Among the companies with shares expected to actively trade in Monday’s session are Keurig Green Mountain Inc.(GMCR), JA Solar Holdings Co.(JASO) and Five Prime Therapeutics Inc.(FPRX)
S&P Dow Jones Indices said Friday it will add Keurig Green Mountain Inc. to its S&P 500 index, one of a handful of index changes announced Friday. Shares rose 2.7% to $116.31 premarket.
JA Solar Holdings Co. posted stronger-than-expected fourth-quarter results. The solar-products company’s chief executive said that stabilizing prices and cost-cutting efforts helped strengthen margins. Shares rose 14% to $13.05 premarket.
Five Prime Therapeutics Inc. reached a collaboration agreement with Bristol-Myers Squibb Co.(BMY) to discover, develop and commercialize immuno-oncology therapies directed toward targets identified in two undisclosed immune checkpoint pathways. The clinical-stage biotechnology company’s shares rose 19% to $22.35 premarket.
Top 5 Canadian Companies To Own For 2015: Synergy Pharmaceuticals Inc (SGYP)
Synergy Pharmaceuticals, Inc., incorporated on February 11, 1992, is a biopharmaceutical company focused primarily on the development of drugs to treat gastrointestinal (GI), disorders and diseases. The Company�� lead product candidate is plecanatide, a guanylyl cyclase C (GC-C), receptor agonist, to treat GI disorders, primarily chronic constipation (CC), and constipation-predominant-irritable bowel syndrome (IBS-C). It is also developing SP-333, the second generation GC-C receptor agonist for the treatment of gastrointestinal inflammatory diseases, such as ulcerative colitis (UC). The Company�� active pharmaceutical ingredients (APIs) and the final formulated drug products are manufactured for it by third party contractors.
As of December 31, 2011, the Company was developing plecanatide, a synthetic hexadecapeptide designed to mimic the actions of the GI hormone uroguanylin, for the treatment of CC and IBS-C. Plecanatide is an agonist of GC-C receptor. As of December 31, 2011, the Company was dosing patients in an 800-patient Phase II/III clinical trial of plecanatide to treat. It is also developing a second generation GC-C receptor analog, SP-333, which is in pre-clinical development for the treatment of gastrointestinal inflammatory diseases. SP-333 is a synthetic analog of uroguanylin, a natriuretic hormone.
The Company competes with Ironwood Pharmaceuticals, Inc., Forest Laboratories, Inc., Takeda Pharmaceuticals America, Inc., Sucampo Pharmaceuticals, Inc., Salix Pharmaceuticals, Inc. and Shire Plc.
Advisors' Opinion:- [By Monica Gerson]
Breaking news
Time Warner Cable (NYSE: TWC) reported a drop in its third-quarter profit. Time Warner Cable's quarterly profit fell to $532 million, or $1.84 per share, from $808 million, or $2.60 per share, in the year-ago period. To read the full news, click here. Synergy Pharmaceuticals (NASDAQ: SGYP) today announced the start of a phase 2 clinical trial to evaluate the safety and efficacy of SP-333, its second-generation GC-C agonist and once-daily oral treatment, in adult patients with opioid-induced constipation (OIC). To read the full news, click here. Cigna (NYSE: CI) reported a 19% rise in its third-quarter earnings and lifted its full-year earnings outlook. To read the full news, click here. Charm Communications (NASDAQ: CHRM) announced today that the special committee of the Company's board of directors, consisting of independent directors Mr. Zhan Wang, Mr. Andrew J. Rickards and Mr. Gang Chen, has retained China Renaissance Securities (Hong Kong) Limited as its financial advisor and Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP as its legal advisor. To read the full news, click here.Posted-In: Bank of America US Stock FuturesNews Eurozone Futures Global Pre-Market Outlook Markets
- [By Sean Williams]
Finally, Synergy Pharmaceuticals (NASDAQ: SGYP ) may have had the wildest week of them all. Synergy's share price spiked 16% on Tuesday as an analyst at Cantor Fitzgerald raised her peak sales estimate for plecanatide, the company's midstage drug for chronic idiopathic constipation and irritable bowel syndrome with constipation, to $1.58 billion from $1.05 billion, as clinical data has been stronger than expected. However, the company didn't return the favor to shareholders by -- the very next day, mind you ��announcing a secondary offering of 16.375 million shares. The downside of clinical-stage companies is the always apparent risk of dilution. Shares have lost 25% since their Tuesday close.
Top 5 Biotech Stocks To Watch 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 Hilary Kramer]
InterMune is a $2.9 billion market cap company focused on developing drugs for pulmonology and orphan-status fibrotic diseases. Much like former GameChanger winner Intercept Pharmaceuticals (ICPT), ITMN develops drugs to treat a rare disease, which means that it targets a small domestic or global population.
- [By Ben Levisohn]
Sure Intercept Pharmaceuticals (ICPT) might feel like the only biotech stock that matters today, but there are others. For instance, Incyte (INCY) and� BioMarin (BMRN) are on the move after Barclays changed its ratings on the pair.
REUTERSBut before getting into that, let’s talk about Barclays’ Ying Huang and team’s thoughts on the sector. Would you believe they echo those of Goldman Sachs in its downgrade of the sector earlier this week (and just about everyone else) by calling this a stock picker’s market?
Huang explains:
Biotech should continue to outperform in 2014, but may be a more stock-specific year: We believe biotech as a group will continue to outperform the broad market in 2014 but do not expect a repeat of 2013. In 2013, the Nasdaq Biotech Index outperformed the S&P 500 by a large margin (+65.6% vs. S&P +29.6%), driven by a combination of generalist investor interest, hunt for growth opportunities, healthy long-term outlook for the industry, and an accommodative FDA. While we expect trends to remain strong in the overall industry and for biotech to outperform the broader market in 2014, it will likely be more muted, with fewer meaningful catalysts and as investors favor larger companies with less downside risk.
Huang too falls back on the PEG ratio–Price/Earnings to Growth–while explaining away the sectors P/E of 31.4, which dwarfs the 18 P/E in U.S. pharmaceuticals. “Looking at PEG ratios, which we view as a more appropriate metric given the growth profile of biotech companies, the group has traded at a reasonable and stable 1.0x for the past decade,” Huang says.
As for Incyte and BioMarin, Huang explains why he’s bullish on the former, bearish on the latter:
After taking a closer look at [Incyte's] pipeline assets, we are increasingly bullish on its proprietary JAK1 inhibitor INCB39110 and its IDO inhibitor INCB024360 and have increased ou
Top 5 Biotech Stocks To Watch For 2014: 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�� 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�� 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
Navidea�� 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�� 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�� 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-center 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 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)
Top 5 Biotech Stocks To Watch For 2014: 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.
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