Amazon Inc ( NASDAQ: AMZN ) was down more than 4 % in regular trading session on Tuesday and loose as much as 15 % in after hours trade. Traders and Investors are betting that company's profit is deteriorating as company announced 73 % less profit in Q3 and issued a guidance below analysts' expectations. Stock was hit hard and close after hour session at $198.89, more than 12 % down after market close.
More bearish bets have been made on this online e commerce company and might see more down side as sentiment might worsen about this particular stock.
Below is the news release:
The earnings decline was far worse than Wall Street had expected from the e-commerce giant. That — along with a weak profitability forecast for the fourth quarter — sparked a sell-off in after-hours trading that pinched about 12% from the company’s stock, which had already slipped more than 4% in the regular session to close at $227.15.
Colin Sebastian of Robert W. Baird said the fact that Amazon’s missed Wall Street’s earnings target is not new, but noted that revenue results also came in slightly below analysts’ forecasts — a change from previous quarters.
“The lack of upside in revenue combined with guidance that looks pretty conservative is going to pressure the stock for the time being,” Sebastian said in an interview.
For the period ended Sept. 30, Amazon AMZN -12.44% reported net income of $63 million, or 14 cents a share, compared to net income of $231 million, or 51 cents a share, for the same period the previous year.
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Revenue jumped 44% to $10.88 billion.
Analysts were expecting earnings of 24 cents a share on revenue of $10.95 billion for the quarter, according to consensus forecasts from FactSet Research.
The company reported operating income of $79 million for the quarter, a drop of 70% from last year’s third quarter and well below Wall Street’s forecast of $149.7 million. That put operating margin for the period at a relatively anemic 0.7%. Operating expenses jumped by 48% for the quarter.
Amazon added about 8,100 workers during the quarter, which Sebastian noted as a significant growth in the company’s headcount, which now numbers 51,300 workers.
“This fast pace of growth is costing Amazon a lot of money,” Sebastian said. “No one is going to really challenge Amazon, but the pace of their growth may be in question. In this environment, at this multiple, that’s not good enough.”
The company said Tuesday that it is adding a total of 17 fulfillment centers this year, up two from its previously disclosed plan. Fulfillment expenses soared by 65% in the third quarter, with a 74% gain in expenses related to technology and content.
For the fourth-quarter, Amazon projected a revenue range of $16.45 billion to $18.65 billion, compared to Wall Street’s forecast of $18.15 billion.
“We don’t view these results as thesis-changing,” Citi analyst Mark Mahaney wrote in an email, noting that Amazon s spending “seems clearly elective/discretionary/offensive against very large market opportunities.”
But he added that “we are surprised that the Q4 revenue guide isn’t more robust.”
The profitability line for the fourth quarter is expected to come in between an operating loss of $200 million and operating earnings of $250 million, implying a targeted operating margin range of 1.3% at the top end of the forecast. Analysts had been expecting an operating margin of 2.7% for the period.
Amazon is planning to launch its new Kindle Fire tablet in the middle of the fourth quarter. Analysts generally expect the device to boost sales, but its low price tag of $199 has some concerned that it may pressure margins even more during the crucial holiday period.
Scott Devitt of Morgan Stanley says he currently expects Amazon to sell about 2.8 million units of the tablet in the fourth-quarter. “Short of material disruption of the business model in the seasonally strongest quarter of the year, we believe the guidance is light provided the sales impact of the Kindle Fire,” he wrote in a report Tuesday afternoon. ( Source: MarketWatch )
WPCS International Incorporated ( NASDAQ: WPCS ) to get an offer to be acquired by Multibrand Corporation at $3.20 per share. Stock jumped more than 30% to $2.90 and might see a little further upside to close to $3.20 before the end of trading session.
Below is the News from Reuters
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| WPCS International Inc |
Parkvale Financial Corp ( NASDAQ: PVSA ) to be acquired by F.N.B. corporation at approx. $22.48 per share. Stock was trading at $20 and there isa little room for more upside in the stock.
Below is the News From Reuters
F.N.B. Corporation and Parkvale Financial Corporation jointly announced the signing of a definitive merger agreement pursuant to which F.N.B. Corporation will acquire Parkvale Financial Corporation, in an all stock transaction valued at approximately $22.48 per share, or $130 million in the aggregate. Under the terms of the merger agreement, which has been approved by the boards of directors of both companies, shareholders of Parkvale Financial Corporation will be entitled to receive 2.178 shares of F.N.B. Corporation common stock for each share of Parkvale Financial Corporation stock. The exchange ratio is fixed and is expected to be a tax-free exchange for shareholders of Parkvale Financial Corporation. .B. Corporation and Parkvale Financial Corporation expect to complete the transaction in the fourth quarter of 2011. Subject to the receipt of requisite approvals, it is expected that Parkvale Financial Corporation will redeem all of its preferred stock held by the U.S. Treasury under the Capital Purchase Program prior to closing or extinguished upon closing of the merger
PRNewswire-- NF Energy Saving Corp. (NASDAQ: NFEC) ("NF Energy" or the "Company"), a leading provider of energy management services and producer of energy efficiency products, announced today that the Company will hold its annual general meeting of stockholders ("the meeting") on Monday, June 27, 2011 in Shenyang, China.
The time and venue of NF Energy's annual meeting of shareholders are as follows:
Date:
Monday, June 27, 2011
Time:
09:00 a.m. Local Time
Venue:
Liaoning Hotel
97 Zhongshan Road,
Heping District, Shenyang,
Liaoning Province, PRC, 110001
At the annual meeting of stockholders, the following proposals have been submitted for stockholder approval and are fully described in the Proxy Statement issued on May 25, 2011. The Company's proxy and annual report are also available for download on the Company's corporate website: http://www.nfenergy.com/en/2011.asp
To elect eight directors to serve for the ensuing year and until their successors are elected.
To ratify the selection by the Audit Committee of the Board of Directors of HKCMCPA Company Limited as the Company's independent registered public accounting firm for the fiscal year ending December 31, 2011.
To conduct any other business properly brought before the meeting.
If you are interested in attending, please RSVP by contacting CCG Investor Relations via email mark.collinson@ccgir.com or phone 310-954-1343.
About NF Energy Saving Corporation
NF Energy Saving Corporation (NASDAQ: NFEC) is a China-based provider of integrated energy conservation solutions utilizing energy-saving equipment, technical services and energy management re-engineering project operations to provide energy saving services to clients. The Company's customers are mainly concentrated in the electrical generation (large-scale thermal power generation, hydroelectric power, wind power, and nuclear power), water supply, and heat supply industries. The majority of revenues are from energy efficient flow control equipment and energy efficiency projects. For more information, visit http://www.nfenergy.com
Safe Harbor Statement
The statements contained herein that are not historical facts are considered "forward-looking statements." Such forward-looking statements may be identified by, among other things, the use of forward-looking terminology such as "believes," "expects," "may," "will," "should," or "anticipates" or the negative thereof or other variations thereon or comparable terminology, or by discussions of strategy that involve risks and uncertainties. In particular, statements regarding the efficacy of investment in research and development are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the effect of political, economic, and market conditions and geopolitical events; legislative and regulatory changes that affect our business; the availability of funds and working capital; the actions and initiatives of current and potential competitors; investor sentiment; and our reputation. We do not undertake any responsibility to publicly release any revisions to these forward-looking statements to take into account events or circumstances that occur after the date of this report. Additionally, we do not undertake any responsibility to update you on the occurrence of any unanticipated events, which may cause actual results to differ from those expressed or implied by any forward-looking statements. The factors discussed herein are expressed from time to time in our filings with the Securities and Exchange Commission available at http://www.sec.gov.
Company Contact:
Investor Relations Contact:
Ms. Lihua Wang, Director & CFO
Mr. Mark Collinson, Partner
Tel: +86 24-8563 1159
Tel: +1 310-954-1343
Email: wlh@nfenergy.com
Email: mark.collinson@ccgir.com
NF Energy Saving Corp.
CCG Investor Relations
Website: www.nfenergy.com
Website: www.ccgirasia.com
RiT Technologies Ltd ( NASDAQ: RITT ), company has announced a partnership with Samsung Fiber Optics for advanced IIM ( intelligent infrastructure management ) solutions. It may be consider as a big development in the company and Partnership has already generated an initial significant deal.
Our Call: Buy positions may be initiated for trading or investment purpose as stock might see more upside in near future.
Below is the News Release:
(PRNewswire)
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| RiT Technologies Ltd |
RiT Technologies (NASDAQ: RITT), the leading provider of intelligent infrastructure management solutions, today announcedthat it has formed a strategic partnership with Samsung Fiber Optics under which Samsung Fiber Optics will market, sell and distribute RiT's PatchView™ intelligent infrastructure management (IIM) solution on an OEM basis.
As the partnership's first project, Samsung Fiber Optics has deployed a cutting-edge PatchView™ IIM system in one of Korea's largest convention and exhibition centers. This highly visible installation demonstrates the growing traction of the managed infrastructure concept throughout Korea, a market where managed infrastructure systems are becoming ubiquitous in residential, enterprise and commercial settings.
"We are extremely excited about this milestone partnership. The new relationship has already contributed its first significant deal and we believe it will make a strong impact on our sales success in the future," commented Eran Ayzik, RiT's President & CEO.
"The fact that this industry player feels the need to add IIM to its portfolio reflects a sharp rise in market demand, especially in its home market of Korea. This is an encouraging trend for RiT, which is recognized as the most experienced IIM player by far, with reliable, field-proven technologies and support capabilities."
Mr. Ayzik concluded, "We are committed to work closely with Samsung Fiber Optics to bring PatchView's proven benefits to its top-tier customers. In parallel, we will continue working to establish additional partnerships as the key for expanding our reach into additional high-potential regions."
About Samsung Fiber Optics
Samsung Fiber Optics began as a optical fiber/fiber optic cable business division of Samsung Electronics, and spun off from the parent company in 2004 as a fiber optics specialist. Today, Samsung Fiber Optics offers a broad line of fiber optic cable products, and also components for mobile phones and touch panels. As a global leader of fiber optics industry, Samsung Fiber Optics supplies its products to more than 60 countries around the world, and holds a share of approximately 30% of the broadband network market in Korea.
http://www.samsungfiberoptics.com/En/main.aspx
About RiT Technologies
RiT is a leading provider of intelligent solutions for infrastructure management, asset management, environment and security, and network utilization. RiT Enterprise solutions address datacenters, communication rooms and workspace environments, ensuring maximum utilization, reliability, decreased downtime, physical security, automated deployment, asset tracking, and troubleshooting. RiT Carrier solutions provide carriers with the full array of network mapping, testing and bandwidth qualification capabilities needed for access network installation and service provisioning. RiT's field-tested solutions are delivering value in thousands of installations for top-tier enterprises and operators throughout the world.
For more information, please visit our website: http://www.rittech.com
Safe Harbor Statement
In this press release, all statements that are not purely about historical facts, including, but not limited to, those in which we use the words "believe,""anticipate," "expect,""plan,""intend, ""estimate", "forecast", "target", "could" and similar expressions, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. For example, when we discuss a field trial which could lead to a multi-million dollar Carrier deal, we are using a forward looking statement. While these forward-looking statements represent our current judgment of what may happen in the future, actual results may differ materially from the results expressed or implied by these statements due to numerous important factors, including, but not limited to, those described under the heading "Risk Factors" in our most recent Annual Report filed with the Securities and Exchange Commission (SEC) on Form 20-F, which may be revised or supplemented in subsequent reports filed with the SEC. These factors include, but are not limited to, the following: our ability to raise additional financing, if required; the continued development of market trends in directions that benefit our sales; our ability to maintain and grow our revenues; our dependence upon independent distributors, representatives and strategic partners; our ability to develop new products and enhance our existing products; the availability of third-party components used in our products; the economic condition of our customers; the impact of government regulation; and the economic and political situation in Israel. We are under no obligation, and expressly disclaim any obligation, to update the forward-looking statements in this press release, whether as a result of new information, future events or otherwise.
COMPANY CONTACT:
Ben Carmi
VP Product Management & Business Development
+972-3-766-4217
benc@rit.co.il
NF Energy Savings Corp ( NASDAQ: NFEC ), stock jumped more than 30% and up about 20% to $2.41 without any specific news or announcements. Volumes are already ten times higher than average. Up move might not convincing and there is a higher risk to initiate buy positions at this levels.
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| NF Energy Savings Corp. |
Our Call : Cautious call, Might prefer to stay away before any news announcements.
Penny Stock Recon Technology Ltd ( NASDAQ: RCON ), stock jumped more than 60 % without any specific news. Volumes are picking up as more intraday traders participating i the trade. One might consider small trading opportunity for intraday gains.
Our Call: Small trade positions might be initiated at current levels.
Chelsea Therapeutics ( NASDAQ: CHTP ), stock jumped more than 18 % in the morning trade after company reported that its patented Northera Treatment provide durable beneficial effects. As far as hte impact of the news is concerned, stock might see big upside from here. Also One analyst Roth Capital's David Moskowitz has raised a price target from $6 to $18. He is expecting possible FDA approval as early as Q1. He believes the drug could generate $250 million of annual sales by 2015.
Our Call: Traders and Investors might take a buy positions.
Below is the News Release about Chelsea's Northera Treatment.
Northera Treatment Provides Durable Beneficial Effects on both Systolic Blood Pressure and the Symptoms of NOH in Patients with Multiple System Atrophy
Robust Symptomatic Benefit of Northera Associated with Fewer Falls in Patients with NOH and Parkinson's Disease Prone to Falling
Improvements in MDS-UPDRS and Hoehn & Yahr Scores Seen with Northera Treatment May Indicate Benefit in Non-Motor and Motor Features of Parkinson's Disease
Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) announced that new data from Phase III trials in symptomatic neurogenic orthostatic hypotension (NOH) demonstrating the activity and tolerability of NORTHERA™ (droxidopa), an orally active synthetic precursor of norepinephrine, were presented at the Movement Disorder Society's 15th International Congress of Parkinson's Disease and Movement Disorders in Toronto, Ontario, Canada.
In addition to the two posters presentations, Chelsea sponsored a symposium detailing the clinical results of Northera for the treatment of neurogenic orthostatic hypotension and reviewing the role of norepinephrine depletion in the pathophysiology of Parkinson's disease (PD) and autonomic failure. Copies of both posters and the presentations from the symposium are available on the Chelsea website at www.chelseatherapeutics.com.
In a poster, "Safety and efficacy of Northera (droxidopa) in Multiple System Atrophy," (Abstract Number: 778), Gregor K. Wenning, MD, PhD MSc, Medical University, Innsbruck, Austria, highlighted the results of a meta-analysis of Northera Studies 301 and 302 showing the mean Orthostatic Hypotension Questionnaire (OHQ) composite score of Northera-treated patients improved significantly (2.9 units; P<0.05) from baseline to study completion when compared to placebo-treated patients (1.7 units). Greater improvement in standing systolic blood pressure, mean composite Orthostatic Hypotension Symptom Assessment (OHSA), and Orthostatic Hypotension Daily Activity Scale (OHDAS) scores of the Northera- vs. placebo-treated patients was also observed. These findings were consistent with the results of the full study population in Study 301, presented by Dr. Wenning during the symposium, in which Northera-treated patients demonstrated improvements in multiple signs and symptoms of NOH including a statistically significant (p=0.003) improvement in OHQ Composite score, statistically significant benefit in 8 out of 10 individual OHQ items and a significant improvement (p ≤ 0.001) in standing SBP compared to placebo.
Detailing the results from Northera Study 306A, in a poster "Efficacy of Northera (droxidopa) in Patients with Neurogenic Orthostatic Hypotension associated with Parkinson's disease (PD)," (Abstract Number: LB21) and during his symposium presentation, Robert A. Hauser, MD, University of South Florida, Tampa, FL, described the symptomatic benefit of Northera treatment in this population and the associated reduction in falls reported during the study. Of note, Dr. Hauser reported that data from the study suggests that a majority of patients with symptomatic NOH and PD fall, and many of these fall more than once, in a 10-week period. In Study 306A, approximately 43% of patients fell more than once during the course of the study. Among these repeat fallers, the robust benefit of Northera treatment in reducing dizziness and improving Hoehn & Yahr (HY) and the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scores was associated with a 60% reduction in falls and 52% reduction in falls-related injuries.
The pronounced improvement in MDS-UPDRS and HY scores among Northera-treated patients in Study 306A further suggests that Northera may provide therapeutic benefit in the non-motor and motor symptoms of Parkinson's disease beyond the symptomatic improvement of NOH. In addition to a mean improvement of 1.37 units on Part I of the MDS-UPDRS (non-motor experiences of daily living), Northera treatment showed a mean improvement of 2.1 units on Part II of the MDS-UPDRS (motor experiences of daily living) and a 0.4 unit improvement in HY scores over the course of the treatment period.
"The results from our clinical trials in neurogenic orthostatic hypotension have consistently highlighted the broad symptomatic benefits of Northera in patients with autonomic failure and we are delighted to have had these findings showcased at the Movement Disorder Society's annual meeting," commented Dr. Art Hewitt, Chelsea's Chief Scientific Officer. "These most recent data from Study 306A, though preliminary, suggests that in addition to chronic symptoms such as dizziness, weakness and fatigue, patients with NOH associated with Parkinson's disease are at a high risk for falls and associated injuries. If our on-going trial, Study 306B, replicates these early findings, it could not only have significant implications for the future treatment of neurogenic orthostatic hypotension but could also have important implications for subsequent studies in Parkinson's disease and other movement disorders associated with norepinephrine depletion. "
About Neurogenic Orthostatic Hypotension
NOH is a neurogenic disorder resulting from deficient release of norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to send signals to the blood vessels and the heart to regulate blood pressure. This deficiency results in lightheadedness, dizziness, blurred vision and fainting episodes when a person assumes a standing position. Symptoms of chronic NOH can be incapacitating, not only putting patients at high risk for falls and associated injuries, but also severely affecting the quality of life of patients and their loved ones. The only FDA-approved treatment for orthostatic hypotension has a black box warning indicating that the drug has not been shown to be effective in alleviating the symptoms of the condition and is associated with a pronounced side-effect profile including significant supine hypertension.
About Northera
NORTHERA™ (droxidopa), the lead investigational agent in Chelsea Therapeutics' broad pipeline, is currently in Phase III clinical trials for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure – a group of diseases that includes Parkinson's disease, multiple system atrophy (MSA [FREE Stock Trend Analysis]) and pure autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally. Droxidopa is also being studied for the treatment of fibromyalgia in an ongoing Phase II trial and completed a Phase II trial in intradialytic hypotension (IDH) study with positive results.
About Chelsea Therapeutics
Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. Chelsea's most advanced drug candidate, NORTHERA™ (droxidopa), is an orally active synthetic precursor of norepinephrine initially being developed for the treatment of neurogenic orthostatic hypotension. In addition to Droxidopa, Chelsea is also developing a portfolio of metabolically inert oral antifolate molecules engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders, including two clinical stage product candidates: CH-1504 and CH-4051. Preclinical and clinical data suggest superior safety and tolerability, as well as increased potency versus methotrexate.
This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include risk of regulatory approvals, including our planned NDA for Northera; risks and costs of drug development, including the uncertainty of cost, timing and outcome of clinical trials; our reliance on our lead drug candidates Droxidopa and CH-4051; our need to raise operating capital; our history of losses; reliance on collaborations and licenses; intellectual property risks; competition; market acceptance for our products, if any are approved for marketing; and reliance on key personnel including specifically Dr. Pedder.
Catalyst Pharmaceuticals Partners Inc ( NASDAQ: CPRX ), a small biotech company sneakily moving up since last few trading sessions. Stock has logged more than 36 % upside in last 3 trading sessions. Traders might keep an eye on the stock as you might see a huge breakout in the stock. As of now, there is no announcements from the company regarding any development.
Our Call: Keep an eye on the stock and wait for any positive development announced from the company.
Immucell Corp ( NASDAQ: ICCC ), stock jumped after company has announced that Center for Veterinary Medicine, USFDA has accepted the data of Nisin Residue in milk. Stock jumped more than 20%. Liquidity in the stock is low and there might be a hight risk game to trade the stock.
Our Call: We think the news might not significant enough to trigger a huge upside in the stock and Traders might stay away to play the stock based on news.
Below is the news from Reuters:
ImmuCell Corporation announced that the Center for Veterinary Medicine, U.S. Food and Drug Administration (FDA) has accepted the pivotal Nisin residue data in milk and has assigned a zero milk discard time and zero meat withdrawal period. These claims are subject to obtaining the Human Food Safety (HFS) Technical Section Complete Letter and ultimately approval of the New Animal Drug Application (NADA). Zero Discard means that there would be no requirement to discard milk during treatment or for a period of time thereafter. Coffee Holdings Co Inc ( NASDAQ: JVA ), company has announced quarterly dividend of $0.03 per share payable to common stockholders as of the close of business on July 18, 2011. The dividend will be paid on August 1, 2011.
Stock jumped more than 40 % to $11.90. Volumes are abnormally high and an up move might be considered a breakout. stock might be considered for trade or investment purpose.
Smart-Tek Solutions Inc ( PINK:STTN ), penny stock moving up without specific development news. Stock is trading up more than 42 % and volumes are also abnormal.
Our Call: Cautious call for trade as stock might not see much upside
Our Call: Cautious call for trade as stock might not see much upside
High Plains Gas Inc ( OTC: HPGS ), Stock jumped more than 62 % to $ 1.20 in the morning trade. There was o specific news or announcements relevant to company's developments. Volumes are much stronger and traders might take buy positions as stock might see more upside at this level.
Our Call: Buy positions may be initiated only for intraday trade.
Last news from the company was it has amended a pact with J.M huber corporation on June 1st 2011.
High Plains Gas Inc announced the amendment of the Purchase and Sale Agreement between High Plains and J.M. Huber Corporation. The transaction involves certain coalbed methane assets in Wyoming and Montana and has been extended. The amendment expires June 30, 2011, but has provisions which allow the parties to either close or cancel the amendment prior to that date. Details of the transaction were first announced on February 27, 2011. This amendment grants High Plains Gas, Inc. additional time to close the purchase of Huber's Powder River Basin coalbed methane assets as amended. Huber has the right to pursue sales to third parties and may terminate the agreement upon written notice and pursue actions that it deems appropriate. High Plains may notice Huber at anytime of its intentions to close the transaction prior to any termination notice and the transaction may proceed to close. Huber continues to hold non-refundable deposits in the amount of $2 million and 2 million shares of HPGS common stock which may be applied towards the closing price.
Our Call: Buy positions may be initiated only for intraday trade.
Last news from the company was it has amended a pact with J.M huber corporation on June 1st 2011.
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| High Plains Gas Inc |
Brinx Resources Ltd ( PINK: BNXR ) stock jumped 34% without any specific news or announcements. Volumes are more than 2.5 millions shares. Stock move might be consider a technical breakout and high risk traders might consider trading the stock for intraday gains. Open positions might not carry forward.
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| Brinx Resources Ltd |
Our Call: High risk trade, very cautious on buying for intraday gains.
As per our last alert on the stock Westinghouse Solar Inc ( NASDAQ: WEST ) on June 1st to trade the stock for intraday gains ( Read Here ). Stock has logged 99% upside during the trading session. Today stock exploded to another 31% to close to $ 2.50. What to do now?
Our Call: Small buy positions for intraday trade purpose may be initiated but cautious call as stock might see profit booking later today or tomorrow. Don't consider as investment positions.
Temple-Inland Inc ( NYSE: TIN ) , Stock move up 41% as company announced Dividend distribution of preferred share purchase rights. Stock has touched a new 52 week high of $29.97. Volumes are quite stronger and move will be a fresh break out and stock might see further upside.
Our Call: Small Investment positions may be initiated .
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| Temple-Inland Inc |
Below is the detailed news from Reuters:
Temple-Inland Inc. announced that it has declared a dividend distribution of one Preferred Share Purchase Right on each outstanding share of Temple-Inland common stock. The Rights will be exercisable only if a person or group acquires 10% or more of Temple-Inland’s common stock. Each Right will entitle stockholders to buy one one-hundredth of a share of a new series of junior participating preferred stock at an exercise price of $120. The dividend distribution will be made on June 17, 2011, payable to stockholders of record as of the close of business on that date, and is not taxable to stockholders. The Rights will expire on June 7, 2016.
After our first alert on penny biotech stock Genta Incorporated ( OTC: GNTA ), stock has logged an up move of more than 62 % during yesterday's trading session. We announced an alert when stock was just 28% up.
Read our alert here
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Read our alert here
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Biotech Mover: Rxi Pharmaceuticals ( NASDAQ: RXII ) announced positive Phase II efficacy results of NeuVax (E75) , Stock jumped 15 % to $1.56.
Below is the News Release:
RXi Pharmaceuticals Announces Positive NeuVaxTM (E75) Phase 2 Efficacy Results After 36 Months of Follow-Up
NeuVax (E75) demonstrates statistical significance in 3-year Disease Free Survival (DFS) in adjuvant breast cancer, with 0% recurrence in the treated group versus 22.2% in the untreated group
NeuVax continues to demonstrate an excellent safety and tolerability profile
Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment) study expected to initiate in 1H 2012 under FDA approved Special Protocol Assessment (SPA)
WORCESTER, Mass.--(BUSINESS WIRE)--RXi Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics, announced updated data from its Phase 2 clinical trial of NeuVax™ at the American Society of Clinical Oncology (ASCO) annual meeting. RXi is developing NeuVax for the adjuvant treatment of low to intermediate HER2 expressing breast cancer.
“We are committed to initiating the Phase 3 trial per the approved SPA in the first half of 2012, in order to accelerate this treatment for women who suffer from this terrible disease and who are not eligible for other HER2 directed therapies.”
The NeuVax Phase 2 trials enrolled 182 patients, including node positive and node negative, HER2 1+, 2+ and 3+ patients. All patients received standard of care (SoC) therapy and were confirmed to be disease-free prior to enrollment. Following enrollment, eligible patients were administered the NeuVax vaccine once a month for six months, followed by booster shots one every 6 months thereafter. The efficacy endpoint for the trial was disease free survival (DFS), the same endpoint in the FDA approved SPA (Special Protocol Assessment) for the Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment) study.
“These encouraging clinical results underscore the potential for cancer immunotherapy to develop into potent and well tolerated targeted therapies,” stated Dr. Beth Mittendorf, Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, who was also named the primary investigator for the Phase 3 trial. “The results of this trial suggest that NeuVax addresses an unmet medical need and clearly warrants a randomized, multicenter Phase 3 study to confirm efficacy and safety in a larger population.”
Key highlights from the Phase 2 trial include:
Statistically significant increase in disease free survival (DFS) at 36 months in the NeuVax treated group vs the control group for the planned Phase 3 patient population (p=0.035). The vaccine treated group showed no recurrences of cancer (0% recurrence rate), while the control group demonstrated a 22% recurrence rate which is consistent with historical norms. The planned Phase 3 patient population as defined in the FDA approved Special Protocol Assessment (SPA) includes breast cancer patients who are node positive, have low to intermediate HER2 expression (HER2 1+ and 2+ by IHC), are HLA A2+ & A3+ and who are disease free following standard of care therapy.
An excellent safety profile, with no serious adverse events (SAE’s) related to drug reported to date. All adverse events (AE’s) reported were minor and resolved within 24 hours.
In the ITT (intent to treat) population who received all ranges of doses and schedules, the low to intermediate HER2 expressers continued to show significant activity in improvement of DFS (p=0.045), with the vaccine group demonstrating a reduction of 66% in relative risk for recurrence. This data demonstrates strong support for targeting of low to intermediate HER2 expressers, a group for which there is currently no HER2 directed therapies.
The optimally dosed (1 milligram of E75 plus 250 micrograms of GM-CSF) group continues to demonstrate superior efficacy compared to sub-optimal doses (varying doses from 100 - 500 micrograms E75 plus 125 – 500 micrograms GM-CSF), with a recurrence rate of 3% for the optimally dosed group vs 12% for the sub-optimally dosed group and 14% for the control group.
“These promising results strongly build upon and support previously reported efficacy and safety data,” commented Dr. Mark Ahn, CEO and president of RXi. “We are committed to initiating the Phase 3 trial per the approved SPA in the first half of 2012, in order to accelerate this treatment for women who suffer from this terrible disease and who are not eligible for other HER2 directed therapies.”
About NeuVax™ (E75)
NeuVax consists of the E75 peptide derived from HER2 combined with the immune adjuvant granulocyte macrophage colony stimulating factor (GM-CSF). Treatment with NeuVax stimulates cytotoxic (CD8+) T cells in a highly specific manner to target cells expressing any level of HER2. NeuVax is given as an intradermal injection once a month for six months, followed by a booster injection once every six months. Based on a successful Phase II trial, which achieved its primary endpoint of disease free survival (DFS), the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for a Phase 3 clinical trial in adjuvant therapy of women with low-to-intermediate HER2+ status.
According to the National Cancer Institute, over 200,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, about 75% test positive for Human Epidermal growth factor Receptor 2 (IHC 1+, 2+ or 3+). Only 25% of all breast cancer patients, those with HER2 3+ disease are eligible for Herceptin® (trastuzumab; Roche-Genentech) which had revenues of over $5 billion in 2010. NeuVax targets the remaining 50% of HER2 positive patients (HER2 1+ and 2+) who achieve remission with current standard of care, but have no available HER2 targeted adjuvant treatment options to maintain their disease free status.
About RXI-109
RXi Pharmaceuticals has initiated development of clinical candidate RXI-109, a self-delivering RNAi compound (sd-rxRNA) for the reduction of dermal scarring in planned surgeries. RXI-109 is designed to reduce the expression of CTGF (connective tissue growth factor), a critical regulator of several biological pathways involved in fibrosis, including scar formation in the skin. RXi is beginning manufacturing activities with an experienced cGMP oligonucleotide manufacturer to support its IND enabling toxicology program, and is preparing a pre-IND package for submission to the FDA. Pending FDA review, the company intends to use an innovative clinical trial design to study safety and tolerability as well as initial efficacy in its first clinical trial targeted for 2012.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics. For more information, visit www.rxipharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the future expectations, plans and prospects of the development of RXi Pharmaceuticals Corporation's products. These forward-looking statements about future expectations, plans and prospects of the development of the Company's products are subject to a number of risks, uncertainties and assumptions, including those identified under "Risk Factors" in the Company's most recently filed Annual Report on Form 10-K, Quarterly Report on Form 10-Q and in other filings the Company periodically makes with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. The Company does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this presentation.
Genta Incorporated ( OTC: GNTA ), penny stock moving higher 28 % today and stock up more than 61 % since last 3 trading sessions. Company has announced an updated results of its Phase II clinical trials of Tesetaxel. Investors seeing a hope in the positive results of trials. Traders might keep an eye on the stock before it explode.
Below is the detailed news release from Genta Incorporated
Genta Presents Updated Results of Phase 2 Trial of Tesetaxel in Patients With Advanced Gastric Cancer
Weight-Based Dose Established for Global Clinical Studies
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| Genta Inc |
BERKELEY HEIGHTS, N.J., June 3, 2011 (GLOBE NEWSWIRE) -- Genta Incorporated (OTCBB:GNTA) today announced updated interim results from a trial of tesetaxel used as 2nd-line treatment in patients with advanced gastric cancer. The ongoing trial is lead by the M.D. Anderson Cancer Center in Houston, TX. The data are presented in conjunction with the 2011 annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL. Tesetaxel is the leading oral taxane in clinical development.
The trial is evaluating 3 cohorts of patients, all of whom had failed one prior chemotherapy regimen that must have included a platinum-containing compound (cisplatin, oxaliplatin, or carboplatin) and a fluoropyrimidine compound (5-fluorouracil [5-FU] or capecitabine [Xeloda®; Hofmann LaRoche, Inc.]). Two patient cohorts were treated over a range of "fixed" (as opposed to "weight-based") doses starting at 40-45 mg (Cohort 1) and 50-60 mg (Cohort 2), whereas Cohort 3 is using conventional weight-based dosing at the previously identified maximally tolerable dose (MTD).
In Cohorts 1 and 2, wide variations in body weight were observed. By example, body surface area (BSA, a composite measure of weight and height), of an average U.S. adult male approximates 1.7 m2, whereas the median BSA for patients in the first 2 study cohorts was 1.9 and 2.0 m2, respectively. One major response was observed in each of 11 and 13 patients in the first 2 cohorts, respectively; however, no episodes of > Grade 3 neutropenia were observed in either fixed-dose cohort, suggesting that patients had been substantially under-dosed. Accordingly, Cohort 3 – which is currently open to accrual – employs a starting dose of 27 mg/m2 with escalation to 35 mg/m2 as tolerated in subsequent cycles. Data from this cohort are too early to evaluate.
Since overall survival (OS) is the primary endpoint in planned Phase 3 studies, an analysis of OS was conducted across all 3 cohorts in which any patient's actual starting dose converted to a weight-based dose of > 26 mg/m2. With early followup, median OS in this group of 12 patients has not been reached, but currently exceeds a median of 7.5+ months. For context, docetaxel (Taxotere®; Sanofi, Inc.), a standard taxane, is approved for 1st-line treatment of gastric cancer. Four publications have reported the use of docetaxel as 2nd-line therapy in gastric cancer that show response rates ranging from 5% to 19% and median OS ranging from 3.5 to 8.4 months.
"While fixed dosing is convenient, the extremes of body weight observed in Western subjects has lead to substantial under-dosing, which in a global study would greatly increase the risk of under-treatment in seriously ill patients," said Dr. Raymond P. Warrell, Jr., Genta's Chief Executive Officer. "We now have a broadening experience in 1st and 2nd-line gastric cancer in both Western and Asian patients, both alone and in combination with other agents. Consequently, we have high confidence that safe and potentially effective dosing schedules of tesetaxel have been identified for these disparate populations."
Tesetaxel in Advanced Gastric Cancer
In a completed Phase 2a study, 35 patients with advanced gastric cancer were treated with tesetaxel at doses ranging from 27 to 35 mg/m2 once every three weeks. All patients had received extensive prior treatment, having failed a combination regimen that included cisplatin plus 5-fluorouracil or capecitabine. All but 2 patients had also received a 3rd chemotherapy drug. Results showed 7 major objective responses (5 confirmed and 2 unconfirmed) in 35 evaluable patients, with 14 patients having achieved stable disease, for an overall major response rate of 20% and a disease-control rate of 60%. The most serious adverse reaction was Grade 3-4 neutropenia, which occurred in 57% of patients.
About Tesetaxel
Taxanes (including paclitaxel and docetaxel) are the most widely used chemotherapy drug class in cancer medicine. However, these agents are associated with serious safety issues, particularly hypersensitivity reactions related to intravenous infusions that are occasionally fatal and that require careful premedication and observation. Other prominent side-effects of this drug class include myelosuppression (low blood counts) and peripheral neuropathy (disabling nerve damage).
Unlike standard taxanes that must be administered intravenously, tesetaxel is a capsule that is taken by mouth. Compared with the standard agents, clinical and preclinical data show that tesetaxel:
Is active in diseases that are resistant to standard taxanes
Is not associated with serious (occasionally fatal) hypersensitivity reactions
Eliminates requirements for premedication (e.g., steroids, antihistamines, etc.)
Reduces damage to peripheral nerves
Offers flexible and convenient dosing for patients
Thus, the drug offers substantial opportunities to improve patient convenience, safety, and anticancer activity.
About Gastric Cancer
Cancer of the stomach (gastric cancer) is the second most common cause of death worldwide due to cancer. The disease is the fourth most common type of cancer, and approximately one million new cases of gastric cancer are diagnosed each year. The illness shows a marked geographic distribution, with most cases arising in East Asia. The disease is especially prevalent in Korea, Japan, and China. The American Cancer Society estimates that approximately 21,000 new cases of gastric cancer will be diagnosed in the U.S. during 2010, resulting in approximately 11,000 deaths.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. The Company is developing tesetaxel, a novel, orally absorbed taxane that is in the same class of drugs as paclitaxel and docetaxel. As the leading oral taxane in clinical development, tesetaxel has been evaluated in a broad program of completed or ongoing Phase 2a/Phase 2b clinical trials. The Company has announced that gastric (stomach) cancer will be the lead indication for Phase 3 registration studies. A second portfolio compound, Genasense® (oblimersen sodium) Injection, is a modified DNA-based antisense drug that may enhance the effectiveness of anticancer therapy. The Company has recently announced that a randomized trial of Genasense did not increase overall survival in patients with advanced melanoma. Genta is exclusively marketing Ganite® (gallium nitrate injection) in the U.S, which is indicated for treatment of symptomatic patients with cancer-related hypercalcemia that is resistant to hydration. The Company has developed proprietary oral formulations of the active ingredient in Ganite® that are being evaluated as potential treatments for diseases associated with accelerated bone loss. Ganite® and Genasense® are available on a "named-patient" basis in countries outside the United States. For more information about Genta, please visit our website at: www.genta.com.
Safe Harbor
This press release may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Such forward-looking statements include those that express plan, anticipation, intent, contingency, goals, targets, or future developments and/or otherwise are not statements of historical fact. The words "potentially," "anticipate," "could," "calls for," and similar expressions also identify forward-looking statements. The Company does not undertake to update any forward-looking statements. Factors that could affect actual results include, without limitation, risks associated with:
the Company's ability to obtain necessary regulatory approval for its product candidates from regulatory agencies, such as the U.S. Food and Drug Administration and the European Medicines Agency;
the safety and efficacy of the Company's products or product candidates;
the timing of commencement and completion of any clinical trials;
the Company's assessment of its clinical trials;
the Company's ability to develop, manufacture, license, or sell its products or product candidates;
the Company's ability to enter into and successfully execute any license and collaborative agreements;
the adequacy of the Company's capital resources and cash flow projections, the Company's ability to obtain sufficient financing to maintain the Company's planned operations, or the risk of bankruptcy;
the adequacy of the Company's patents and proprietary rights;
the impact of litigation that has been brought against the Company; and
the other risks described under Certain Risks and Uncertainties Related to the Company's Business, as contained in the Company's Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company's Annual Report on Form 10-K for 2011 and its most recent quarterly report on Form 10-Q.
Penny Stock exploded : Broadcast Mrktg New ( PINK : BDCM ) up more than 420% without any specific news or announcements. Volumes are much above than average but its not significant enough as stock price is just 37 cents.
There is not enough response form penny stock traders as volumes haven't reached a million share trade. Cautious call for trade.
Our Call: Stay away, Don't initiate any positions.
There is not enough response form penny stock traders as volumes haven't reached a million share trade. Cautious call for trade.
Our Call: Stay away, Don't initiate any positions.
