Medical device companies have been under fire recently. Pricing pressures, a down economy, cash-strapped hospitals, and a competitive landscape have sent sales reeling at several major firms. Boston Scientific (NYSE: BSX ) has been hit especially hard, with its cardiac rhythm management (CRM) and interventional cardiology businesses seeing revenues fall across the board.
This company won't sit by as its outlook wanes, however. Boston's Watchman atrial fibrillation device has been turned down once by the Food and Drug Administration already, but promising new trial data has breathed life back into this new technology. With the atrial fibrillation industry on the rise, is this just what Boston needed to save its cardiovascular business' future? Motley Fool contributor Dan Carroll and health care analyst Max Macaluso discuss that and more below.
Hot Bank Stocks To Own For 2015: Acceleron Pharma Inc (XLRN)
Acceleron Pharma Inc., incorporated on June 13, 2003, is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of protein therapeutics for cancer and rare diseases. The Company�� research focuses on the biology of the Transforming Growth Factor-Beta (TGF-b) protein superfamily, a large and diverse group of molecules that are key regulators in the growth and repair of tissues throughout the human body. By coupling its discovery and development expertise, including its knowledge of the TGF-b superfamily, with its internal protein engineering and manufacturing capabilities, it has built a productive research and development platform that has generated clinical and preclinical protein therapeutic candidates with mechanisms of action.
The Company focuses on discovering and developing protein therapeutics that target a group of approximately 30 secreted proteins, or ligands, that are collectively referred to as the TGF-b superfamily. These ligands bind to subsets of 12 different receptors on the surface of cells, triggering intra-cellular changes in gene expression that guide cell growth and differentiation. The TGF-b superfamily ligands and their receptors represent an under-explored and diverse set of drug targets with the potential to yield therapeutics that modulate the growth and repair of diseased cells and tissues.
The Company has three internally discovered protein therapeutic candidates that are being studied in 12 ongoing Phase 2 clinical trials, focused on cancer and rare diseases. The Company�� two advanced protein therapeutic candidates, sotatercept and ACE-536, promote red blood cell production through a novel mechanism. Together with its collaboration partner, Celgene Corporation, the Company is developing sotatercept and ACE-536 to treat anemia and associated complications in patients with b-thalassemia and myelodysplastic syndromes (MDS). These red blood cell disorders are generally unresponsive to approved dru! gs. The Company�� third clinical stage protein therapeutic candidate, dalantercept, is designed to inhibit blood vessel formation through a mechanism that is distinct from, and potentially synergistic with, the dominant class of cancer drugs that inhibit blood vessel formation, the vascular endothelial growth factor (VEGF) pathway inhibitors. The Company is developing dalantercept primarily for use in combination with these products to produce better outcomes for cancer patients.
The Company and Celgene have conducted six human clinical trials with sotatercept in over 160 healthy volunteers and cancer patients. The Company has conducted one clinical trial with ACE-536 in healthy volunteers. In these studies, both sotatercept and ACE-536 caused a dose-dependent increase in the number of red blood cells. Based on these results, the Company and Celgene have initiated Phase II clinical trials with each of these protein therapeutic candidates in b-thalassemia and MDS. In the ongoing trial of sotatercept in patients with b-thalassemia, the Company has observed encouraging, dose-dependent increases in hemoglobin in a subset of patients at the two lowest dose levels.
Sotatercept is a soluble receptor fusion protein consisting of the extracellular domain of the activin receptor type IIA (ActRIIA) linked to the Fc domain of human IgG1. Sotatercept acts as a protein trap for TGF-b superfamily ligands that signal through the ActRIIA receptor. Sotatercept has increased red blood cells in multiple clinical trials. ACE-536 is a soluble receptor fusion protein consisting of a modified extracellular domain of the activin receptor type IIB (ActRIIB) linked to the Fc domain of human IgG1.
Advisors' Opinion:- [By Ben Levisohn]
3. We see 23+ partnered pipeline assets and are most positive on Phase I/II MOR202 anti-CD38 for myeloma with data in 2015, and others such as Acceleron Pharma (XLRN), Agios Pharmaceuticals (AGIO), Epizyme (EPZM), Concert Pharmaceuticals (CNCE) (just started Phase I for next-gen Revlimid).
- [By John Udovich]
Yesterday, small cap biotech Acceleron Pharma Inc (NASDAQ: XLRN) rose 9.76%�plus shares are up 183.6% for retail investors since its September IPO, meaning its worth taking a closer look at the stock along with the performance of other biotech IPOs like BIND Therapeutics Inc (NASDAQ: BIND), Ophthotech Corp (NASDAQ: OPHT) and Foundation Medicine Inc (NASDAQ: FMI) which also debuted at the same time.
Hot Medical Stocks For 2014: Rexahn Pharmaceuticals Inc (RNN)
Rexahn Pharmaceuticals, Inc. (Rexahn) is a development-stage biopharmaceutical company. The Company focuses on the development of cures for cancer to patients worldwide. The Company�� pipeline features one drug candidate in Phase II clinical trials. The Company also has several other drug candidates in pre-clinical development. In addition, the Company has two renal cell carcinoma (CNS) candidates, Serdaxin, CNS Disorders drug for depression and neurodegenerative diseases and Zoraxel, which is a erectile dysfunction (ED) and sexual dysfunction drug that are in clinical stages and the Company is are exploring options for further development . The Company�� drug candidate, Archexin is an anticancer Akt inhibitor.
Archexin
Archexin is potent inhibitor of the Akt protein kinase (Akt) in cancer cells. Archexin has FDA orphan drug designations for five cancers (RCC, glioblastoma, and cancers of the ovary, stomach and pancreas). Multiple indications for other solid tumors can also be pursued. Archexin inhibit both activated and inactivated forms of Akt, and to reverse the drug resistance observed with the protein kinase inhibitors. Archexin is an antisense oligonucleotide (ASO) compound that is complementary to Akt mRNA, and selective for inhibiting mRNA expression and production of Akt protein. As of December 31, 2011, Archexin was in Phase II clinical trials for the treatment of pancreatic cancer with enrollment completed in September, 2011.
Serdaxin
Serdaxin is an extended release formulation of clavulanic acid, which is an ingredient present in antibiotics approved by the FDA. The Company had been developing Serdaxin for the treatment of depression and neurodegenerative disorders. From January to September, 2011, the Company conducted a randomized, double-blind, placebo-controlled study compared two doses of Serdaxin, 0.5 milligram and 5 milligram, to placebo over an eight-week treatment period for major depressive disorder (MDD) patients. As of Dec! ember 31, 2011, the Company had not made a determination of Serdaxin�� future paths or resource allocations to further develop Serdaxin to treat MDD.
Zoraxel
Zoraxel is an orally administered, on-demand tablet to treat sexual dysfunction. Zoraxel is a dual enhancer of neurotransmitters in the brain that play a key role in sexual activity phases of motivation and arousal, erection and release, and may be the ED drug to affect all three of these phases of sexual activity. As of December 31, 2011, the Company was evaluating how to proceed with the Phase IIb study of Zoraxel.
The Company�� Pre-clinical Pipeline Drug Candidates includes RX-1792, which is a small molecule anticancer EGFR inhibitor; RX-5902, which is a small molecule anticancer ribonucleic acid (RNA) helicase regulator; RX-3117, which is a Small molecule anticancer deoxyribonucleic acid (DNA) synthesis Inhibitor; RX-8243, which is a small molecule anticancer aurora kinase inhibitor; RX-0201-Nano, which is a nanoliposomal anticancer Akt inhibitor; RX-0047-Nano, which is an nanoliposomal anticancer HIF-1 alpha inhibitor and RX-21101, which is a nano-polymer Anticancer.
Advisors' Opinion:- [By James E. Brumley]
If you were lucky enough to step into Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN) when your truly suggested it was a budding buy back on December 23rd, then congratulations - you're now up a little more than 60% (assuming you bought into RNN after the break above a key resistance line on the 27th). Now get out. Instead, use your profits from the Rexahn to take on a stake in GTx, Inc. (NASDAQ:GTXI). No, GTXI may not look like much at first, but when you take a step back and look at a chart of GTx, Inc. through a longer-term lens, the upside potential becomes clear.
Hot Medical Stocks For 2014: Atrion Corp (ATRI)
Atrion Corporation (Atrion), and its subsidiaries, develop and manufacture products, primarily for medical applications. The Company�� medical products range from fluid delivery devices to ophthalmic and cardiovascular products. During the year ended December 31, 2011, the Company�� fluid delivery products accounted for 38% of the Company�� revenues. These products include valves that promote infection control and needle safety. The Company has developed a variety of luer syringe check valves and one-way valves designed to fill, hold and release controlled amounts of fluids or gasses on demand for use in various intubation, catheter and other applications. The Company also makes tubing clamps in a variety of materials and colors that are compatible with various grades of tubing and sterilization processes, and produce specialized intravenous sets for use in numerous applications, including anesthesia and oncology.
The Company�� cardiovascular products accounted for 29% of its revenues during 2011. The Company's principal cardiovascular product is the Myocardial Protection System (MPS2), a technology that delivers essential fluids and medications to the heart during open-heart surgery. The MPS2 integrates key functions relating to the delivery of solutions to the heart, such as varying the rate and ratio of oxygenated blood, crystalloid, potassium and other additives, and controlling temperature, pressure and other variables to allow simpler, more flexible management of this process, indicating improved patient outcomes. The MPS2 is the device used in open-heart surgery that allows for the mixing of drugs into the bloodstream without diluting the blood. The MPS2 employs advanced pump, temperature control and microprocessor technologies and includes a line of disposable products. It also develops and manufactures other cardiovascular products that include cardiac surgery vacuum relief valves; Retract-O-Tape silicone vessel loops for retracting and occluding vessels in minimally inva! sive surgical procedures; inflation devices for balloon catheter dilation, stent deployment and fluid dispensing, and Clean-Cut rotating aortic punch and PerfectCut Aortotomy System, both of which are used in heart bypass surgery to make a precision opening in the heart for attachment of the bypass vessels.
The Company�� ophthalmic products accounted for 17% of its revenues during 2011. The Company is a manufacturer of contact lens disinfection cases. It also manufactures a line of balloon catheters used in the treatment of nasolacrimal duct obstruction in children and adults. The Company�� other medical and non-medical products accounted for 16% of its revenues during 2011. These product lines consist of instrumentation and associated disposables used to measure the activated clotting time of blood. In addition, it manufactures and sells a line of products designed for safe needle and scalpel blade containment. It is also the manufacturer of inflation systems and valves used in marine and aviation safety products. The Company manufactures inflation systems and valves for products, such as life vests, life rafts, inflatable boats, survival equipment and other inflatable structures. The Company also produces one-way and two-way pressure relief valves for use on electronics cases, munitions cases, pressure vessels, transportation container cases, escape slides, and many other medical and non-medical applications.
The Company market components to other equipment manufacturers for incorporation in their products and sell finished devices to physicians, hospitals, clinics and other treatment centers. It sells its products through a sales force which consists of direct sales personnel, independent sales representatives and distributors. It offers customer service, training and education, and technical support such as field service, spare parts, maintenance and repair for certain of its products. The Company�� medical products and other components are produced at facilities in ! Florida, ! Alabama and Texas.
Advisors' Opinion:- [By Seth Jayson]
There's no foolproof way to know the future for ATRION (Nasdaq: ATRI ) or any other company. However, certain clues may help you see potential stumbles before they happen -- and before your stock craters as a result.
Hot Medical Stocks 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:
Hot Medical Stocks For 2014: BioTime Inc (BTX)
BioTime, Inc., incorporated on November 30, 1990, is a biotechnology company focused on the emerging field of regenerative medicine. Its commercial strategy is focused on its line of research products, such as ACTCellerate cell lines and associated ESpan culture media, HyStem hydrogels, human embryonic stem (hES) cell lines, and royalties from Hextend. Its focus is to provide regenerative therapies for age-related degenerative diseases. In January 2011, the Company acquired the assets of Cell Targeting, Inc. (CTI), a biotechnology company focused on methods of painting molecules on the surface of cells, which in turn causes the cells to adhere to particular tissues, such as those afflicted with disease. On March 21, 2011, the Company acquired Glycosan BioSystems, Inc. (Glycosan) through a merger of Glycosan with OrthoCyte Corporation (OrthoCyte). Through the merger, OrthoCyte acquired all of Glycosan�� assets, including Glycosan�� Hystem hydrogel product line. In March 2011, the Company entered into an agreement with XenneX, Inc., pursuant to which it organized LifeMap Sciences, Inc. (LifeMap), a subsidiary formed to advance the development and commercialization of its human embryonic stem (hES) cell data base. In August 2011, four hES cell lines (ESI-035, ESI-049, ESI-051 and ESI-053) developed by its subsidiary ES Cell International (ESI) were approved by the National Institutes of Health (NIH) for inclusion in the NIH Human Embryonic Stem Cell Registry. In May 2012, the Company acquired XenneX, Inc., through a merger of XenneX into LifeMap Sciences. In September 2012, the Company formed a wholly owned subsidiary, BioTime Acquisition Corporation. In October 2013, Geron Corporation announced the closing of the transaction to divest the Company's stem cell assets to Asterias Biotherapeutics, Inc., a subsidiary of BioTime, Inc.
HyStem is a biomaterial, which mimics the human extracellular matrix, which is the network of molecules surrounding cells in organs and tissues which is essent! ial to cellular function. Its HyStem hydrogels may have other applications when combined with the diverse and scalable cell types its scientists have isolated from hES cells. HyStem-Rx is a clinical grade formulation of HyStem-C, a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications. Its subsidiary, OncoCyte Corporation, is developing PanC-Dx, a non-invasive blood-based cancer screening test designed to detect the presence of various human cancers, including cancers of the breast, lung, bladder, uterus, stomach, and colon, during routine check -ups. BioTime Asia, Limited (BioTime Asia) sells products for research use and may develop therapies to treat cancer and neurological and orthopedic diseases in Asia. OrthoCyte Corporation (OrthoCyte) is developing therapies to treat orthopedic disorders, diseases and injuries. ReCyte Therapeutics, Inc. (ReCyte Therapeutics) is developing therapies for age-related cardiovascular and blood disorders. Cell Cure Neurosciences Ltd. (Cell Cure Neurosciences), is a biotechnology company focused on developing stem cell-based therapies for retinal and other neurological disorders, including the development of retinal pigment epithelial (RPE) cells for the treatment of age-related macular degeneration. LifeMap Sciences, Inc. (LifeMap) is advancing the development and commercialization of our embryonic stem cell database and plans to make the database available for the marketing of research products and for use by stem cell researchers at pharmaceutical and biotechnology companies and other institutions via paid subscriptions or on a fee per use basis.
The Company�� blood plasma expander product, Hextend, is a physiologically balanced intravenous solution used in the treatment of hypovolemia, a condition caused by low blood volume, often from blood loss during surgery or injury. Hextend maintains circulatory system fluid volume and blood pressure, and keeps vital organs perfused during surgery and t! rauma car! e. Hextend is manufactured and distributed in the United States by Hospira, Inc., and in South Korea by CJ CheilJedang (CJ), under license from it.
Human Embryonic Stem Cell Lines for Research Use
Combined with the Company�� ACTCellerate technology, it derives of a range of markets human embryonic progenitor cells (hEPCs). ESI�� six current good manufacturing practices (cGMP) hES cell lines have been approved by the NIH for inclusion in the Human Embryonic Stem Cell Registry, which renders those cell lines eligible for use in federally funded research. The ESI hES cell lines are available for purchase through www.biotimeinc.com. It also markets hEPCs developed using ACTCellerate technology. Its hEPCs are also available for sale through www.biotimeinc.com. It derived the complete genome sequence of five of the ESI hES cell lines to facilitate the development of products derived from these cell lines. It has made these GMP-grade cell lines, along with certain documentation and complete genomic deoxyribonucleic acid (DNA) sequence information, available for sale.
The Company offers human stem cell products and technology that can be used by researchers at universities and at companies in the bioscience and biopharmaceutical industries. It has developed research and clinical grade hES cell lines, which it markets for both basic research and therapeutic product development. It also markets human embryonic progenitor cell (hEPCs) developed using ACTCellerate technology. These hEPCs are purified lineages of cells, which are intermediate in the developmental process between embryonic stem cells and fully differentiated cells. The ACTCellerate cell lines are also available for purchase through http://www.biotimeinc.com.
Human Embryonic Progenitor Cells
Through the Company�� subsidiary ReCyte Therapeutics, it had a license from Advanced Cell Technology, Inc. (ACT) to use ACTCellerate technology, and the rights to market more than 200 human c! ell types! made using that process. ACTCellerate allows the rapid isolation of hEPCs, which are cells that are intermediate in the developmental process between embryonic stem cells and fully differentiated cells.
Through an agreement with ReCyte Therapeutics, Millipore Corporation became a global distributor of ACTCellerate hEPC lines. In addition to the products, which it is co-marketing with Millipore, it offers 92 other ACTCellerate hEPC lines for purchase at www.biotimeinc.com. Through its subsidiary LifeMap, it provides online biomedical database services to increase awareness of molecular markers and diverse cell types comprising its ACTCellerate hEPC lines. It also focuses to market additional cell types manufactured with its PureStem technology. PureStem cell lines are produced by the exogenous expression of specific transcription factors, which regulate the differentiation of cell types from hES or induced pluripotent stem (iPS) cells. BioTime Asia has an agreement with Shanghai Genext Medical Technology Co., Ltd. to sell ACTCellerate hEPC lines and related ESpan growth media to the medical and biological research communities in China, Taiwan, Hong Kong, and Macau on an exclusive basis. The marketing agreement includes provisions for an initial stocking inventory and annual milestones to maintain exclusivity. The Company�� California Institute of Regenerative Medicine (CIRM)-funded research addresses the need for industrial scale production of purified therapeutic cells.
hES Cells Carrying Genetic Diseases
The Company focuses to add to its product line muscle progenitor cells produced from five hES cell lines carrying genes for Duchenne muscular dystrophy, Emery-Dreifuss muscular dystrophy, spinal muscular atrophy Type I, facioscapulohumeral muscular dystrophy 1A, and Becker muscular dystrophy. It obtained the diseased hES cell lines from Reproductive Genetics Institute (RGI).
ESpan Cell Growth Media
The Company is marketing a range of! cell-gro! wth media products called ESpan. These growth media are optimized for the growth of hEPC types. Cells need to be propagated in liquid media, in both the laboratory setting, where basic research on stem cells is performed, and in the commercial sector. Its ESpan products are marketed through Millipore and Genext.
ESpy Cell Lines
The Company focuses for development of ESpy cell lines. The ability of the ESpy cells to emit light will allow researchers to track the location and distribution of the cells in both in vitro and in vivo studies.
HyStem Hydrogel for Research and HyStem-Rx for Cell Delivery Medical Devices
HyStem is a patented biomaterial that mimics the ECM, the network of molecules surrounding cells in organs and tissues that is essential to cellular function. Its HyStem technology forms the foundation for stem cell delivery products in both the adult and embryonic stem cell marketplace, including products manufactured using its ACTCellerate technology. As an injectable product, HyStem-Rx may address need in cosmetic and reconstructive surgeries and other procedures by transplanting adipose derived cells or other adult stem cells. The transfer of cells in HyStem-Rx localizes the transplanted cells at the intended site and by providing a three-dimensional scaffold upon which cells can rebuild normal tissue. HyStem-Rx may support other emerging cell and tissue transplant therapies, such as those derived from hES and iPS cells, in addition to its potential application in the treatment of a range of conditions such as osteoarthritis, brain tumors, stroke, bone fracture, and wounds.
Advisors' Opinion:- [By Brian Pacampara]
Based on the aggregated intelligence of 180,000-plus investors participating in Motley Fool CAPS, the Fool's free investing community, biotechnology company BioTime (NYSEMKT: BTX ) has received the dreaded one-star ranking.
- [By John Udovich]
Stem cell stocks have not exactly been the best performers lately in part because the controversy over their use has died down over the years while major breakthroughs have been few or far between, but the industry along with small cap stem cell stocks Pluristem Therapeutics Inc (NASDAQ: PSTI), BioTime, Inc (NYSEMKT: BTX) and BioRestorative Therapies (OTCBB: BRTX) are still quietly producing their share of news or minor breakthroughs worth taking note of. Just consider the following stem cell news or news from small cap players in the sector:
Hot Medical Stocks For 2014: Neuroderm Ltd (NDRM)
Neuroderm Ltd. is a clinical-stage pharmaceutical company. The Company is engaged in the development of treatments for central nervous system (CNS) disorders. The Company develops liquid levodopa (LD), which is a treatment for Parkinson�� disease (PD). The Company designs product candidates that address needs in the field of Parkinson�� disease and cognition. The Company�� product pipelines includes ND0612L for moderate PD, ND0612H for severe PD, ND0680 for severe PD, ND0701 for severe PD and ND0801for Cognitive Disorders. The Company developed a liquid formulation of levodopa/carbidopa (LD/CD). The Company through its reformulation technology develops a line of LD/CD product candidates administered through a patch-pump or small belt pump that deliver a continuous, controlled dose of LD/CD to the blood stream. The Company�� LD/CD line of product candidates includes ND0612L, ND0612H and ND0680. The Company also develops ND0701, a formulation of continuous apomorphine therapy for the treatment of Parkinson�� disease.
ND0612L for moderate Parkinson�� disease
ND0612L is under development for the treatment of moderate Parkinson�� disease patients who can no longer effectively control their motor complications with oral levodopa. ND0612L is developed as a fixed dose liquid formulation of levodopa and carbidopa to be administered subcutaneously, over a day and night period. The product ND0612L has two versions under development: ND0612L belt pump version, which is subcutaneously administrated via a small belt-pump, and ND0612L Patch Pump Version, which is a second generation product that is subcutaneously administrated via a patch pump.
The Company has conducted two Phase I studies and a Phase IIa clinical study with N0612L. The clinical studies was a single-dose, 24-hour continuous-administration, randomized, double-blind, placebo-controlled study on eight subjects with moderate Parkinson�� disease. The study results demonstrated that subcutaneous deli! very of ND0612L was safe and tolerable, and achieved steady-state plasma levodopa concentrations of 700-900 nanogram/milliliter. Additionally, administration of ND0612L was shown to significantly reduce fluctuations in plasma levodopa concentrations.
The Company is conducting a Phase II randomized, placebo-controlled, double-blind study of ND0612L on approximately 30 Parkinson�� disease patients suffering from motor complications. The study�� primary endpoints are safety and tolerability, as well as the pharmacokinetic profile of levodopa plasma concentrations.
ND0612H for severe Parkinson�� disease
The Company is developing ND0612H for the treatment of severe-stage Parkinson�� disease patients for whom oral drugs are no longer effective. The ND0612H belt pump (CRONO Twin ND) is a drug pump that delivers levodopa/carbidopa (LD/CD) to treat severe Parkinson�� disease patients. ND0612H provides continuous subcutaneous delivery of an adjustable, high dose, LD/CD formulation to improve motor and non-motor complications in patients refractory to oral LD/CD. ND0612H�� is subcutaneously administrated utilizing a belt-pump allowing patients to receive continuous LD/CD therapy round the clock. The Company is conducting Phase II clinical trials on the product ND0612H for the treatment of severe-stage Parkinson�� disease.
ND0680 for severe Parkinson�� disease
ND0680 is indicated for the treatment of very severe Parkinson�� disease, which requires high doses of LD/CD which cannot be provided via oral delivery or using ND0612L and ND0612H. ND0680 is administered via a tube to the duodenum. ND0680 formulation contains a much higher concentration of LD/CD and is administered with the CRONO ND belt pump via the duodenum. The Company is conducting Phase I clinical trials for the development of ND0680
ND0701 for severe Parkinson�� disease
ND0701 is an apomorphine-based product candidate. ND0701 is desi! gned for ! the treatment of patients with severe Parkinson�� disease and do not respond well to LD/CD. ND0701 is administered via a CRONO ND belt pump or a patch pump (1st and 2nd generation, respectively). The Company is conducting Phase I clinical trials for the development of ND0701 indicated for the treatment of severe Parkinson�� disease.
ND0801 for Cognitive Disorders
ND0801 is under development for the treatment of cognition disorders associated with central nervous system diseases, such as Attention Deficit Disorder/Attention Deficit Hyperactivity Disorder (ADD/ADHD), Alzheimer�� disease, Parkinson�� disease and schizophrenia. ND0801�� is covered by a reformulation and is designed to be a nicotine-based combination drug treatment. ND0801 is administered via a transdermal patch.
The Company is conducting tests on ND0801 for the treatment of ADD/ADHD in two centers in Israel in an open-label, Phase IIa, proof-of-concept dose escalation study on approximately 45 adult patients. The study is designed to demonstrate the safety, tolerability and optimal therapeutic doses of ND0801, and evaluate the cognitive improvement in subjects following treatment with escalating doses of ND0801. Interim results from 30 patients enrolled have demonstrated a dose dependent improvement in attention and cognition following seven days of ND0801 treatment with no observed serious side effects.
Advisors' Opinion:- [By Johanna Bennett]
NeuroDerm (NDRM) almost tripled in value to $18.14 during regular market hours after posting clinical trial results for its experimental treatment for Parkinson�� disease.
Hot Medical Stocks For 2014: Intercept Pharmaceuticals Inc (ICPT)
Intercept Pharmaceuticals, Inc., incorporated on September 4, 2002, is a biopharmaceutical company focused on the development and commercialization of therapeutics to treat chronic liver diseases utilizing its bile acid chemistry.The Company�� product candidates treat orphan and more prevalent liver diseases for which there are limited therapeutic solutions. The Company�� product candidate, obeticholic acid, or OCA, is a bile acid analog, a chemical substance that has a structure based on a naturally occurring human bile acid. It is developing OCA initially for primary biliary cirrhosis, or PBC, as a second line treatment for patients who have an inadequate response to or who are unable to tolerate standard of care therapy and therefore need additional treatment. The Company is conducting a Phase 3 clinical trial of OCA in PBC, which it calls the POISE trial, that serves as the basis for seeking regulatory approval in the United States and Europe. As of December 19, 2012, the Company completed enrollment of the POISE trial with 217 patients.
The Company�� clinical focus is on the development of OCA, orally administered, first-in-class FXR agonist that has broad liver-protective properties and may a variety of chronic insults to the liver that cause fibrosis, which can eventually lead to cirrhosis, liver transplant and death. The Company owns worldwide rights to OCA outside of Japan and China, where it has licensed the compound to Dainippon Sumitomo Pharma, or DSP, and granted it an option to license OCA in certain other Asian countries.The Company is sponsoring an independent study involving more than ten leading PBC centers in North America and Europe, or collectively the Global PBC Study Group, that are pooling their long-term patient data to evaluate the relationship between biochemical and clinical endpoints.
The Company competes with Eli Lilly, Exelixis, Inc., Phenex Pharmaceuticals AG, , Johnson & Johnson, NovImmune SA, Dr. Falk Pharma GmbH, Galmed Medical Researc! h Ltd., Immuron Ltd., Mochida Pharmaceutical Co., Ltd., NasVax Ltd. , Raptor Pharmaceutical Corp. Astellas Pharma US, Inc., AstraZeneca, Salix Pharmaceuticals, Inc. and Tioga Pharmaceuticals, Inc.
Advisors' Opinion:- [By Jake L'Ecuyer]
Equities Trading UP
Shares of Intercept Pharmaceuticals (NASDAQ: ICPT) got a boost, shooting up 289.85 percent to $282.21 after the company reported that the FLINT trial of obeticholic acid has been stopped early and the NASH primary endpoint has been met. - [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 Jake L'Ecuyer]
Equities Trading UP
Shares of Intercept Pharmaceuticals (NASDAQ: ICPT) got a boost, shooting up 62.40 percent to $452.02. Citigroup lifted the price target on the stock from $60.00 to $400.00, while Bank of America raised the price target from $81.00 to $872.00.
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