For Tuesday, January 29th
GSPT, CAMH, AHFD, FARE, RVLT, KERX
Our Stocks to Watch today include Terralene Fuels Corp. (OTCBB: GSPT), Cambridge Heart Inc. (OTCBB: CAMH), Active Health Foods Inc. (OTCBB: AHFD), World Moto Inc. (OTCBB: FARE), Revolution Lighting Technologies Inc. (Nasdaq: RVLT) and Keryx Biopharmaceuticals Inc. (Nasdaq: KERX).
TERRALENE FUELS CORPORATION (OTCBB: GSPT)
"Up 650.00% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/GSPT.php
Terralene Fuels Corporation provides alternative renewable fuels. It offers Terralene, an alternative fuel formulation that reduces greenhouse gases and other environmentally damaging emissions in existing gasoline combustion engines. The company offers its products for government, industry, and consumers. The company was formerly known as Golden Spirit Enterprises Ltd. and changed its name to Terralene Fuels Corporation in November 2011. Terralene Fuels Corporation was founded in 1993 and is based in Patchogue, New York.
GSPT News:
No recent news for Terralene Fuels Corporation (OTCBB: GSPT).
CAMBRIDGE HEART INCORPORATED (OTCBB: CAMH)
"Up 23.08% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/CAMH.php
Cambridge Heart is engaged in the development and commercialization of products for the non-invasive diagnosis of cardiac disease, particularly the identification of those at risk of sudden cardiac arrest. The Company's products incorporate its proprietary Microvolt T-Wave Alternans measurement technologies, coupled with its patented Spectral Analytic Method and ultra-sensitive disposable electrode sensors. Only Spectral Analytic Method MTWA tests are reimbursed by Medicare under its National Coverage Policy that covers patients with a wide variety of cardiac symptoms. Other major insurers in the USA also have coverage policies for the test. The T-Wave Alternans test is included in the Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death jointly developed by the American College of Cardiology (ACC), The American Heart Association (AHA) and the European Society of Cardiology (ESC). The Company, founded in 1990, is based in Tewksbury, Massachusetts and is traded on the OTCBB under the symbol CAMH.
CAMH News:
January 1 - Cambridge Heart Provides Update
Announces Preliminary Fourth Quarter Revenue and Restructuring
Cambridge Heart, Inc. (OTCBB: CAMH), a developer of non-invasive diagnostic tests for cardiac disease, announced today that preliminary revenue for the quarter and year ended December 31, 2012 was approximately $305,600, and $1,740,300, respectively. Cash and cash equivalents were an estimated $38,000.
As previously announced, the Company has been engaged in a process of exploring strategic alternatives, which to date has not yet resulted in a definitive transaction. In light of the Company's limited cash resources, the Board and management have restructured operations and personnel levels, with the expectation of being able to achieve cash flow breakeven on the current level of revenue, while maintaining the ability to manufacture and ship product, and provide ongoing customer support.
In order to reduce operating expenses, Messrs. Ali Haghighi-Mood, the Company's President and Chief Executive Officer, Vincenzo LiCausi, the Company's Chief Financial Officer, and Roderick de Greef, the Company's Chairman of the Board, have stepped down as employees and officers of the Company. Mr. de Greef will remain Chairman of the Board of Directors and serve as the interim President and Treasurer, and Dr. Haghighi-Mood will remain a director of the Company in order to assist the Company in pursuing its ongoing initiatives. In addition to continuing to explore strategic and financing alternatives, the Company intends to focus on its clinical strategies in an effort to increase and expand adoption and utilization of its MTWA technology.
Questions can be directed to Mr. de Greef at the contact numbers provided.
ACTIVE HEALTH FOODS INCORPORATED (OTCBB: AHFD)
"Up 44.44% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/AHFD.php
Active Health Foods, Inc., a development stage company, develops and markets energy bars under the ‘Active X’ brand name in the United States. It offers energy bars in almond chocolate delight, peanut butter chocolate joy, cashew berry dream, and coconut cocoa passion flavors. It intends to sell its products to retailers, including health food stores, gyms, grocery retail outlets, and convenience stores, as well as to distributors. Active Health Foods, Inc. was founded in 2008 and is based in Riverside, California.
AHFD News:
No recent news for Active Health Foods Inc. (OTCBB: AHFD).
WORLD MOTO INCORPORATED (OTCBB: FARE)
"Up 14.71% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/FARE.php
World Moto, Inc. is the global authority on the $500 billion dollar a year motorcycle taxi industry and creator of Yes, the world's most unique concierge service. World Moto has revolutionized the taxi industry by inventing the Moto-Meter, a landmark device that CNN, Newsweek, Wired, Moneylife, among others, are calling "the world's first motorcycle taxi meter" and "world's first portable taxi meter" and "first-ever black box for motorcycles," while the Times named it "one of the most significant innovations of this decade" and Fast Company declared it "The First Real Taxi Meter Innovation in 100 Years... a $3 billion dollar idea."
FARE News:
January 23 - Google Trading Higher by 5% Pre-Market After Earnings Beat - Top 5 Volume Stocks Focus List: A.P. Pharma Inc, World Moto Corp, Wuhan General Corp, AMR Corp, Swingplane Ventures
Futures were mixed ahead of the open on Wall Street as Google beat numbers and raised guidance going forward. The company reported earnings of $8.62 per share as increased advertising revenues were cited. Google's stock is indicating a higher open this morning by more than 5% as investors shifted their appetite away from Apple (AAPL) and into Google (GOOG).
AMR Corp (AAMRQ) closed higher in yesterday's trading for the first time in four trading sessions as we have some profit taking in the name over the last trading week. It seems AAMRQ may have found a base and was higher yesterday by 7% on a substantial $20 million traded.
World Moto Corp (FARE) was back in focus yesterday as we saw the company bounce off of recent lows during a big sell-off in the stock. There is much anticipation surrounding the release of Awesome Penny Stocks' latest release which is supposed to be due on Wednesday. In the meantime shares of FARE were higher by 91% on $1.5 million traded on Wall Street in Tuesday's session.
Wuhan General Corp (WUHN) was a new name featured on the watch list today. Shares of the company yesterday were all about price performance with the stock trading higher by an astronomical 672% on over $1.4 million traded.
Swingplane Ventures (SWVI) traded down substantially in Tuesday's session on the OTCQB market. SWVI was lower by 43% on over $2.6 million traded which is a substantial volume for that particular company.
A.P. Pharma (APPA) finished off our focus list today as the company had a good solid day trading yesterday and looking for follow-through on the street in today's session. Shares of APPA were higher by 12% again on over $1.5 million in volume.
REVOLUTION LIGHTING TECHNOLOGIES (NASDAQ: RVLT)
"Up 14.25% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/RVLT.php
Revolution Lighting Technologies, Inc. engages in the design, manufacture, marketing, and sale of light emitting diode (LED) replacement light bulbs; and LED-based signage, channel letter, and contour lighting products in the United States, Canada, and internationally. The company offers white light LED replacement lamps, and LED signage and lighting strips for use in commercial, hospitality, institutional, retail, and sign markets. It also provides LED signage and lighting strips for non-signage applications, such as vending machines, illuminated display tables, and architectural applications. The company sells its products under the Array Lighting and Lumificient brand names. Revolution Lighting Technologies, Inc. markets and distributes its products through a network of independent sales representatives and distributors, as well as through energy savings companies and national accounts. The company was formerly known as Nexxus Lighting, Inc. and changed its name to Revolution Lighting Technologies, Inc. in November 2012. Revolution Lighting Technologies, Inc. was founded in 1991 and is headquartered in Charlotte, North Carolina.
RVLT News:
January 25 - Revolution Lighting Technologies, Inc. Announces Seesmart LED Lighting Order
Revolution Lighting Technologies, Inc. (Nasdaq: RVLT), a leader in advanced LED lighting technology, announces the receipt of a $5 million order for LED lighting products with a total potential value of $10 million. The energy-efficient LED products will be manufactured by U.S.-based Seesmart, Inc., a wholly owned subsidiary of Revolution Lighting Technologies, and will be installed in retail stores, office complexes, warehouses and storage facilities. The majority of the order will be installed within the first quarter of 2013. Revolution Lighting Technologies expects to receive a second order totaling $5 million immediately thereafter.
"This initial order further validates our belief that there is an acceleration of the LED lighting market taking place in the U.S. and abroad. We continue to see a significant increase in our addressable market and believe this will continue for the remainder of 2013 and beyond," said Robert V. LaPenta, Chairman of Revolution Lighting Technologies, Inc.
KERYX BIOPHARMACEUTICALS INCORPORATED (NASDAQ: KERX)
"Up 33.72% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/KERX.php
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease and cancer. Keryx is developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is also developing KRX-0401 (perifosine), which is in Phase 3 clinical development for multiple myeloma. Keryx is headquartered in New York City.
KERX News:
January 28 - Keryx Biopharmaceuticals Announces Zerenex™ (ferric citrate) Meets Primary and All Key Secondary Endpoints in Phase 3 Long-Term Study as a Treatment for Hyperphosphatemia in End-Stage Renal Disease Patients on Dialysis
* Zerenex Significantly Increases Iron Storage Parameters and Decreases Need for Intravenous Iron and Erythropoiesis-Stimulating Agents Versus Active Control
U.S. and European New Drug Application Submissions Anticipated in Second Quarter 2013
* Conference Call to Be Held Today, Monday, January 28, 2013, at 8:00 am Eastern Time
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced successful top-line results from the long-term Phase 3 study of Zerenex™ (ferric citrate), the Company's ferric iron-based phosphate binder drug candidate, for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis. In this study, Zerenex met the study's primary endpoint, described below, demonstrating a highly statistically significant change in serum phosphorus versus placebo over the four-week Efficacy Assessment Period of the study. In addition, Zerenex met the key secondary endpoints of increasing ferritin and transferrin saturation (TSAT) and reducing the use of intravenous (IV) iron and erythropoiesis-stimulating agents (ESAs) versus the active control over the 52-week Safety Assessment Period of the study. This long-term study was the final component of the Company's Phase 3 registration program, which was conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA). In April 2011, the Company reported the positive final dataset from the short-term study component of this Phase 3 registration program. The Company expects to submit a New Drug Application (NDA) with the FDA and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for Zerenex in the second quarter of 2013.
Study Design
This Phase 3 long-term study was a multicenter, randomized, open-label, safety and efficacy clinical trial in 441 ESRD patients on hemodialysis or peritoneal dialysis. The study consisted of a 2-week washout period followed by a 52-week Safety Assessment Period in which subjects were randomized 2:1 to receive either Zerenex or an active control (Renvela® [sevelamer carbonate] and/or Phoslo® [calcium acetate]). The 52-week Safety Assessment Period was followed by a 4-week Efficacy Assessment Period. During the Efficacy Assessment Period, only those subjects randomized to treatment with Zerenex during the Safety Assessment Period were randomized in a 1:1 ratio to either continue treatment with Zerenex or switch to placebo for a 4-week treatment period. Subjects were titrated during the study to achieve serum phosphorus levels that ranged between 3.5 to 5.5 mg/dL.
The primary objectives of this study were to determine the long-term safety of KRX-0502 (ferric citrate) in subjects with ESRD undergoing either hemodialysis or peritoneal dialysis, and the efficacy of Zerenex following 52 weeks of treatment in a four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period. Zerenex was administered using a 1 gram oral caplet formulation.
Oral iron therapy was not permitted during the course of the study. IV iron therapy was not permitted if a subject's serum ferritin level was greater than 1,000 ng/mL or the transferrin saturation (TSAT) was greater than 30%. The use of ESAs was at the physician's discretion.
Primary Efficacy Endpoint
The primary efficacy endpoint of this trial was the mean change in serum phosphorus from baseline (Week 52) to end of the four-week Efficacy Assessment Period (Week 56) versus placebo in the Intent-to-Treat (ITT) group. The ITT group included 183 subjects, representing all subjects who took at least one dose of Zerenex or placebo in the Efficacy Assessment Period and provided at least one post-baseline efficacy assessment.
Zerenex met the primary efficacy endpoint with a highly statistically significant result (p<0.0001). In addition, as agreed to with the European Medicines Agency (EMA), the treatment difference between Zerenex and Renvela® (sevelamer carbonate) at Week 12 of the Safety Assessment Period in terms of change from baseline (Day 0) in serum phosphorus was analyzed. Zerenex successfully achieved the non-inferiority endpoint versus Renvela®.
Key Secondary Efficacy Endpoints Related to Iron
The objectives of the key iron-related secondary endpoints, which were all pre-specified in the statistical analysis plan, were to corroborate prior data which suggested that Zerenex may increase iron storage parameters and reduce the need for IV iron and/or ESAs. Zerenex met all the key secondary efficacy endpoints related to iron with statistically significant treatment differences versus the active control group (Renvela® [sevelamer carbonate] and/or Phoslo® [calcium acetate]).
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