At the end of this week,�congressional scrutiny was weighting down large cap biotech Gilead Sciences, Inc (NASDAQ: GILD) and dragging down much of the biotech sector, but there was still good news surrounding small cap biotech stocks like Endocyte, Inc (NASDAQ: ECYT), Aastrom Biosciences Inc (NASDAQ: ASTM)�and TNI BioTech (OTCMKTS: TNIB) plus there were more biotech IPOs which debuted:
Congress Takes Aim at Gilead Sciences and the High Cost of Drugs. A letter from three Democrats on the House�� Energy and Commerce Committee requesting a briefing with Gilead Sciences regarding its Sovaldi Hep C drug that the FDA approved back in February helped to send the stock down 4.57% today. The letter stated:
Our concern is that a treatment will not cure patients if they cannot afford it. Reports indicate that Gilead intends to sell Sovaldi at $84,000 per treatment. In cases where Sovaldi is prescribed with other treatments the costs could be even higher.
Hot Information Technology Stocks For 2015: Bioanalytical Systems Inc.(BASI)
Bioanalytical Systems, Inc. provides drug discovery and development services for pharmaceutical, biotechnology, academic, and government organizations primarily in North America, the Pacific Rim, and Europe. The company operates in two segments, Contract Research Services and Research Products. The Contract Research Services segment offers various services, including product characterization, method development, and validation; bioanalytical testing to measure drug and metabolite concentrations in complex biological matrices; stability testing to establish and confirm product purity, potency, and shelf life; in vivo sampling services for the continuous monitoring of chemical changes in life; and pharmacokinetic and safety testing services, as well as provides screening and pharmacological testing, preclinical safety testing, formulation development, regulatory compliance, and quality control testing services. The Research Products segment offers analytical products compris ing liquid chromatographic and electrochemical instruments with associated accessories; in vivo sampling products, such as Culex family of automated in vivo sampling and dosing instruments; and Vetronics? products consisting of instruments and related software to monitor and diagnose cardiac function, and measure other vital physiological parameters in cats and dogs. The company was founded in 1974 and is headquartered in West Lafayette, Indiana.
Advisors' Opinion:- [By Laura Brodbeck]
Monday
Earnings Releases Expected: Steelcase (NYSE: SCS), Bioanalytical Systems (NASDAQ: BASI) Economic Releases Expected: Italian trade balance, Greek current account, US existing home salesTuesday
Best Biotech Companies To Watch In Right Now: Mast Therapeutics Inc (MSTX)
Mast Therapeutics, Inc., formerly ADVENTRX Pharmaceuticals, Inc., incorporated in December 1995, is a development-stage company biopharmaceutical company focused on developing product candidates. The Company's product candidate is ANX-188, a rheologic, antithrombotic and cytoprotective agent that improves microvascular blood flow and has application in treating a range of diseases and conditions, such as complications arising from sickle cell disease. As of December 31, 2011, the Company also is developing ANX-514, a detergent-free formulation of the chemotherapy drug docetaxel. The Company offers ANX-188 (purified poloxamer 188), ANX-514 (docetaxel for injectable emulsion) and Exelbine (vinorelbine injectable emulsion). In April 2011, the Company acquired SynthRx, Inc. In February 2014, Mast Therapeutics Inc completed its acquisition of Aires Pharmaceuticals, Inc. Aires became a wholly-owned subsidiary of Mast Therapeutics.
ANX-188 (purified poloxamer 188)
ANX-188 is an aqueous solution of a purified form of poloxamer 188. Poloxamer 188 (P1880, is a nonionic, block copolymer that has been found to improve microvascular blood flow by reducing viscosity, particularly under low shear conditions, and by reducing adhesive frictional forces. The Company�� purified form of P188 (purified P188), which is the active ingredient in ANX-188, was designed to eliminate certain low molecular weight substances present in P188 (non-purified), which is primarily responsible for the moderate to moderately severe elevations in serum creatinine levels (acute renal dysfunction) observed in prior clinical studies of P188 (non-purified). Purified P188 has been evaluated in multiple clinical studies by a prior sponsor, including a 255-patient, phase III study.
ANX-514 (docetaxel for injectable emulsion)
ANX-514 is a detergent-free emulsion formulation of docetaxel, an intravenously-injected chemotherapy drug commonly used to treat solid tumors. Taxotere, a branded form! ulation of docetaxel, is approved to treat breast, non-small cell lung, prostate, gastric, and head and neck cancers. ANX-514 was designed to have clinically comparable release of docetaxel relative to Taxotere while eliminating the presence of polysorbate 80 and ethanol, both of which are used to solubilize docetaxel in the Taxotere formulation. The ANX-514 formulation solubilizes docetaxel using oil droplets consists of a combination of non-toxic excipients. Docetaxel is contained within these oil droplets and can be administered intravenously without using detergents as pharmaceutical vehicles. Once in central circulation, the emulsion is metabolized rapidly, leaving chemically-identical active ingredient to exert its cytotoxic effect. ANX-514 may reduce the incidence and severity of hypersensitivity reactions and delay the onset of fluid retention.
Exelbine (vinorelbine injectable emulsion)
Exelbine is an emulsion formulation of the chemotherapy drug vinorelbine. Navelbine, a branded formulation of vinorelbine, is approved in the United States to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin, and approved in the European Union to treat non-small cell lung cancer and advanced or metastatic breast cancer.
In August 2011, the Company received a complete response letter from the Food and Drug Administration (FDA) stating that it could not approve the Exelbine Non Disclosure Agreement (NDA) in its present form and that the bioequivalence study would need to be repeated because the authenticity of the drug products used in the bioequivalence trial could not be verified in accordance with FDA standards. However, the Company elected to discontinue independent development of Exelbine and as of December 31, 2011, the Company was seeking a partner or outside investor for the program to complete the necessary bioequivalence study.
The Company competes with GlaxoSmithKline, Provenge and Pfizer.
Advisors' Opinion:- [By Lauren Pollock]
Mast Therapeutics Inc.(MSTX) said the U.S. Food and Drug Administration gave orphan-drug designation to its MST-188 drug for the treatment of acute limb ischemia, providing a boost for the biopharmaceutical firm. Shares surged.
- [By Roberto Pedone]
Mast Therapeutics (MSTX), a biopharmaceutical company, focuses on developing therapies for serious or life-threatening diseases. This stock closed up 2.1% 65 cents per share in Thursday's trading session.
Thursday's Range: $0.63-$0.67
52-Week Range: $0.40-$1.10
Thursday's Volume: 1.11 million
Three-Month Average Volume: 1.88 millionFrom a technical perspective, MSTX spiked modestly higher here right above its 50-day moving average of 61 cents per share with decent upside volume. This stock has been trending sideways and consolidating for the last month, with shares moving between 60 cents on the downside and 72 cents on the upside. Shares of MSTX are now starting to push higher and into range of triggering a big breakout trade above the upper-end of its recent sideways trading chart pattern. That trade will hit if MSTX manages to clear some near-term overhead resistance levels at 68 to 72 cents per share with high volume.
Traders should now look for long-biased trades in MSTX as long as it's trending above some key near-term support at 60 cents per share and then once it sustains a move or close above those breakout levels with volume that hits near or above 1.88 million shares. If that breakout materializes soon, then MSTX will set up to re-test or possibly take out its next major overhead resistance levels at 80 to 85 cents per share, or even 93 cents per share.
- [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:
- [By James E. Brumley]
A little over a month ago, owning Mast Therapeutics, Inc. (NYSE: MSTX) was nothing but pure misery. Shares plunged from $0.63 to $0.43 in one day, when details of a dilutive public offering were unveiled. As is so often the case though, the market may have overshot with the selling effort that KO's MSTX. Though putting more shares 'out there' mathematically meant existing shareholders would have to share more of the company's upside with newcomers, what's slowly coming to light is that the inflow of new cash is still more advantageous to those prior shareholders; the company would progress little without it.
Best Biotech Companies To Watch In Right Now: Epizyme Inc (EPZM)
Epizyme, Inc., incorporated on November 1, 2007, is a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize personalized therapeutics for patients with genetically defined cancers. The Company systematically identify the genetic alterations that create cancer causing genes, called oncogenes, select patients in whom the identified genetic alteration is found and then design small molecule therapeutics to inhibit the oncogene. The clinical development plan for each of its product candidates is directed towards patients with a particular genetically defined cancer.The Company is conducting a Phase I clinical trial of its advanced product candidate, EPZ-5676, an inhibitor targeting the DOT1L HMT, for the treatment of mixed lineage leukemia (MLL-r). The Company has identified its two lead product candidates using its product platform.
EPZ-5676-DOT1L Inhibitor
EPZ-5676 is an intravenously administered small molecule inhibitor of DOT1L. The Company is developing EPZ-5676 for the treatment of MLL-r, an aggressive subtype of the two most common forms of acute leukemia, ALL and AML. Patients with MLL-r are routinely diagnosed with existing technologies that are commonly used in clinical setting. The Company�� Phase 1 clinical trial of EPZ-5676 is an open label, multicenter trial that has two phases.
EPZ-6438-EZH2 Inhibitor
The Company is developing EPZ-6438 as an orally available small molecule inhibitor of EZH2 for the treatment of non-Hodgkin lymphoma patients who have an oncogenic point mutation in EZH2. EZH2 is an HMT that can become oncogenic and cause non-Hodgkin lymphoma and a range of other solid tumors. Two types of non-Hodgkin lymphoma, diffuse large B-cell lymphoma of germinal-center origin, or DLBCL, and follicular lymphoma, or FL, are particularly associated with an EZH2 point mutation. There are no therapies approved specifically for the treatment of cancer associated with an EZH2 point mutation.
Advisors' Opinion:- [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:
Best Biotech Companies To Watch In Right Now: PTC Therapeutics Inc (PTCT)
PTC Therapeutics, Inc., incorporated on March 31, 1998 , is a biopharmaceutical company focused on the discovery and development of orally administered, small-molecule drugs that target post-transcriptional control processes. The Company�� lead product candidate includes ataluren, which is used for the treatment of patients with genetic disorders that arise from a type of genetic mutation known as a nonsense mutation. Ataluren is in late stage clinical development for the treatment of Duchenne muscular dystrophy caused by nonsense mutations (nmDMD) and cystic fibrosis caused by nonsense mutations (nmCF).
Ataluren is orally administered small-molecule compound that targets nonsense mutations. The Company is engaged in the development of ataluren for the treatment of genetic disorders in, which a nonsense mutation is the cause of the disease. Genetic tests are available for many genetic disorders, including Duchenne muscular dystrophy and cystic fibrosis, to determine if the underlying cause is a nonsense mutation. The EMA has designated ataluren as an orphan medicinal product for the treatment of nmDMD and nmCF. During the year ended December 31, 2012, the Phase III clinical trial completed. The Company�� Ataluren clinical trials in patients with nonsense mutation genetic disorders include Ataluren for nmDMD: Phase 2b clinical trial complete; Confirmatory Phase III clinical trial initiated, and Ataluren for nmCF: Phase III trial completed.
Advisors' Opinion:- [By WWW.DAILYFINANCE.COM] Records fell on Wall Street Friday as another solid report on housing lifted the market for the second day in a row. There's a three-day weekend coming up -- something that often prompts investor caution -- but the gains were broad-based even though volume was fairly light. The VIX, which measures volatility, fell to its lowest level this year. The Dow Jones industrial average (^DJI) gained 63 points, the Nasdaq composite (^IXIC) rose 31, and the Standard & Poor's 500 index (^GPSC) added 8, topping the record high set last week. The Dow Transportation average also raced to an all-time high, lifted by airline stocks. United (UAL) soared more than 4 percent; Delta (DAL) gained more than 1 percent and Southwest (LUV) gained 2 percent. Southwest is at an all-time high, up 79 percent from a year ago. New home sales bounced back with a better than expected 6.4 percent increase last month. Lennar (LEN) and D.R. Horton (DHI) both rose 4 percent. Pulte (PHM), Beazer (BZH) and Hovnanian (HOV) also solid posted gains. Earnings continue to drive retail stocks. Gap (GPS) edged higher even though net fell. Foot Locker (FL) gained 1½ percent after topping expectations. GameStop (GME) rose 4 percent. Its net rose, helped by the rollout last year of new Xbox and PlayStation consoles. Zumiez (ZUMZ) rose 5½ percent on an earnings beat. But Aeropostale (ARO) tumbled 24 percent. Its loss widened and sales declined. The retailer continues to struggle with teen fashion trends. Also on the earnings front, TiVo (TIVO) rose 2 percent as it swung to a profit from a year ago loss. It also reported an increase in the number of subscribers. Hewlett-Packard (HPQ) rose 6 percent on news the company plans to eliminate up to 16,000 additional workers in an effort to cut costs. And several stocks extended big moves from yesterday. Best Buy (BBY) rose more than 3 percent for the second straight day after earnings beat expectations. Isis Pharmaceuticals (ISIS) jumped
- [By John Kell]
PTC Therapeutics Inc.(PTCT) said the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a negative opinion on the biopharmaceutical company’s marketing authorization application for its muscular dystrophy treatment. Shares slumped 21% to $20.60 in premarket trading.
Best Biotech Companies To Watch In Right Now: 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 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 Jake L'Ecuyer]
Equities Trading UP
Shares of Alnylam Pharmaceuticals (NASDAQ: ALNY) got a boost, shooting up 53.25 percent to $101.47 after the company reported that it has acquired investigational RNAi Therapeutic assets from Merck (NYSE: MRK). Genzyme and Alnylam expanded their collaboration on rare genetic diseases. - [By Sean Williams]
On the clinical data front, Alnylam Pharmaceuticals (NASDAQ: ALNY ) and Inovio Pharmaceuticals (NYSEMKT: INO ) both put investors in their happy place.
- [By Garrett Cook]
Alnylam Pharmaceuticals (NASDAQ: ALNY) shares were also up, gaining 20.89 percent to $88.07 after the company reported six-month clinical data from patisiran phase 2 OLE study in patients with familial amyloidotic polyneuropathy.
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