marketing in 14 European countries. LODOTRA achieved significant results and met the primary endpoint in each of the two pivotal Phase III clinical trials. Its LODOTRA product was developed and is owned by Horizon Pharma AG. As of December 31, 2010, the Company markets LODOTRA in Europe through three separate agreements. Pursuant to two separate agreements, it granted Merck Serono GmbH and Merck GesmbH, an affiliate of Merck Serono, the rights to distribute and market LODOTRA in each of Germany and Austria, respectively, and pursuant to the third agreement, it granted Mundipharma rights to distribute and market LODOTRA in the rest of Europe. The Company also has a manufacturing and supply agreement with Jagotec AG under which Jagotec or its affiliates manufacture and supply LODOTRA to the Company as bulk tablets.
The Company competes with Pfizer Inc., Pozen Inc., Abbott Laboratories and Amgen Inc.
Advisors' Opinion:- [By Jake L'Ecuyer]
Leading and Lagging Sectors
Wednesday morning, the healthcare sector proved to be a source of strength for the market. Leading the sector was strength from Horizon Pharma (NASDAQ: HZNP) and Pernix Therapeutics Holdings (NASDAQ: PTX). In trading on Wednesday, telecommunications services shares were relative laggards, down on the day by about 0.39 percent. Top decliners in the sector included Shenandoah Telecommunications Co (NASDAQ: SHEN), off 3.3 percent, and CalAmp (NASDAQ: CAMP), down around 2.4 percent.
Hot Biotech Stocks To Invest In 2014: 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�� 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�� 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. In 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�� 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.
Hot Biotech Stocks To Invest In 2014: Intercept Pharmaceuticals Inc (ICPT)
Intercept Pharmaceuticals, Inc., incorporated on September 4, 2002, is a biopharmaceutical company focused on the development and commercialization of therapeutics to treat chronic liver diseases utilizing its bile acid chemistry.The Company�� product candidates treat orphan and more prevalent liver diseases for which there are limited therapeutic solutions. The Company�� product candidate, obeticholic acid, or OCA, is a bile acid analog, a chemical substance that has a structure based on a naturally occurring human bile acid. It is developing OCA initially for primary biliary cirrhosis, or PBC, as a second line treatment for patients who have an inadequate response to or who are unable to tolerate standard of care therapy and therefore need additional treatment. The Company is conducting a Phase 3 clinical trial of OCA in PBC, which it calls the POISE trial, that serves as the basis for seeking regulatory approval in the United States and Europe. As of December 19, 2012, the Company completed enrollment of the POISE trial with 217 patients.
The Company�� clinical focus is on the development of OCA, orally administered, first-in-class FXR agonist that has broad liver-protective properties and may a variety of chronic insults to the liver that cause fibrosis, which can eventually lead to cirrhosis, liver transplant and death. The Company owns worldwide rights to OCA outside of Japan and China, where it has licensed the compound to Dainippon Sumitomo Pharma, or DSP, and granted it an option to license OCA in certain other Asian countries.The Company is sponsoring an independent study involving more than ten leading PBC centers in North America and Europe, or collectively the Global PBC Study Group, that are pooling their long-term patient data to evaluate the relationship between biochemical and clinical endpoints.
The Company competes with Eli Lilly, Exelixis, Inc., Phenex Pharmaceuticals AG, , Johnson & Johnson, NovImmune SA, Dr. Falk Pharma GmbH, Galmed Medical Researc! h Ltd., Immuron Ltd., Mochida Pharmaceutical Co., Ltd., NasVax Ltd. , Raptor Pharmaceutical Corp. Astellas Pharma US, Inc., AstraZeneca, Salix Pharmaceuticals, Inc. and Tioga Pharmaceuticals, Inc.
Advisors' Opinion:- [By Jake L'Ecuyer]
Intercept Pharmaceuticals (NASDAQ: ICPT) was also down, falling 26.36 percent to $268.60 after a Wall Street Journal article Friday reported that the NIH had said patient's of the company's drug had more bad cholesterol than when they had started treatment.
- [By Ben Levisohn]
It’s always exciting when a stock quadruples in value, as Intercept Pharmaceuticals (ICPT) has this year. But are investors too excited? FBR’s Andrew Berens and Thomas Smith think they are:
Steve RemichWe are initiating coverage of Intercept Pharmaceuticals, Inc. with an Underperform rating and a 12-month price target of $172 per share. We believe investors are much too optimistic about the accessibility of the nonalcoholic steatohepatitis (NASH) market and the regulatory pathway to commercialization. We agree that NASH is a highly prevalent disease globally but see this potential market as facing significant challenges before it can be accessed. We think payors are unlikely to embrace intervention for NASH, especially given the anticipated hepatitis C (HCV) burden on the system. NASH would be competing with HCV for payor dollars and provider access, as both diseases are treated by hepatologists.
Furthermore, unlike HCV, which is cured after one course of treatment, NASH is likely to require chronic therapy. NASH is also a relatively unrecognized disease with no treatment paradigms, necessitating building the market. Despite compelling efficacy, we do not think the FDA is likely to approve obeticholic acid (OCA) without an adequate safety database, making an accelerated approval unlikely in the time frame expected by investors. The co-morbidities in this patient population are too significant, and the lipid changes with OCA are concerning, especially in light of the reported cardiovascular events disclosed in the top-line FLINT data release.
Shares of Intercept Pharmaceuticals have dropped 3.2% to $286.78 at 2:40 p.m. today.
- [By John Udovich]
It�� a new year and the first one and a half trading weeks of 2014 has not disappointed biotech investors as the sector and mid cap or small cap biotech or�pharma stocks like Intercept Pharmaceuticals Inc (NASDAQ: ICPT), Epizyme Inc (NASDAQ: EPZM), Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) and TNI BioTech Inc (OTCQB: TNIB) either surging or producing some news plus there have been IPO filings for future listings for�Flexion Therapeutics (NASDAQ: FLXN), Aldexa Therapeutics (NASDAQ: ALDX), Retrophin (NASDAQ:�RTRX) and Dicerna Pharmaceuticals (NASDAQ: DRNA). Consider the following news so far this year:
Hot Biotech Stocks To Invest In 2014: Johnson & Johnson(JNJ)
Johnson & Johnson engages in the research and development, manufacture, and sale of various products in the health care field worldwide. The company operates in three segments: Consumer, Pharmaceutical, and Medical Devices and Diagnostics. The Consumer segment provides products used in baby care, skin care, oral care, wound care, and women?s health care fields, as well as nutritional, over-the-counter pharmaceutical products, and wellness and prevention platforms under the brands of JOHNSON?S, AVEENO, CLEAN & CLEAR, JOHNSON?S Adult, NEUTROGENA, RoC, LUBRIDERM, DABAO, LISTERINE, REACH, BAND-AID, CAREFREE, STAYFREE, SPLENDA, TYLENOL, SUDAFED, ZYRTEC, MOTRIN IB, and PEPCID AC. The Pharmaceutical segment offers products in various therapeutic areas, such as anti-infective, antipsychotic, contraceptive, dermatology, gastrointestinal, hematology, immunology, neurology, oncology, pain management, and virology. Its principal products include REMICADE for the treatment of immune me diated inflammatory diseases; STELARA for the treatment of moderate to severe plaque psoriasis; SIMPONI, a treatment for adults with moderate to severe rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis; VELCADE for the treatment of multiple myeloma; PREZISTA and INTELENCE for treating HIV/AIDS patients; NUCYNTA for moderate to severe acute pain; INVEGA SUSTENNAtm for the acute and maintenance treatment of schizophrenia in adults; RISPERDAL CONSTA for the management of bipolar I disorder and schizophrenia; and PROCRIT to stimulate red blood cell production. The Medical Devices and Diagnostics segment primarily offers circulatory disease management products; orthopaedic joint reconstruction, spinal care, and sports medicine products; surgical care, aesthetics, and women?s health products; blood glucose monitoring and insulin delivery products; professional diagnostic products; and disposable contact lenses. The company was founded in 1886 and is based in Ne w Brunswick, New Jersey.
Advisors' Opinion:- [By Sean Williams]
With regard to diabetes, it really just depends whether you're dealing with the genetic and rarer form of the disease, type 1 diabetes, or the much more common type 2 diabetes, whose onset is based on a number of factors that includes diet, activity level, and genetics. For the sake of argument -- and to take nothing away from type 1 diabetes patients, who recently had an encouraging discovery of their own -- Johnson & Johnson's (NYSE: JNJ ) new SGLT-2 inhibitor, Invokana, looks to be the next big thing in type 2 diabetes treatment. Working in the kidneys instead of the liver or pancreas, Invokana allows the body to excrete excess glucose through the urine. Better yet, Invokana has also been shown to induce weight loss (which can be a good thing since a majority of diabetics are overweight) and reduce hypertension.
Hot Biotech Stocks To Invest In 2014: Alnylam Pharmaceuticals Inc.(ALNY)
Alnylam Pharmaceuticals, Inc., a biopharmaceutical company, engages in discovering, developing, and commercializing novel therapeutics based on RNA interference (RNAi). Its core product programs under clinical or pre-clinical development include ALN-TTR, a Phase I clinical trial program for the treatment of transthyretin-mediated amyloidosis; ALN-APC, a Phase I clinical trial program for the treatment of hemophilia; ALN-PCS for the treatment of severe hypercholesterolemia; ALN-HPN, a pre-clinical development for the treatment of refractory anemia; and ALN-TMP, a pre-clinical development for the treatment of hemoglobinopathies, including beta-thalassemia and sickle cell anemia. The company?s partner-based programs comprise ALN-RSV01, a Phase II clinical trial program for the treatment of respiratory syncytial virus infection; ALN-VSP, a Phase I clinical trial completed program for the treatment of liver cancers; and ALN-HTT, a pre-clinical development for the treatment of Huntington?s disease. It has strategic alliances with Novartis Pharma AG; F. Hoffmann-La Roche Ltd; Takeda Pharmaceutical Company Limited; Isis Pharmaceuticals, Inc.; Medtronic Inc.; Kyowa Hakko Kirin Co., Ltd.; and Cubist Pharmaceuticals, Inc. The company was founded in 2002 and is headquartered in Cambridge, Massachusetts.
Advisors' Opinion:- [By Keith Speights]
Early validation
Alnylam Pharmaceuticals (NASDAQ: ALNY ) was another big winner this week, with shares jumping 32%. Good news from an early-stage study powered the stock's climb. - [By Ben Levisohn]
Markey rates the stock a Buy with an $11 price target. Shares of MannKind have jumped 14% to $7.85 today. The SPDR Biotech ETF (XBI) has gained 0.7% to $119.85 today, while Alnylam Pharmaceuticals (ALNY) has gained 1% to $49.05, NPS Pharmaceuticals (NPSP) has fallen 4.1% to $23.56, and InterMune (ITMN) has risen 2.6% to $14.89.
- [By Markus Aarnio]
2. Alnylam Pharmaceuticals (ALNY), a biopharmaceutical company, engages in discovering, developing, and commercializing novel therapeutics based on RNA interference [RNAi].
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