One of our recommended biotech stocks provided an interesting surprise by revealing that the final survival results from a Phase III Synergy trial for custirsen in prostate cancer patients has been moved up to a mid-year event from a year-end event, notes John McCamant, in The Medical Technology Stock Letter.
2014 is shaping up to be the most important year for OncoGenex Pharmaceuticals (OGXI), and, we believe, it can very well represent a major inflection point for the company with positive Synergy results.
The firm now has expectations for the primary endpoint events to occur in late Q1 or early Q2, with the final survival results due by mid-year.
The company will follow up the release of this Synergy trial with results from Borealis-1, their Phase II survival trial for apatorsen in 180 bladder cancer patients, in H2:14. These two data events will go a long way towards validating OGXI and their cancer platform.
We also prefer that Synergy will report before Borealis-1��s the latter would have largely been ignored by the Street��nd investors are understandably fixated on the Phase III Synergy results.
Top 10 Cheap Stocks To Buy For 2015: Celgene Corp (CELG)
Celgene Corporation is a global biopharmaceutical company primarily engaged in the discovery, development and commercialization of therapies designed to treat cancer and immune-inflammatory related diseases. The Company is engaged in the research and development, which is designed to bring new therapies to market, and is engaged in research in several scientific areas that may deliver therapies, focusing areas, such as intracellular signaling pathways in cancer and immune cells, immunomodulation in cancer and autoimmune diseases, and therapeutic application of cell therapies. The Company�� primary commercial stage products include REVLIMID, VIDAZA, THALOMID, ABRAXANE and ISTODAX. Additional sources of revenue include a licensing agreement with Novartis, which entitles it to royalties on FOCALIN XR and the entire RITALIN family of drugs, the sale of services through its Cellular Therapeutics subsidiary and other miscellaneous licensing agreements. In March 2012, it acquired Avila Therapeutics.
The Company invests in research and development, and the drug candidates in its pipeline at various stages of preclinical and clinical development. These candidates include pomalidomide and apremilast, its oral anti-cancer and anti-inflammatory agents, PDA-001, its cellular therapy, oral azacitidine, CC-223 and CC-115 for hematological and solid tumor malignancies, CC-122, its anti-cancer pleiotropic pathway modifier, and ACE-011 and ACE-536 biological products for anemia in several clinical settings of unmet need. Celgene product candidates include Pomalidomide (CC-4047), Oral Anti-Inflammatory: Apremilast (CC-10004), CC-11050, Kinase Inhibitors:Tanzisertib (CC-930), Cellular Therapies: PDA-001, Activin Biology: Sotatercept (ACE-011) ACE-536, and Anti-tumor Agents: CC-22, CC-115, CC-122 and Oral Azacitidine. It owns and operates a manufacturing facility in Zofingen, Switzerland. The Company also owns and operates a drug product manufacturing facility in Boudry, Switzerland.
Commercial! Stage Products
REVLIMID (lenalidomide) is an oral immunomodulatory drug marketed in the United States and many international markets, in combination with dexamethasone, for treatment of patients with multiple myeloma who have received at least one prior therapy. It is also marketed in the United States and certain international markets for the treatment of transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID is distributed in the United States through contracted pharmacies under the RevAssist program, which is a risk-management distribution program. Internationally, REVLIMID is distributed under mandatory risk-management distribution programs.
REVLIMID continues to be evaluated in numerous clinical trials worldwide either alone or in combination with one or more other therapies in the treatment of a range of hematological malignancies, including multiple myeloma (MDS) various lymphomas, chronic lymphocytic leukemia (CLL) other cancers and other diseases. VIDAZA (azacitidine for injection) is a pyrimidine nucleoside. VIDAZA is a Category 1 recommended treatment for patients with intermediate-2 and high-risk MDS and is marketed in the United States for the treatment of all subtypes of MDS. In Europe, VIDAZA is marketed for the treatment of intermediate-2 and high-risk MDS, as well as acute myeloid leukemia (AML) with 30% blasts and has been granted orphan drug designation for the treatment of MDS and AML.
THALOMID (thalidomide) is marketed for patients with newly diagnosed multiple myeloma and for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) an inflammatory complication of leprosy and as maintenance therapy for prevention and suppression of the cutaneous manifestation of ENL recurrence. THALOMID is distributed in the United States under its System f! or Thalid! omide Education and Prescribing Safety (S.T.E.P.S.) program. Internationally, THALOMID is also distributed under mandatory risk-management distribution programs. ABRAXANE (paclitaxel albumin-bound particles for injectable suspension) is a solvent-free chemotherapy treatment option for metastatic breast cancer, which was developed using its nab technology platform. This protein-bound chemotherapy agent combines paclitaxel with albumin. As of December 31, 2011, ABRAXANE was in various stages of investigation for the treatment of expanded applications for metastatic breast; non-small cell lung; malignant melanoma; pancreatic; bladder and ovarian.
ISTODAX (romidepsin) has received orphan drug designation for the treatment of non-Hodgkin's T-cell lymphomas, which includes CTCL and PTCL. The Company has licensed the worldwide rights (excluding Canada) regarding certain chirally pure forms of methylphenidate for FOCALIN and FOCALIN XR to Novartis. It also licensed to Novartis the rights related to long-acting formulations of methylphenidate and dex-methylphenidate products which are used in FOCALIN XR and RITALIN LA.
Preclinical and Clinical-Stage Pipeline
The product candidates in the Company�� pipeline are at various stages of preclinical and clinical development. Pomalidomide is a small molecule that is orally available and modulates the immune system and other biologically important targets. Pomalidomide is being evaluated in a phase III clinical trial for the treatment of myelofibrosis and a phase III clinical trial evaluating pomalidomide as a treatment for patients with relapsed/refractory multiple myeloma is accruing patients.
The Company is developing a product, ORAL ANTI-INFLAMMATORY AGENTS, which is orally available small molecules that target PDE4, an intracellular enzyme that modulates the production of multiple pro-inflammatory and anti-inflammatory mediators, including interleukin-2 (IL-2), IL-10, IL-12, IL-23, INF-gamma, TNF-a, leukotrienes,! and nitr! ic oxide synthase. Its investigational drug, apremilast (CC-10004), is used for the treatment of moderate to severe psoriasis and active psoriatic arthritis and is being evaluated in a phase II trial for rheumatoid arthritis and six phase III multi-center international clinical trials. In addition, it is investigating its oral PDE4 inhibitor, CC-11050, which is an anti-inflammatory compound that treat a variety of chronic inflammatory conditions, such as Cutaneous Lupus Erythematosus (CLE).
The Company�� oral kinase inhibitor platform includes inhibitors of the c-Jun N-terminal kinase (JNK) mTOR kinase, spleen tyrosine kinase (Syk) c-fms tyrosine kinase (c-FMS) and DNA-dependent protein kinase (DNAPK). Its oral Syk, c-FMS and DNAPK kinase inhibitors are being investigated in pre-clinical studies. The Company�� new second generation JNK inhibitor, tanzisertib (CC-930), is being evaluated in a phase II trial for the treatment of idiopathic pulmonary fibrosis and a phase II trial for the treatment of discoid lupus is accruing patients. Amrubicin is a third-generation fully synthetic anthracycline molecule with potent topoisomerase II inhibition.
At Celgene Cellular Therapeutics (CCT), it is researching stem cells derived from the human placenta, as well as from the umbilical cord. CCT is the Company�� research and development division. Stem cell based therapies provide disease-modifying outcomes for serious diseases, which lack adequate therapy. It has developed technology for collecting, processing and storing placental stem cells with broad therapeutic applications in cancer, auto-immune diseases, including Crohn's disease, multiple sclerosis, neurological disorders, including stroke and amyotrophic lateral sclerosis (ALS), graft-versus-host disease, and other immunological / anti-inflammatory, rheumatologic and bone disorders.
The Company has collaborated with Acceleron Pharma, Inc. (Acceleron) to develop sotatercept. Two phase I clinical studies have been co! mpleted. ! An additional phase II clinical study has been initiated and is ongoing related to treatments for end-stage renal anemia and to evaluate effects on red blood cell mass and plasma volume.
The Company competes with Abbott Laboratories, Amgen Inc. (Amgen), AstraZeneca PLC., Biogen Idec Inc., Bristol-Myers Squibb Co., Eisai Co., Ltd., F. Hoffmann-LaRoche Ltd., Johnson and Johnson, Merck and Co., Inc., Novartis AG, Pfizer, Sanofi and Takeda Pharmaceutical Co. Ltd. (Takeda).
Advisors' Opinion:- [By Keith Speights]
Celgene (NASDAQ: CELG ) was one of several companies presenting at the American Society of Clinical Oncology, or ASCO, annual meeting in Chicago this week. Here's what the big biotech had to say.
- [By Charley Blaine]
First up is Celgene Corp. (NASDAQ: CELG), which reports before Thursday’s open. The company is expected to earn $1.54 a share, up from $1.32 a year ago. Revenue is forecast at $1.72 billion, 19.1% higher than a year ago.
- [By Ben Levisohn]
After big rallies by biotech stocks, the folks at Weeden wondered if the rally getting overdone.�UBS analyst Matthew Roden and team think biotech stocks like Gilead Sciences�(GILD), Celgene�(CELG),�Vertex Pharmaceuticals (VRTX),�Puma Biotechnology (PBYI) and Achillion Pharmaceuticals (ACHN) can keep running. They explain why:
- [By Sean Williams]
In addition, by moving ibrutinib along via this expedited pathway, it gives a previous small fry in the biotech sector, Pharmacyclics, a chance to kick around the big boys like AbbVie (NYSE: ABBV ) and Celgene (NASDAQ: CELG ) . AbbVie's experimental late-stage CLL and SLL drug, ABT-199, was placed on clinical hold in February following the death of two patients from a condition known as tumor lysis syndrome. This hold will delay any additional trials until the proper dosing is worked out and gives ibrutinib a chance to run away in treating CLL/SLL. For Celgene, which just received the added indication for Revlimid to treat MCL, it's a kick in the pants. Revlimid's MCL trial overall response rate was 26% compared to the 68% ORR in ibrutinib's mid-stage trial.
Top 10 Medical Stocks To Own For 2014: Decision Diagnostics Corp (DECN)
Decision Diagnostics Corp., formerly instaCare Corp., incorporated on March 2, 2001, is a prescription and non-prescription diagnostics and home testing products distributor. The Company distributes brand name prescription and non-prescription diagnostics products, as well as several lines of ostomy, wound cares and post-surgery medical products. The Company through its subsidiaries, PDA Services, Inc. and Decision IT Corp. offers information technology solutions in several medical cares market channels by providing physicians with information at the point of care. The Company's retail prescription business maintains three operating units, which include Licensed wholesale prescription drug distribution business; Licensed distribution of diabetes diagnostics and supplies; and Internet pharmacy/prescription fulfillment.
The Company's software is designed to integrate point of service applications. The Company is also a developer of products that offer solutions in medical care and management by providing physicians with essential information instantaneously as they meet with their patients. In addition, the Company markets its MD@Hand and MD @Work software application, which also leverages the connectivity of smart cell phones devices through the Internet. The Company's applications run on smart phones manufactured by Apple, Palm, Motorola and Samsung.
Advisors' Opinion:- [By Bryan Murphy]
Over the past few weeks, Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) and Decision Diagnostics Corp. (OTCBB:DECN) have dominated the diabetes diagnostics and diabetes treatment landscape. Shares of LXRX jumped 20% on Tuesday following news that one of the key drugs in its pipeline showed more than enough efficacy in its clinical trials. DECN shares are up more than 250% on the heels of an almost-assured victory in its patent lawsuit against industry giant Johnson & Johnson (NYSE:JNJ). Anyone looking for a new trade in the diabetes diagnostics space, however, may want to look past overbought Lexicon Pharmaceuticals and Decision Diagnostics at this point, and instead turn their attention to newly-budding Neurometrix Inc. (NASDAQ:NURO).
Top 10 Medical Stocks To Own For 2014: Amarantus Bioscience Holdings Inc (AMBS)
Amarantus BioScience Holdings, Inc., formerly Amarantus BioSciences, Inc., incorporated on March 22, 2013, is focuses on developing intellectual property and proprietary technology in order to develop drug candidates and diagnostic blood tests to diagnose and treat human diseases. The Company owns the intellectual property rights to a therapeutic protein known as Mesencephalic-Astrocyte-derived Neurotrophic Factor (MANF), owns the intellectual property rights to biomarkers related to oncology and neurodegeneration named BC-SeraPro and NuroPro respectively, has a license to an Alzheimer�� disease blood test named LymPro, and owns a number of proprietary cell lines called PhenoGuard. MANF was the first therapeutic protein discovered from a PhenoGuard Cell Line. In December 2012, the Company acquired neurodegenerative diagnostic portfolio from Power3 Medical Products. On March 22, 2013, the Company was merged with into Amarantus Bioscience Inc.
The Company also owns an inventory of 88 cell lines that Amarantus refers to as PhenoGuard Cell Lines. MANF is a protein that corrects protein misfolding. The Company�� MANF product development effort is centered on a therapy for Parkinson�� disease.
Advisors' Opinion:- [By James E. Brumley]
What do Acasti Pharma Inc. (NASDAQ:ACST), Kandi Technologies Group Inc. (NASDAQ:KNDI), and Amarantus Bioscience Holdings, Inc. (OTCBB:AMBS) have in common? Not a lot, if you're simply looking at their business lines. Kandi Technologies Group makes electric cars, and even though Amarantus Bioscience Holdings and Acasti Pharma are both in the pharmaceutical arena, they're not too much alike. There is one common element among AMBS, ACST, and KNDI right now, however... they're three of the market's most bullish setups. Anyone looking for a new trading idea here should start with one of these three.
- [By Bryan Murphy]
I've taken bullish swings on - and been wrong to do so - Amarantus BioScience, Inc. (OTC:AMBS) before. My most recent bullish call on the budding biotech name was in April... a rally that fizzled shortly after I said it was just getting started. Somehow though, I find myself coming back to AMBS as a breakout candidate. This time, however, it's for a slightly different reason.
- [By Bryan Murphy]
Two weeks ago I penned some bullish thoughts on Amarantus BioScience, Inc. (OTC:AMBS). In simplest terms, I liked the way the stock had spent some time in consolidation mode, and looked like was testing the upper boundary of that zone - I figured a breakout from AMBS was imminent. So I waited... and waited.... and waited. Nothing. A week and a half later, I let the stock fall off my mental radar. As it turns out, I should have been a little more patient. Amarantus BioScience finally did the deed yesterday, and is following through today.
Top 10 Medical Stocks To Own For 2014: Boston Scientific Corp (BSX)
Boston Scientific Corporation is a developer, manufacturer and marketer of medical devices that are used in a range of interventional medical specialties. During the year ended December 31, 2011, its products were offered for sale by seven core businesses: Interventional Cardiology, CRM, Endoscopy, Peripheral Interventions, Urology/Women�� Health, Neuromodulation, and Electrophysiology. In January 2011, it completed the acquisition of Intelect Medical, Inc. In January 2011, it completed the acquisition of Sadra Medical, Inc. In March 2011, the Company completed the acquisition of Atritech, Inc. In February 2011, it announced the acquisitions of S.I. Therapies and ReVascular Therapeutics, Inc. In January 2011, the Company sold its Neurovascular business to Stryker Corporation. In June 2012, the Company acquired Cameron Health, Inc. of San Clemente, California and, as a result, added to its product portfolio subcutaneous implantable cardioverter defibrillator, called the S-ICD System.
Interventional Cardiology
The Company offers coronary stent product. Coronary stents are tiny, mesh tubes used in the treatment of coronary artery disease, which are implanted in patients to prop open arteries and facilitate blood flow to and from the heart. The Company offers a two-drug platform strategy with its paclitaxel-eluting and everolimus-eluting stent system offerings, and it offers a range of stent sizes. The Company markets its next-generation internally-developed and self-manufactured PROMUS Element stent system in the United States, its Europe/Middle East/Africa (EMEA) region and certain Inter-Continental countries, including China and India. It markets the PROMUS everolimus-eluting stent system, supplied to the Company by Abbott Laboratories, in Japan. It also markets its TAXUS paclitaxel-eluting stent line, including its third-generation TAXUS Element paclitaxel-eluting stent system in the U.nited States, Japan, EMEA and certain Inter-Continental countries.
The Compa! ny markets a line of products used to treat patients with atherosclerosis, a principal cause of coronary artery obstructive disease. Its product offerings include balloon catheters, rotational atherectomy systems, guide wires, guide catheters, embolic protection devices, and diagnostic catheters used in percutaneous transluminal coronary angioplasty (PTCA). The Company markets a family of intraluminal catheter-directed ultrasound imaging catheters and systems for use in coronary arteries and heart chambers, as well as certain peripheral vessels. The iLab Ultrasound Imaging System continues as its flagship console and is compatible with its line of imaging catheters. The system is designed to enhance the diagnosis and treatment of blocked vessels and heart disorders. Sadra is developing a repositionable and retrievable device for transcatheter aortic valve replacement (TAVR) to treat patients with severe aortic stenosis. The Lotus Valve System consists of a stent-mounted tissue valve prosthesis and catheter delivery system for guidance and placement of the valve. Atritech has developed a device designed to close the left atrial appendage in patients with atrial fibrillation who are at risk for ischemic stroke. The WATCHMAN Left Atrial Appendage Closure Technology, developed by Atritech, is the first device proven in a randomized clinical trial to offer an alternative to anticoagulant drugs, and is approved for use in CE Mark countries.
Cardiac Rhythm Management
The Company develops, manufactures and markets a variety of implantable devices that monitor the heart and deliver electricity to treat cardiac abnormalities, including Implantable cardioverter defibrillator (ICD) systems used to detect and treat abnormally fast heart rhythms (tachycardia) that could result in sudden cardiac death, including implantable cardiac resynchronization therapy defibrillator (CRT-D) systems used to treat heart failure, and implantable pacemaker systems used to manage slow or irregular heart rhyth! ms (brady! cardia), including implantable cardiac resynchronization therapy pacemaker (CRT-P) systems used to treat heart failure. Its product offerings include its COGNIS cardiac resynchronization therapy defibrillator (CRT-D), its TELIGEN ICD systems and its ALTRUA family of pacemaker systems. During 2011, it began the United States launch of its next-generation line of defibrillators, INCEPTA, ENERGEN and PUNCTUA.
Endoscopy
The Company markets a range of products to diagnose, treat and ease a variety of digestive diseases, including those affecting the esophagus, stomach, liver, pancreas, duodenum, and colon. Common disease states include esophagitis, portal hypertension, peptic ulcers as well as esophageal, biliary, pancreatic and colonic cancer. The Company offers the Radial Jaw 4 Single-Use Biopsy Forceps, which are designed to enable collection of large high-quality tissue specimens without the need to use large channel therapeutic endoscopes. Its exclusive line of RX Biliary System devices are designed to provide greater access and control for physicians to diagnose and treat challenging conditions of the bile ducts, such as removing gallstones, opening obstructed bile ducts and obtaining biopsies in suspected tumors. The Company also markets the Spyglass Direct Visualization System for direct imaging of the pancreatico-biliary system. The Spyglass System is a single-operator cholangioscopy device that offers clinicians a direct visualization of the pancreatico-biliary system and includes supporting devices for tissue acquisition, stone management and lithotripsy. Its products also include the WallFlex family of stents, in particular, the WallFlex Biliary line and WallFlex Esophageal line; and in 2011, the Company launched its Advanix Biliary Plastic Stent System and the Expect Endoscopic Ultrasound Aspiration Needle in the United States and certain international markets. Its Resolution Clip Device is an endoscopic mechanical clip designed to treat gastrointestinal bleeding.
T! he Company markets devices to diagnose, treat and ease pulmonary disease systems within the airway and lungs. Its products are designed to help perform biopsies, retrieve foreign bodies from the airway, open narrowings of an airway, stop internal bleeding, and ease symptoms of some types of airway cancers. Its product line includes pulmonary biopsy forceps, transbronchial aspiration needles, cytology brushes and tracheobronchial stents used to dilate narrowed airway passages or for tumor management. Asthmatx, Inc. designs, manufactures and markets a less-invasive, catheter-based bronchial thermoplasty procedure for the treatment of severe persistent asthma. The Alair Bronchial Thermoplasty System, developed by Asthmatx, has both CE Mark and Food and Drug Administration (FDA) approval and is the first device-based asthma treatment approved by the FDA.
Peripheral Interventions
The Company sells various products designed to treat patients with peripheral disease, including a line of medical devices used in percutaneous transluminal angioplasty and peripheral vascular stenting. Its peripheral product offerings include stents, balloon catheters, wires, peripheral embolization devices and vena cava filters. In 2010 and 2011, it launched several of its products internationally, including the EPIC self-expanding nitinol stent system in certain international markets, and the Carotid WALLSTENT stent system in Japan. The Company launched three new peripheral angioplasty balloons in 2011, including its next-generation Mustang percutaneous transluminal angioplasty (PTA) balloon, its Coyote balloon catheter, a highly deliverable and ultra-low profile balloon dilatation catheter designed for a range of peripheral angioplasty procedures and its Charger PTA Balloon Catheter, a 0.035 inch percutaneous transluminal angioplasty balloon catheter designed for post-stent dilatation, as well as conventional balloon angioplasty to open blocked peripheral arteries. The Company has commenced a limited ma! rket rele! ase of its OFFROAD re-entry catheter system in certain international markets, and in February 2012, it launched its TRUEPATH intraluminal CTO device in the United States.
The Company sells products designed to treat patients with non-vascular disease. Its non-vascular suite of products include biliary stents, drainage catheters and micro-puncture sets designed to treat, diagnose and ease various forms of benign and malignant tumors. The Company continues to market its extensive line of Interventional Oncology product solutions, including the Renegade HI-FLO Fathom microcatheter and guidewire system and Interlock - 35 Fibered IDC Occlusion System for peripheral embolization. The Company�� FilterWire EZ Embolic Protection System is a filter designed to capture embolic material that may become dislodged during a procedure, which could otherwise travel into the microvasculature where it could cause a heart attack or stroke. It is commercially available in the United States, its EMEA region and certain Inter-Continental countries for multiple indications, including the treatment of disease in peripheral, coronary and carotid vessels. It is also available in the United States for the treatment of saphenous vein grafts and carotid artery stenting procedures.
Urology/Women�� Health
The Company�� Urology/Women�� Health division develops, manufactures and sells devices to treat various urological and gynecological disorders. The Company sells a variety of products designed to treat patients with urinary stone disease, stress urinary incontinence, pelvic organ prolapse and excessive uterine bleeding. The Company offers a line of stone management products, including ureteral stents, wires, lithotripsy devices, stone retrieval devices, sheaths, balloons and catheters.
The Company markets a range of devices for the treatment of conditions, such as female urinary incontinence, pelvic floor reconstruction (rebuilding of the anatomy to its original state), and ! menorrhag! ia (excessive menstrual bleeding). It offers a breadth of mid-urethral sling products, sling materials, graft materials, pelvic floor reconstruction kits, and suturing devices. The Company markets its Genesys Hydro ThermAblator (HTA) system, a next-generation endometrial ablation system designed to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia. The Genesys HTA System features a smaller and lighter console, simplified set-up requirements, and an enhanced graphic user interface and is designed to improve operating performance.
Neuromodulation
The Company within its Neuromodulation business markets the Precision Spinal Cord Stimulation (SCS) system, used for the management of chronic pain. In 2011, the Company launched its Clik Anchor for its Precision Plus SCS System, a rechargeable SCS device for chronic pain management. During 2011, it received FDA approval for and launched the Infinion 16 Percutaneous Lead, a 16-contact percutaneous lead. The Company also markets the Linear 3-4 and Linear 3-6 Percutaneous Leads for use with its SCS systems, which are designed to provide physicians more treatment options for their chronic pain patients. Intelect Medical, Inc. is a development-stage company developing advanced visualization and programming for the Vercise system.
Electrophysiology
The Company within its Electrophysiology business develops less-invasive medical technologies used in the diagnosis and treatment of rate and rhythm disorders of the heart. Included in its product offerings are radio frequency (RF) generators, steerable RF ablation catheters, intracardiac ultrasound catheters, diagnostic catheters, delivery sheaths, and other accessories. Its products include the Blazer and Blazer Prime line of temperature ablation catheters, designed to deliver enhanced performance, responsiveness, and durability. Its cooled ablation portfolio includes the closed-loop irrigated catheter on the market, the Chilli II cooled! ablation! catheter, and the newly launched Blazer Open-Irrigated ablation catheter with a Total Tip Cooling Design.
The Company competes with Abbott Laboratories, Medtronic, Inc., St. Jude Medical, Inc. and Johnson & Johnson.
Advisors' Opinion:- [By Vera Yuan]
��edical device manufacturer Boston Scientific Corp. (BSX) reported solid earnings for the first quarter but investors focused on near-term headwinds in the cardiac-rhythm management business. The company also announced a delay in potential approval for its Watchman�� heart device. Given the breadth of the company�� pipeline, potential for margin upside, and attractive valuation, we continue to like the outlook for the shares going forward.From Diamond Hill Capital (Trades, Portfolio)'s Select Fund Second Quarter 2014 Commentary.Also check out: Diamond Hill Capital Undervalued Stocks Diamond Hill Capital Top Growth Companies Diamond Hill Capital High Yield stocks, and Stocks that Diamond Hill Capital keeps buying Currently 0.00/512345
Rating: 0.0/5 (0 votes)
- [By Dan Caplinger]
Right out of the gate, Abbott found some success, getting FDA approval for its XIENCE Xpedition drug-eluting stent. The stent market could prove increasingly important for Abbott going forward, as its Absorb line of products moves through clinical trials. Boston Scientific (NYSE: BSX ) has a competing product, its Synergy line, which looks like the only potential roadblock for Abbott to capture first-mover status in bioresorbable stents.
- [By Ben Levisohn]
Boston Scientific (BSX) has dropped 4.2% to $10.81, making it the second-biggest loser in the S&P 500, while Zions Bancorp (ZION) has fallen 4.1% to $28.03.
- [By Dan Carroll]
Investors can be forgiven in thinking that Boston Scientific's (NYSE: BSX ) on the right track. After all, this medical device stock has soared more than 58% year-to-date, rising as one of the top performers in the medical device industry in 2013. Yet underneath that rise in shares, Boston Scientific's hiding a struggling business and lagging sales.
Top 10 Medical Stocks To Own For 2014: 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 Garrett Cook]
Healthcare shares gained 0.81 percent in the US market on Friday. Top gainers in the sector included Shire plc (NASDAQ: SHPG), StemCells (NASDAQ: STEM), and Flamel Technologies SA (NASDAQ: FLML).
Top 10 Medical Stocks To Own For 2014: Puma Biotechnology Inc (PBYI)
Puma Biotechnology, Inc., incorporated in April 2007, is a development-stage biopharmaceutical company that acquires and develops products for the treatment of various forms of cancer. The Company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seeks to further develop those drug candidates for commercial use. As of December 31, 2011, the Company licensed three drug candidates: PB272 (neratinib (oral)), which the Company is developing for the treatment of advanced breasts cancer patients and gastric cancer patients; PB272 (neratinib (intravenous)), which the Company is developing for the treatment of advanced cancer patients, and PB357.
PB272 (neratinib (oral))-Breast Cancer
Neratinib is a potent irreversible tyrosine kinase inhibitor, or TKI, that blocks signal transduction through the epidermal growth factor receptors (EGFRs), HER1, HER2 and HER4. The Company's initial focus is on the development of neratinib as an oral treatment of patients with HER2 positive metastatic breast cancer.
PB272 (neratinib (intravenous))
The Company develops neratinib as an intravenously administered agent. In pre-clinical studies the intravenous version of neratinib resulted in higher exposure levels of neratinib in pre-clinical models.
PB357
PB357 is an orally administered agent that is an irreversible TKI that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2, and HER4. PB357 is structurally similar to PB272. Pfizer completed single dose Phase I trials of PB357. The Company is evaluating PB357.
The Company competes with Genentech, GlaxoSmithKline, Roche, Boehringer Ingelheim, Takeda, Array Biopharma and Ambit Biosciences.
Advisors' Opinion:- [By John Udovich]
Yesterday, small cap biopharmaceutical stock Puma Biotechnology Inc (NYSE: PBYI) jumped 11.98% after announcing they will have a conference call next week to update�investors on�its clinical trials of PB272 (neratinib) in cancer patients, meaning its probably time to take a closer look at the stock to see if investor might be counting the chickens before they hatch along with the performance of large cap AbbVie Inc (NYSE: ABBV) which also recently had positive news about its own breast cancer treatment plus biotech ETFs iShares NASDAQ Biotechnology Index ETF (NASDAQ: IBB) and SPDR S&P Biotech ETF (NYSEARCA: XBI).
Top 10 Medical Stocks To Own For 2014: 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:
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