Gilead Sciences (GILD) can't do anything offbase. Not only has the biotech's hepatitis C treatment Sovaldi turned into a multibillion-dollar sedate short of a year into its release, but also Gilead got two bits of uplifting news today in the proclamations of a positive result from a lawsuit and scope of Sovaldi by the U.K.'s NICE.
Gilead stated that a discretion board managed its support in a lawsuit Roche recorded against the organization. Roche guaranteed rights to Sovaldi as a feature of its 2004 coordinated effort with Pharmasset, which Gilead accordingly bought. The decade-old arrangement approved the European pharma monster to permit Pharmasset's "PSI-6130 and its prodrugs."
Roche asserted Sovaldi was a prodrug, a term that portrays medicates that break down into the dynamic medication once inside the patient ��for this situation, breaking down into PSI-6130. Prodrugs can at times cover symptoms on the grounds that they're latent until they break down, so it boded well for Roche to request prodrug subsidiaries and the principle compound.
Hot Trucking Stocks To Buy For 2016: Chromadex Corp (CDXC)
Chromadex Corporation, incorporated on June 19, 2008, is a provider of research and quality-control products and services to the natural products industry. The Company�� products are used by customers worldwide in the dietary supplement, food and beverage, cosmetic and pharmaceutical industries. The Company together with its subsidiaries supplies phytochemical reference standards, which are small quantities of plant-based compounds used to research an array of potential attributes, and reference materials, related contract services, technical consulting and ingredients. On December 3, 2012, ChromaDex Inc. acquired Spherix Consulting Inc. The Company�� principal subsidiaries include ChromaDex, Inc., Chromadex Analytics, Inc. and Spherix Consulting, Inc (Spherix).
The Company provides its clients in the food, supplement and pharmaceutical industries with solutions to manage potential health and regulatory risks. Its science-based solutions are for both new and existing products that may be subject to product liability and/or exposed to changing scientific standards or public perceptions; literature evaluations, and design and assessment of pre-clinical and clinical safety testing. It specializes in regulatory submissions for food and dietary supplement ingredients. For its clients involved in drug development within the pharmaceutical industry, the Company provides similar services, as well as risk-based strategies, including intellectual property data and compliance gap identification, due diligence assessments and investigational new drug writing.
Products and Services
The Company offers bulk raw materials for inclusion in dietary supplements, food, beverage and cosmetic products. Through its catalog, it supplies a range of products necessary to conduct quality control of raw materials and consumer products. The Company through Chromadex Analytics, provides a range of contract services ranging from routine contract analysis for the production of dietary sup! plements, cosmetics, foods and other natural products to elaborate contract research for clients in these industries. The Company provides a range of consulting services in the areas of regulatory support, new ingredient or product development, risk management and litigation support. With an addition of Spherix, it provides regulatory approval and scientific advisory services.
The Company competes with Sigma-Aldrich, Phytolab, US Pharmacopoeia, Extrasynthese, Covance, Eurofins, and Silliker Canada Co.
Advisors' Opinion:- [By Peter Graham]
Small cap stocks Chromadex Corp (OTCMKTS: CDXC) and 22nd Century Group Inc (OTCBB: XXII) are, one way or the other, focused on natural products and have been getting some extra attention lately. Moreover, one of these stocks have been the subject of a disclosed investor awareness campaign. Keeping that in mind, are these two small cap stocks natural winners for investors? Here is a quick look:
Top 10 Biotech Companies To Invest In Right Now: Alcobra Ltd (ADHD)
Alcobra Ltd is an Israel-based Biopharmaceutical company. It focuses on the development and commercialization of a proprietary drug, MG01CI, to treat Attention Deficit Hyperactivity Disorder (ADHD), a common and morbid neuropsychiatric condition in children and adults. Adult ADHD is associated with increased health risks and healthcare costs, higher divorce rates, lower levels of socioeconomic attainment, lower academic achievement, unemployment and work place deficits, increased risks for motor vehicle accidents, greater likelihood of additional psychiatric disorders, increased criminal activity and incarceration, and higher rates of substance use and abuse. MG01CI product has completed phase two studies. Advisors' Opinion:- [By MONEYMORNING.COM]
For example, a phase 3 clinical trial on metadoxine extended release as a treatment for adult attention deficit hyperactivity disorder (ADHD) will be finishing up at the end of this year. Positive data could give the stock a huge boost.
- [By Roberto Pedone]
A biopharmaceutical stock that's starting to trend within range of triggering a big breakout trade is Alcobra (ADHD), which is engaged in the development and commercialization of its proprietary drug, MG01CI, to treat attention deficit hyperactivity disorder. This stock has been on fire so far in 2013, with shares up huge by 126%.
If you take a look at the chart for Alcobra, you'll notice that this stock has been trending sideways and consolidating over the last month and change, with shares moving between $14.78 on the downside and $18.75 on the upside. Shares of ADHD have now started to uptrend a bit over the last few weeks, with shares moving higher from its low of $15.05 to its recent high of $18.45 share. That move has started to push shares of ADHD within range of triggering a big breakout trade above the upper-end of its recent sideways trading chart pattern.
Traders should now look for long-biased trades in ADHD if it manages to break out above its 50-day moving average of $17.79 a share, and then once it takes out some more key overhead resistance levels at $18.45 to $18.75 a share with high volume. Look for a sustained move or close above those levels with volume that hits near or above its three-month average action of 74,869 shares. If that breakout triggers soon, then ADHD will set up to re-test or possibly take out its next major overhead resistance levels at $22 to $24 a share. Any high-volume move above those levels will then give ADHD a chance to re-test or possibly take out its all-time high at $26.96 a share.
Traders can look to buy ADHD off any weakness to anticipate that breakout and simply use a stop that sits right below some near-term support levels at $16.17 to $15.05 a share, or around $14.78 a share. One could also buy ADHD off strength once it starts to clear those breakout levels with volume and then simply use a stop that sits a comfortable percentage from your entry point.
Top 10 Biotech Companies To Invest In Right Now: Conatus Pharmaceuticals Inc (CNAT)
Conatus Pharmaceuticals Inc., incorporated on July 13, 2005, is a biotechnology company focused on the development and commercialization of medicines to treat liver disease. The Company is developing its lead compound, emricasan, for the treatment of patients in orphan populations with chronic liver disease and acute exacerbations of chronic liver disease. The Company has designed a clinical program to demonstrate the therapeutic benefit of emricasan across the spectrum of fibrotic liver disease. The Company�� initial development strategy targets indications for emricasan with high unmet clinical need in orphan patient populations, such as patients with acute-on-chronic liver failure (ACLF), chronic liver failure (CLF), and patients who have developed liver fibrosis post-orthotopic liver transplant due to Hepatitis C virus infection (HCV-POLT).
The Company has completed two placebo-controlled Phase II trials in patients with liver disease showing reductions in ALT levels that occur rapidly, within as little as one day after initiation of therapy, and are maintained throughout the treatment period. In the Company�� 204-patient Phase 2b trial, it also measured cCK18, an important biomarker of apoptosis and disease severity. Emricasan has been generally well-tolerated in all of the clinical studies. As of July 23, 2013, the Company had not generated any revenue.
Advisors' Opinion:- [By Lauren Pollock]
Conatus Pharmaceuticals Inc.'s(CNAT) shares jumped 26% to $7.75 premarket after the biotechnology firm said its treatment for chronic liver disease has been granted a status that could mean quicker approval.
- [By John Udovich]
Recent IPO�FibroGen Inc (NASDAQ: FGEN) surged 22.96% today, reportedly after the journal Hepatology published the results of a workshop between the FDA and the American Association for the Study of Liver Disease (AASLD) which laid out criteria for a phase three study of a treatment for non-alcoholic steatohepatitis (NASH)���meaning its worth taking a closer look at the stock along with the performance of potential small cap or mid cap liver disease stock peers like Conatus Pharmaceuticals Inc (NASDAQ: CNAT), Intercept Pharmaceuticals Inc (NASDAQ: ICPT) and Raptor Pharmaceutical Corp (NASDAQ: RPTP) which rose 24.35%, 10.98% and 2.02%, respectively. According to Investors Business Daily, NASH (the more serious version of fatty liver disease) is potentially an enormous market with about 6 million�US patients but the�lack of previous treatments had left it unclear how the FDA would measure success against the disease while FibroGen Inc doesn't yet have a NASH human trial in the works, it has said it hopes to start one for its lead candidate FG-3019 (its in mid-stage trials for pulmonary fibrosis and liver fibrosis due to hepatitis B infection).
- [By John Udovich]
While Intercept Pharmaceuticals Inc (NASDAQ: ICPT) surged earlier this year and Achillion Pharmaceuticals, Inc (NASDAQ: ACHN) has surged this week after Merck & Co. Inc (NYSE: MRK) agreed to purchase hepatitis stock�Idenix Pharmaceuticals Inc (NASDAQ: IDIX) at a 239% premium, it seems the herd has realized that small cap Conatus Pharmaceuticals Inc (NASDAQ: CNAT) is also a liver disease stock as shares suddenly surged 56.69% on no apparent company news. But just what is�Conatus Pharmaceuticals and is it worth taking a chance on?
Top 10 Biotech Companies To Invest In Right Now: Gilead Sciences Inc.(GILD)
Gilead Sciences, Inc., a biopharmaceutical company, engages in the discovery, development, and commercialization of therapeutics for the treatment of life threatening diseases worldwide. Its products include Atripla, Truvada, Viread, Emtriva for the treatment of human immunodeficiency virus infection in adults; Hepsera, an oral formulation for the treatment of chronic hepatitis B; AmBisome, a amphotericin B liposome injection to treat invasive fungal infections; Letairis, an endothelin receptor antagonist for the treatment of pulmonary arterial hypertension; Ranexa for the treatment of chronic angina; Vistide, an antiviral medication for the treatment of cytomegalovirus retinitis in patients with AIDS; and Cayston, an inhaled antibiotic used as a treatment to enhance respiratory systems. The company?s products also comprise Tamiflu, an oral antiviral for the treatment and prevention of influenza A and B; Macugen, an intravitreal injection for the treatment of neovascular a ge-related macular degeneration; and Lexiscan/Rapiscan, an injection used as a pharmacologic stress agent in radionuclide myocardial perfusion imaging. Its products under the Phase III clinical trials consist of Cobicistat, a pharmacoenhancer that is under evaluation as a boosting agent for HIV medicines; Elvitegravir, an oral integrase inhibitor being evaluated as part of combination therapy for HIV; Integrase Single-Tablet, a ?Quad? regimen of elvitegravir, cobicistat, tenofovir disoproxil fumarate, and emtricitabine for the treatment of HIV/AIDS in treatment-naive patients; and Aztreonam for inhalation solution for the treatment of cystic fibrosis patients with Pseudomonas aeruginosa. The company?s Phase II clinical trials products comprise Cicletanine, Ranolazine, and Aztreonam, as well as GS 9190, GS 9256, and GS 9451. Its Phase I clinical trial products include GS 7340, GS 5885, GS 6620, GS 9620, and GS 6624. The company was founded in 1987 and is headquartered in Fost er City, California.
Advisors' Opinion:- [By Brian Orelli]
Why the other big biotechs aren't dividend stocks
True confession: I started this article with a plan to argue that the other three big biotechs -- Biogen Idec (NASDAQ: BIIB ) , Celgene (NASDAQ: CELG ) , and Gilead Sciences (NASDAQ: GILD ) -- should also offer a dividend. - [By James Brumley]
Selling its diabetes business to now-former-partner AstraZeneca is some evidence to that end, but it’s not the only sign that BMY is migrating to a policy of self-sufficiency. The company has also given up on partnering with Gilead (GILD) on the hepatitis C front.
Top 10 Biotech Companies To Invest In Right Now: BIND Therapeutics Inc (BIND)
BIND Therapeutics, Inc., incorporated on May 19, 2006, is a clinical-stage nanomedicine platform company developing Accurins, its targeted and programmable therapeutics. Accurins are designed with specified physical and chemical characteristics to target specific cells or tissues and concentrate a therapeutic payload at the site of disease to enhance efficacy while minimizing adverse effects on healthy tissues. Its drug candidate, BIND-014, is in Phase II clinical trials for non-small cell lung cancer, or NSCLC, and metastatic castrate-resistant prostate cancer (mCRPC).
Accurins represent the evolution of targeted therapies and nanomedicine. Accurins are polymeric nanoparticles that incorporate a therapeutic payload and are designed to have prolonged circulation within the bloodstream, enable targeting of the diseased tissue or cells, and provide for the controlled and timely release of the therapeutic payload. The four components include Targeting ligands, Stealth and protective layer, Controlled-release polymer matrix and Therapeutic payload. The Company focuses to use its medicinal nanoengineering platform to develop Accurins in several therapeutic areas, with an initial focus on the treatment of various types of cancer. In addition, the Company entered into collaboration agreements with several biopharmaceutical companies to develop and commercialize Accurins that are based on its collaborators��therapeutic payloads. The Company�� programs include BIND-014, solid tumor accurin and hematologic cancer accurin.
Advisors' Opinion:- [By Anna Prior]
Bind Therapeutics sa(BIND)id a collaboration with Amgen Inc.(AMGN) has been ended after both companies agreed not to pursue an option to jointly develop a molecularly targeted cancer therapy. Bind Therapeutics shares fell 11% to $11.50 premarket.
- [By John Udovich]
Yesterday, small cap biotech Acceleron Pharma Inc (NASDAQ: XLRN) rose 9.76%�plus shares are up 183.6% for retail investors since its September IPO, meaning its worth taking a closer look at the stock along with the performance of other biotech IPOs like BIND Therapeutics Inc (NASDAQ: BIND), Ophthotech Corp (NASDAQ: OPHT) and Foundation Medicine Inc (NASDAQ: FMI) which also debuted at the same time.
Top 10 Biotech Companies To Invest In Right Now: Chimerix Inc (CMRX)
Chimerix, Inc., incorporated on April, 07, 2000, is a biopharmaceutical company committed to the discovery, development and commercialization of novel, oral antiviral therapeutics that are designed to transform patient care in areas of high unmet medical need. Its lipid technology has given rise to two clinical-stage compounds, CMX001 and CMX157, which have demonstrated the potential for enhanced antiviral activity and safety in convenient, orally administered dosing regimens.
CMX001 is an orally administered drug that utilizes its lipid technology to deliver intracellular concentrations of a potent antiviral compound, cidofovir-diphosphate (CDV-PP). Following oral dosing, CMX001 is absorbed through the gut, remains intact in the plasma, and is readily taken up by and delivered into cells. Once inside cells, CMX001 is converted into CDV-PP, which acts as an alternative substrate in a replicating virus. CMX001 is similar to the drug cidofovir in that both drugs are converted into CDV-PP once inside cells. Although cidofovir is approved for administration in an intravenous formulation, Vistide, it requires a plasma concentration to deliver a therapeutic level of cidofovir into cells and its use is limited due to the risk of kidney damage.
CMX157, Its second clinical stage compound, is an oral nucleotide compound in Phase 1 development for the treatment of human immunodeficiency virus (HIV) infection. In July 2012, the Company granted Merck an exclusive worldwide license to develop and commercialize CMX157 for all human uses. Merck is responsible for all development and marketing activities for CMX157 on a worldwide basis.
Advisors' Opinion:- [By Ben Levisohn]
Biotech companies that are most likely to benefit because they are “Ahead in clinical development and/or have established relationships with [the Biomedical Advanced Research and Development Authority, or] BARDA which may facilitate getting a contract” include GlaxoSmithKline (GSK), NewLink Genetics (NLNK), Johnson & Johnson (JNJ) and Chimerix (CMRX). Kantor includes Tekmira�(TKMR) and Sarepta (SRPT) among “companies with viable programs” that are “moving forward and likely to attract additional funding.”
Top 10 Biotech Companies To Invest In Right Now: 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]
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.
- [By Ben Levisohn]
In what’s turned into a bad day for biotech stocks, Intercept Pharmaceuticals (ICPT) is among the worst performers.
REUTERSShares of Intercept Pharmaceuticals have dropped 8.3% to $295, lagging the 3.3% drop in the iShares Nasdaq Biotechnology ETF (IBB) and the 4.7% decline in the SPDR S&P Biotech ETF (XBI). Gilead Sciences (GILD) has fallen 2.1% to $72.44 and Amgen (AMGN) is off just 1.8% at $121.88.
Blame SAC’s decision to drastically cut its position and a secondary offering for Intercept’s decline.
Wedbush’s Liana Moussatos explains the purpose of the secondary offering:
Intercept raised approximately $183.3MM in a follow-on offering of 600,000 shares at $320/share. We project runway into Q3 2016 from Q3 2015, which covers major milestones, including regulatory review and potential approval of OCA in PBC in 2015…
Reiterate OUTPERFORM rating and acquisition value of $493. Our acquisition value is calculated by applying a 30% annual discount to our net peak WW revenues for each drug/indication and applying a 1-10x multiple depending on stage of development to reflect risk. Each combination is added in a sum-of-parts to calculate an acquisition value for [Intercept Pharmaceuticals] and projected to the end of 2015 to include the time frame we see for potential acquisition.
Just expect a heck of a lot of volatility before then.
- [By Jayson Derrick]
Intercept Pharmaceuticals (NASDAQ: ICPT) priced its one million common share offering at $320 per share, below Thursday's closing price of $321.81. Additionally, in a 13G filing, Steven Cohen's hedge fund SAC Capital disclosed on Thursday night that it holds 6,123 shares in the company, down from its 1,369,046 shares the fund held at the end of the last quarter. Shares plunged 9.61 percent, closing at $290.89.
No comments:
Post a Comment