We’re smack-dab in the middle of earnings season — a time of year when you can be sure to see a lot of sudden movements in the market. Although the S&P 500 Index (SNPINDEX: ^GSPC ) added 7 points — or 0.5% — today, three of the 500 components distinguished themselves because of their poor performance on Monday, not their bullish movements.
The first of today’s laggards, Alexion Pharmaceuticals (NASDAQ: ALXN ) , lost 2.3% just a few days before it’s set to report quarterly earnings on Thursday. The $18 billion Alexion is primarily driven by the success of its Soliris drug, which treats a rare disease known as paroxysmal nocturnal hemoglobinuria. Behind the success of Soliris, Alexion revenues rose 45% in 2012. However, the company’s business model is so one-dimensional that my colleague Sean Williams worries it will have to exceed estimates by at least 10% to maintain current price levels.
One of the most successful innovators in the field of medical technology in recent years, Intuitive Surgical (NASDAQ: ISRG ) , saw shares drop 2% Monday. Investors continued to sell off shares in the company after last week’s earnings report, which depicted unimpressive growth in surgeries performed by Intuitive Surgical’s moneymaker, the da Vinci robot. Trading at about 28 times earnings, the 23% sales growth and 31% net income growth didn’t quite meet expectations.
Top 10 Medical Companies To Buy Right Now: Vocera Communications Inc (VCRA)
Vocera Communications, Inc. (Vocera), incorporated on February 16, 2000, is a provider of mobile communication solutions. The Companys solutions consist of its Voice Communication, Messaging and Care Transition solutions. Its Voice Communication solution, which includes a communication badge and a software platform, enables users to connect with other hospital staff. The Companys Messaging solution delivers text messages and alerts directly to and from smartphones. Its Care Transition solution is a voice and text-based software application that captures, manages and monitors patient information when responsibility for the patient is transferred or handed-off from one caregiver to another, or when the patient is discharged from the hospital. Users can communicate with others using the Vocera communication badge or through Vocera Connect client applications available for BlackBerry, iPhone and Android smartphones, as well as Cisco wireless Internet protocol (IP) phones and other mobile devices. In January 2014, Vocera Communications Inc announced the acquisition of mVisum.
Communication solution can also be integrated with nurse call and other clinical systems to alert hospital workers to patient needs. The Companys solutions are deployed in over 800 hospitals and healthcare facilities, including hospital systems, hospitals, and clinics, surgery centers and aged-care facilities. During the year ended December 31, 2011, the Company had shipped over 400,000 communication badges to its customers. The Company outsources the manufacturing of its products. Vocera offers a range of services, including clinical workflow design, wireless assessment, solution configuration, training and project management. It also provides a classroom-based curriculum for systems administrators, information technology professionals and clinical educators. The Company provides around-the-clock technical support to its customers through its support c enters in San Jose, California, and Reading, United Kingdom.!
Voice Communication solution
The Companys Voice Communication solution consists of a software platform that connects communication devices, including its hands-free, wearable, voice-controlled communication badges, Vocera-branded smartphones and third-party mobile devices that use its software applications to become part of the Vocera system. The system transforms the way mobile workers communicate by enabling them to connect with the right person simply by the name, function or group name of the person they want to reach, often while remaining at the point-of-care. Its system responds to over 100 voice commands.
Voceras Voice Communication solution is a software platform that runs on its customers Windows-based servers. In addition, it controls the calling and messaging functions of the mobile client devices and maintains profiles for users and groups that enable customization of workflow patterns for each customer. The Compa nys communication badge is a wearable device that operates over customers wireless fidelity (Wi-Fi) networks. The badge is worn clipped to a shirt or on a lanyard. It can be used to conduct hands-free communication. It enables two-way voice conversations without the need to remember a phone number or use a handset. Its badge also incorporates automatic diagnostic mechanisms that feed data on wireless network performance back to the software platform for reporting and diagnosis of problems. In October 2011, it introduced the Vocera B3000 badge. In 2012, the Company added Cisco wireless IP phones to the list of mobile devices it supports.
The Companys Messaging solution delivers text messages, alerts and other information, directly to and from smartphones. Its solution consists of a software platform and client applications that run on BlackBerry, iPhone or Android devices. Its Messaging solution includes a range of client applications, including Alert, Chat and Commander.
Care! Transition Solution
The Companys platform, which includes modules for patient transfers, shift changes, physician sign-outs and patient and family information exchanges, allows hospitals to standardize and monitor patient hand-offs. Its Care Transition solution can be deployed through either a hosted software-as-a-service model or as a server-on-site model and has been deployed by over 120 hospitals.
The Company competes with Cisco Systems, Ascom and Polycom.
- [By Victor Selva]
On Dec.24, Mario Gabelli, the Chairman and Chief Executive Officer of GAMCO Investors, Inc. added Communications Systems Inc. (JCS) at an average price of $11.05 and currently holds 330,172 shares of the stock. It was the 5th time he added the stock during this year, which makes me feel that he is betting in favor of a positive future for the consumption of network capacity.
Recommendations of the Board
Communications Systems is engaged in the manufacture and sale of modular connecting and wiring devices for voice and data communications, digital subscriber line filters, and structured wiring systems, and through its Transition Networks business unit in the manufacture of media and rate conversion products for telecommunications networks.
Few months ago the firm announceda series of actions to increase revenues and improve profitability. The first change was to operate as a holding company, monitoring and supporting all the business units: Suttle, Transition Ne tworks (TN) unit and JDL Technologies. With this new format, each unit will operate with a high degree of autonomy. This will result in the reduction of labor costs, the emphasizing of accountability in the units as well as better recognition of performance. “While difficult decisions for the Board, we believe the changes we have taken to restructure our parent company as a holding company and to focus on individual business unit performance is in the best interest of our shareholders and will increase shareholder value” said Curtis A. Sampson, the Company’s Board Chair and Interim CEO. Furthermore, strategic investments in the TN unit such as marketing, sales and product development will boost revenues in the future.
Severe Warning Signs
Not all are good news, we found three severe warning signs issued by GuruFocus: Piotroski F-Score of 2 is low, which usually implies poor business operation; revenue has been in decline over the past 3 years and operating margi n has been in 5-year
- [By Evan Niu, CFA]
What: Shares of Vocera Communications (NYSE: VCRA ) have gotten slaughtered by 38% today after the company reported earnings.
So what: Revenue in the first quarter came in at $22.4 million, which translated into a non-GAAP net loss of $0.07 per share. Both figures were significantly worse than the $24.3 million in revenue and $0.02 per share adjusted loss that the Street was expecting. CEO Bob Zollars conceded that management was disappointed with the results.
Top 10 Medical Companies To Buy Right Now: CEL-SCI Corp (CVM)
CEL-SCI Corporation (CEL-SCI), incorporated on March 22, 1983, is engaged in the business of Multikine cancer therapy; New cold fill manufacturing service to the pharmaceutical industry, and ligand epitope antigen presentation System (LEAPS) technology, with two products, hemagglutinin type 1 and neuraminidase type 1 (H1N1) swine flu treatment for H1N1 hospitalized patients and CEL-2000, a rheumatoid arthritis treatment vaccine.
CEL-SCI’s Multikine, is being developed for the treatment of cancer. It is a cancer immunotherapy drugs called Combination Immunotherapy because it combines active and passive immunity in one product. It is the only cancer immunotherapy that both kills cancer cells and activates the general immune system to destroy the cancer. Multikine target the tumor micro-metastases for treatment failure. Multikine is also applicable in many other solid tumors.
New Manufacturing Facility
CEL-SCI’s facility manufactures Multikine for CEL-SCI’s Phase III clinical trial. CEL-SCI offers the use of the facility as a service to pharmaceutical companies and others, particularly those that need to fill and finish their drugs in a cold environment. Fill and finish is the process of filling injectable drugs in a sterile manner.
CEL-SCI’s patented T-cell Modulation Process uses heteroconjugates to direct the body to choose a specific immune response. The heteroconjugate technology, referred to as LEAPS, is intended to stimulate the human immune system to fight bacterial, viral and parasitic infections, as well as autoimmune, allergies, transplantation rejection and cancer. Administered like vaccines, LEAPS combines T-cell binding ligands with small, disease associated and peptide antigens.
Using the LEAPS technology, CEL-SCI has created a peptide treatment for H1N1 (swine flu) hospitalized patients. This LEAPS flu treatment is designe d to focus on the conserved, non-changing epitopes of the di! fferent strains of Type A Influenza viruses, including swine, avian or bird, and Spanish Influenza. CEL-SCI’s LEAPS flu treatment contains epitopes.
- [By Bryan Murphy]
To say that 2014 has been a good year so far for CEL-SCI Corporation (NYSEMKT:CVM) would be an understatement. It’s been a great year for the company, and more specifically, its shareholders. CVM is up 96% year-to-date, cutting into a big chunk of the loss that was suffered in 2013. And, though a near-doubling in less than a month would normally be an invitation to a painful wave of profit-taking, in the case of CEL-SCI, the situation says this is one of those rallies that could get hotter the hotter it gets.
- [By Bryan Murphy]
Look out AbbVie Inc. (NYSE:ABBV), and Gilead Sciences, Inc. (NASDAQ:GILD), you may want to look over your shoulder as well. There’s a new immunology player coming to town, and its name is CEL-SCI Corporation (NYSEMKT:CVM). Yes, AbbVie may be the name behind blockbuster drug Humira – with nearly $10 billion in sales in 2012 – while Gilead Sciences is saving HIV patients’ lives with immunological therapies Stribild and Complera. But, small cap company CEL-SCI may be closer to launching its own immunology drug sooner than most investors realize.
- [By James E. Brumley]
When biotech-savvy investors think of immunology stocks, they tend to gravitate towards a name like Dendreon Corporation (NASDAQ:DNDN), which for all intents and purposes introduced the world’s first cancer vaccine, Provenge, as a treatment for prostate cancer. Traders with a better-than-average knowledge of the immunology field may turn their attention to a company like CEL-SCI Corporation (NYSEMKT:CVM). CEL-SCI doesn’t have a product on the market yet, but its head and neck cancer drug – which also uses immunology – is in Phase 3 testing right now, and looks very promising. There are other, and smaller, stocks within the world of immunology, however, that deserve a closer look from the market, and one of the most exciting ones further down the size scale is TNI Biotech Inc. (OTCMKTS:TNIB).
Top 10 Gold Stocks To Own Right Now: Cerus Corporation(CERS)
Cerus Corporation, a biomedical products company, engages in the development and commercialization of the INTERCEPT Blood System. The company?s INTERCEPT system is designed to inactivate blood-borne pathogens in donated blood components intended for transfusion. It markets the INTERCEPT system for platelets and plasma primarily in Europe, the Russian Federation, and the Middle East. The company is also developing INTERCEPT Blood System for red blood cells or red blood cell system, which is designed to inactivate blood-borne pathogens in donated red blood cells for transfusion. Cerus Corporation has collaboration agreements with Baxter International, Inc.; and BioOne Corporation, as well as the United States Armed Forces. The company was founded in 1991 and is based in Concord, California.
- [By Seth Jayson]
Cerus (Nasdaq: CERS ) is expected to report Q1 earnings on April 30. Here’s what Wall Street wants to see:
The 10-second takeaway
Comparing the upcoming quarter to the prior-year quarter, average analyst estimates predict Cerus’s revenues will expand 15.0% and EPS will remain in the red.
Top 10 Medical Companies To Buy Right Now: Boston Therapeutics Inc (BTHE)
Boston Therapeutics, Inc. is a development-stage company. The Companys business is the development, manufacture and commercialization of therapeutic drugs and dietary supplements with a focus on glyco-pathology, a specialized field involving understanding the importance of carbohydrates in biochemistry and progression of diseases. The Company is focusing on three products: IPOXYN, an injectable anti-hypoxia drug, which it is developing; PAZ320, which is a non-systemic, chewable drug candidate for reduction of blood glucose in diabetics in development and SUGARDOWN, a complex carbohydrate-based chewable dietary supplement, which it is marketing. The Companys non-systemic compounds for prediabetes and diabetes, SUGARDOWN and PAZ320, belong to the class of carbohydrate-hydrolyzing enzyme inhibitors.
The Company has developed SUGARDOWN, a non-systemic complex carbohydrate-based dietary supplement to moderate post-meal blood glucose us ing processes and technology. It has unrestricted access to both sufficient raw materials at commodity pricing and processing facilities to produce sufficient supply of SUGARDOWN to support product distribution across multiple sales channels as a dietary supplement. Its SUGARDOWN dietary supplement consists of a stabilized complex carbohydrate composition. The Company has completed development of SUGARDOWN as a dietary supplement. On January 24, 2012 the Company announced the clinical trial results in healthy volunteers performed at the University of Sydney on SUGARDOWN.
PAZ320 is a non-systemic, non-toxic, chewable drug candidate for prevention of diabetes and its complications. PAZ320 inhibits the enzymes, which release glucose from complex carbohydrate in foods during digestion, reducing the amount of available glucose absorbed through the intestine. PAZ320 is in development as a drug candidate. The Companys non-systemic compounds for p rediabetes and diabetes, SUGARDOWN and PAZ320, belong to the! class of carbohydrate-hydrolyzing enzyme inhibitors.
The Company has developed a drug candidate product IPOXYN, a glyco-protein based therapeutic agent. Its IPOXYN anti-hypoxia drug consists of a stabilized glycoprotein composition containing oxygen-rechargeable iron, targeting both human and animal tissues and organ systems deprived of oxygen and in need of metabolic support. In addition to potential uses for human patients, it also focuses to file a registration for IPOXYN for veterinary applications under the name OXYFEX. The Companys pharmaceutical agents are intended for intravenous administration into the circulatory system to target acute and late stage diseases.
- [By CRWE]
Today, BTHE remains (0.00%) +0.000 at $1.10 thus far (ref. google finance Delayed: 12:25PM EDT October 10, 2013).
Boston Therapeutics has previously closed the final tranche of approximately $1.8 million to bring total gross proceeds of approximately $5.3 million from the private placement of Common Stock and warrants to existing and new accredited investors (the “Offering”).
Proceeds of the offering will be used to fund additional clinical trials for PAZ320, a non-systemic chewable drug designed to reduce the elevation of postprandial glucose or post-meal blood sugar for treatment of patients with Type 2 diabetes, and for general corporate purposes. PAZ320 is the first compound in a new class of therapies for this disease.
Top 10 Medical Companies To Buy Right Now: Haemonetics Corp (HAE)
Haemonetics Corporation, incorporated on August 29, 1985, is a healthcare company engaged in providing blood management solutions to its customers. The Companys 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.
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 Companys 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.
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 spec ific 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 co mponent 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 o f 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.
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 Companys TEG Thrombelastograph Hemostasis Analyz er 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 s urgery, 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 Companys IMPACT Online Web-based software platform, which monitors and measures improvements in a hospitals 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.
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 manufac turing 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 Companys 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 Companys 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.
- [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 va lue at 12x our $3.50 estimate of earnings power.
- [By Monica Gerson]
Analysts at Benchmark downgraded Haemonetics (NYSE: HAE) from buy to hold. The target price for Haemonetics has been lowered from $49 to $46.
- [By Seth Jayson]
Calling all cash flows
When you are trying to buy the market’s best stocks, it’s worth checking up on your companies’ free cash flow once a quarter or so, to see whether it bears any relationship to the net income in the headlines. That’s what we do with this series. Today, we’re checking in on Haemonetics (NYSE: HAE ) , whose recent revenue and earnings are plotted below.
Top 10 Medical Companies To Buy Right Now: Horizon Pharma Inc (HZNP)
Horizon Pharma, Inc. (Horizon), incorporated on March 23, 2010, is a biopharmaceutical company that develops and commercializes medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases. On April 23, 2011, the United States Food and Drug Administration, approved DUEXIS (formerly HZT-501), a tablet formulation containing a fixed-dose combination of ibuprofen and famotidine in a single pill. The Companys other product, LODOTRA (NP-01), is a programmed release formulation of low-dose prednisone that is marketed in Europe by the Companys distribution partner, Mundipharma International Corporation Limited (Mundipharma). As of December 31, 2010, Horizon completed multiple Phase III clinical trials of LODOTRA. In addition to these product candidates, the Company has a pipeline of earlier-stage product candidates to treat pain-related diseases and chronic inflammation. On April 1, 2010, Horizon effected a recapitalization and acquisition pursua nt to which Horizon Pharma, Inc. became a holding company, that operates through its wholly owned subsidiaries, Horizon Pharma USA, Inc. (formerly Horizon Therapeutics, Inc.) and Horizon Pharma AG (formerly Nitec Pharma AG (Nitec)).
DUEXIS is a combination of 800 milligram ibuprofen and 26.6 milligram famotidine in a single pill and is indicated for the relief of signs and symptoms of rheumatoid arthritis (RA), and osteoarthritis (OA), and to decrease the risk of developing upper gastrointestinal (GI), ulcers in patients who are taking ibuprofen for those indications. The Company has completed two Phase III clinical trials in a total of over 1,500 patients with mild to moderate pain or arthritis that demonstrated a significant reduction in the incidence of non-steroidal anti-inflammatory drugs (NSAID)-induced upper GI ulcers when treated with DUEXIS versus ibuprofen alone.
LODOTRA is a programmed release for mulation of low-dose prednisone, a well-established drug use! d to inhibit the production of various pro-inflammatory cytokines, which are proteins associated with joint inflammation in RA. LODOTRA has received regulatory approval in Europe for the treatment of moderate to severe, active RA in adults when accompanied by morning stiffness. As of December 31, 2010, the Company had completed two pivotal Phase III clinical trials of LODOTRA in a total of over 600 patients with RA. The first pivotal Phase III trial supported the approval of LODOTRA in Europe in March 2009, where it is approved for marketing in 14 European countries. LODOTRA achieved significant results and met the primary endpoint in each of the two pivotal Phase III clinical trials. Its LODOTRA product was developed and is owned by Horizon Pharma AG. As of December 31, 2010, the Company markets LODOTRA in Europe through three separate agreements. Pursuant to two separate agreements, it granted Merck Serono GmbH and Merck GesmbH, an affiliate of Merck Serono, the rights to distribute and market LODOTRA in each of Germany and Austria, respectively, and pursuant to the third agreement, it granted Mundipharma rights to distribute and market LODOTRA in the rest of Europe. The Company also has a manufacturing and supply agreement with Jagotec AG under which Jagotec or its affiliates manufacture and supply LODOTRA to the Company as bulk tablets.
The Company competes with Pfizer Inc., Pozen Inc., Abbott Laboratories and Amgen Inc.
- [By Lisa Levin]
Horizon Pharma (NASDAQ: HZNP) shares reached a new 52-week high of $17.12 after the company announced its plans to acquire privately held Vidara Therapeutics International for around $660 million.
- [By Bryan Murphy]
After a 16% rally on Tuesday, it would be understandable is a newcomer wanted to steer clear of Horizon Pharma Inc. (NASDAQ:HZNP). After all, how much more upside can there be for this fairly typical small cap biotech stock. Yet, HZNP may well be one of the rare exceptions to the “tough to follow-through” tendency.
For those not familiar, HZNP is a biopharma name with a couple of rheumatoid arthritis, COPD, and asthma drugs on the market… Duexis, and Rayos. There’s a third drug in the pipeline – Lodotra, for polymyalgia rheumatica, though it’s already approved as a treatment for RA. Either way, Horizon Pharma Inc. is unique in the sense that though it’s a small biopharma company, it’s at least driving revenue with a handful of marketable products.
The pipeline and portfolio are secondary at this point, however. What matters most to traders now is whether or not there’s actually any upside left to tap into with Horizon Pharma. The answer is, it depends.
Given just the nearby daily chart, no, it looks like HZNP has burned up all of its fuel. Aside from the fact that it’s overextended now, Tuesday’s volume spike also implies anybody who was thinking about buying went ahead and took the plunge. That may well mean nobody is left to keep buying tomorrow. There may well be, however, plenty of nervous-Nellie profit-takers ready to head for the exit.
The assessment changes quite a bit when you zoom out to a longer-term chart of Horizon Pharma, though.
While this won’t allow the stock to sidestep a near-term pullback, Tuesday’s pop was something a game-changer for the long-term chart. The move shook the stock out of a narrow range that had trapped the stock between $2.80 and $2.12 for the last ten months.
The proverbial “so what” is, with nearly a years’ worth of pent-up energy finally being unleashed, we’re nowhere near the end of the final resting place. Once we burn off this initial, knee-jerk reaction to the
- [By Lisa Levin]
Horizon Pharma (NASDAQ: HZNP) shares gained 24.15% to $18.23 after the company announced its plans to acquire privately held Vidara Therapeutics International for around $660 million.
- [By Jake L’Ecuyer]
Leading and Lagging Sectors
Wednesday morning, the healthcare sector proved to be a source of strength for the market. Leading the sector was strength from Horizon Pharma (NASDAQ: HZNP) and Pernix Therapeutics Holdings (NASDAQ: PTX). In trading on Wednesday, telecommunications services shares were relative laggards, down on the day by about 0.39 percent. Top decliners in the sector included Shenandoah Telecommunications Co (NASDAQ: SHEN), off 3.3 percent, and CalAmp (NASDAQ: CAMP), down around 2.4 percent.
Top 10 Medical Companies To Buy Right Now: IsoRay Inc (ISR)
IsoRay, Inc. (IsoRay), incorporated on June 15, 2004, develops, manufactures and sells isotope-based medical products and devices for the treatment of cancer and other malignant diseases. IsoRay International LLC (International) is a wholly owned subsidiary of the Company. IsoRay obtained clearance from the Food and Drug Association (FDA) for treatment for all solid tumor applications using Cesium-131. Such applications include prostate cancer; ocular melanoma; head, neck and lung tumors; breast cancer; liver cancer; brain cancer; colorectal cancer; gynecological cancer; esophageal cancer, and pancreatic cancer. The seed may be used in surface, interstitial and intracavity applications for tumors with known radio sensitivity. The Company has an existing distribution agreement with UralDial LLC (UralDial) that allows UralDial to distribute Proxcelan Cs-131 brachytherapy seeds in Russia. The Company, through UralDial, has regulatory approval to sell Cs-131 seeds in Russia. < /p>
IsoRay markets the Proxcelan Cesium-131 brachytherapy seed for the treatment of prostate cancer; lung cancer; ocular melanoma; head and neck cancers; colorectal cancer, brain cancer; and gynecological cancer. The Company focuses to market Cesium-131 for the treatment of other malignant disease, such as breast cancer, in the near future through the use of existing technologies that have received FDA-clearance. Cesium-131 is a radioactive isotope that can be produced by the neutron bombardment of Barium-130 (Ba-130). When placed into a nuclear reactor and exposed to a flux of neutrons, Ba-130 becomes Ba-131, the radioactive material that is the parent isotope of Cesium-131. The radioactive isotope Cesium-131 is normally produced by placing a quantity of stable non-radioactive barium (ideally barium enriched in isotope Ba-130) into the neutron flux of a nuclear reactor. The irradiation process converts a small fraction of this material into a radioactive form of ba rium (Ba-131). The Ba-131 decays by electron capture to the ! radioactive isotope of interest (Cesium-131).
As of June 30, 2011, IsoRay had agreements with several independent radiopharmacies to assay, preload, and sterilize loose seeds. During the fiscal year ended June 30, 2011, the Company loaded approximately 90% of Mick cartridges in the Company’s own facility, which accounted for approximately 61% of seeds sold. Approximately 33% of seeds sold are strand configurations, including strands preloaded in needles and the remaining 6% of seeds are sold as loose seeds.
- [By Vanina Egea]
Strengthening portfolio and business stability is to be reinforced by the introduction of new products. Last December, Textron announced the successful first flight of the Scorpion Intelligence, Surveillance and Reconnaissance (ISR)/Strike aircraft. The Scorpion compares very favorably to more costly aircraft currently used for low-threat missions, pilot Dan Hinson said. The new product is expected to accommodate the budget constraints and shifting mission requirements of the US Department of Defense. The same department has granted the firm an additional contract worth $22.5 million to “deprocess” Mobile Strike Force vehicles and train the Afghan Army.
- [By James E. Brumley]
Ugh. It’s fun to be right about a stock, but it’s exhausting to be too right, too fast. Case in Point? IsoRay, Inc. (NYSE: ISR). Yours truly posted some bullish comments on ISR just a couple of days ago, explaining how that day’s move above a key ceiling meant a new bull trend was underway, and more gains from that price would be far easier to muster. Well, good news for those who heeded the advice – IsoRay shares are up 44% today.
- [By James E. Brumley]
I hate to be the one to say I told you so, but, I told you so. Back on February 26th I suggested IsoRay, Inc. (NYSEMKT:ISR) shares were a budding breakout play. The 48% rally that’s played out for ISR in the meantime unfurled right on cue. While overbought in the very short run, this small cap stock looks like it’s earning the right to be compared to the likes of bigger brothers in the cancer-treatment space… names like Roche Holding Ltd. (OTCMKTS:RHHBY) or Theragenics Corporation (NYSE:TGX).
Top 10 Medical Companies To Buy Right Now: 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 Companys 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 Companys drug candidate, Archexin is an anticancer Akt inhibitor.
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 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 pe riod for major depressive disorder (MDD) patients. As of Dec! ember 31, 2011, the Company had not made a determination of Serdaxins future paths or resource allocations to further develop Serdaxin to treat MDD.
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 Companys 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.
- [By James E. Brumley]
With just a quick glance at a chart of Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN), it would be easy to conclude it’s nothing but a volatile mess. When you take a step back and look at a long-term weekly chart of RNN, however, it starts to become clear that this small cap biopharma name is on the verge of a monster-sized breakout. First things first, however.
- [By Roberto Pedone]
One under-$10 biopharmaceutical player that’s just starting to move into breakout territory is Rexahn Pharmaceuticals (RNN), which is engaged in the development of novel treatments for cancer to patients. This stock has been on fire so far in 2013, with shares up sharply by 62%.
If you take a look at the chart for Rexahn Pharmaceuticals, you’ll notice that this stock has been uptrending strong for the last month, with shares moving higher from its low of 36 cents per share to its intraday high of 53 cents per share. During that uptrend, shares of RNN have been making mostly higher lows and higher highs, which is bullish technical price action. That move has now pushed shares of RNN into breakout territory above some near-term overhead resistance levels at 49 cents to 50 cents per share. It’s worth noting that volume today is tracking in extremely strong with over 3 million shares traded, versus its three-month average action of 1.22 million shares.
Traders should now look for long-biased trades in RNN if it manages to break out above Thursday’s intraday high of 53 cents per share with high volume. Look for a sustained move or close above that level with volume that hits near or above its three-month average action of 1.22 million shares. If that breakout hits soon, then RNN will set up to re-test or possibly take out its next major overhead resistance levels at 64 cents to its 52-week high at 66 cents per share. Any high-volume move above 66 cents to 67 cents per share could then send RNN towards its next major overhead resistance levels at 81 cents per share.
Traders can look to buy RNN off any weakness to anticipate that breakout and simply use a stop that sits right below its 50-day moving average at 47 cents per share. One can also buy RNN off strength once it clears 53 cents per share with volume and then simply use a stop that sits a comfortable percentage from your entry point.
Top 10 Medical Companies To Buy Right Now: Pharmacyclics Inc (PCYC)
Pharmacyclics, Inc., incorporated on April 19, 1991, is a clinical-stage biopharmaceutical company focused on developing and commercializing small-molecule drugs for the treatment of cancer and immune mediated diseases. The Company’s clinical development and product candidates are small-molecule enzyme inhibitors designed to target biochemical pathways involved in human diseases. As of June 30, 2011, it had three drug candidates under clinical development and a number of preclinical lead molecules. This includes an inhibitor of Brutons tyrosine kinase (Btk) (PCI-32765) in Phase II studies in hematologic malignancies; a Btk inhibitor lead optimization program targeting autoimmune indications, an inhibitor of Factor VIIa (PCI-27483) in a Phase II clinical trial in pancreatic cancer, and a histone deacetylase (HDAC) inhibitor (PCI-24781) in Phase I and II clinical trials in solid tumors and hematological malignancies as of June 30, 2012.
As of June 30, 2012, t he Company developed ibrutinib, which has demonstrated clinical activity and tolerability in Phase I and Phase II clinical trials in a variety of B-cell malignancies, including chronic lymphocytic leukemia (CLL) and a number of non-Hodgkins lymphoma (NHL) subtypes. CLL, mantle cell lymphoma (MCL), follicular lymphoma (FL), diffuse B-cell lymphoma (DLBCL) and multiple myeloma (MM) are specific indications of its current or planned Phase Ib/II and Phase III development program. had development programs for B-cell malignancies and autoimmune diseases. For malignant indications it has developed PCI-32765, which has demonstrated clinical activity and tolerability in Phase I and Phase II clinical trials in a range of B-cell malignancies, including chronic lymphocytic leukemia (CLL) and a number of non-Hodgkins lymphoma (NHL) subtypes. CLL, mantle cell lymphoma (MCL), follicular lymphoma (FL), diffuse large B cell lymphoma (DLBCL) and multiple myeloma (MM) are specific indica tions of its Phase II development. It has developed an assay! to measure occupancy of Btk in PBMCs using a cell-permeable fluorescently-labeled derivative of PCI-32765.
Factor VII is an enzyme that becomes activated (FVIIa) by binding to the cell surface protein tissue factor (TF), a protein found in the body that helps to trigger the process of blood clotting in response to injury. TF is over expressed in many cancers including gastric, breast, colon, lung, prostate, ovarian and pancreatic cancers. In these tumors, the FVIIa/TF complex induces intracellular signaling pathways by activating protease activated receptor 2 (PAR-2), another cell-surface protein. This in turn increases the expression of interleukin-8 (IL-8), a protein produced by white blood cells and other immune cells in response to pathogenic stimulation, and vascular endothelial growth factor (VEGF), a signal protein produced by cells that stimulate the growth of blood vessels. Both proteins play an important role in tumor growth and metastases as well as angiogenesis (growth of new blood vessels). FVIIa/TF complex also initiates the coagulation (a process by which blood forms clots) processes implicated in the high incidence of thromboembolic (the process by which the blood clots within a blood vessel) complications seen in patients with TF-expressing cancers. Thromboembolic events are a cause of death in patients with cancer and anticoagulant treatment has been shown to improve survival in a variety of cancers (Klerk et al. JCO. 2005).
PCI-27483 Factor VIIa Inhibitor
The Companys Factor VIIa inhibitor PCI-27483 is a first-in-human small molecule inhibitor that selectively targets FVIIa. As an inhibitor of FVIIa, PCI-27483 has two potential mechanisms of action: inhibition of intracellular signaling involved in tumor growth and metastases and inhibition of early coagulation processes associated with thromboembolism.
Factor VIIa PCI-27483 Clinical Development Update
A mu lticenter Phase I/II of PCI-27483 in patients with locally a! dvanced o! r metastatic pancreatic cancer that are either receiving or are planned to receive gemcitabine therapy has completed enrollment. The Phase II portion of the study randomized patients to receive either gemcitabine alone or gemcitabine plus PCI-27483 (1.2 mg/kg twice daily). The objectives are to assess the safety of FVIIa Inhibitor PCI-27483 at pharmacologically active dose levels, to assess potential inhibition of tumor progression and to obtain initial information of the effects on the incidence of thromboembolic events. Due to a paradigm shift away from the use of gemcitabine alone for the treatment of pancreatic cancer, enrolling patients in this randomized study has been challenging. PCYC is evaluating other alternatives for development of this agent.
A multicenter Phase I/II of PCI-27483 in patients with locally advanced or metastatic pancreatic cancer that are either receiving or are planned to receive gemcitabine therapy has completed enrollment. The Phas e II portion of the study randomized patients to receive either gemcitabine alone or gemcitabine plus PCI-27483 (1.2 mg/kg twice daily). PCI-27483 is covered by United States patents and patent applications and counterpart patents and patent applications in fourteen ex-United States territories, including Europe, Canada, Mexico, Japan, China, India, South Korea, Australia and Brazil.
- [By Sean Williams]
What’s perhaps more remarkable is the fact that Pharmacyclics (NASDAQ: PCYC ) has three of those 23 approved breakthrough therapy designations for its lead experimental drug, ibrutinib. Ibrutinib, which is also licensed to Johnson & Johnson (NYSE: JNJ ) subsidiary Janssen Pharmaceuticals, was designated as a breakthrough therapy for patients with chronic lymphocytic leukemia, mantle cell lymphoma, and Waldenstrom’s macroglobulinemia. The big potential indication here is CLL, which is the most common adulthood leukemia and occurs in 113,000 people in the U.S. By comparison, MCL diagnoses number about 5,000 each year.
Top 10 Medical Companies To Buy Right Now: Lpath Inc (LPTN)
Lpath, Inc. (Lpath), incorporated on September 18, 2002, is a biotechnology company focused on the discovery and development of bio-active lipid-targeted monoclonal antibody (mAb) therapeutics. The Company has three product candidates, iSONEP, ASONEP and Lpathomab. The Company’s program, iSONEP, is a mAb against Sphingosine-1-Phosphate (S1P). As of December 31, 2012, it was in phase-II clinical trials for wet Age-Related Macular Degeneration. The Company is also advancing ASONEP, the systemic formulation of the mAb to S1P. ASONEP has completed a phase-I clinical trial and is entering phase-II clinical trials in Renal Cell Carcinoma.
Lpath’s third product candidate, Lpathomab, is a mAb to the bioactive lipid, Lysophosphatidic Acid (LPA). The Company also applies its technology platform, ImmuneY2, to discovering mAbs to new bioactive lipid targets.
- [By Lauren Pollock]
Biotechnology company Lpath Inc.(LPTN) warned Pfizer Inc.(PFE) may divest itself of its exclusive option to co-develop the smaller firm’s leading product candidate. Lpath’s stock fell.
- [By Lauren Pollock]
Lpath Inc.(LPTN) said it is no longer actively seeking to reacquire exclusive rights to its leading product candidate from Pfizer Inc.(PFE), saying the pharmaceutical giant informed the company that its offers weren’t competitive. The biotechnology company in October had warned that Pfizer might may divest itself of its exclusive option to co-develop the smaller firm’s leading product candidate–known as iSONEP.