After weeks of speculation, Amgen’s (AMGN) purchase of Onyx Pharmaceuticals (ONXX) looks like a done deal. The Wall Street Journal has the details:
Associated PressAmgen�Inc. reached a deal Sunday to buy fellow biotech�Onyx Pharmaceuticals�Inc. for roughly $10.4 billion, the latest proposed takeover aimed at tapping into growth expected from the cancer-drug industry.
The all-cash takeover values Onyx at $125 a share. The price Amgen is paying is below what investors expected in the days after the possible deal surfaced in late June. Amgen had approached Onyx with an offer of $120 a share for the company, whose primary attraction is a blood-cancer drug called Kyprolis…
The deal is expected to close at the beginning of the fourth quarter.
RBC’s Michael Yee and team list three reasons for Amgen stockholders to like the deal:
10 Best Biotech Stocks For 2014: Cell Therapeutics Inc (CTIC)
Cell Therapeutics, Inc. (CTI), incorporated in 1991, develops, acquires and commercializes treatments for cancer. The Company�� research, development, acquisition and in-licensing activities concentrate on identifying and developing new ways to treat cancer. As of December 31, 2011, CTI focused its efforts on Pixuvri (pixantrone dimaleate) (Pixuvri), OPAXIO (paclitaxel poliglumex) (OPAXIO), tosedostat, brostallicin and bisplatinates. As of December 31, 2011, it developed Pixuvri, an anthracycline derivative for the treatment of hematologic malignancies and solid tumors. Another late-stage drug candidate of the Company, OPAXIO, is being studied as a potential maintenance therapy for women with advanced stage ovarian cancer, who achieve a complete remission following first-line therapy with paclitaxel and carboplatin. As of December 31, 2011, it also developed tosedostat in collaboration with Chroma Therapeutics, Ltd. (Chroma). On May 31, 2012, CTI completed its acquisition gaining worldwide rights to S*BIO Pte Ltd.'s (S*BIO) pacritinib.
Pixuvri
As of December 31, 2011, the Company developed Pixuvri, an aza-anthracenedione derivative, for the treatment of non-Hodgkin�� lymphoma (NHL), and various other hematologic malignancies, and solid tumors. Pixuvri was studied in the Company�� EXTEND, or PIX301, clinical trial, which was a phase III single-agent trial of Pixuvri for patients with relapsed, refractory aggressive NHL who received two or more prior therapies and who were sensitive to treatment with anthracyclines. On September 28, 2011, CTI announced that a second independent radiology assessment of response and progression endpoint data from its PIX301 clinical trial of Pixuvri was achieved with statistical significance. The results of the EXTEND trial met its primary endpoint and showed that patients randomized to treatment with Pixuvri achieved a significantly higher rate of confirmed and unconfirmed complete response compared to patients treated with standard chem! otherapy had a significantly increased overall response rate and experienced a statistically significant improvement in median progression free survival. Pixuvri had predictable and manageable toxicities when administered at the proposed dose and schedule in the EXTEND clinical trial in heavily pre-treated patients. In March 2011, the Company initiated the PIX-R trial to study Pixuvri in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Pixuvri has also been studied in patients with HER2-negative metastatic breast cancer who have tumor progression after at least two, but not more than three, prior chemotherapy regimens. In the second quarter of 2010, the NCCTG opened this phase II study for enrollment. The study is closed to accrual and results are expected to be reported by the NCCTG later in 2012.
OPAXIO
OPAXIO is the Company�� biologically-enhanced chemotherapeutic agent that links paclitaxel to a biodegradable polyglutamate polymer, resulting in a new chemical entity. As of December 31, 2011, the Company focused its development of OPAXIO on ovarian, brain, esophageal, head and neck cancer. OPAXIO was designed to improve the delivery of paclitaxel to tumor tissue while protecting normal tissue from toxic side effects. In November 2010, results were presented by the Brown University Oncology Group from a phase II trial of OPAXIO combined with temozolomide (TMZ), and radiotherapy in patients with newly-diagnosed, high-grade gliomas, a type of brain cancer. The trial demonstrated a high rate of complete and partial responses and a high rate of six month progression free survival (PFS). Based on these results, the Brown University Oncology Group has initiated a randomized, multicenter, phase II study of OPAXIO and standard radiotherapy versus TMZ and radiotherapy for newly diagnosed patients with glioblastoma with an active gene termed MGMT that reduces responsiveness to TMZ. A phase I/II study of OPAXIO combined with radi! otherapy ! and cisplatin was initiated by SUNY Upstate Medical University, in patients with locally advanced head and neck cancer.
Tosedostat
In March 2011, the Company entered into a co-development and license agreement with Chroma Therapeutics, Ltd. (Chroma), providing the Company with marketing and co-development rights to Chroma�� drug candidate, tosedostat, in North, Central and South America. Tosedostat is an oral, aminopeptidase inhibitor that has demonstrated anti-tumor responses in blood related cancers and solid tumors in phase I-II clinical trials. Interim results from the phase II OPAL study of tosedostat in elderly patients with relapsed or refractory acute myeloid leukemia (AML) showed that once-daily, oral doses of tosedostat had predictable and manageable toxicities and results demonstrated response rates, including a high-response rate among patients who received prior hypomethylating agents, which are used to treat myelodysplastic syndrome (MDS), a precursor of AML.
Brostallicin
As of December 31, 2011, the Company developed brostallicin through its wholly owned subsidiary, Systems Medicine LLC, which holds rights to use, develop, import and export brostallicin. Brostallicin is a synthetic deoxyribonucleic acid (DNA) minor groove binding agent that has demonstrated anti-tumor activity and a favorable safety profile in clinical trials, in which more than 230 patients have been treated as of December 31, 2011. The Company uses a genomic-based platform to guide the development of brostallicin. A phase II study of brostallicin in relapsed, refractory soft tissue sarcoma met its predefined activity and safety hurdles and resulted in a first-line phase II clinical trial study that was conducted by the European Organization for Research and Treatment of Cancer (EORTC).
The Company competes with Bristol-Myers Squibb Company, Sanofi-Aventis, Pfizer, Roche Group, Genentech, Inc., Astellas Pharma, Eli Lilly and Company, Celgene, Telik, I! nc., TEVA! Pharmaceuticals Industries Ltd. and PharmaMar.
Advisors' Opinion:- [By Nathalie Tadena]
Among the companies with shares expected to actively trade in Friday’s session are Vanda Pharmaceuticals Inc.(VNDA), Kimberly-Clark(KMB) and Cell Therapeutics(CTIC).
- [By John Udovich]
Large and small cap cancer stocks Gilead Sciences, Inc (NASDAQ: GILD), Celgene Corporation (NASDAQ: CELG), Veracyte (NASDAQ: VCYT), Genomic Health, Inc (NASDAQ: GHDX), Cell Therapeutics Inc (NASDAQ: CTIC) and MetaStat Inc (OTCMKTS: MTST) have all been producing a steady stream of news lately for biotech investors looking for a way to cash in on the growth in development of�cancer treatments. Just consider the following news:
- [By Bryan Murphy]
If you're reading this, then odds are you already know that the last two weeks (not even a full two weeks) have been more fruitful for Cell Therapeutics Inc. (NASDAQ:CTIC) shareholders than the prior two years have been - the stock's up 28% since last Thursday. And, odds are you already know why. The question most of you are asking now is, can CTIC actually keep climbing at this pace, or even keep climbing at any pace? The answer is "yes", though floating that answer almost inherently requires a deeper explanation.
- [By John Udovich]
If you have not been watching the biotech sector lately, you should start paying attention as the sector along with small cap biotech stocks like Cell Therapeutics Inc (NASDAQ: CTIC), BIND Therapeutics Inc (NASDAQ: BIND) and TNI BioTech (OTCMKTS: TNIB) continue to produce a steady stream of good news for investors thanks to positive industry trends. Moreover, Ophthotech Corp (NASDAQ: OPHT), Foundation Medicine Inc (NASDAQ: FMI), Evoke Pharma and Fate Therapeutics Inc (NASDAQ: FATE) are this week's biotech IPOs that will no doubt be watched closely by Wall Street and industry observers in general. With that in mind, consider the following biotech news or recent articles about the industry and the small cap players in it:
10 Best Biotech Stocks For 2014: Dyadic International Inc (DYAI)
Dyadic International, Inc. (Dyadic), incorporated in September 2002, is a holding company. The Company is a global biotechnology company. The Company has operations at the United States and the Netherlands. Dyadic uses its technologies to conduct research and development (R&D) and commercial activities for the discovery, development, manufacture and sale of enzymes and proteins for the bioenergy, industrial enzyme, and biopharmaceutical industries. The Company derives all of its revenues from the licensing of its technologies, the sale of its enzymes and conducting research and development (R&D) activities for third parties. The Company operates in two segments: the United States operations and The Netherlands operations. The United States segment includes a subsidiary in Poland.
The United States operating segment is a developer, manufacturer and distributor of enzyme products, proteins, peptides and other bio-molecules derived from genes and a collaborative licensor of enabling technologies for the development and manufacturing of biological products and use in R&D. The Netherlands operating segment is also a researcher and developer of enzyme products, proteins, peptides and other bio-molecules derived from genes and, to date, has mainly invested in R&D activities.
Dyadic�� R&D activities focus on its fungal strains and associated technologies. Dyadic uses its Trichoderma and C1 fungal strains in the production of its industrial enzymes. Dyadic manufactures and sells liquid and dry enzyme products to global customers for use within the animal feed, pulp and paper, starch and alcohol, food and brewing, textiles, and biofuels industries.
Dyadic also utilizes a technology platform based on its patented and C1 fungus (the C1 Platform Technology), which enables the development and manufacture of proteins and enzymes for diverse market opportunities. The C1 Platform Technology can also be used to screen for the discovery of novel genes and proteins. The C1 Platf! orm Technology also has the potential of developing and producing other biological products such as antibodies, vaccines, proteins and polypeptides for the biopharmaceutical industry.
Top High Tech Companies For 2014: Exelixis Inc.(EXEL)
Exelixis, Inc., a biotechnology company, develops small molecule therapies for the treatment of cancer. It focuses on developing Cabozantinib, an inhibitor of tumor growth, metastasis, and angiogenesis that target MET, VEGFR2, and RET, which are key kinases involved in the development and progression of various cancers. The cabozantinib is in Phase III clinical trial for the treatment for medullary thyroid cancer. The company also engages in various clinical programs for cabozantinib focused on the treatment of metastatic castration-resistant prostate cancer, ovarian cancer, breast cancer, renal cell carcinoma, non-small cell lung cancer, hepatocellular cancer, and melanoma. In addition, Exelixis, Inc. involves in developing a portfolio of other novel compounds to address serious unmet medical needs through collaborations with various pharmaceutical and biotechnology companies, including Bristol-Myers Squibb Company, sanofi-aventis, Genentech, Inc., Boehringer Ingelheim Gm bH, and GlaxoSmithKline and Daiichi Sankyo Company Limited. Its products under development through collaborations include XL475, XL281, XL139, and XL413 inhibitors; ROR antagonists; therapies targeted against LXR, a nuclear hormone receptor implicated in various cardiovascular and metabolic disorders; XL147, XL765, and isoform-selective PI3K inhibitors; XL518, a small-molecule inhibitor of MEK; sphingosine-1-phosphate type 1 receptor; XL880 inhibitor; and therapies targeted against the mineralocorticoid receptor, a nuclear hormone receptor implicated in various cardiovascular and metabolic diseases. The company was formerly known as Exelixis Pharmaceuticals, Inc. and changed its name to Exelixis, Inc. in February 2000. Exelixis, Inc. was founded in 1994 and is headquartered in South San Francisco, California.
Advisors' Opinion:- [By Selena Maranjian]
The biggest new holdings are The Finish Line�and Aeropostale. Other new holdings of interest include biotech company Exelixis (NASDAQ: EXEL ) , which received FDA approval last year for its thyroid cancer drug, Cometriq. The drug may also get approved to treat prostate cancer, and the company is looking at treating as many as nine different cancers with it. On the other hand, Cometriq is expensive, and the company's debt has been growing, along with its share count.
- [By Selena Maranjian]
Finally, SAC Capital's biggest closed positions included Coach�and Dover. Other closed positions of interest include Exelixis (NASDAQ: EXEL ) and, also,�Tronox Ltd. (NYSE: TROX ) . Biotech company Exelixis recently reported non-blowout early sales of its thyroid cancer drug, Cometriq. Some are waiting to see if the drug gets approved to treat prostate cancer, too, and the company is looking at treating as many as nine different�conditions with it, such as bone tumors. On the other hand, Cometriq is expensive, and the company's debt has been growing, along with its share count.
- [By Selena Maranjian]
D. E. Shaw reduced its stake in lots of companies, including Acadia Pharmaceuticals (NASDAQ: ACAD ) and Exelixis (NASDAQ: EXEL ) . Acadia has skyrocketed over the past year, rising more than 10-fold, on high hopes for its pimavanserin drug, which treats psychosis in patients with Parkinson's disease. If the drug gains FDA approval, it will enjoy little competition and could be a big winner for Acadia. The company thinks the drug might be effective against psychosis related to Alzheimer's disease as well and is conducting trials for that, too. Acadia is also raising about $100 million via a secondary stock offering to fund ongoing and future trials.
10 Best Biotech Stocks For 2014: Quintiles Transnational Holdings Inc (Q)
Quintiles Transnational Holdings Inc. is a provider of biopharmaceutical development services and commercial outsourcing services. The Company operates in two segments: Product Development and Integrated Healthcare Services. The Company�� Product Development segment operates as a contract research organization (CRO) focused primarily on Phase II-IV clinical trials and associated laboratory and analytical activities. The Company�� Integrated Healthcare Services segment is a global commercial pharmaceutical sales and service organizations and Integrated Healthcare Services provides a range of services, including commercial services, such as providing contract pharmaceutical sales forces in geographic markets, as well as healthcare business services for the healthcare sector, such as outcome-based and payer and provider services. In August 2012, it acquired Expression Analysis, Inc.
Product Development
Product Development provides services and that allow biopharmaceutical companies to outsource the clinical development process from first in man trials to post-launch monitoring. The Company�� service offering provides the support and functional necessary at each stage of development, as well as the systems and analytical capabilities. Product Development consists of clinical solutions and services and consulting. Clinical solutions and services provides services necessary to develop biopharmaceutical products, including project management and clinical monitoring functions for conducting multi-site trials (generally Phase II-IV) (core clinical) and clinical trial support services that improve clinical trial decision making and include global laboratories, data management, biostatistical, safety and pharmacovigilance, and early clinical development trials, and strategic planning and design services that improve decisions and performance. Consulting provides strategy and management consulting services based on life science and advanced analytics, as well as regulatory and comp! liance consulting services.
The Company competes with Covance, Inc., Pharmaceutical Product Development, Inc., PAREXEL International Corporation, ICON plc, inVentiv Health, Inc. (inVentive), INC Research and PRA International.
Integrated Healthcare Services
Integrated Healthcare Services provides the healthcare industry with both geographic presence and commercial capabilities. The Company�� commercialization services are designed to accelerate the commercial of biopharmaceutical and other health-related products. Service offerings include commercial services (sales representatives, strategy, marketing communications and other areas related to commercialization), outcome research (drug therapy analysis, real-world research and evidence-based medicine, including research studies to prove a drug�� value) and payer and provider services comparative and cost-effectiveness research capabilities, clinical management analytics, decision support services, medication adherence and health outcome optimization services, and Web-based systems for measuring quality improvement.
The Company competes with inVentiv, PDI, Inc., Publicis Selling Solutions, United Drug plc, EPS Corporation and CMIC HOLDINGS Co., Ltd.
10 Best Biotech Stocks For 2014: Vertex Pharmaceuticals Incorporated(VRTX)
Vertex Pharmaceuticals Incorporated engages in discovering, developing, manufacturing, and commercializing small molecule drugs for the treatment of serious diseases worldwide. Its products include telaprevir, a prescription medicine used for the treatment of patients with genotype 1 hepatitis C virus (HCV) infection; and Ivacaftor, a prescription medicine used for the treatment of cystic fibrosis. The company markets its products under the INCIVEK brand name in the United States and Canada; INCIVO brand in the United Kingdom, Germany, France, Sweden, Austria, Finland, Denmark, Switzerland, and Norway; KALYDECO brand in the United States; and TELAVIC brand in Japan. Its drug candidates comprise VX-222, a Phase II clinical trial drug candidate, and ALS-2200 and ALS-2158, a Phase I clinical trial drug candidates that are designed to inhibit the replication of HCV; VX-809 and VX-661, a Phase II clinical trial drug candidates that improve the function of defective cystic fibro sis; VX-509, a Phase II clinical trial drug candidate for the treatment of patients with rheumatoid arthritis and other immune-mediated inflammatory diseases; VX-765, a Phase II clinical trial drug for the treatment of epilepsy; and VX-787, an investigational drug candidate for the treatment of influenza A. The company was founded in 1989 and is headquartered in Cambridge, Massachusetts.
Advisors' Opinion:- [By Sue Chang and Saumya Vaishampayan]
Vertex Pharmaceuticals Inc. (VRTX) �shares gained 3.9%. Geoff Meacham, an analyst at J.P. Morgan, said last week that he rates the drug maker�� stock at overweight due to opportunities for the company in the cystic fibrosis area.
10 Best Biotech Stocks For 2014: Applied Nanotech Holdings Inc (APNT)
Applied Nanotech Holdings, Inc., incorporated on May 22, 1989, is engaged in nanotechnology research and development business. The Company's nanotechnology research involves performing contract research and development services for others to develop products and materials for new applications, and then leveraging this research by applying it to other similar applications in other industries. The Company also develops intellectual property (IP) around its products and technologies. The Company develops five technology platforms: nanosensor technology; nanocomposites, based on carbon nanotube composites; thermal management materials; nanoelectronics applications, and electron emission activities, primarily in the display area. The Company's electron emission IP is divided into display activities and non-display activities. Applied Nanotech Holdings, Inc. is the parent company. Applied Nanotech, Inc. (ANI) is a subsidiary of ANHI. During the year ended December 31, 2012, the Company formed EZDiagnostix, Inc., (EZDX).
Sensors
The Company develops sensors based on ion mobility sensor technology and differential mobility spectroscopy. The Company is involved in projects to develop Mercaptan and Methane sensors for uses in the natural gas industry. The Company is also applying this technology to other applications, including agricultural pathology, wound care, and breath analysis. The Company develops hydrogen sensor for use in the measurement of hydrogen in power transformer products. The Company develops carbon monoxide sensor that can last for 10,000 hours on a single battery. The Company's carbon nanotube technology is for use in biosensors. Sensors based on carbon nanotubes or other nanomaterials can be used to detect chemical, organic, or biological warfare agents, as well as explosives, hydrogen, ammonia and numerous other chemicals.
Nanocomposites
The Company is in the advanced stages of development of nanomaterials using carbon nanotube (CNT) and! other composites. Epoxies are used in industries with worldwide markets, with applications, including adhesives, paints, coatings, and composites. In addition to epoxy resins, the Company develops other types of resins, including polyesters and vinyl esters. Vinyl esters are used in a variety of industrial applications, including storage tanks, piping, and construction. The Company develops a process for coating nylon pellets with CNTs to improves electrical conductivity. Nylon 6 with improved electrical conductivity can be used for its anti-static qualities, electrostatic discharge, and electromagnetic/RF shielding.
Thermal Management
The Company markets thermal management material called CarbAl. CarbAl provides a passive thermal management solution for temperature control issues that plague electronics manufacturers. CarbAl is a carbon based metal nanocomposite comprised of 80% carbonaceous matrix and a dispersed metal component of 20% aluminum. The Company also develops a simplified version of CarbAl based on graphite.
Conductive Inks
The Company develops aluminum and silver inks and pastes that is ideal for use in the production of solar cells. The Company also develops aluminum paste that can be used in current solar cell production.
The Company competes with Zyvex Performance Materials, GSI Creos, Amroy Europe, Ltd., DuPont and Ferro
Advisors' Opinion:- [By Anuchit Nguyen]
India�� S&P BSE Sensex rose, holding at a three-year high, amid better-than-estimated corporate earnings. Engineering company Larsen & Toubro Ltd. (LT) rallied to a three-month high and Asian Paints Ltd. (APNT) surged about 6 percent after reporting profit that beat forecasts.
10 Best Biotech Stocks For 2014: Elan Corporation PLC (ELN)
Elan Corporation, plc (Elan), incorporated in December 1969, is a neuroscience-based biotechnology company. The Company is focused on discovering and developing advanced therapies in neurodegenerative and autoimmune diseases. Elan�� business focuses on neurodegenerative diseases, such as Alzheimer�� disease and Parkinson�� disease; autoimmune diseases, including MS and Crohn�� disease and neo-epitope based targets for treatments across a range of therapeutic indications. Tysabri is a treatment for MS and Crohn�� disease that the Company markets and distributes with Biogen Idec. On September 16, 2011, Elan sold its EDT business to Alkermes, Inc. In November 2011, Elan launched a collaboration with the University of Cambridge, England, the Cambridge-Elan Centre for Research Innovation and Drug Discovery (Cambridge-Elan Centre). On December 21, 2012, the Company completed the demerger of Prothena Corporation plc. In April 2013, it closed the TYSABRI (natalizumab) Collaboration Transaction with Biogen Idec.
Tysabri
Tysabri, which is an alpha-4 integrin inhibitor, is a therapy for MS, a neurological disorder involving central nervous system dysfunction among adults. Tysabri is approved in more than 65 countries. Tysabri is approved in the United States as a monotherapy for relapsing forms of MS, for patients who have had an inadequate response to, or are unable to tolerate, an alternative MS therapy. In the European Union, it is approved for relapsing-remitting MS (RRMS) in adult patients who have failed to respond to beta interferon or have rapidly evolving, severe RRMS. As of December 31, 2011, there were approximately 64,400 patients on Tysabri therapy worldwide.
In June 2011, the European Commission (EC) approved the inclusion of the anti-JCV antibody status as an additional factor in stratifying patients at risk for developing PML in the Summary of Product Characteristics��(SmPC) for Tysabri in the European Union. The Company has developed a two-step ! enzyme-linked immunosorbent assay (ELISA), STRATIFY JCV, with Biogen Idec. The assay detects anti-JCV antibodies in the blood of patients, and is commercially available in Europe. In January 2012, the FDA cleared the assay for commercial use in the United States. As of December 31, 2011, over 80,000 tests had been administered using the assay. Tysabri is marketed and distributed by Elan and Biogen Idec. The Company�� research group, Neotope, is focused on creating monoclonal antibodies based on neo-epitope targets for the treatment of a range of therapeutic indications.
Beta Amyloid Immunotherapies (AIP)
Beta amyloid immunotherapy includes the treatment of Alzheimer�� disease by inducing or enhancing the body�� immune response in order to clear toxic species of beta amyloid from the brain. The AIP includes bapineuzumab (intravenous and subcutaneous delivery) and ACC-001, as well as other compounds. Bapineuzumab is an experimental humanized monoclonal antibody delivered intravenously that is being studied as a treatment for mild to moderate Alzheimer�� disease. It is designed to provide antibodies to beta amyloid directly to the patient (passive immunotherapy).
ELND005, an A� Aggregation Inhibitor
The small molecule ELND005 (Scyllo-inositol) is a beta amyloid anti-aggregation agent. Preclinical data suggest that ELND005 may act through the mechanism of preventing and reversing the fibrilisation of beta amyloid (the aggregation of beta amyloid into clumps of insoluble oligomers). ELND005 may have additional applications in psychiatric indications, such as bipolar disorder. In November 2011, the Company entered into a manufacturing agreement for the supply of the active pharmaceutical ingredient for ELND005 with Lonza Group AG.
Neotope Biosciences Limited
Neotope Biosciences Limited (Neotope) is the Company�� wholly owned subsidiary that focuses on the discovery and development of antibodies to neo-epitope related targ! ets for t! he treatment of a range of indications. It includes amyloidosis, diabetes, cancer and macular degeneration. Neotope�� portfolio of targets includes alpha-synuclein for the potential treatment of synucleinopathies, such as Lewy body dementia and Parkinson�� disease, tau for Alzheimer�� disease and other tauopathies. It also has a program for type 2-diabetes.
Onclave Therapeutics Limited
Elan�� wholly owned subsidiary Onclave Therapeutics Limited (Onclave) was formed to develop assets originating from Elan that have application in oncology related diseases. Onclave�� program, NEOD001, which originated from Neotope, is being investigated for the treatment of AL amyloidosis, which is a fatal disease involving abnormal accumulation of amyloid in organs and tissue. During the year ended December 31, 2011, Onclave filed for orphan drug designation of NEOD001. Onclave�� pipeline includes additional compounds with relevance in diverse cancer indications.
The Company competes with Biogen Idec, Bayer Schering Pharma AG, Bayer Schering Pharma, Merck Serono, Pfizer, Teva Neurosciences, Inc., Sanofi-Aventis and Novartis AG.
Advisors' Opinion:- [By Tim Brugger]
After confirming an unsolicited takeover bid from privately held investment firm Royalty Pharma in late February, Ireland-based Elan (NYSE: ELN ) announced today that its board has unanimously rejected the offer.
- [By Brian Orelli]
Johnson & Johnson (NYSE: JNJ ) is the leader for the long-acting antipsychotic, selling $1.4 billion worth of Risperdal Consta and $800 million worth of Invega Sustenna last year. Alkermes (NASDAQ: ALKS ) also benefits from a royalty on both drugs. It developed the extended-release technology in Risperdal Consta, and Alkermes acquired the royalty rights to Invega Sustenna when it bought Elan's (NYSE: ELN ) drug technology division.
- [By John Maxfield]
Of the dozens of trades alleged in the various documents, the one that best demonstrates this is SAC's bet on the pharmaceutical giant Elan (NYSE: ELN ) in anticipation of the latter's Phase II trial results for a drug to treat Alzheimer's disease. I've mapped out the trade in the chart below.
10 Best Biotech Stocks For 2014: Prosensa Holding NV (RNA)
Prosensa Holding N.V., formerly Prosensa Holding B.V., is a biotechnology company engaged in the discovery and development of ribonucleic acid-modulating (RNA)-modulating, therapeutics for the treatment of genetic disorders. The Company�� primary focus is on rare neuromuscular and neurodegenerative disorders with a large unmet medical need, including Duchenne muscular dystrophy, myotonic dystrophy and Huntington�� disease. The Company�� clinical portfolio of RNA-based product candidates is focused on the treatment of Duchenne muscular dystrophy (DMD). The Company�� platform technology allows the development of RNA-modulating therapeutics that either interferes with splicing (exon skipping, exon inclusion, or splice mutation correction), remove mutant RNA, or block RNA expression, for different indications.
DMD is a rare, severe muscle wasting disease that occurs in up to 1 in 3,500 male births. It is commonly diagnosed between the ages of three to five, when boys begin to show signs of impaired motor development. PRO044, the Company�� product candidate, addresses a separate sub-population of DMD patients. The Company developed PRO044 using its exon-skipping technology to generate a product candidate with the same mechanism of action that is used by drisapersen.
Advisors' Opinion:- [By Brian Orelli]
Ironically, phase 3 data from Sarepta's direct competitor -- GlaxoSmithKline (NYSE: GSK ) and Prosensa's (NASDAQ: RNA ) drisapersen -- that's due in the fourth quarter could help the FDA answer the question about whether dystrophin is an acceptable surrogate endpoint. If increases in dystrophin correlate with clinical outcomes, it would support approving eteplirsen with less data. It's not clear to me whether Glaxo and Prosensa would have to share that correlation with the FDA -- the clinical phase 3 data should be sufficient for approval -- and if it does make those calculations whether the FDA could legally use it to support the approval of another drug since NDA data is proprietary while under patent.
- [By Keith Speights]
An "alley-oop" from the opponent
Prosensa (NASDAQ: RNA ) shares made something of a slam dunk this week, jumping more than 16%. That dunk was made with what amounts to an "alley-oop" from its primary rival, Sarepta Therapeutics (NASDAQ: SRPT ) . - [By John Udovich]
Recent news surrounding small cap biotech stocks like�Xencor Inc (NASDAQ: XNCR), Prosensa Holding NV (NASDAQ: RNA),�Puma Biotechnology Inc (NYSE: PBYI),�Geron Corporation (NASDAQ: GERN)
and TNI BioTech Inc (OTCQB: TNIB) show that while the sector and appetite for biotech�IPOs may have cooled, lottery tickets can still be found or occur in the sector. Just consider the following recent news or trends: - [By Keith Speights]
Successful launch
You couldn't even buy stock in Prosensa (NASDAQ: RNA ) just a few weeks ago. The biotech launched its IPO on June 28. To say that launch has gone successfully is an understatement. Shares are now more than double the IPO price and climbed 41% this week.
10 Best Biotech Stocks For 2014: 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 Lu Wang]
Nektar Therapeutics (NKTR) tumbled 24 percent, its biggest slide in five years, to $10.54. The company said a study of the slow-release painkiller NKTR-181 showed it failed to meet the primary endpoint of a Phase 2 study, citing an ��nusual lack��of a gain in pain scores for patients taking a placebo.
- [By Luke Jacobi]
Nektar Therapeutics (NASDAQ: NKTR) were down 23.90 percent to $10.54 after the company reported that the results from Phase 2 trial of NKTR-181 missed primary efficacy endpoint.
- [By Jay Silverman]
Steve Halpern: Another stock you follow closely is Nektar (NKTR). What do you see happening there?
Jay Silverman: Yes, Nektar is another platform company at the MTSL and they are about to release data on one of their compounds that is a pain reliever-unlike the very severe side effects of OxyContin, the opioid pain relievers that are out there, which have caused severe health and addictive concerns, leading to very, very troublesome side effects and death in some cases.
10 Best Biotech Stocks For 2014: 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 Dan Carroll]
Yet no stock in biotech had a week like Alnylam Pharmaceuticals (NASDAQ: ALNY ) , whose stock shot up more than 32% over the past five days. Company shares rocketed up 19% on Thursday alone, after the company released early-stage clinical results that showed Alnylam's developmental therapy ALN-TTRsc, a treatment for a rare genetic disorder, reduced levels of the disease, transthyretin (or TTR) amyloidosis, by 80%. Alnylam also noted that the drug had been well received by clinical subjects, a critical key for investors cautious about the drug's safety.
- [By Dan Carroll]
Biotech's known for volatility, and one of this year's biggest booms suffered a hit on that end this week. Alnylam Pharmaceuticals (NASDAQ: ALNY ) , which has seen shares explode for gains of more than 142% year to date in 2013, lost more than 11% this past week to rank as one of biotech's biggest busts over the last five days.
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