Our top stock selection for 2014 has received three Breakthrough Therapy Designations (BTD) by the FDA, and subsequent approval, in November, for Imbruvica, a very safe pill that has shown unprecedented efficacy to treat mantle cell lymphoma (MCL), suggests John McCamant, editor of The Medical Technology Stock Letter.
The company��hich we consider conservative among biotech stocks��s Pharmacyclics (PCYC). Its pill is also expected to be approved for a much larger B-cell cancer market, chronic lymphocytic leukemia (CLL), by the end of February.
The next catalyst for PCYC will be the release of data, at the end of January, from the RESONATE trial, the first Phase III study of Imbruvica in patients with refractory/relapsed CLL. RESONATE should continue to demonstrate Imbruvica's incredible efficacy and safety as a once-a-day cancer pill.
With the drug already on the market for MCL, we expect CLL sales to ramp up rapidly, as there is a large pool of CLL patients that have been watching and waiting for a safe and effective treatment for CLL.
10 Best Medical Stocks For 2015: Stemline Therapeutics Inc (STML)
Stemline Therapeutics, Inc. (Stemline), incorporated on August 8, 2003, is a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics that target both cancer stem cells (CSCs) and tumor bulk. The Company is developing two clinical-stage product candidates, SL-401 and SL-701, for which it holds global marketing rights. The indication for SL-401, a biologic-drug conjugate, is acute myeloid leukemia (AML). The indications for SL-701, a synthetic peptide vaccine, are pediatric and adult brain cancer. It has a platform, StemScreen, for the discovery of CSC-targeted compounds, from which it has discovered or validated several of its clinical and preclinical product candidates. Stemline�� StemScreen consists of StemScreen-1 and StemScreen-2 for the identification of CSC-directed compounds.
SL-301 is a small molecule gamma-secretase inhibitor that inhibits Notch, a pathway expressed by CSCs and tumor bulk of multiple cancer types. SL-101 is a monoclonal antibody-based (mAb -based) compound that targets CD123 and has shown in vitro activity against certain hematologic cancers. SL-201 is a small molecule active against certain hematologic and solid tumor types. SL-601 is a mAb-based compound that targets a cell surface marker on bladder CSCs, which is also expressed on a variety of other solid tumor types. It has also in-licensed certain intellectual property directed to mAb-based therapeutics to validated oncology targets, including Glypican-3, Tie-1, CD133, Frizzled, Smoothened and Patched.
SL-401 - An IL-3R-Directed Compound Targeting Cancer Stem Cells and Tumor Bulk
SL-401 is a clinically active biologic-drug conjugate consisting of human interleukin-3 (IL-3) genetically linked to a truncated version of diphtheria toxin. SL-401 targets the IL-3 receptor (IL-3R), which is overexpressed on both the CSCs and tumor bulk of multiple hematologic cancers, including AML. SL-401 has demonstrated preclinical in vit! ro and in vivo activity against both leukemia blasts (which includes tumor bulk) and CSCs of a range of human leukemia cell lines and primary leukemia cells from patients.
SL-701
SL-701 is a clinically active synthetic peptide vaccine that targets several epitopes on CSCs and tumor bulk of brain cancer. In two completed Phase 1/2 clinical trials, SL-701 demonstrated single agent anti-tumor activity in pediatric patients with newly diagnosed brainstem glioma (BSG) and other high-grade gliomas (HGGs) and in adult patients with refractory or recurrent GBM, and other HGGs.
StemScreen-1
StemScreen-1 is a drug discovery platform designed to identify CSC-targeted compounds based on the isolation of CSCs and evaluation of CSC gene expression profiles. CSCs are isolated from primary tumor tissue or cell lines, and then subjected to gene expression analysis using a variety of technologies, including microarray. A control tissue, such as normal bone marrow is analyzed as a comparator against the gene expression profile of the isolated CSCs. These data are then interfaced with an information base of compounds and their mechanisms of action (that is which gene products and pathways they impact). It has utilized StemScreen-1 to discover a number of its preclinical drug candidates. These include SL-201, SL-301, and SL-601. In addition, SL-401 demonstrated activity against CSCs as determined by both an in vitro colony formation and in vivo animal implantation assay, thereby validating certain StemScreen-1 anti-CSC assays.
StemScreen-2
StemScreen-2 is a high throughput drug discovery platform it is developing to discover anti-CSC compounds. StemScreen-2 utilizes a cell-based assay that can track and follow CSCs in their natural state during high throughput screening. In particular, StemScreen-2 utilizes a CSC-specific promoter linked to a reporter as a method for identifying and following CSCs in their native environment of surrounding tumor b! ulk. In t! his way, StemScreen-2 enables the identification of compound hits, in a high throughput manner, with anti-CSC activity.
The Company competes with Boston Biomedical, Inc., Eclipse Therapeutics, Inc., OncoMed Pharmaceuticals, Inc., Verastem, Inc., Astellas Pharma US, Inc., Boehringer Ingelheim GmbH, Dainippon Sumitomo Pharma Co. Ltd., Geron Corp., GlaxoSmithKline plc, ImmunoCellular Therapeutics, Ltd, Macrogenics Inc., Amgen, Inc., Pfizer Inc., Roche Holding AG, Sanofi U.S. LLC., Cyclacel Pharmaceuticals, Inc., Sunesis Pharmaceuticals Inc., Clavis Pharma ASA, Ambit Biosciences Corporation, Celgene Corporation, Eisai Co. Ltd., Celator Pharmaceuticals, Inc., Merck & Co., Inc., Eisai Co., Inc., Roche Holding AG, Novartis AG and Celldex Therapeutics, Inc.
Advisors' Opinion: - [By David Zeiler]
3. Stemline Therapeutics Inc. (Nasdaq: STML): This biotech develops drugs that target cancer stem cells and tumors. Stemline went public January 29 at $10 a share and rose just 11.78% on its first day. But STML has climbed steadily since, and currently trades at $37.46, up 274.6% from its IPO price.
- [By Keith Speights]
Best-performing biotech IPO
Stemline Therapeutics� (NASDAQ: STML ) has only traded publicly this year, but what a year it's been. The stock's performance ranks Stemline as the best-performing biotech IPO so far in 2013. This week has been pretty good also, with shares moving up by 28%.
- [By Jay Silverman]
Some of the biggest leaders in that field, and there have been dozens in fields, if not more this year, such as Bluebird (BLUE) and Stemline Therapeutics (STML) and have all pulled back to significantly lower levels; even below, in Bluebird's case, the price that had actually opened up as an IPO, even though it's above its IPO price.
10 Best Medical Stocks For 2015: Galectin Therapeutics Inc (GALT)
Galectin Therapeutics Inc., formerly Pro-Pharmaceuticals, Inc., incorporated on January 26, 2001, is a development-stage company. The Company is engaged in drug development to create therapies for cancer and fibrotic disease. As of December 31, 2011, the Company has two compounds in development, one is to be used in cancer therapy and the other intended to be used in the treatment of liver fibrosis and fatty liver disease. These two compounds are produced from different natural starting materials, both possessing the property, which lends itself to binding to and inhibiting galectin proteins. GM-CT-01, the Company's product candidate for cancer therapy, is a linear polysaccharide polymer consisted of mannose and galactose that has a defined chemical structure and is derived from a plant source. GR-MD-02, the Company's product for treatment of liver fibrosis and fatty liver disease with inflammation and fibrosis, is a polysaccharide polymer possessing both linear and globular structures, which also is derived from a plant source.
GM-CT-01 has in development for the therapy of colorectal cancer and is in a Phase I/II clinical trial as a combination therapy with a tumor vaccine in patients with advanced melanoma. Based on the completed Phase I and partially completed Phase II clinical trials, the Company is exploring two additional potential indicia for the use of GM-CT-01 in combination with cancer chemotherapy. There are two additional pathways for the development of GM-CT-01 for use in treatment of cancer. GM-CT-01 was found to be generally safe when studied in a Phase I clinical trial in end-stage cancer patients with multiple tumor types alone and in combination with 5-Fluorouracil (5-FU), which is an Food and Drug Administration (FDA)-approved chemotherapy used for treatment of various types of cancer.
Advisors' Opinion: - [By Roberto Pedone]
Galectin Therapeutics (GALT) offers drug research and development to create new therapies for fibrotic disease and cancer. This stock closed up 9.6% to $12.06 in Monday's trading session.
Monday's Volume: 674,000
Three-Month Average Volume: 222,171
Volume % Change: 149%
Shares of GALT jumped higher on Monday after Ascendiant initiated coverage on the stock with a buy recommendation.
From a technical perspective, GALT spiked sharply higher here with strong upside volume. This stock has been uptrending for the last three months, with shares ripping higher from its low of $3.95 to its recent high of $13.21. During that move, shares of GALT have been making mostly higher lows and higher highs, which is bullish technical price action. That move has now pushed shares of GALT within range of triggering a near-term breakout trade. That trade will hit if GALT manages to take out Monday's high of $12.44 and then once it clears its 52-week high at $13.21 with high volume.
Traders should now look for long-biased trades in GALT as long as it's trending above some near-term support levels at $11 or at $10 and then once it sustains a move or close above those breakout levels with volume that hits near or above 222,171 shares. If that breakout hits soon, then GALT will set up to enter new 52-week-high territory above $13.21, which is bullish technical price action. Some possible upside targets off that breakout are $15 to $16.
Top Consumer Service Stocks To Own For 2015: 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:
10 Best Medical Stocks For 2015: Covidien PLC (COV)
Covidien Public Limited Company is engaged in the development, manufacture and sale of healthcare products for use in clinical and home settings. It operates its businesses through three segments: Medical Devices, which includes the development, manufacture and sale of endomechanical instruments, energy devices, soft tissue repair products, vascular products, oximetry and monitoring products, airway and ventilation products; Pharmaceuticals, which includes the development, manufacture and distribution of specialty pharmaceuticals and active pharmaceutical ingredients, and Medical Supplies, SharpSafety products and original equipment manufacturer products. In May 2012, it acquired Newport Medical Instruments, Inc. In May 2012, it acquired superDimension, Ltd. In June 2012, the Company acquired Oridion Systems Ltd. In October 2012, its Mallinckrodt acquired CNS Therapeutics, Inc. In January 2013, the Company acquired CV Ingenuity.
Advisors' Opinion: - [By Ben Levisohn]
Intuitive Surgical has gained 4.3% to $397.20 today, easily trumping the gains in other healthcare-equipment companies. �Covidien�(COV) has ticked down 0.3% to $60.08, Medtronic�(MDT) has gained 0.5% to $52.97, Abbott Laboratories�(ABT) has fallen 0.8% to $33.24, and C.R. Bard (BCR) is little changed at $114.52.
- [By Jon C. Ogg]
Covidien Ltd. (NYSE: COV) was started as Buy at Needham & Co.
Halliburton Co. (NYSE: HAL) was reinstated as Outperform and added to the U.S. Focus List with a new price target of $58 (versus $48.30 now) at Credit Suisse, and it was reiterated as Buy and the price target was raised to $63 from $58 by Sterne Agee.
- [By Laura Brodbeck]
Friday
Earnings Expected From: Covidien plc. (NYSE: COV), Eldorado Gold Corporation (NYSE: EGO), Vaalco Energy Inc. (NYSE: EGY) Economic Releases Expected: �US Wholesale Trade, US non-farm payrolls Posted-In: Bank Of England European Central Bank Federal ReserveNews Eurozone Previews Global Economics Federal Reserve Markets Trading Ideas Best of Benzinga
- [By John Udovich]
One way or the other, Merrimack Pharmaceuticals Inc (NASDAQ: MACK), Covidien plc (NYSE: COV), NeoGenomics, Inc (NASDAQ: NEO) and�CollabRx Inc (NASDAQ: CLRX) are targeting Barrett's Esophagus�or�esophageal cancer�(the former often leads to the latter) ��a form of cancer that may not be on the top of your list of cancers but is nevertheless on the rise. Approximately 3 million Americans suffer from Barrett's Esophagus, �a condition that�develops as a result of chronic injury from gastroesophageal reflux disease (GERD) where the�normal esophageal lining is replaced with abnormal cells (known as Barrett�� tissue), putting patients at greater risk of developing cancer of the esophagus. And although less than 1% of these patients develop cancer each year, esophageal carcinoma is frequently not detected until later stages, at which point therapy options are limited, extremely invasive, and often ineffective.�This means that�early detection is important�along with�regular surveillance is recommended.�
10 Best Medical Stocks For 2015: Haemonetics Corp (HAE)
Haemonetics Corporation, incorporated on August 29, 1985, is a healthcare company engaged in providing blood management solutions to its customers. The Company�� portfolio of integrated devices, information management and consulting services offers blood management solutions for each facet of the blood supply chain, helping improve clinical outcomes and reduce costs for blood and plasma collectors, hospitals, and patients around the world.The Company serves three markets: manufacturers of plasma derived pharmaceuticals, blood collectors and hospitals. Plasma includes plasma collection devices and consumables. Blood Center includes blood collection and processing devices and consumables. Hospital includes surgical blood salvage and blood demand diagnostic devices and consumables. Software Solutions includes information technology platforms and consulting services provided to all three markets. On April 30, 2013, the Company acquired of certain assets of Hemerus LLC.
The Company helps its customers create and maintain a safe and efficient blood supply chain. Specifically, it develops and markets a wide range of systems used with plasma and blood donors that collect and process blood into its components using both manual and automated methods. It also develops and markets a variety of systems to hospitals that automate the cleaning and reinfusion of a surgical patient's blood during surgery, automate the tracking and distribution of blood in the hospital, and enhance blood diagnostics. The Company sells information technology platforms to promote efficient and compliant operations for all of its customer groups. The Company provides consulting services to reduce costs and improve operating efficiencies in blood management. . Its products and services help prevent a transfusion to a patient who does not need one and provide the right blood product, at the right time, in the right dose to the patient who does.
Plasma
Human plasma is collected and processed by bio-ph! armaceutical companies into therapeutic and diagnostic products that aid in the treatment of immune diseases and coagulation disorders. While plasma is also used to aid patients with extreme blood loss, such as trauma victims, this portion of its business solely focuses on plasma's pharmaceutical uses. Automated plasma collection technology allows for the safe and efficient collection of plasma. The Company manufactures and market plasma collection devices and respective disposables, but do not make plasma-derived pharmaceuticals.
The Company�� portfolio of products and services is designed to support multiple facets of plasma collector operations. The Company with its PCS brand automated plasma collection technology, more plasma can be collected during any one donation event because the other blood components are returned to the donor through the sterile disposable sets used for the plasma donation procedure. The Company offers one stop shopping to its plasma collection customers, enabling them to source from them the full range of products necessary for plasma collection and storage, including PCS brand plasma collection equipment and consumables, plasma collection containers, and intravenous solutions. It also offers a robust portfolio of integrated information technology platforms for plasma customers to manage their donors, operations, and supply chain. Its products automate the donor interview and qualification process; streamline the workflow process in the plasma center; provide the controls necessary to evaluate donor suitability; determine the ability to release units collected; and manage unit distribution.
Blood Center
The Company offers automated blood component and manual whole blood collection systems to blood collection centers to collect blood products.The Company markets the MCS (Multicomponent Collection System) brand apheresis equipment which is designed to collect specific blood components integrated from the donor. Utilizing t! he MCS au! tomated platelet collection protocols, blood centers collect one or more therapeutic doses of platelets during a single donation by a volunteer blood donor. The MCS two-unit protocol or double red cell collection device helps blood collectors optimize the collection of red cells by automating the blood separation function, eliminating the need for laboratory processing, and enabling the collection of two units of red cells from a single donor thus maximizing the amount of red cells collected per eligible donor and helping to mitigate red cell shortages in countries where this problem exists. Blood collectors can also use the MCS system to collect one unit of red cells and a jumbo (double) unit of plasma, or one unit of red cells and one unit of platelets from a single donor. The MCS plasma protocol providing the possibility to collect 600-800ml of plasma for transfusion to patients or for pharmaceutical industry use completes the comprehensive portfolio of different blood component collection options on this device.
The Company offers a portfolio of products for manual whole blood collection and processing. Haemonetics' portfolio of disposable whole blood collection and component storage sets offer flexibility in collecting a unit of whole blood and the subsequent production and storage of the red blood cell, platelet, and/or plasma products, including options for in-line or dockable filters for leukoreduction of any blood component. In addition Acrodose product line provides a closed system for the pooling, storage, and bacteria testing of leukoreduced whole blood derived platelet concentrates, an Acrodose Platelet, that is transfusion ready for the hospital. Use of Acrodose platelets lowers hospital handling costs by eliminating the need for pooling and bacteria testing at the hospital.
The Company with ACP(Automated Cell Processor) brand offers a small bench-top solution to automate the washing and freezing of red cell components in the lab. The automated red cell was! hing proc! edure removes plasma proteins within the red cell units to provide a safer product for transfusion to frequently transfused patients, neonates, or patients with a history of transfusion reactions. The automated glycerolization and deglycerolization steps are required to prepare red cells for frozen storage. Freezing the red cell units can expand the shelf life of these products up to 10 years. Customers utilize this technology to implement strategic red cell inventories for catastrophe cases, storage of rare blood types, or enhanced inventory management.
Hospital
The Company offers a range of blood management solutions that significantly improve a hospital's systems for acquiring blood, storing it in the hospital, and dispensing it efficiently and correctly. Its products and integrated solution platforms help hospitals optimize performance of blood acquisition, storage, and distribution.The Company�� TEG Thrombelastograph Hemostasis Analyzer system is a blood diagnostic instrument that measures a patient's hemostasis or the ability to form and maintain blood clots.
The Cell Saver system is a surgical blood salvage system targeted to procedures that involve rapid, high-volume blood loss, such as cardiovascular surgeries. It has become the standard of care for high blood-loss surgeries. During the year ended December 31,2012, the Company launched the Cell Saver Elite system, which is autotransfusion option to minimize allogeneic blood use for surgeries with medium to high blood loss. The OrthoPAT surgical blood salvage system is targeted to procedures, such as orthopedic, that involve slower, lower volume blood loss that often occurs well after surgery. The cardioPAT system is a surgical blood salvage system targeted to open heart surgeries when there is less blood loss during surgery, but where the blood loss continues post-surgery. These systems are designed to remain with the patient following surgery, to recover blood and produce a washed red cell produ! ct for au! totransfusion. Their Quick-Connect feature permits customers to utilize the blood processing set selectively, depending on the patient's need.
The Company�� IMPACT Online Web-based software platform, which monitors and measures improvements in a hospital�� blood management practices, provides hospitals with a baseline view of their blood management metrics and helps monitor transfusion rates. Business consulting solutions are offered to support process and blood management efforts. It also provides blood management assessment tools to hospitals that enables its customers to monitor their progress in order to continually improve their blood management performance.
Software Solutions
The Companby has a suite of integrated software solutions for improving efficiencies and helping ensure donor and patient safety. This includes solutions for blood drive planning, donor recruitment and retention, blood collection, component manufacturing and distribution, transfusion management, and remote blood allocation. For its plasma customers, it also provides information technology platforms for managing donors and information associated with the collection of plasma products within fractionation facilities.
The Company�� software solutions , including information technology platforms and consulting services can be combined with its devices and sold through its plasma, blood center, and hospital sales forces. The Company�� software products help hospitals track and safely deliver stored blood products. SafeTrace Tx is its software solution that helps manage blood product inventory, perform patient cross-matching, and manage transfusions. In addition, its BloodTrack suite of solutions manages tracking and control of blood products from the hospital blood center through to transfusion to the patient. Smart refrigerators located in or near operating suites, emergency rooms, and other parts of the hospital dispense blood units with secure control and autom! ated trac! eability for efficient documentation. With its offerings, hospitals are better able to manage processes across the blood supply chain and identify increased opportunities to reduce costs and enhance processes. Its software solutions, such as its SafeTrace and El Dorado Donor donation and blood unit management systems, span blood center operations and automate and track operations from the recruitment of the blood donor to the disposition of the blood product. Its Hemasphere software solution provides support for more efficient blood drive planning, and Donor Doc and e-Donor software help to improve recruitment and retention.
The Company competes with Fenwal, Inc., Terumo BCT ,Caridian BCT, Rotem, MAK Systems, Mediware, MacoPharma , Medtronic, Fresenius, Sunquest Information Systems and Sorin Biomedica.
Advisors' Opinion: - [By Monica Gerson]
Analysts at Benchmark downgraded Haemonetics (NYSE: HAE) from ��uy��to ��old.��The target price for Haemonetics has been lowered from $49 to $46.
- [By Holly LaFon]
Haemonetics (HAE) is the market leader in blood management products for collection centers and hospitals. The company's equipment and related consumables allow collection centers to separate blood into the components of plasma, red cells and white cells. Hospital-based products include blood diagnostics, devices to salvage patient blood during surgery and software to manage blood supply. Earnings temporarily declined due to two product quality issues that management of Haemonetics has stated have been remedied. In our opinion, earnings growth may be expected to accelerate in the next few years as Haemonetics rolls out its automated whole blood collection solution to collection centers. Relative to the existing manual process, the company's automated solution speeds up the collection process and reduces discard rates. Cost and efficiency gains become more important to collection centers as hospitals better manage their blood supply. We believe the company is a compelling value at 12x our $3.50 estimate of earnings power.
10 Best Medical Stocks For 2015: Hemispherx Biopharma Inc (HEB)
Hemispherx Biopharma, Inc. (Hemispherx) is a specialty pharmaceutical company engaged in the clinical development of new drugs therapies based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders. Hemispherx focuses on two core pharmaceutical technology platforms Ampligen and Alferon N Injection.The commercial focus for Ampligen includes application as a treatment for Chronic Fatigue Syndrome (CFS) and as an influenza vaccine enhancer (adjuvant) for both therapeutic and preventative vaccine development. Alferon N Injection is a United States Food and Drug Administration (FDA) approved product with an indication for refractory or recurring genital warts. Alferon LDO (Low Dose Oral) is a formulation under development targeting influenza. It has three subsidiaries BioPro Corp., BioAegean Corp., and Core BioTech Corp. The Company's foreign subsidiary is Hemispherx Biopharma Europe N.V./S.A.
Ampligen
Ampligen is an experimental drug, which is undergoing clinical development for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Over 1,000 patients have participated in the Ampligen clinical trials representing the administration of more than 90,000 doses of this drug. The Company is also engaged in ongoing, experimental studies assessing the efficacy of Ampligen against influenza viruses.
Alferon N Injection
Alferon N Injection is the registered trademark for the Company's injectable formulation of natural alpha interferon. Interferons are a group of proteins produced and secreted by cells to combat diseases. The Company's natural alpha interferon is produced from human white blood cells. Alferon N Injection [Interferon alfa-n3 (human leukocyte derived)] is a highly purified, natural-source, glycosylated, multi-species alpha interferon product.
Alferon LDO (Low Dose Oral)
Alferon LDO [Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)]! is an experimental low-dose, oral liquid formulation of Natural Alpha Interferon and like Alferon N Injection should not cause antibody formation, which is a problem with recombinant interferon. It is an experimental immunotherapeutic that works by stimulating an immune cascade response in the cells of the mouth and throat, enabling it to bolster systemic immune response through the entire body by absorption through the oral mucosa.
The Company competes with Pfizer, GlaxoSmithKline, Merck, AstraZeneca, Baxter International, Fletcher/CSI, AVANT Immunotherapeutics, AVI BioPharma and Genta.
Advisors' Opinion: - [By MONEYMORNING]
Hemispherix Biopharma Inc. (NYSE: HEB) is a specialty pharmaceutical company. It engages in the clinical development of new drug therapies based on natural immune system enhancing technologies and targets the treatment of viral and immune-based clinical disorders. The Philadelphia, Pa.-headquartered company gained widespread attention over the last several months for its work on flu research. Its flagship products include Alferon N Injection, approved by the FDA for a category of sexually transmitted disease infection. Experimental treatments include Ampligen and Oragens, in development stages for the potential treatment of global viral diseases and disorders of the immune system including human papilloma virus, human immunodeficiency virus, chronic fatigue syndrome, hepatitis, and influenza. Shares have traded as low as $0.18 and as high as $0.55 over the last year. At last check, shares were changing hands around $0.50 on volume of 2 million shares.
10 Best Medical Stocks For 2015: MedeFile International Inc (MDFI)
Medefile International, Inc.(Medefile), incorporated on July 16, 1997, through its MedeFile, Inc. subsidiary, has developed a patient-centric, Internet-enabled Personal Health Record (iPHR) system for gathering, digitizing, maintaining, accessing and sharing an individual's actual medical records. MedeFile's products and services are designed to provide healthcare providers with the ability to reference their patient's actual past medical records.
MedeFile iPHR
MedeFile is a Business-to-Business and a Business-to-Consumer subscription service. MedeFile is designed to create a cradle to grave longitudinal record for each of its members by retrieving and consolidating copies of their medical records. When the records are received, the MedeFile system consolidates them into a single medically correct format. The records are then stored in Medefile's MedeVault, a secure repository that can be accessed by MedeFile members 24 hours a day, 7 days a week.
MedeFile's Emergency Medical Information (EMI) Card
Upon becoming a MedeFile member, each individual will receive a Membership / Emergency Medical Information (EMI) Card. It contains instructions on how to contact MedeFile in order to retrieve the member's medical records.
The Digital Health Profile (DHP)
A part of a member's MedeFile is their Digital Health Profile (DHP). This form is completed by the patient in order to provide a summary of the patient's healthcare history which assists healthcare providers in understanding the patient's course of medical treatment.
MedeDrive
The MedeDrive is an external universal serial bus (USB) drive, which stores all of a patient's Emergency Medical Information and their MedeFile which can be viewed on a personal computer. MedeDrive self loads its own viewer, so no special program or software is required.
MedeVault
The MedeVault is designed to serve as an electronic data and document repo! sitory that incorporates state-of-the-art security features in order to prevent unauthorized access to a patient's records. Access to the MedeVault is provided through an encrypted connection to a Web service run by MedeFile. This connection is provided by Secure Sockets Layer (SSL) technology.
MedeMinder
MedeMinder is MedeFile's reminder service. The member tells the Company when and where to call, and the Company automatically contacts the member day or night with an appropriate reminder, spoken by real people.
MedePro
During the year ended December 31, 2011, the Company introduced MedePro. MedePro is a medical record retrieval and document management solution created specifically by MedeFile for legal and insurance professionals.
SecurMed
SecurMed is designed to serve as an authentication process. SecurMed protects against any information being viewed by unauthorized persons.
The Company competes with GE Healthcare, Bio-Imaging Technologies, and Cyber Records.
Advisors' Opinion: - [By Peter Graham]
Small cap healthcare and lifestyle stocks Axxess Pharma Inc (OTCMKTS: AXXE), Medefile International Inc (OTCMKTS: MDFI) and Intelligent Living Inc (OTCMKTS: ILIV) have all been getting some extra attention lately thanks in part to a few disclosed paid promotions or investor relations type of activities. But just how healthy are these small cap stocks for investors and traders alike? Here is a quick reality check:
10 Best Medical Stocks For 2015: OncoMed Pharmaceuticals Inc (OMED)
OncoMed Pharmaceuticals, Inc. (OncoMed) incorporated on July 19, 2004, is a clinical development-stage biopharmaceutical company. The Company focuses on discovering and developing monoclonal antibody therapeutics targeting cancer stem cells (CSCs). It utilizes its technologies to identify, isolate and evaluate CSCs; identify and/or validate multiple potential targets and pathways critical to CSC self-renewal and differentiation; and develop targeted antibody and other protein-based therapeutics that are designed to modulate these CSC targets and inhibit the growth of CSCs. The Company's anti-cancer therapeutics include anti-DLL4 (demcizumab, OMP-21M18), Anti-DLL4/Anti-VEGF Bispecific, and Anti-Notch2/3 (OMP-59R5), Anti-Notch1 (OMP-52M51, Anti-Fzd7, Fzd8-Fc, RSPO-LGR.
Anti-DLL4 (demcizumab, OMP-21M18) is a humanized monoclonal antibody that inhibits Delta Like Ligand 4 (DLL4) in the Notch signaling pathway. The Company has completed a single-agent Phase Ia trial in advanced solid tumor patients. The Company focuses on conducting two Phase Ib combination trials of demcizumab. Anti-DLL4/anti-VEGF bispecific is a monoclonal antibody that targets and inhibits both DLL4 and vascular endothelial growth factor ( VEGF). VEGF is the target of Avastin. Anti-Notch2/3 (OMP-59R5) is a human monoclonal antibody that targets the Notch2 and Notch3 receptors.
Anti-Notch1 OMP-52M51 is a humanized monoclonal antibody targeted to the Notch1 receptor. Anti-Fzd7 OMP-18R5 is a human monoclonal antibody identified by screening against the Frizzled7 receptor (Fzd7) that binds a conserved epitope on five Frizzled receptors and inhibits Wnt signaling. OMP-18R5 is in a Phase I single-agent trial in advanced solid tumor patients. Fzd8-Fc OMP-54F28 is a fusion protein based on a truncated form of the Frizzled8 receptor ( Fzd8). RSPO-LGR ligands signal through the LGR receptor family.
The Company utilizes several robust technologies for the discovery and optimization of its antibody and protein-bas! ed therapeutics, including multiple proprietary technologies. Its antibody technologies include Mammalian Display Technology, Bispecific Antibody Technology, Hybridoma Technology. Mammalian Display Technology utilizes flow cytometry to isolate mammalian cells expressing antibodies on the cell surface with desired characteristics from large libraries of candidate antibodies. Bispecific Antibody Technology is used to generate its anti-DLL4/anti-VEGF antibody. Hybridoma Technology is used for isolating antibodies from mice, including multiplex single-cell screening techniques.
Advisors' Opinion: - [By Jake L'Ecuyer]
Equities Trading UP
OncoMed Pharmaceuticals (NASDAQ: OMED) shot up 8.62 percent to $30.09 after the company initiated Phase 1B trial of WNT-parthway-target antibody. Jefferies lifted the price target on the stock from $27 to $46.
- [By Lauren Pollock]
Among the companies with shares expected to actively trade in Tuesday’s session are OncoMed Pharmaceuticals Inc.(OMED), Lexicon Pharmaceuticals Inc.(LXRX) and Krispy Kreme Doughnuts Inc.(KKD)
- [By Stephen Quickel]
Recently, too, Celgene has formed a strategic partnership with OncoMed (OMED) to develop up to six anti-cancer stem-cell antibodies.
Celgene itself has posted four successive quarters of revenue growth, which is expected to lift annual sales from $5.5 to $6.4 billion for calendar 2013, and to $7.5 billion in 2014. Despite its expanding size, earnings per share are projected to grow by 23.2% a year, by 28 Street analysts following its stock.
10 Best Medical Stocks For 2015: Tonix Pharmaceuticals Holding Corp (TNXP)
Tonix Pharmaceuticals Holding Corp., incorporated on November 16, 2011, is a specialty pharmaceutical company focused on developing novel pharmaceutical products for disorders of the central nervous system (CNS). The Company develops TNX-102 sublingual tablet, or TNX-102 SL. TNX-102 SL is a novel dose and formulation of cyclobenzaprine (CBP), the active pharmaceutical ingredient of two prescribed muscle relaxant products, Flexeril and Amrix. TNX-102 SL is also intended for chronic use. It develops TNX-102 SL for the treatment of FM under a United States Investigational New Drug application (IND), and under three clinical trial applications (CTAs), filed in Canada. It also develops TNX-102 SL for the treatment of post-traumatic stress disorder (PTSD). As of January 25, 2013, the Company focuses on product development, and had not generated any revenues.
The Company searches for potential therapeutic solutions among known pharmaceutical agents that lack regulatory approval for the indications it seeks, but may be approved for use in other indications. It seeks to create new dose and formulation options that are tailored to the therapeutic uses to which it applies these agents. TNX-102 SL is a small, rapidly disintegrating tablet containing CBP for sublingual administration at bedtime. The Company designed TNX-102 SL for delivery of CBP to the systemic circulation through sublingual transmucosal absorption and to avoid first-pass liver metabolism.
CBP is the active pharmaceutical ingredient in its lead product candidate, TNX-102 SL. In addition to CBP, TNX-102 SL contains inactive ingredients, called excipients, which are approved for pharmaceutical use. In addition to TNX-102 SL, it develops other formulations of CBP, including TNX-102 promicellar gelatin capsule, or TNX-102 gelcap. It developed TNX-102 gelcap under an agreement with Lipocine, Inc. (Lipocine), a contract formulation developer and small-scale manufacturer. In addition it has other pipeline of other product cand! idates, including TNX-201 and TNX-301. TNX-201 is based on isometheptene mucate and is under development as a treatment for certain types of headaches.
Advisors' Opinion: - [By John Udovich]
It�� a new year and the first one and a half trading weeks of 2014 has not disappointed biotech investors as the sector and mid cap or small cap biotech or�pharma stocks like Intercept Pharmaceuticals Inc (NASDAQ: ICPT), Epizyme Inc (NASDAQ: EPZM), Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) and TNI BioTech Inc (OTCQB: TNIB) either surging or producing some news plus there have been IPO filings for future listings for�Flexion Therapeutics (NASDAQ: FLXN), Aldexa Therapeutics (NASDAQ: ALDX), Retrophin (NASDAQ:�RTRX) and Dicerna Pharmaceuticals (NASDAQ: DRNA). Consider the following news so far this year:
- [By John Kell]
Tonix Pharmaceuticals Holding Corp.(TNXP) is planning to offer some shares to raise money to fund clinical trials and the continued development of the specialty pharmaceutical company’s treatments. Shares edged up 2.1% to $16.75 premarket.
10 Best Medical Stocks For 2015: Galena Biopharma Inc (GALE)
Galena Biopharma, Inc. (Galena), formerly RXi Pharmaceuticals Corporation, incorporated on April 3, 2006, is a biotechnology company focused on discovering, developing and commercializing therapies addressing unmet medical needs using targeted biotherapeutics. The Company is pursuing the development of cancer therapeutics using peptide-based immunotherapy products, including its main product candidate, NeuVaxTM (E75), for the treatment of breast cancer and other tumors. NeuVax is a peptide-based immunotherapy intended to reduce the recurrence of breast cancer in low-to-intermediate HER2-positive breast cancer patients not eligible for trastuzumab (Herceptin; Genentech/Roche). On January 19, 2012, the Company initiated enrollment in its Phase 3 PRESENT clinical trial for NeuVax (E75 peptide plus GM-CSF) vaccine in low-to-intermediate HER2 1+ and 2+ breast cancer patients in the adjuvant setting to prevent recurrence (Clinicaltrials.gov identifier NCT01479244). The Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment study is a randomized, multicenter, multinational clinical trial that will enroll approximately 700 breast cancer patients. The Company�� Phase 2 trial of NeuVax achieved its primary endpoint of disease-free survival (DFS). On April 13, 2011, the Company completed its acquisition of Apthera, Inc.,(Apthera).
The Company focuses to start a Phase 2 trial comparing NeuVax in combination with trastuzumab (Herceptin) versus trastuzumab, alone, in a 300-patient, randomized study in the adjuvant breast cancer setting. The Company's second product candidate, Folate Binding Protein-E39 (FBP), is a vaccine, consisting of the peptides E39 and J65, aimed at preventing the recurrence of ovarian, endometrial, and breast cancers. On February 14, 2012, the Company announced the initiation of a Phase 1/2 clinical trial in two gynecological cancers: ovarian and endometrial adenocarcinomas. Folate binding protein has ! very limited tissue distribution and expression in non-malignant tissue and is over-expressed in more than 90% of ovarian and endometrial cancers, as well as in 20% to 50% of breast, lung, colorectal and renal cell carcinomas.
In April 2011, the Company acquired Apthera Inc and its NeuVax product candidate. The Company focuses on developing a pipeline of immunotherapy product candidates for the treatment of various cancers based on the E75 peptide, the advanced of which is NeuVax, which is targeted at preventing the recurrence of breast cancer. NeuVax has had positive Phase 1/2 clinical trial results for the prevention of breast cancer recurrence in patients who have had breast cancer and received the standard of care treatment (surgery, chemotherapy, radiotherapy and hormonal therapy as indicated). The Company had also initiated its Phase 3 PRESENT clinical trial of NeuVax for the prevention of breast cancer recurrence in early-stage low-to-intermediate HER2 breast cancer patients. NeuVax directs killer T-cells to target and destroy cancer cells that express HER2/neu, a protein associated with epithelial tumors in breast, ovarian, pancreatic, colon, bladder and prostate cancers. NeuVax is comprised of a HER2/neu-derived peptide called E75. E75 is a nine-amino acid sequence that is immunogenic (produces an immune response) and GM-CSF is a commercially available protein that acts to stimulate and activate components of the immune system such as macrophages and dendritic cells.
The Company also develops novel applications for NeuVax based on preclinical studies and phases 2 clinical trials which suggest that combining NeuVax and trastuzumab (Herceptin; Genentech/Roche) can increase antigen presentation by tumor cells by promoting receptor internalization and subsequent proteosomal degradation of the HER2 protein. The Company also is pursuing additional therapeutic indications for NeuVax that are in Phase 1/2 clinical trials. RXI-109, is a dermal anti-scarring therapy that targets! connecti! ve tissue growth factor (CTGF) and that may inhibit connective tissue formation in human fibrotic disease.
The Company competes with Roche Laboratories, Inc., Pfizer Inc., Bayer HealthCare AG, Sanofi-Aventis, US, LLC, Amgen, Inc., GlaxoSmithKline plc, Renovo Group plc, CoDa Therapeutics, Inc., Sirnaomics, Inc., FirstString Research, Inc., Merz Pharmaceuticals, LLC, Capstone Therapeutics, Halscion, Inc., Garnet Bio Therapeutics, Inc., AkPharma Inc., Promedior, Inc., Kissei Pharmaceutical Co., Ltd., Eyegene, Derma Sciences, Inc., Healthpoint Biotherapeutics, Pharmaxon, Excaliard Pharmaceuticals, Inc., Alnylam Pharmaceuticals, Inc., Marina Biotech, Inc., Tacere Therapeutics, Inc., Benitec Limited, OPKO Health, Inc., Silence Therapeutics plc, Quark Pharmaceuticals, Inc., Rosetta Genomics Ltd., Lorus Therapeutics, Inc., Tekmira Pharmaceuticals Corporation, Arrowhead Research Corporation, Regulus Therapeutics Inc. and Santaris.
Advisors' Opinion: - [By Paul Ausick]
Stocks on the move: Galena Biopharma Inc. (NASDAQ: GALE) is down 15.4% at $1.93 after pricing a secondary offering of 17.5 million units at $2.00. Safeway Inc. (NYSE: SWY) is up 6.1% at $28.21, after an analyst�� upgrade which sent shares to a new 52-week high of $28.88 earlier. Avanir Pharmaceuticals Inc. (NASDAQ: AVNR) is down 18.2% at $4.08.
