Yesterday, small cap�biotech Idera Pharmaceuticals Inc (NASDAQ: IDRA) surged 21.89% apparently on news about open enrollment for a clinical trial in what amounts to an orphan drug treatment, meaning its probably worth taking a closer look at the stock as well as consider its performance verses that of biotech ETFs like the iShares NASDAQ Biotechnology Index ETF (NASDAQ: IBB) and SPDR S&P Biotech ETF (NYSEARCA: XBI).
What is Idera Pharmaceuticals Inc?Small cap Idera Pharmaceuticals is a clinical stage biotechnology company developing a ��ovel approach��for the treatment of autoimmune diseases and certain genetically defined forms of B-cell lymphoma.�The technology platform is based on nucleic acid therapeutics designed to inhibit overactivation of Toll-like receptors. In addition,�the company is conducting clinical development of TLR antagonists in autoimmune and inflammatory diseases, and preclinical development of their use in certain genetically defined forms of B-cell lymphoma.
Best Sliver Stocks To Buy For 2015: Galectin Therapeutics Inc (GALT)
Galectin Therapeutics Inc., formerly Pro-Pharmaceuticals, Inc., incorporated on January 26, 2001, is a development-stage company. The Company is engaged in drug development to create therapies for cancer and fibrotic disease. As of December 31, 2011, the Company has two compounds in development, one is to be used in cancer therapy and the other intended to be used in the treatment of liver fibrosis and fatty liver disease. These two compounds are produced from different natural starting materials, both possessing the property, which lends itself to binding to and inhibiting galectin proteins. GM-CT-01, the Company's product candidate for cancer therapy, is a linear polysaccharide polymer consisted of mannose and galactose that has a defined chemical structure and is derived from a plant source. GR-MD-02, the Company's product for treatment of liver fibrosis and fatty liver disease with inflammation and fibrosis, is a polysaccharide polymer possessing both linear and globular structures, which also is derived from a plant source.
GM-CT-01 has in development for the therapy of colorectal cancer and is in a Phase I/II clinical trial as a combination therapy with a tumor vaccine in patients with advanced melanoma. Based on the completed Phase I and partially completed Phase II clinical trials, the Company is exploring two additional potential indicia for the use of GM-CT-01 in combination with cancer chemotherapy. There are two additional pathways for the development of GM-CT-01 for use in treatment of cancer. GM-CT-01 was found to be generally safe when studied in a Phase I clinical trial in end-stage cancer patients with multiple tumor types alone and in combination with 5-Fluorouracil (5-FU), which is an Food and Drug Administration (FDA)-approved chemotherapy used for treatment of various types of cancer.
Advisors' Opinion:- [By Roberto Pedone]
Galectin Therapeutics (GALT) offers drug research and development to create new therapies for fibrotic disease and cancer. This stock closed up 9.6% to $12.06 in Monday's trading session.
Monday's Volume: 674,000
Three-Month Average Volume: 222,171
Volume % Change: 149%Shares of GALT jumped higher on Monday after Ascendiant initiated coverage on the stock with a buy recommendation.
From a technical perspective, GALT spiked sharply higher here with strong upside volume. This stock has been uptrending for the last three months, with shares ripping higher from its low of $3.95 to its recent high of $13.21. During that move, shares of GALT have been making mostly higher lows and higher highs, which is bullish technical price action. That move has now pushed shares of GALT within range of triggering a near-term breakout trade. That trade will hit if GALT manages to take out Monday's high of $12.44 and then once it clears its 52-week high at $13.21 with high volume.
Traders should now look for long-biased trades in GALT as long as it's trending above some near-term support levels at $11 or at $10 and then once it sustains a move or close above those breakout levels with volume that hits near or above 222,171 shares. If that breakout hits soon, then GALT will set up to enter new 52-week-high territory above $13.21, which is bullish technical price action. Some possible upside targets off that breakout are $15 to $16.
Top Biotech Companies To Own In Right Now: Taro Pharmaceutical Industries Ltd (TARO)
Taro Pharmaceutical Industries Ltd., incorporated in 1959, is a science-based pharmaceutical company. The Company develops manufactures, and markets prescription and over-the-counter (OTC) pharmaceutical products, primarily in the United States, Canada and Israel. The Company also develops and manufactures active pharmaceutical ingredients (APIs), primarily for use in its finished dosage form products. The Company�� primary areas of focus include pediatric creams and ointments, liquids, capsules and tablets, mainly in the dermatological and topical, cardiovascular, neuropsychiatric and anti-inflammatory therapeutic categories. The Company operates through three companies: Taro Pharmaceutical Industries Ltd. (Taro Israel), and two of its subsidiaries (including indirect), Taro Pharmaceuticals Inc. (Taro Canada) and Taro U.S.A. The Company markets more than 180 pharmaceutical products in over 25 countries.
Taro Israel manufactures more than 160 finished dosage form pharmaceutical products for sale in Israel and for export. It produces APIs used in the manufacture of finished dosage form pharmaceutical products. It markets and distributes generic products in the local Israeli market. Taro Israel�� primary product lines include dermatology, prescription and OTC semi-solid products (creams, ointments and gels) and liquids; cardiology and neurology, prescription oral dosage products; oral analgesics, both prescription and OTC, and OTC oral and nasal sprays and ophthalmic products.
Taro Canada manufactures more than 70 finished dosage form pharmaceutical products for sale in Canada and for export. It markets and distributes generic products in the local Canadian market. Its product line includes dermatology: prescription and OTC semi-solid products (creams, ointments and gels) and liquids, cardiology, oncology, gastrointestinal and neurology: prescription oral and injects able dosage products, and allergy (antihistamine): OTC oral dosage products.
Taro U.S.A markets! and distributes generic products in the United States market. Its primary product lines include dermatology: prescription and OTC semi-solid products (creams, ointments and gels) and liquids, cardiology and neurology: prescription oral dosage products, and other prescription and OTC products.
The Company competes with Bristol-Myers Squibb, GlaxoSmithKline, Merck, Novartis, Pfizer/Wyeth, Valeant, Galderma, Merck/Schering-Plough, Teva Pharmaceuticals U.S.A., Mylan Laboratories, Perrigo Company, Ranbaxy Pharmaceuticals Inc., Sandoz Pharmaceuticals, Merck Canada Inc., Pfizer Canada Inc., Janssen Inc., Schering-Plough Canada, Novartis Pharmaceuticals Canada Inc., GlaxoSmithKline Inc., Bayer Inc., Bristol-Myers Squibb Canada, Apotex Inc., Teva Canada Limited, Mylan Pharmaceuticals ULC, Sandoz Canada Incorporated, Pharmascience Inc., Teva Pharmaceutical Industries Ltd., Perrigo Israel Pharmaceuticals Ltd., Dexxon Ltd., Rafa Laboratories Ltd., Bayer AG, Eli Lilly and Company, Merck & Co., Inc. and Pfizer Inc.
Advisors' Opinion:- [By Rich Smith]
Israeli drugmaker Taro Pharmaceutical Industries (NYSE: TARO ) has a new CEO -- and a new Chairman of the Board, as well.
On Thursday, Taro announced the imminent retirement of Interim Chief Executive Officer Mr. James Kedrowsk, who will be replaced August 1 by new permanent CEO Mr. Kalyanasundaram Subramanian ("Kal Sundaram"). Additionally, the company said that Dilip Shanghvi�has been appointed Chairman of its Board of Directors.
- [By Ben Levisohn]
Teva has dropped 7.7% to $37.85 today at 3:23 p.m. but doesn’t seem to be spreading though the generic drug space. Taro Pharmaceuticals (TARO) ha gained 1.1% to $79, while Actavis (ACT) has gained 1.2% to $156.25 and Dr. Reddy’s Laboratories (RDY) has advanced 1% to $40.24. Mylan (MYL) has dropped 0.7% to $38.40.
Top Biotech Companies To Own In Right Now: KYTHERA Biopharmaceuticals Inc (KYTH)
KYTHERA Biopharmaceuticals, Inc., incorporated in June 2004, is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of prescription products for the aesthetic medicine market. The Company�� initial focus is on the facial aesthetics market. The Company�� product candidate, ATX-101, is a injectable drug in Phase III clinical development for the reduction of submental fat, which commonly presents as an undesirable double chin. Based on clinical trials conducted, ATX-101 has exhibited results in the reduction of submental fat. ATX-101 contains a synthetic form of sodium deoxycholate. In the United States and Canada, the Company is conducting two pivotal Phase III trials of ATX-101 for the reduction of submental fat. The Company initiated this pivotal Phase III clinical program, with planned enrollment of 1,000 patients, in March 2012.
In Europe, Bayer, its collaborator outside the United States and Canada, recently completed two pivotal Phase III trials of ATX-101 for the reduction of submental fat. In these multi-center, randomized, double-blind, placebo-controlled pivotal trials involving 723 patients, ATX-101 resulted in a reduction in submental fat, as assessed by a validated clinician scale and a patient satisfaction scale.
ATX-101 contains a synthetic form of sodium deoxycholate. ATX-101 is designed to be a locally-injected drug that causes proximal, preferential destruction of adipocytes, or fat cells, with minimal effect on surrounding tissue. Upon subcutaneous injection under the skin, ATX-101 disrupts cell membranes in protein-poor tissues, such as fat, while being attenuated by interactions with protein-rich tissue, such as skin, muscle and blood vessels. This attenuation by protein-rich tissue results in the preferential destruction of adipocytes by ATX-101. The destruction of adipocytes, or adipocytolysis, elicits a natural response, in which macrophages are attracted to remove cellular debris and fat particles t! hrough the lymphatic system. The macrophages also emit low levels of chemical messengers, known as cytokines, which attract fibroblasts, another cell type, to the area. Fibroblasts produce collagen, and it is believed that new collagen production, or neocollagenesis, promotes retraction of the skin in the areas of fat reduction. The fat removal process with ATX-101 is incremental with each treatment, thereby allowing for control of the aesthetic outcome.
Advisors' Opinion:- [By Jake L'Ecuyer]
Equities Trading UP
Repros Therapeutics (NASDAQ: RPRX) shot up 29.82 percent to $27.60 after the company announced topline results from both the second pivotal efficacy study as well as the 6 month safety study of Androxal庐. Shares of Kythera Biopharmaceuticals (NASDAQ: KYTH) got a boost, shooting up 26.04 percent to $42.26 after the company reported positive ATX-101 top line phase III trial results for the reduction of submental fat. Aeropostale (NYSE: ARO) was also up, gaining 16.75 percent to $10.05 after private equity firm Sycamore Partners reported that it had bought a 7.96 percent stake in the company. - [By Lisa Levin]
Kythera Biopharmaceuticals (NASDAQ: KYTH) shares moved up 24.01% to $41.58. The volume of Kythera Biopharmaceuticals shares traded was 6431% higher than normal. Kythera reported positive ATX-101 top line phase III trial results for the reduction of submental fat.
- [By John Udovich]
On Tuesday, small cap biotech stock Kythera Biopharmaceuticals Inc (NASDAQ: KYTH) surged around 25% after announcing that its ATX-101 REFINE-1 and REFINE-2 Phase III trials met all primary and secondary endpoints for the reduction of so-called double chins; but if investors missed out on that rally, small caps Zeltiq Aesthetics Inc (NASDAQ: ZLTQ), Solta Medical Inc (NASDAQ: SLTM) and Cynosure, Inc (NASDAQ: CYNO) each have a piece of the aesthetic market as well. In the case of Kythera Biopharmaceuticals, its ATX-101 can be injected to deal with double chins���meaning its less invasive than liposuction as the drug dissolves fat cells but leaves other tissue alone. JP Morgan has noted:
- [By Lisa Levin]
Kythera Biopharmaceuticals (NASDAQ: KYTH) jumped 24.43% to $41.72 after the company reported positive ATX-101 top line phase III trial results for the reduction of submental fat.
Top Biotech Companies To Own In Right Now: Cell Therapeutics Inc (CTIC)
Cell Therapeutics, Inc. (CTI), incorporated in 1991, develops, acquires and commercializes treatments for cancer. The Company�� research, development, acquisition and in-licensing activities concentrate on identifying and developing new ways to treat cancer. As of December 31, 2011, CTI focused its efforts on Pixuvri (pixantrone dimaleate) (Pixuvri), OPAXIO (paclitaxel poliglumex) (OPAXIO), tosedostat, brostallicin and bisplatinates. As of December 31, 2011, it developed Pixuvri, an anthracycline derivative for the treatment of hematologic malignancies and solid tumors. Another late-stage drug candidate of the Company, OPAXIO, is being studied as a potential maintenance therapy for women with advanced stage ovarian cancer, who achieve a complete remission following first-line therapy with paclitaxel and carboplatin. As of December 31, 2011, it also developed tosedostat in collaboration with Chroma Therapeutics, Ltd. (Chroma). On May 31, 2012, CTI completed its acquisition gaining worldwide rights to S*BIO Pte Ltd.'s (S*BIO) pacritinib.
Pixuvri
As of December 31, 2011, the Company developed Pixuvri, an aza-anthracenedione derivative, for the treatment of non-Hodgkin�� lymphoma (NHL), and various other hematologic malignancies, and solid tumors. Pixuvri was studied in the Company�� EXTEND, or PIX301, clinical trial, which was a phase III single-agent trial of Pixuvri for patients with relapsed, refractory aggressive NHL who received two or more prior therapies and who were sensitive to treatment with anthracyclines. On September 28, 2011, CTI announced that a second independent radiology assessment of response and progression endpoint data from its PIX301 clinical trial of Pixuvri was achieved with statistical significance. The results of the EXTEND trial met its primary endpoint and showed that patients randomized to treatment with Pixuvri achieved a significantly higher rate of confirmed and unconfirmed complete response compared to patients treated with standard chem! otherapy had a significantly increased overall response rate and experienced a statistically significant improvement in median progression free survival. Pixuvri had predictable and manageable toxicities when administered at the proposed dose and schedule in the EXTEND clinical trial in heavily pre-treated patients. In March 2011, the Company initiated the PIX-R trial to study Pixuvri in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Pixuvri has also been studied in patients with HER2-negative metastatic breast cancer who have tumor progression after at least two, but not more than three, prior chemotherapy regimens. In the second quarter of 2010, the NCCTG opened this phase II study for enrollment. The study is closed to accrual and results are expected to be reported by the NCCTG later in 2012.
OPAXIO
OPAXIO is the Company�� biologically-enhanced chemotherapeutic agent that links paclitaxel to a biodegradable polyglutamate polymer, resulting in a new chemical entity. As of December 31, 2011, the Company focused its development of OPAXIO on ovarian, brain, esophageal, head and neck cancer. OPAXIO was designed to improve the delivery of paclitaxel to tumor tissue while protecting normal tissue from toxic side effects. In November 2010, results were presented by the Brown University Oncology Group from a phase II trial of OPAXIO combined with temozolomide (TMZ), and radiotherapy in patients with newly-diagnosed, high-grade gliomas, a type of brain cancer. The trial demonstrated a high rate of complete and partial responses and a high rate of six month progression free survival (PFS). Based on these results, the Brown University Oncology Group has initiated a randomized, multicenter, phase II study of OPAXIO and standard radiotherapy versus TMZ and radiotherapy for newly diagnosed patients with glioblastoma with an active gene termed MGMT that reduces responsiveness to TMZ. A phase I/II study of OPAXIO combined with radi! otherapy ! and cisplatin was initiated by SUNY Upstate Medical University, in patients with locally advanced head and neck cancer.
Tosedostat
In March 2011, the Company entered into a co-development and license agreement with Chroma Therapeutics, Ltd. (Chroma), providing the Company with marketing and co-development rights to Chroma�� drug candidate, tosedostat, in North, Central and South America. Tosedostat is an oral, aminopeptidase inhibitor that has demonstrated anti-tumor responses in blood related cancers and solid tumors in phase I-II clinical trials. Interim results from the phase II OPAL study of tosedostat in elderly patients with relapsed or refractory acute myeloid leukemia (AML) showed that once-daily, oral doses of tosedostat had predictable and manageable toxicities and results demonstrated response rates, including a high-response rate among patients who received prior hypomethylating agents, which are used to treat myelodysplastic syndrome (MDS), a precursor of AML.
Brostallicin
As of December 31, 2011, the Company developed brostallicin through its wholly owned subsidiary, Systems Medicine LLC, which holds rights to use, develop, import and export brostallicin. Brostallicin is a synthetic deoxyribonucleic acid (DNA) minor groove binding agent that has demonstrated anti-tumor activity and a favorable safety profile in clinical trials, in which more than 230 patients have been treated as of December 31, 2011. The Company uses a genomic-based platform to guide the development of brostallicin. A phase II study of brostallicin in relapsed, refractory soft tissue sarcoma met its predefined activity and safety hurdles and resulted in a first-line phase II clinical trial study that was conducted by the European Organization for Research and Treatment of Cancer (EORTC).
The Company competes with Bristol-Myers Squibb Company, Sanofi-Aventis, Pfizer, Roche Group, Genentech, Inc., Astellas Pharma, Eli Lilly and Company, Celgene, Telik, I! nc., TEVA! Pharmaceuticals Industries Ltd. and PharmaMar.
Advisors' Opinion:- [By Nathalie Tadena]
Among the companies with shares expected to actively trade in Friday’s session are Vanda Pharmaceuticals Inc.(VNDA), Kimberly-Clark(KMB) and Cell Therapeutics(CTIC).
Top Biotech Companies To Own In Right Now: 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.
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