This week, six capital markets stocks are improving their overall rating on Portfolio Grader. Each of these rates an “A” (“strong buy”) or “B” overall (“buy”).
Top 5 Heal Care Companies To Buy For 2015: Nektar Therapeutics(NKTR)
Nektar Therapeutics, a clinical-stage biopharmaceutical company, engages in developing a pipeline of drug candidates that utilize its PEGylation and polymer conjugate technology platforms. The company?s product pipeline consists of drug candidates across various therapeutic areas, including oncology, pain, anti-infectives, anti-viral, and immunology. Its research and development activities involve small molecule drugs, peptides, and other potential biologic drug candidates. The company?s proprietary drug candidates in clinical development comprise NKTR-118, a peripheral opioid antagonist, which has completed Phase II clinical trail for the treatment of opioid-induced constipation; BAY41-6551 that has completed Phase II clinical trail to treat gram-negative pneumonias; NKTR-102, a topoisomerase I inhibitor-polymer conjugate, which is in Phase II clinical trail for multiple cancer indications, including breast, ovarian, and colorectal; and NKTR-105 that is in Phase I clinica l trail to treat solid tumors. Its preclinical products consists of NKTR-119 (Opioid/NKTR-118 combinations) for the treatment of pain; NKTR-181 (abuse deterrent, tamper-resistant opioid) to treat pain; NKTR-194 (non-scheduled opioid) for the treatment of mild to moderate pain; NKTR-171 (tricyclic antidepressant) to treat neuropathic pain; and NKTR-140 (protease inhibitor candidate) to treat HIV. The company has collaboration with Bayer Healthcare LLC to develop BAY41-6551 (NKTR-061, Amikacin Inhale), which is an inhaled solution of amikacin, an aminoglycoside antibiotic; and a license agreement with AstraZeneca AB for the development and commercialization of Oral NKTR-118 and NKTR-119. In addition, Nektar Therapeutics has various license, manufacturing, and supply agreements for its technology with biotechnology and pharmaceutical companies, such as Affymax, Amgen, Baxter, Roche, Merck, Pfizer, and UCB Pharma. The company was founded in 1990 and is headquartered in San Franc isco, California.
Advisors' Opinion:- [By Sean Williams]
Nektar Therapeutics (NASDAQ: NKTR ) delivered a double-digit gain for shareholders this week after reporting positive top-line data for NKTR-181, its oral chronic pain-treatment drug. NKTR-181 is an opioid-based compound that's designed to enter the brain slower than traditional opiates like oxycodone without sacrificing effectiveness and ultimately reducing addiction-like qualities to the medication. In trials, the data demonstrated that NKTR-181 had a statistically significant lower "drug liking" and "feeling high" score than oxycodone. While I'd certainly exercise caution in getting too excited, as the Food and Drug Administration is very harsh with regard to its regulation of opioid-based drugs, it's nonetheless good news for Nektar.
- [By Rich Bieglmeier]
Wednesday, June 11, 2014 could be a happy or sad day for event traders who follow the Food and Drug Association's (FDA) calendar. Two biotechs with considerable potential are slated to hear from the regulatory body regarding their applications for approval.
Nektar Therapeutics (NASDAQ:NKTR) Orexigen Therapeutics, Inc. (NASDAQ:OREX)The duo hopes to see �thumbs up from the FDA in a little more than a week. If all things go well, it could be party time for shareholders too.
- [By John McCamant]
Nektar Therapeutics (NKTR) is expected to get FDA approval this year for its lead drug naloxegol, a once-a-day pill for opioid-induced constipation (OIC). The drug is licensed to AstraZeneca. NKTR will receive up to $245 million in milestone payments, plus royalties.
- [By Keith Speights]
How sweet it is
Nektar Therapeutics (NASDAQ: NKTR ) shareholders saw sweet gains this week. The stock climbed 18% on positive clinical study results.
Hot Biotech Companies For 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]
Equities Trading UP
Shares of Intercept Pharmaceuticals (NASDAQ: ICPT) got a boost, shooting up 289.85 percent to $282.21 after the company reported that the FLINT trial of obeticholic acid has been stopped early and the NASH primary endpoint has been met. - [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.
Hot Biotech Companies For 2014: 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.
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 barium (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 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. ��he 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).
Hot Biotech Companies For 2014: Clovis Oncology Inc (CLVS)
Clovis Oncology, Inc. (Clovis) incorporated on April 20, 2009, is a Development-stage Company. The Company is a Biopharmaceutical Company. The Company focuses on acquiring, developing and commercializing anti-cancer agents in the United States, Europe and additional international markets. The Company also focuses on the treatment of specific subsets of cancer populations. During the year ended December 31, 2010, the Company was in the process of developing three product candidates for which it holds global marketing rights: CO-101, a lipid-conjugated form of the anti-cancer drug gemcitabine; CO-1686, an oral epidermal growth factor receptor (EGFR) mutant-selective inhibitor and CO-338, a poly ADP (Adenosine Diphosphate)-ribose polymerase (PARP) inhibitor. Effective November 19, 2013, Clovis Oncology Inc acquired the entire share capital of Ethical Oncology Science SpA.
CO-101 - a Lipid-Conjugated Form of the Anti-Cancer Drug Gemcitabine
CO-101 is designed to treat patients with pancreatic cancer whose tumors express low amounts of a membrane transporter protein on the surface of the cancer cell known as hENT1 and are thus expected to be resistant to standard gemcitabine-based therapy. Based on the published results of multiple studies assessing the correlation of hENT1 expression to survival outcomes in pancreatic cancer patients treated with gemcitabine, the Company estimates that approximately 40% to 50% of pancreatic patients express low levels of hENT1, and thus derive little or no benefit from gemcitabine therapy. CO-101 is in an international, randomized and controlled 360-patient study for the first-line treatment of metastatic pancreatic cancer. This open-label study compares CO-101 to gemcitabine as a first-line therapy in patients with metastatic pancreatic cancer. Clovis is partnered with Ventana Medical Systems for the development and commercialization of a companion diagnostic for the assessment of hENT1 levels.
CO-1686-an Oral EGFR Mutant-Selective ! Inhibitor
CO-1686 is an orally available, small molecule covalent inhibitor of the cancer-causing mutant forms of EGFR for the treatment of non-small cell lung cancer (NSCLC). CO-1686 targets both the initial activating EGFR mutations as well as the primary resistance mutation, T790M, it treats both first- and second-line NSCLC patients with EGFR mutations. Such initiating activating mutations occur in approximately 10% to 15% of NSCLC cases in Caucasian patients and approximately 30% to 35% of NSCLC cases in East Asian patients. Following treatment with approved NSCLC therapies, Tarceva (erlotinib) or Iressa (gefitinib), both known as tyrosine kinase inhibitors (TKIs), approximately half of these patients develop the T790M mutation.
The Company focuses on the development of CO-1686 as both a second-line therapy for EGFR-mutated NSCLC patients who become resistant to TKIs due to the emergence of the T790M secondary mutation and as a first-line treatment for EGFR-mutated NSCLC. Clovis is partnered with Roche Molecular Systems for the development and commercialization of a companion diagnostic for identification of EGFR mutations.
CO-338-a PARP Inhibitor
CO-338 is a small molecule PARP inhibitor that the Company focuses to develop as both monotherapy and in combination with chemotherapeutic agents for the treatment of selected cancer patients. CO-338 is in a Phase I clinical trial to determine the maximum tolerated dose of oral CO-338 that can be combined with intravenous, or IV, platinum chemotherapy in the treatment of solid tumors. This program is supplemented by two ongoing investigator-initiated trials, using the IV formulation of CO-338: a Phase I/II study in germ-line BRCA mutant breast and ovarian cancer and a Phase II study in the adjuvant treatment of germ-line BRCA mutant and triple-negative breast cancer. The Company also focuses on initiating a Phase I monotherapy study of the oral formulation, to determine an appropriate dose and schedule.!
The Company competes with Eli Lilly, Teva Pharmaceutical Industries, APP Pharmaceuticals, AB Science SA, Amgen Inc., Astellas Pharma, BioSante Pharmaceuticals, Inc., Celgene Corporation, Immunomedics, Inc., Lorus Therapeutics, Threshold Pharmaceuticals, Inc., Boehringer Ingelheim, Pfizer, Sanofi-Aventis, Astra Zeneca, Abbott, Merck, Eisai, Cephalon and Biomarin.
Advisors' Opinion:- [By Sean Williams]
What: Shares of Clovis Oncology (NASDAQ: CLVS ) , a biopharmaceutical company that's developing anti-cancer therapies, vaulted higher by as much as 136% (that's not a typo!) after reporting positive data on two early stage experimental treatments -- CO-1686 in EGFR-mutant non-small cell lung cancer (NSCLC) and Rucaparib in a monotherapy study of solid tumors -- at the American Society of Clinical Oncology's annual meeting.
Hot Biotech Companies 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 Jim Jubak]
But a bigger reason to sell, in my opinion, right now, is a change in the risk/reward profile of the market as a whole. The recent sell off in momentum stocks��hich now looks like it's spreading to consumer discretionary leaders��akes me want to raise cash for the inevitable bounce back in these stocks. I don't know when we might see that bounce��nd I'm not buying yet, since I think we're still in ��atch a falling knife��territory. But when stocks such as FireEye (FEYE), or Palo Alto Networks (PANW), or Incyte (INCY), or Chipotle Mexican Grill (CMG) do bounce, the gains will be bigger and quicker than those in holding Citigroup.
- [By Ben Levisohn]
Somaiya and team named Gilead and�Neurocrine Biosciences (NBIX) their top picks, hile putting Buy ratings on Celgene, Biogen Idec, Alexion (ALXN), Incyte (INCY), Pharmacyclics (PCYC) and Synageva (GEVA). BioMarin (BMRN), Infinity Pharmaceuticals (INFI) and Amgen (AMGN) earned Neutral ratings.
Hot Biotech Companies For 2014: International Stem Cell Corp (ISCO)
International Stem Cell Corporation, incorporated on June 7, 2005 is a developmental-stage biotechnology company. The Company focused on therapeutic and biomedical product development. The Company�� wholly owned subsidiary Lifeline Cell Technology, LLC (LCT) develops, manufactures and commercializes over 130 human cell culture products, including frozen human primary cells and the reagents (media) needed to grow, maintain and differentiate the cells, in order to address this market opportunity. The Company�� scientists have used a technology called basal medium optimization to systematically produce optimized products designed to culture specific human cell types and to elicit specific cellular behaviors. The Company�� wholly owned subsidiary Lifeline Skin Care, Inc. (LSC) develops, manufactures and markets cosmetic skin care products using an extract derived from its pluripotent stem cells.
Therapeutic Product Candidates
Using the Company's technologies and know-how, the Company is exploring and creating a range of cell types that is useful in therapeutic treatments, which include Liver cells (hepatocytes) that may be used to treat a range of congenital and acquired liver diseases. Neuronal cells for potential treatment of Parkinson's disease and other central nervous system disorders, such as traumatic brain injury, stroke and Alzheimer�� disease. Three-dimensional eye structures to treat degenerative retinal diseases, corneal blindness, and to accelerate corneal healing.
Skin Care Products
The Company�� research scientists developed two skin care products, Defensive Day Serum and Recovery Night Serum, using an extract derived from human parthenogenic stem cells. Defensive Serum contains sunscreen, along with stem cell-derived ingredients. The day serum not only protects the skin from the aging effects of harsh light, but it continues to nurture the skin�� collagen and fibroblasts to give noticeably firmer, smoother, younger-looking ! skin. The Recovery Night Serum is a nighttime therapy that complements the Defensive Day Serum. The night serum nurtures the skin�� collagen and elastin and contains ingredients to defend against damaging free radicals, to help build firmer, smoother, younger and healthier-looking skin.
Research Products
The Company�� Lifeline subsidiary produces and sells over 250 human cell culture products. These products include frozen human cells and stem cells and the reagents needed to grow, maintain and differentiate the cells. These human cell-based products are used domestically and internationally by research scientists in pharmaceutical, academic and government research organizations to study human disease and basic cell biology.
The Company competes with Genzyme Corporation, StemCell, Advanced Cell Technology Inc., Aastrom Biosciences, ViaCyte, Obagi, SkinCeuticals, SkinMedica, Murad, Lonza, Chemicon, Life Technologies, StemCell Technologies, Merck, BioTime and Specialty Media.
Advisors' Opinion:- [By John Udovich]
From stem cell burgers to earnings reports, the stem cell industry and small cap players in it like NeoStem Inc (NASDAQ: NBS), International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX) have been producing some news lately that has probably been overlooked by investors and traders alike given its August. Nevertheless, you might want to pay attention to the following stem cell news:
- [By John Udovich]
Stem cells may not be in the news much�as the sector has moved beyond the use of embryotic�ones, but small cap stem cell stocks Cellular Dynamics International Inc (NASDAQ: ICEL), International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX) have been fairly active over the past several trading days as ICEL went public, ISCO raised additional funding and BRTX grabbed more attention:
- [By John Udovich]
The results of a recent Pew Center Poll regarding attitudes towards abortion and various forms of stem cell research could be a good sign for the stem cell industry along with small cap stem cell stocks like StemCells Inc (NASDAQ: STEM), NeoStem Inc (NASDAQ: NBS), Neuralstem, Inc (NYSEMKT: CUR),�International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX). Basically, Americans think that having an abortion is a moral issue with 49% of American adults believing abortion is morally wrong, 23%�view it not as a moral issue and and 15% view it as morally acceptable. However and when Americans were asked about issues surrounding�human embryos, such as stem cell research or in vitro fertilization, as a matter of morality, their views were different.
Hot Biotech Companies For 2014: ArQule Inc.(ARQL)
ArQule, Inc., a clinical-stage biotechnology company, engages in the research and development of cancer therapeutics directed toward molecular targets and biological processes. Its lead product ARQ 197 is non-adenosine triphosphate competitive inhibitor of the c-Met receptor tyrosine kinase, which is being evaluated as monotherapy and in combination therapy in a Phase II clinical development program that includes trials in non-small cell lung cancer, c-Met-associated soft tissue sarcomas, pancreatic adenocarcinoma, hepatocellular carcinoma, germ cell tumors, and colorectal cancer. The company is also developing ARQ 621, a Phase I program focused on inhibition of the Eg5 kinesin spindle protein. Its clinical stage products include ARQ 501, ARQ 761, and ARQ 171, which are designed to kill cancer cells selectively while sparing normal cells through the direct activation of DNA damage response/checkpoint pathways. In addition, the company involves in pre-clinical development o f B-RAF and AKIP Kinase inhibitors. The company has collaborations with Kyowa Hakko Kirin Co., Ltd. and Daiichi Sankyo Co., Ltd. ArQule, Inc. was founded in 1993 and is headquartered in Woburn, Massachusetts.
Advisors' Opinion:- [By Roberto Pedone]
ArQule (ARQL), a clinical-stage biotechnology company, researches and develops cancer therapeutics. This stock closed up 3.4% to $1.49 in Thursday's trading session.
Thursday's Range: $1.44-$1.54
52-Week Range: $1.29-$2.94
Thursday's Volume: 908,000
Three-Month Average Volume: 567,811From a technical perspective, ARQL jumped higher here right above some near-term support at $1.40 with above-average volume. This move briefly pushed shares of ARQL back above its 50-day moving average of $1.53, before the stock closed just below that level at $1.49. This move is starting to push shares of ARQL within range of triggering a near-term breakout trade. That trade will hit if ARQL manages to take out some near-term overhead resistance levels at $1.54 to $1.60 with high volume.
Traders should now look for long-biased trades in ARQL as long as it's trending above some near-term support levels at $1.40 or at $1.35 and then once it sustains a move or close above those breakout levels with volume that hits near or above 567,811 shares. If that breakout hits soon, then ARQL will set up to re-test or possibly take out its next major overhead resistance levels at $1.66 to $1.78, or even $1.90 to $2.
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