Our top stock selection for 2014 has received three Breakthrough Therapy Designations (BTD) by the FDA, and subsequent approval, in November, for Imbruvica, a very safe pill that has shown unprecedented efficacy to treat mantle cell lymphoma (MCL), suggests John McCamant, editor of The Medical Technology Stock Letter.
The company��hich we consider conservative among biotech stocks��s Pharmacyclics (PCYC). Its pill is also expected to be approved for a much larger B-cell cancer market, chronic lymphocytic leukemia (CLL), by the end of February.
The next catalyst for PCYC will be the release of data, at the end of January, from the RESONATE trial, the first Phase III study of Imbruvica in patients with refractory/relapsed CLL. RESONATE should continue to demonstrate Imbruvica's incredible efficacy and safety as a once-a-day cancer pill.
With the drug already on the market for MCL, we expect CLL sales to ramp up rapidly, as there is a large pool of CLL patients that have been watching and waiting for a safe and effective treatment for CLL.
Best Biotech Companies To Own 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
Best Biotech Companies To Own In Right Now: Amgen Inc.(AMGN)
Amgen Inc., a biotechnology medicines company, discovers, develops, manufactures, and markets human therapeutics based on advances in cellular and molecular biology for grievous illnesses primarily in the United States, Europe, and Canada. The company markets recombinant protein therapeutics in supportive cancer care, nephrology, and inflammation. Its principal products include Aranesp and EPOGEN erythropoietic-stimulating agents that stimulate the production of red blood cells; Neulasta and NEUPOGEN to stimulate the production of neutrophils, which is a type of white blood cell that helps the body to fight infections; and Enbrel, an inhibitor of tumor necrosis factor that plays a role in the body?s response to inflammatory diseases. The company also markets other products comprising Sensipar/Mimpara, a small molecule calcimimetic that lowers serum calcium levels; Vectibix, a monoclonal antibody that binds specifically to the epidermal growth factor receptor; and Nplate, a thrombopoietin (TPO) receptor agonist that mimics endogenous TPO, the primary driver of platelet production. In addition, it provides Denosumab, a human monoclonal antibody that targets RANKL, an essential regulator of osteoclasts. Further, the company offers product candidates in mid-to-late stage development in a variety of therapeutic areas, including oncology, hematology, inflammation, bone, nephrology, cardiovascular, and general medicine consisting of neurology. It markets its products to healthcare providers, including physicians or their clinics, dialysis centers, hospitals, and pharmacies; consumers; and wholesale distributors of pharmaceutical products. The company has various collaborative arrangements with Pfizer Inc.; GlaxoSmithKline plc; Takeda Pharmaceutical Company Limited; Daiichi Sankyo Company, Limited; Array BioPharma Inc.; Kyowa Hakko Kirin Co. Ltd.; and Cytokinetics, Inc. Amgen Inc. was founded in 1980 and is headquartered in Thousand Oaks, California.
Advisors' Opinion:- [By Keith Speights]
I have jokingly referred to Amgen (NASDAQ: AMGN ) in the past as a "senior citizen" of biotech. The company was founded 33 years ago, making Amgen a virtual Methuselah when it comes to biotech companies. Regardless of age, every stock needs a checkup every now and then. Let's see how Amgen stock holds up in this month's checkup.
- [By Brian Orelli]
The insiders -- most likely Onyx's bankers -- release the confidential information to help drive up the price. You'll recall that Amgen (NASDAQ: AMGN ) recently made an unsolicited bid for $120 per share that Onyx rejected before putting itself on the auction block. The more potential bidders, the higher Amgen has to raise its bid, assuming, of course, that Amgen believes what's reported in the press.
- [By Bryan Murphy]
When most investors think of cancer stocks, names like Amgen, Inc. (NASDAQ:AMGN) or Roche Holding Ltd. (OTCMKTS:RHHBY) come to mind. And to be fair, they're both top-of-mind names for good reasons. Five of the world's top-ten selling cancer drugs are from Roche Holding, and Amgen is the world's biggest biotech company; it just spent $10 billion on the acquisition of an entire company almost to add just one cancer therapy to its library. Thing is, while Roche Holding Ltd. and Amgen, Inc. make top-notch drugs to treat cancer once acquired, neither actually does anything to prevent the development of cancer through metastasization. Indeed, the prevention of the spread of cancer isn't on the biopharma industry's radar at all, save one company - a little outfit called MetaStat Inc. (OTCBB:MTST).
Hot Quality Companies To Own In Right Now: Pharmacyclics Inc (PCYC)
Pharmacyclics, Inc., incorporated on April 19, 1991, is a clinical-stage biopharmaceutical company focused on developing and commercializing small-molecule drugs for the treatment of cancer and immune mediated diseases. The Company's clinical development and product candidates are small-molecule enzyme inhibitors designed to target biochemical pathways involved in human diseases. As of June 30, 2011, it had three drug candidates under clinical development and a number of preclinical lead molecules. This includes an inhibitor of Bruton�� tyrosine kinase (Btk) (PCI-32765) in Phase II studies in hematologic malignancies; a Btk inhibitor lead optimization program targeting autoimmune indications, an inhibitor of Factor VIIa (PCI-27483) in a Phase II clinical trial in pancreatic cancer, and a histone deacetylase (HDAC) inhibitor (PCI-24781) in Phase I and II clinical trials in solid tumors and hematological malignancies as of June 30, 2012.
As of June 30, 2012, the Company developed ibrutinib, which has demonstrated clinical activity and tolerability in Phase I and Phase II clinical trials in a variety of B-cell malignancies, including chronic lymphocytic leukemia (CLL) and a number of non-Hodgkin�� lymphoma (NHL) subtypes. CLL, mantle cell lymphoma (MCL), follicular lymphoma (FL), diffuse B-cell lymphoma (DLBCL) and multiple myeloma (MM) are specific indications of its current or planned Phase Ib/II and Phase III development program. had development programs for B-cell malignancies and autoimmune diseases. For malignant indications it has developed PCI-32765, which has demonstrated clinical activity and tolerability in Phase I and Phase II clinical trials in a range of B-cell malignancies, including chronic lymphocytic leukemia (CLL) and a number of non-Hodgkin�� lymphoma (NHL) subtypes. CLL, mantle cell lymphoma (MCL), follicular lymphoma (FL), diffuse large B cell lymphoma (DLBCL) and multiple myeloma (MM) are specific indications of its Phase II development. It has developed an assay! to measure occupancy of Btk in PBMCs using a cell-permeable fluorescently-labeled derivative of PCI-32765.
Factor VII is an enzyme that becomes activated (FVIIa) by binding to the cell surface protein tissue factor (TF), a protein found in the body that helps to trigger the process of blood clotting in response to injury. TF is over expressed in many cancers including gastric, breast, colon, lung, prostate, ovarian and pancreatic cancers. In these tumors, the FVIIa/TF complex induces intracellular signaling pathways by activating protease activated receptor 2 (PAR-2), another cell-surface protein. This in turn increases the expression of interleukin-8 (IL-8), a protein produced by white blood cells and other immune cells in response to pathogenic stimulation, and vascular endothelial growth factor (VEGF), a signal protein produced by cells that stimulate the growth of blood vessels. Both proteins play an important role in tumor growth and metastases as well as angiogenesis (growth of new blood vessels). FVIIa/TF complex also initiates the coagulation (a process by which blood forms clots) processes implicated in the high incidence of thromboembolic (the process by which the blood clots within a blood vessel) complications seen in patients with TF-expressing cancers. Thromboembolic events are a cause of death in patients with cancer and anticoagulant treatment has been shown to improve survival in a variety of cancers (Klerk et al. JCO. 2005).
PCI-27483 Factor VIIa Inhibitor
The Company�� Factor VIIa inhibitor PCI-27483 is a first-in-human small molecule inhibitor that selectively targets FVIIa. As an inhibitor of FVIIa, PCI-27483 has two potential mechanisms of action: inhibition of intracellular signaling involved in tumor growth and metastases and inhibition of early coagulation processes associated with thromboembolism.
Factor VIIa PCI-27483 Clinical Development Update
A multicenter Phase I/II of PCI-27483 in patients with locally a! dvanced o! r metastatic pancreatic cancer that are either receiving or are planned to receive gemcitabine therapy has completed enrollment. The Phase II portion of the study randomized patients to receive either gemcitabine alone or gemcitabine plus PCI-27483 (1.2 mg/kg twice daily). The objectives are to assess the safety of FVIIa Inhibitor PCI-27483 at pharmacologically active dose levels, to assess potential inhibition of tumor progression and to obtain initial information of the effects on the incidence of thromboembolic events. Due to a paradigm shift away from the use of gemcitabine alone for the treatment of pancreatic cancer, enrolling patients in this randomized study has been challenging. PCYC is evaluating other alternatives for development of this agent.
A multicenter Phase I/II of PCI-27483 in patients with locally advanced or metastatic pancreatic cancer that are either receiving or are planned to receive gemcitabine therapy has completed enrollment. The Phase II portion of the study randomized patients to receive either gemcitabine alone or gemcitabine plus PCI-27483 (1.2 mg/kg twice daily). PCI-27483 is covered by United States patents and patent applications and counterpart patents and patent applications in fourteen ex-United States territories, including Europe, Canada, Mexico, Japan, China, India, South Korea, Australia and Brazil.
Advisors' Opinion:- [By Sean Williams]
Very few breakthrough therapies have been approved up to this point -- then again, we're only working with about 100 days for the Food and Drug Administration to have assigned such a designation. Vertex Pharmaceuticals'�received the first two "breakthrough therapy" designations from the FDA for two cystic fibrosis treatments, of which both involve the use of the already FDA-approved Kalydeco. The more intriguing "breakthrough therapy" designation is Pharmacyclics' (NASDAQ: PCYC ) Ibrutinib for the treatment of two rare blood cancers, which analysts feel could have a peak sales value of $5 billion if approved.
- [By Ben Levisohn]
Somaiya and team named Gilead and�Neurocrine Biosciences (NBIX) their top picks, hile putting Buy ratings on Celgene, Biogen Idec, Alexion (ALXN), Incyte (INCY), Pharmacyclics (PCYC) and Synageva (GEVA). BioMarin (BMRN), Infinity Pharmaceuticals (INFI) and Amgen (AMGN) earned Neutral ratings.
Best Biotech Companies To Own 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 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
- [By Sean Williams]
For this week's round of "Better Know a Stock," I'm going to take a closer look at Intercept Pharmaceuticals (NASDAQ: ICPT ) .
What Intercept Pharmaceuticals does
Intercept Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing treatments aimed at chronic liver diseases. Specifically, Intercept differentiates itself through the utilization of its proprietary bile acid chemistry. The company's lead compound, known as obeticholic acid, or OCA, recently initiated phase 3 trials for primary biliary cirrhosis and has received orphan drug status from the Food and Drug Administration for this disease, which could ultimately expedite its review process and grant it seven years marketing exclusivity from the date of approval -- assuming it gets approved, of course! OCA is also being tested in a number of other indications. - [By Ben Levisohn]
When a biotech stock has already gained 556% this year, like Intercept Pharmaceuticals (ICPT) has, there’s really only one thing for an analyst to do–raise their price target. And that’s exactly what Citigroup did today with Intercept Pharmaceuticals, the best performing biotech company in the Russell 2000.
Intercept Pharmaceutical has surged 576% this year after gaining today, besting InterMune’s (ITMN) 119% spike and Sangamo BioSciences’ (SGMO) 63% advance.
Citigroup’s Jonathan Eckard and team explain why they’re even more excited about Buy-rated Intercept Pharmaceuticals:
We are raising�[Intercept Pharmaceuticals' target price] to $700 (+$100) based on higher regulatory confidence following a thorough assessment of FDA history with blood lipid changes in other settings involving liver damage/repair. We believe the FDA�� understanding of these lipid changes is under-recognized by the Street and the agency�� past ��ack of��response to them highlights this. Therefore, we expect the lipid changes in the FLINT trial are likely to receive less regulatory scrutiny than current Street expectations and this is not reflected in [Intercept Pharmaceuticals'] current valuation. We also believe certain FLINT data could be publicly available by the end of July and before the anticipated AASLD showing.
What does all that mean for Intercept Pharmaceuticals? Here’s the one-sentence version: “Our increase is driven primarily by higher probability of approval and more rapid penetration into the most severe NASH population.”
Shares of Intercept Pharmaceuticals have gained 2.9% to $461.11, while InterMune has dropped 2.9% to $32.29 and Sangamo BioSciences has dipped 0.5% to $22.67.
- [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.
Best Biotech Companies To Own In Right Now: OncoGenex Pharmaceuticals Inc.(OGXI)
OncoGenex Pharmaceuticals, Inc., a biopharmaceutical company, engages in the development and commercialization of new cancer therapies that address treatment resistance in cancer patients. The company?s clinical stage products include Custirsen, a phase III clinical stage product for treatment in men with metastatic castrate-resistant prostate cancer; OGX-427, which is in phase II clinical development stage is designed to inhibit heat shock protein 27; and SN2310 that completed phase I stage of clinical development is designed to evaluate safety in patients with advanced cancer. Its pre clinical stage products include GX-225 that is focused on reducing the production of IGFBP-2 and IGFBP-5; and CSP-9222, lead compound from a family of caspase activators. OncoGenex Pharmaceuticals, Inc. is based in Bothell, Washington.
Advisors' Opinion:- [By Lauren Pollock var popups = dojo.query(".socialByline .popC"); popups.forEach]
Teva Pharmaceutical Industries Ltd.(TEVA) and OncoGenex Pharmaceuticals Inc.(OGXI) said their experimental drug for hard-to-treat cases of prostate cancer didn’t result in statistically significant improvement in overall survival in a Phase 3 study. OncoGenex shares dropped 48% to $5 premarket.
Best Biotech Companies To Own In Right Now: Agios Pharmaceuticals Inc (AGIO)
Agios Pharmaceuticals, Inc., incorporated on August 7, 2007, is a biopharmaceutical company. The Company is intend to apply its deep understanding of metabolism, coupled with the Company�� ability to create medicines that can inhibit or activate metabolic enzymes, to fundamentally change the way cancer and inborn errors of metabolism (IEMs) are treated. The Company has identified and validated novel and druggable targets in both cancer and IEMs. The Company�� two advanced cancer programs are targeting mutations in the enzymes isocitrate dehydrogenase 1 and 2, referred to as IDH1 and IDH2. The Company�� drug candidates are selective for the mutated forms of IDH1 and IDH2 found in cancer cells versus the normal forms of IDH1 and IDH2 found in all other cells.
The Company focused on developing medicines to address IEMs, with a novel approach to these orphan diseases for which no effective or disease-modifying therapy is available. The Company has also de-validated and terminated numerous programs, including many that have been reported in scientific journals. In the Company�� IEM portfolio, it uses an equally rigorous set of validation techniques.
Advisors' Opinion:- [By Jake L'Ecuyer]
Shares of Agios Pharmaceuticals (NASDAQ: AGIO) got a boost, shooting up 29.08 percent to $40.84 after the company reported quarterly results.
Stage Stores (NYSE: SSI) was also up, gaining 13.47 percent to $22.41 after the company reported Q4 results and announced the sale of its Steele's off-price division to a new retail unit of Hilco Global.
- [By Lisa Levin]
Agios Pharmaceuticals (NASDAQ: AGIO) shares touched a new 52-week low of $18.83. Agios Pharmaceuticals' trailing-twelve-month profit margin is -102.87%.
- [By Jake L'Ecuyer]
Equities Trading UP
Sangamo Biosciences (NASDAQ: SGMO) shot up 16.32 percent to $22.81 announced the publication in the NEJM of the first-in-man study of genome editing using its ZFN technology. Shares of Agios Pharmaceuticals (NASDAQ: AGIO) got a boost, shooting up 27.72 percent to $40.41 after the company reported quarterly results. BJ's (NASDAQ: BJRI) was also up, gaining 21.04 percent to $33.48 after the company was upgraded toa Buy rating at Buckingham research.
Best Biotech Companies To Own In Right Now: Nektar Therapeutics(NKTR)
Nektar Therapeutics, a clinical-stage biopharmaceutical company, engages in developing a pipeline of drug candidates that utilize its PEGylation and polymer conjugate technology platforms. The company?s product pipeline consists of drug candidates across various therapeutic areas, including oncology, pain, anti-infectives, anti-viral, and immunology. Its research and development activities involve small molecule drugs, peptides, and other potential biologic drug candidates. The company?s proprietary drug candidates in clinical development comprise NKTR-118, a peripheral opioid antagonist, which has completed Phase II clinical trail for the treatment of opioid-induced constipation; BAY41-6551 that has completed Phase II clinical trail to treat gram-negative pneumonias; NKTR-102, a topoisomerase I inhibitor-polymer conjugate, which is in Phase II clinical trail for multiple cancer indications, including breast, ovarian, and colorectal; and NKTR-105 that is in Phase I clinica l trail to treat solid tumors. Its preclinical products consists of NKTR-119 (Opioid/NKTR-118 combinations) for the treatment of pain; NKTR-181 (abuse deterrent, tamper-resistant opioid) to treat pain; NKTR-194 (non-scheduled opioid) for the treatment of mild to moderate pain; NKTR-171 (tricyclic antidepressant) to treat neuropathic pain; and NKTR-140 (protease inhibitor candidate) to treat HIV. The company has collaboration with Bayer Healthcare LLC to develop BAY41-6551 (NKTR-061, Amikacin Inhale), which is an inhaled solution of amikacin, an aminoglycoside antibiotic; and a license agreement with AstraZeneca AB for the development and commercialization of Oral NKTR-118 and NKTR-119. In addition, Nektar Therapeutics has various license, manufacturing, and supply agreements for its technology with biotechnology and pharmaceutical companies, such as Affymax, Amgen, Baxter, Roche, Merck, Pfizer, and UCB Pharma. The company was founded in 1990 and is headquartered in San Franc isco, California.
Advisors' Opinion:- [By Sean Williams]
This is particularly intriguing now both to Allergan, which purchased MAP Pharmaceuticals earlier this year for $958 million, and to�Nektar Therapeutics (NASDAQ: NKTR ) , which would gain royalties from the sale of Levadex due to its intellectual property contribution to the making of the drug.
- [By Jay Silverman]
Jay Silverman: Oh, by the way, if you wanted me to throw a few of those names that might be considered, Novavax would be one of them, and Nektar (NKTR), and the Medicines Company (MDCO) and Pharmacyclics, which has been a great stock, but has come under pressure of late.
- [By Sean Williams]
Nektar Therapeutics (NASDAQ: NKTR ) delivered a double-digit gain for shareholders this week after reporting positive top-line data for NKTR-181, its oral chronic pain-treatment drug. NKTR-181 is an opioid-based compound that's designed to enter the brain slower than traditional opiates like oxycodone without sacrificing effectiveness and ultimately reducing addiction-like qualities to the medication. In trials, the data demonstrated that NKTR-181 had a statistically significant lower "drug liking" and "feeling high" score than oxycodone. While I'd certainly exercise caution in getting too excited, as the Food and Drug Administration is very harsh with regard to its regulation of opioid-based drugs, it's nonetheless good news for Nektar.
- [By Sean Williams]
Levadex's approval or rejection could also mean a good or bad day for Nektar Therapeutics (NASDAQ: NKTR ) , which looks to gain from royalty rights based on its contributions to Levadex's development. While impossible to predict, I'm going to go out on a limb and project an approval for Allergan.
Best Biotech Companies To Own In Right Now: Enanta Pharmaceuticals Inc (ENTA)
Enanta Pharmaceuticals, Inc., incorporated on July 25, 1995, is a research and development-focused biotechnology company. The Company uses its chemistry-driven approach and drug discovery capabilities to create small molecule drugs in the infectious disease field. The Company is discovering and developing novel inhibitors designed for use against the hepatitis C virus (HCV). These inhibitors include members of the direct acting antiviral (DAA) inhibitor classes-protease (partnered with AbbVie, the former research-based pharmaceutical business of Abbott Laboratories), NS5A (partnered with Novartis) and nucleotide polymerase, as well as a host targeted antiviral (HTA) inhibitor class targeted against cyclophilin. ABT-450, discovered through its collaboration with AbbVie, is a protease inhibitor that has demonstrated in vitro potency against known resistant HCV mutants.
In Phase I studies, ABT-450 co-administered with ritonavir, a commonly used boosting agent to increase the blood concentrations of many protease inhibitors, was shown to be safe and well tolerated. Co-administration of ABT-450 with ritonavir, which it refers to together as ABT-450/r, has enabled once-daily dosing of ABT-450. Phase II studies have demonstrated the efficacy of ABT-450/r in patients with chronic HCV, and other interferon-free Phase II studies of ABT-450-containing regimens continue. AbbVie is developing a next-generation protease inhibitor discovered within the Enanta-AbbVie collaboration. EDP-239 is the NS5A inhibitor discovered by the Company. The Company also has a program to develop nucleotide inhibitors to HCV NS5B polymerase, which is another DAA mechanism considered to have a barrier to resistance. The Company�� Bicyclolide antibiotic product candidate is EDP-788, which it is developing for use as an intravenous drug in the hospital setting and for oral dosing in the home setting. EDP-788 is a prodrug, which means that it is inactive until it is converted in the body into an active compound. EDP-788 is! a water-soluble molecule which, when administered in preclinical models, is cleanly and rapidly converted into the active compound.
Advisors' Opinion:- [By George Budwell]
Normally, such strong efficacy results would be hailed as a major achievement. However, these results are actually less impressive than those by competing drug's developed by AbbVie (NYSE: ABBV ) , Enanta Pharmaceuticals (NASDAQ: ENTA ) and Gilead. Bristol-Myers' therapy also has a treatment duration double that of Gilead's drug Sovaldi for genotype 1 patients. So, while these results are impressive in their own right, the therapy's commercial prospects may be limited due to the presence of superior competitors in the market.�
- [By James Fink]
And lastly I'll go into healthcare, which is kind of a growth cyclical type name. It's partially defensive, partially growth. I think the more growth-oriented section of healthcare would be biotech, and right now, a very promising biotech stock is Enanta Pharmaceuticals. That's a NASDAQ stock; ticker symbol (ENTA).
- [By Sean Williams]
The next big thing in treating hepatitis-C
The other currently experimental therapy very likely to make it onto the FDA's desk before the midpoint of 2014 is AbbVie's (NYSE: ABBV ) direct-acting antiviral combo drug. In similar fashion to Sovaldi, this DAA-combo therapy, which includes ABT-450 from Enanta Pharmaceuticals (NASDAQ: ENTA ) , is running six confirmatory late-stage trials on various genotypes. There are, however, two primary differences between AbbVie's DAA-combo therapy and Sovaldi.
Best Biotech Companies To Own In Right Now: StemCells Inc (STEM)
StemCells, Inc. (StemCells), incorporated in August 1988, is engaged in the research, development, and commercialization of stem cell therapeutics and related tools and technologies for academia and industry. The Company is focused on developing and commercializing stem and progenitor cells as the basis for therapeutics and therapies, and cells and related tools and technologies to enable stem cell-based research and drug discovery and development. The Company�� primary research and development efforts are focused on identifying and developing stem and progenitor cells as potential therapeutic agents. The Company has two therapeutic product development programs, including its CNS Program, which is developing applications for HuCNS-SC cells, its human neural stem cell product candidate, and its Liver Program, which is characterizing the Company�� human liver cells as a therapeutic product.
CNS Program
The Company in its CNS Program, is in clinical development with its HuCNS-SC cells for a range of disorders of the central nervous system. The CNS includes the brain, spinal cord and eye. In February 2012, the Company had completed a Phase I clinical trial in Pelizeaus-Merzbacher Disease (PMD), a fatal myelination disorder in the brain.
The Company�� CNS Program is focused on developing clinical applications, in which transplanting HuCNS-SC cells protect or restore organ function of the patient before such function is irreversibly damaged or lost due to disease progression. The Company�� initial target indications are PMD, and more generally, diseases in which deficient myelination plays a central role, such as cerebral palsy or multiple sclerosis; spinal cord injury, disorders in which retinal degeneration plays a central role, such as age-related macular degeneration or retinitis pigmentosa. The Company�� product candidate, HuCNS-SC cells, is a purified and expanded composition of normal human neural stem cells. Its HuCNS-SC cells can be directly transp! lanted.
Liver Program
Liver stem or progenitor cells offer an alternative treatment for liver diseases. A liver cellular therapy or cell-based therapeutic provide or support liver function in patients with liver disease. The Company held a portfolio of issued and allowed patents in the liver field, which cover the isolation and use of both hLEC cells and the isolated subset, as well as the composition of the cells themselves.
The Company�� range of cell culture products, which are sold under the SC Proven brand, includes iSTEM, GS1-R, GS2-M, RHB-A, RHB-Basal, NDiff N2, and NDiff N2B27. Its iSTEM is a serum-free, feeder-free medium that maintains mouse embryonic stem cells in their pluripotent ground state by using selective small molecule inhibitors to block the pathways, which induce differentiation. RHB-A is a defined, serum-free culture medium for the selective culture of human and mouse neural stem cells and their maintenance and expansion as adherent cell populations. RHB-Basal is a defined, serum-free basal medium. When supplemented with specific growth factors, this media is formulated for the propagation and differentiation of adherent neural stem cells. RHB-Basal can also be tailored to specific-cell type requirements by the addition of customer preferred supplements.
The Company�� NDiff N2 is a defined serum-free scell culture supplement for the derivation, maintenance, expansion and/or differentiation of human and mouse embryonic stem (ES) cells and tissue-derived neural stem cells supplement. Its NDiff N2-AF is a serum-free and animal component-free version of NDiff N2. Its NDiff N2B27 is a defined, serum-free medium for the differentiation of mouse embryonic stem cells to neural cell types. NDiff N27-AF is a serum-free and animal component-free version of NDiff N27. Its GS1-R is a serum-free media formulation shown to enable the derivation and long-term maintenance of true, germline competent rat embryonic stem cells without the add! ition of ! cytokines or growth factors. Its GS2-M is a defined, serum- and feeder-free medium for the derivation and long-term maintenance of true, germline competent mouse iPS cells.
The Company also markets a number of antibody reagents for use in cell detection, isolation and characterization. These reagents are also under the SC Proven brand and it includes STEM24, STEM101, STEM121 and STEM123. Its STEM24 is a human antibody that recognizes human CD24, also known as heat stable antigen (HSA), a glycoprotein expressed on the surface of many human cell types, including immature human hematopoietic cells, peripheral blood lymphocytes, erythrocytes and many human carcinomas. Its CD24 is also a marker of human neural differentiation. Its STEM101 is a human-specific mouse antibody that recognizes the Ku80 protein found in human nuclei. Its STEM121 is a human-specific mouse antibody that recognizes a cytoplasmic protein of human cells. Its STEM123 is a human-specific mouse antibody that recognizes human glial fibrillary acidic protein (GFAP).
The Company�� Other products marketed under SC Proven include total cell genomic DNA (gDNA), RNA and protein lysate reagents purified from homogenous stem cell populations for intra-comparative studies, such as Epigenetic fingerprinting, Southern, Western and Northern blots, PCR, RT-PCR and microarrays. This range of purified stem cell line lysates includes mouse embryonic stem (ES) cells propagated in SC Proven 2i inhibitor-based GS2-M media and mouse ES cell-derived and fetal tissue-derived neural stem (NS) cells propagated in SC Proven RHB-A media.
Advisors' Opinion:- [By John Udovich]
The results of a recent Pew Center Poll regarding attitudes towards abortion and various forms of stem cell research could be a good sign for the stem cell industry along with small cap stem cell stocks like StemCells Inc (NASDAQ: STEM), NeoStem Inc (NASDAQ: NBS), Neuralstem, Inc (NYSEMKT: CUR),�International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX). Basically, Americans think that having an abortion is a moral issue with 49% of American adults believing abortion is morally wrong, 23%�view it not as a moral issue and and 15% view it as morally acceptable. However and when Americans were asked about issues surrounding�human embryos, such as stem cell research or in vitro fertilization, as a matter of morality, their views were different.
Best Biotech Companies To Own 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.
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