Global Market Overview:�BJK Slumps After Wynn Resorts Earnings, XLE SlipsAhead of this week�� slew of economic reports, all three major U.S. equity indexes fell to close in positive territory.�The�Dow Jones Industrial Average ETF fell 0.15% as its underlying index traded in a narrow 75-point range.�The tech-heavy�Nasdaq�ETF slipped 0.24%, while the�S&P�500 ETF shed 0.31%.
Top 10 Shipping Stocks To Invest In Right Now: ANI Pharmaceuticals Inc (ANIP)
ANI Pharmaceuticals, Inc., incorporated on April 11, 2001, is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. In two facilities with combined manufacturing, packaging and laboratory capacity totaling 173, 00 square feet, the Company manufactures oral solid dose products, as well as liquids and topicals, including narcotics. Its other products include The Food and Drug Administration (FDA) approved testosterone gel, which is licensed to Teva Pharmaceuticals USA. In December 2013, the Company acquired 31 generic drug products from Teva Pharmaceuticals, which includes 20 solid-oral immediate release products, four extended release products and seven liquid products.
The Company performs contract manufacturing for other pharmaceutical companies. It has launched three products and has 11 products in development. The Company�� targeted areas of product development include narcotics, anti-cancers and hormones (potent compounds), and extended release niche generic product opportunities.Advisors' Opinion:
- [By Monica Gerson]
ANI Pharmaceuticals (NASDAQ: ANIP) reported that it has bought 31 generic drug products from Teva Pharmaceuticals (NYSE: TEVA) for $12.5 million in cash and a percentage of future gross profits. ANI Pharmaceuticals shares surged 5.14% to $18.00 in the after-hours trading session.
- [By Ben Levisohn]
ANI Pharmaceuticals (ANIP) has climbed 8.9% to $18.80 after it said it would buy 31 generic drugs from Teva Pharmaceuticals (TEVA). Teva’s shares are little changed in pre-open trading.
Top 10 Biotech Stocks To Watch Right Now: Biota Pharmaceuticals Inc (BOTA)
Biota Pharmaceuticals, Inc., formerly Nabi Biopharmaceuticals, incorporated on March 14, 1969, is an anti-infective drug development company, with key expertise in respiratory diseases, particularly influenza. Biota developed the neuraminidase inhibitor, zanamivir, subsequently marketed by GlaxoSmithKline as Relenza. The Company�� researches include a series of candidate drugs aimed at treatment of respiratory syncytial virus (RSV) disease and Hepatitis C (HCV) virus infections. In addition, Biota and Daiichi Sankyo co-own a range of second generation influenza anti-virals, of which the lead product lnavir, is approved for marketing in Japan.
The Company�� products include Zanamivir, Inavi, Phoslyra, BioStar OIA FLU and BioStar OIA FLU A/B. Zanamivir is a neuraminidase inhibitor for the treatment and prophylaxis of influenza marketed as Relenza by GlaxoSmithKline. Inavi (laninamivir) is a neuraminidase inhibitor marketed by Daiichi Sankyo in Japan. Phoslyra is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). BioStar OIA FLU and BioStar OIA FLU A/B are influenza diagnostic tests, which are marketed by Inverness Medical as part of their BioStar product range.
Relenza is delivered directly to the primary site of infection on the lungs, using a Disk Inhaler device. Relenza is approved in over 50 countries for the treatment of influenza, including in the United States, the European Union, Japan and Australia. Relenza is also approved for use as a preventative (prophylactic) treatment against influenza. Inavir is approved for sale in Japan for the treatment of influenza in adults and children. Daiichi Sankyo has applied to sell Inavir in Japan for the prevention of influenza.
PhosLo and Phoslyra are different dose forms of calcium acetate; a phosphate binder approved in multiple countries for the control of hyperphosphatemia (high serum phosphate) in patients with end stage renal disease (ESRD). PhosLo and Pho! slyra were sold to Fresnius Medical Care. Biota, together with its Japanese based partner, Daiichi Sankyo, have developed an inhaled antiviral compounds for influenza, called long acting inhaled neuraminidase inhibitors (LANI). Biota's human rhinovirus (HRV) drug for the prevention and treatment of the causes of the common cold, BTA798, has completed Phase I, Phase IIa and Phase IIb clinical trials.Advisors' Opinion:
- [By gurujx]
Biota Pharmaceuticals Inc (BOTA) Reached the 3-year Low of $2.42
The prices of Biota Pharmaceuticals Inc (BOTA) shares have declined to close to the 3-year low of $2.42, which is 93.3% off the 3-year high of $34.92.
Top 10 Biotech Stocks To Watch Right Now: Insys Therapeutics Inc (INSY)
Insys Therapeutics, Inc., incorporated on June 15, 1990, is a pharmaceutical company that develops and seeks to commercialize pharmaceutical products that target the unmet needs of cancer patients, with an initial focus on cancer-supportive care. The Company�� pharmaceuticals portfolio consists of one approved product and a number of product candidates targeting cancer-supportive care and cancer therapy. The Company�� product candidate includes Subsys, Dronabinol SG Capsule, Dronabinol RT Capsule, Dronabinol Oral Solution, Dronabinol Inhalation Device, and Dronabinol IV Solution. The Company is also developing cancer therapeutics, which is LEP-ETU, a formulation of paclitaxel, the active ingredient in the cancer drugs Taxol and Abraxane. On August 19, 2011, the Food & Drug Administration (FDA) approved its Dronabinol SG Capsule product, a generic equivalent to Marinol, for the treatment of chemotherapy induced nausea and vomiting (CINV), and anorexia associated with weight loss in patients with acquired immune deficiency syndrome (AIDS).
The Company's Subsys is a single-use product that delivers fentanyl, an opioid analgesic, in seconds for transmucosal absorption underneath the tongue. Subsys is a transmucosal product to show pain relief when measuring the sum of pain intensity difference at five minutes in a Phase 3 breakthrough cancer pain (BTCP) clinical trial using fentanyl.
Dronabinol Product Family
The Company has an approved dronabinol product and is developing several dronabinol product candidates for the treatment of CINV and appetite stimulation in patients with AIDS, as well as other indications where dronabinol could have potential therapeutic benefits. Dronabinol, the active ingredient in Marinol, is a synthetic cannabinoid whose chemical name is delta-9-tetrahydrocannabinol (THC). Its portfolio consists of its Dronabinol SG Capsule product and Dronabinol RT Capsule product candidate, which are intended to be generic equi! valents to Marinol, in addition to three formulations, including Dronabinol Oral Solution. Dronabinol SG Capsule is a dronabinol soft gelatin capsule intended to be a generic equivalent to Marinol. Dronabinol RT Capsule is a dronabinol soft gel capsule that is stable at room temperature. Dronabinol Oral Solution is a ynthetic THC in an oral liquid formulation.
In addition to its cancer-supportive care products, the Company intends to develop cancer therapeutics targeting limitations of existing commercial products. LEP-ETU, it advanced cancer therapeutic, is a NeoLipid liposomal, or microscopic membrane-like structure created from lipids, formulation that incorporates paclitaxel. LEP-ETU completed a Phase 2 clinical trial of 70 patients with metastatic breast cancer.
The Company competes with Cephalon, Inc., BioDelivery Sciences International, Inc., ProStrakan Group plc, Nycomed International Management GmbH, Archimedes Pharma Ltd., TEVA Pharmaceuticals USA, Watson Pharmaceuticals, Inc., AcelRx Pharmaceuticals, Inc., Akela Pharma Inc., Abbott Laboratories, Pharmaceutical International, Inc., Par Pharmaceutical Companies Inc., sanofi-aventis, Eisai Inc., Helsinn Group, Roche Holding AG, Par Pharmaceutical Companies Inc., GlaxoSmithKline plc, ProStrakan Group plc, Merck & Co, GW Pharmaceutical, A.P. Pharma, Inc., Aphios Corp., Roche Holding, Tesaro, Inc., Cornerstone Pharmaceutical, Inc., Bristol-Myers Squibb, Celgene Corporation, Laboratories, Amgen Inc., AstraZeneca PLC., Bayer AG, Biogen Idec Inc., Eisai Co., Ltd., F. Hoffmann- LaRoche Ltd., Johnson and Johnson, Merck and Co., Inc., Novartis AG, Onyx Pharmaceuticals Inc., Pfizer Inc., and Takeda Pharmaceutical Co. Ltd.Advisors' Opinion:
- [By Matt Jarzemsky]
Among companies that went public in the U.S. last year, FireEye has seen the second-biggest share rally since its IPO, trailing only pharmaceutical company Insys Therapeutics Inc.(INSY)
Top 10 Biotech Stocks To Watch Right Now: AMAG Pharmaceuticals Inc.(AMAG)
AMAG Pharmaceuticals, Inc., a biopharmaceutical company, engages in the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia (IDA). Its principal product includes Feraheme (ferumoxytol) injection for intravenous (IV) use, which was approved for marketing in the United States in June 2009 by the U.S. Food and Drug Administration, for use as an IV iron replacement therapy for the treatment of IDA in adult patients with chronic kidney disease (CKD). The company is pursuing marketing applications in the European Union, Canada, and Switzerland for Feraheme for the treatment of IDA in CKD patients. AMAG Pharmaceuticals was founded in 1981 and is based in Lexington, Massachusetts.Advisors' Opinion:
- [By Monica Gerson]
AMAG Pharmaceuticals (NASDAQ: AMAG) shares fell 16% to $18.38 in the pre-market trading after the company received a CRL from the FDA for the supplemental NDA for Feraheme for broader IDA indication.
- [By John Udovich]
The start of 2014 shows that biotech is still a hot area with the sector along with small cap biotech stocks like AMAG Pharmaceuticals, Inc (NASDAQ: AMAG), Mast Therapeutics Inc (NYSEMKT: MSTX), Cell Therapeutics Inc (NASDAQ: CTIC), Imprimis Pharmaceuticals Inc (NASDAQ: IMMY) and TNI BioTech (OTCMKTS: TNIB) producing news or returns�plus Auspex Pharmaceuticals (NASDAQ: ASPX), Cara Therapeutics (NASDAQ: CARA), Egalet (NASDAQ: EGLT), Flexion Therapeutics (NASDAQ: FLXN) and Ultragenyx Pharmaceutical (NASDAQ: RARE) are among the (many�� planned biotech IPOs that have recently been announced publicly:
Top 10 Biotech Stocks To Watch Right Now: 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 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.
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.
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 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.
- [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.
Top 10 Biotech Stocks To Watch Right Now: 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�� 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 bulk 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 cancers, 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 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 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 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 following 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 Stocks To Watch 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 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.