Below is the Press Release of the news
Tuesday, 17 Jul 2012 04:05pm EDT
Somaxon Pharmaceuticals, Inc. announced that it has entered into separate settlement arrangements with Mylan Inc. and its subsidiary, Mylan Pharmaceuticals, Inc. and Par Pharmaceutical Companies, Inc. and its subsidiary Par Pharmaceutical, Inc. to resolve pending patent litigation involving Silenor 3 mg and 6 mg tablets. The settlement agreement with Mylan grants Mylan the exclusive right to begin selling an authorized generic version of Silenor (i.e., a generic version sold under Somaxon's New Drug Application) on January 1, 2020, or earlier under certain circumstances. Mylan's right to sell such an authorized generic product could extend for a period of as long as 360 days, and after such period Mylan will have the non-exclusive right to sell a generic version of Silenor under its Abbreviated New Drug Application. In connection with the settlement agreement, the parties also entered into a supply agreement under which Mylan has agreed to supply the Company with commercial quantities of Silenor 3 mg and 6 mg tablets. The settlement agreement with Par grants Par the right to begin selling a generic version of Silenor 180 days after the earlier of the date that a third party's generic version of Silenor is first sold in the United States under a license from Somaxon or a final court decision that the asserted patents are not infringed, invalid or unenforceable, or earlier under certain circumstances.
About Somaxon Pharmaceuticals, Inc.
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. (Peregrine) is a clinical-stage biopharmaceutical company that develops and manufactures monoclonal antibodies for the treatment of cancer and viral infections. As of April 30, 2011, the Company had three Phase II clinical programs, including two oncology programs, as well as a hepatitis C virus (HCV) program. Peregrine’s pipeline of investigational monoclonal antibodies is based on two technology platforms, including phosphatidylserine (PS)-targeting antibodies and deoxyribonucleic acid (DNA)/histone-targeting antibodies. Bavituximab is its PS-targeting antibody. Cotara is the Company’s DNA/histone-targeting antibody-based on its Tumor Necrosis Therapy (TNT) technology platform. Peregrine’s wholly owned biomanufacturing subsidiary is Avid Bioservices, Inc., which provides integrated cGMP commercial and clinical manufacturing services for Peregrine and third-party clients.
Below is the news release from reuters
Reuters reported that U.S. drug advisers backed Onyx Pharmaceuticals’s drug for patients who have failed to successfully treat their blood cancer with other medicines, making it likely the drug would secure approval from U.S. regulators. A panel of outside advisers to the Food and Drug Administration voted unanimously to recommend approval of Onyx’s drug, to be sold as Kyprolis, for treating multiple myeloma in people who have tried at least two other medicines
Patent ruling
Gevo Inc. probably didn’t infringe a patent held by Butamax Advanced Biofuels LLC, a joint venture of DuPont Co. (DD) and BP Plc (BP/), and is free to sell its renewable-fuel products, a judge said in a pretrial ruling.
Butamax sued Gevo, backed by the oil refiner Total SA (FP) and specialty-chemicals maker Lanxess AG (LXS), in 2011 alleging misuse of technology for genetically engineered microorganisms used to produce biofuels. U.S. District Judge Sue Robinson, in an opinion filed yesterday, denied Butamax’s request for a preliminary injunction to block Gevo’s fuel sales.
“The court finds it unlikely that plaintiff will prevail on its claim of infringement” at trial, Robinson wrote in a 25- page opinion in federal court in Wilmington, Delaware. She also said that Gevo “raised a substantial question concerning validity” of two patent claims based on earlier inventions.
Gevo, based in Englewood, Colorado, is involved in several patent lawsuits with Wilmington-based Butamax. Gevo built a biofuels plant in Luverne, Minnesota, to produce renewable additives to be sold to oil refiners that make diesel and jet fuel. The Minnesota plant can also produce ethanol, according to court papers.
Sell Fuels
Based on the ruling, Gevo may sell fuels “in any market, to any customer, in any region,” the company said in a statement today.
Butamax said it plans to appeal.
“This is an early step in a long and complex litigation process,” Butamax Chief Executive Officer Paul Beckwith said in a statement. “We remain highly confident in the ultimate outcome of this case and our other cases against Gevo.”
The case is Butamax Advanced Biofuels LLC v. Gevo Inc. (GEVO), 11cv54, U.S. District Court, District of Delaware (Wilmington).
Buy Rating
Canaccord Genuity maintains a 'Buy' on Gevo, Inc. price target of $16.00.
Analyst, John Quealy, said, "We expect Gevo’s pioneering technology to successfully ramp into commercial production of cost-effective gateway chemicals, such as isobutanol, over the next 12 months. Volatility will remain elevated."
"Looking forward, remaining litigation likely continues for some time, in our
view (remaining a drag given legal expense). That said, risk is now significantly lowered, as upcoming milestones remain firmly intact. A capital raise also looks more likely in the near term ($150M shelf outstanding) with this hurdle now cleared."
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| General molly inc |
Below is the press release
General Moly, Inc. (the "Company") (nyse mkt and tsx:GMO) today, announced that a Nevada State District Court ("the Court") issued its Order affirming the Nevada State Engineer's ("the NSE") Ruling of July 2011 approving the Mt. Hope Project's water rights and the NSE's December 2011 and January 2012 issuance of water permits for the Mt. Hope Project.
The 59 page Order, which has been posted to the Press Release section of the Company's website, describes the Petitioners' arguments before the Court and denies all Petitioners' respective petitions for Judicial Review.
Bruce D. Hansen, Chief Executive Officer of General Moly, said, "I am extremely pleased that the State Engineer's thorough and inclusive process in approving the Mt. Hope Project's water rights and permits has been affirmed by the Court. Obtaining water rights for the Mt. Hope Project has been a long process and I am eager to move beyond the protests and appeals of the past three years toward a more positive and engaged dialogue with the County of Eureka and its citizens. The 3M Plan, approved by the NSE earlier this week, provides mitigation protections to other water users if impacts are caused by the Mt. Hope project. With full access to our water rights and permits we look forward to the receipt of our remaining State and Federal permits and initiating construction activities later this year. The Mt. Hope project is moving forward."
General Moly is a U.S.-based molybdenum mineral development, exploration and mining company listed on the NYSE MKT (formerly the NYSE AMEX) and the Toronto Stock Exchange under the symbol GMO. Our primary asset, our interest in the Mt. Hope project located in central Nevada, is considered one of the world's largest and highest grade molybdenum deposits. Combined with our second molybdenum property, the Liberty project that is also located in central Nevada, our goal is to become the largest primary molybdenum producer by the middle of the decade. For more information on the Company, please visit our website at http://www.generalmoly.com .
The 59 page Order, which has been posted to the Press Release section of the Company's website, describes the Petitioners' arguments before the Court and denies all Petitioners' respective petitions for Judicial Review.
Bruce D. Hansen, Chief Executive Officer of General Moly, said, "I am extremely pleased that the State Engineer's thorough and inclusive process in approving the Mt. Hope Project's water rights and permits has been affirmed by the Court. Obtaining water rights for the Mt. Hope Project has been a long process and I am eager to move beyond the protests and appeals of the past three years toward a more positive and engaged dialogue with the County of Eureka and its citizens. The 3M Plan, approved by the NSE earlier this week, provides mitigation protections to other water users if impacts are caused by the Mt. Hope project. With full access to our water rights and permits we look forward to the receipt of our remaining State and Federal permits and initiating construction activities later this year. The Mt. Hope project is moving forward."
General Moly is a U.S.-based molybdenum mineral development, exploration and mining company listed on the NYSE MKT (formerly the NYSE AMEX) and the Toronto Stock Exchange under the symbol GMO. Our primary asset, our interest in the Mt. Hope project located in central Nevada, is considered one of the world's largest and highest grade molybdenum deposits. Combined with our second molybdenum property, the Liberty project that is also located in central Nevada, our goal is to become the largest primary molybdenum producer by the middle of the decade. For more information on the Company, please visit our website at http://www.generalmoly.com .
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| Theragenics Corporation |
Below is the Press Release
Theragenics Corporation(R), a medical device company serving the surgical products and prostate cancer treatment markets, today announced it is commencing a modified "Dutch Auction" tender offer to purchase up to $10 million of its common stock. Under the terms of the tender offer, Theragenics stockholders will have the opportunity to tender some or all of their shares at a price within a range of $2.00 to $2.40 per share. Based on the number of shares tendered and the prices specified by the tendering stockholders, Theragenics will determine the lowest per share price within the range that will enable it to buy $10 million of its shares, or such lesser number of shares that are properly tendered. All shares accepted for payment will be purchased at the same price, regardless of whether a stockholder tendered such shares at a lower price within the range. At the minimum price of $2.00 per share, Theragenics would repurchase a maximum of 5,000,000 shares, which represents approximately 14% of Theragenics' currently outstanding common stock. Theragenics will fund this repurchase from available cash on hand. The low and high ends of the price range for the tender offer represent premiums of approximately 14% and 36%, respectively, to the closing price per share of $1.76 for Theragenics' common stock on June 11, 2012, the last trading day prior to the announcement of the tender offer.
Bridgeline Digital Inc and United Parcel Service announced that they have signed a multi-year agreement to offer B2B and B2C eCommerce web stores with an end-to-end offering comprised of Bridgeline's Total eCommerceSM solution and UPS logistics and fulfillment services.
Stock jumped as much as 57 % and trading around $2.38, it has made a 52 week high of $3.28 and retreated from high.
Stock jumped as much as 57 % and trading around $2.38, it has made a 52 week high of $3.28 and retreated from high. 
News Release:
Cleveland BioLabs, Inc. today announced strong survival results for its randomized, blinded, placebo-controlled efficacy study of CBLB502 in 179 non-human primates (NHPs) conducted under Good Laboratory Practice (GLP) with elements of Good Clinical Practice (GCP), as required by the U.S. Food and Drug Administration's (FDA) Animal Rule. The study demonstrated with a high degree of statistical significance the dose-response relationship between the administration of CBLB502 and the survival of lethally irradiated animals, the study's primary endpoint.
Animals in the study received a 70% lethal dose of total body irradiation (TBI) followed by a single injection of a range of doses of CBLB502 or a placebo, in each case, 25 hours after irradiation. In addition to determination of 60-day survival, the study measured multiple pharmacodynamic parameters which the Company believes are essential for animal-to-human dose conversion.
A minimal efficacious dose of CBLB502 was determined and doses above the minimal efficacious dose formed a plateau at approximately 75% survival, compared to 27.5% survival in the placebo treated group. These results demonstrated with a high degree of statistical significance (p < 0.0001 for the trend up to the 40 ug/kg dose and p = 0.0021 for the trend up to the 10 ug/kg dose) that a single administration of CBLB502 given 25 hours after TBI led to a nearly three-fold increase in overall survival in the subject animals.
Ann Hards, Ph.D., Executive Vice President of Regulatory Affairs and Quality Assurance, stated, "We are very pleased with the compelling survival data reported in this study. In addition to demonstrating CBLB502's effect on survival, we believe this study supports our methodology for dose conversion between animals and humans. We plan on using the findings from this trial as a basis for finalizing our remaining development steps with the FDA and, ultimately, submitting our Biologic License Application."
Yakov Kogan, Ph.D., MBA, interim Chief Executive Officer, commented: "I congratulate our team on the rigorous execution of this study. To our knowledge, this trial is the first ever GLP/GCP compliant, randomized, blinded study done with any radiation countermeasure. CBLB502 continues to exceed our expectations and we are as committed as ever to moving this program forward."
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| AGR tools Inc |
Stock might gain further as volumes might drive stock further upside. One might consider buying for more upside.
Sino Forest Corp ( PINK: SNOFF ) , company's largest stakeholder dumped all the stake in the company. Stock was down 18% and might see further sell off.
Billionaire hedge fund manager John Paulson, the largest shareholder in Sino-Forest, has sold his entire stake in the Chinese forestry company in the latest in a string of setbacks triggered by a damning short-seller's report.
The Toronto-listed company's shares have collapsed in the wake of accusations by research firm Muddy Waters that it fraudulently exaggerated the size of its forestry assets.
Paulson, who himself made a fortune on a short bet against subprime mortgages, has been burned by the scandal that has engulfed Sino-Forest. The company has shed over C$4 billion in market capitalization since the beginning of June.
Paulson's Advantage Plus fund, one of the $38 billion firm's largest, fell 13 percent in the first two weeks of June, partly due to the plunge in Sino's share price.
"Due to the uncertainty over Sino-Forest's public disclosures and financial statements, we have sold our stock and await the results of the independent committee's investigation," a spokesman for Paulson & Co said in an e-mail on Monday.
While it wasn't immediately clear how much Paulson lost on the sale, his 14.1 percent stake in Sino would have been worth C$897.4 million as of the end of March. The same stake would be worth just C$94.8 million at Monday's closing price.
Earlier, one of Sino's most vocal supporters, Dundee Capital Markets analyst Richard Kelertas, suspended his coverage of the company, pending the outcome of the company's internal review.
Shares of Sino, which counts Glencore [GLEN 5.44 --- UNCH ] Chairman Simon Murray as one of its directors, fell even further on Monday, after Canada's Globe and Mail newspaper in a report said it uncovered "glaring inconsistencies" that raised more doubts about Sino-Forest's assets.
The company continues to deny the allegations leveled against it and said the newspaper report on its timber assets was an "incorrect portrayal" of its business that failed to account for the complexity of operating in China.
Sino-Forest, which buys and sells trees in China, said it stood by earlier statements that there are no discrepancies in its holdings. The company said Saturday's Globe report was published "without all of the facts."
The Globe said it stood by its story.
"The company would like to remind investors that most domestic and multinational companies with significant China exposure, a country with a rapidly evolving business environment, have structures and operations that are complex and significantly different from the North American environment and that can be complex to explain," Sino-Forest, which has set up a committee to review the charges, said in a release.
"The company ... stands by its public disclosure and, as far as possible, asks that investors trust that process, and allow it to be conducted fully and definitively, not over-judging single articles or publications that are not produced by persons necessarily familiar with the forestry business or business practices in China, that might not be fully sourced or accurate."
Analysts Turn Wary
Dundee's Kelertas, who had earlier slammed the Muddy Waters report as a "pile of crap," on Monday suspended his coverage of the Chinese company.
"Until such time as the company has made public the findings of the board appointed independent committee ... we are not in a position to comment on or otherwise speculate on matters as they relate to the business practice or valuation of Sino-Forest," he said in a note to clients.
Dundee, a member of the underwriting syndicate for Sino's equity offerings, has itself been named as a defendant in legal action against Sino-Forest.
RBC Capital Markets analyst Paul Quinn said in a note to clients he will maintain his "outperform" rating on Sino-Forest shares, but he cut his price target to $14 from $27.
"The allegations against Sino-Forest are material and expected to weigh on the company's share price for some time. We continue to expect that it will be some time before Sino shares trade at their pre-Muddy Waters levels," he said.
Sino-Forest's share price has plunged more than 85 percent since short-seller Muddy Waters questioned its business model and labeled it a fraud early this month. Its shares fell a further 14 percent on Monday to C$2.73.
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
Gerber Scientific Inc ( NYSE: GRB ) announced a definitive merger agreement with Vector Capital Corporation at $11 per share. Below is the detailed news.
Gerber Scientific Inc. and Vector Capital Corporation (Vector) announced that they have entered into a definitive merger agreement under which funds affiliated with Vector will acquire the Company. Under the terms of the merger agreement, the shareholders of the Company will receive $11.00 per share in cash, or approximately $281.8 million in total. In addition to the cash payment, each shareholder of the Company will receive for each share they own a non-transferable right to receive contingent cash payments at future times, if recoveries are made pursuant to certain litigation claims in respect of U.S. Patent 5,537,135 (a computerized print to cut technology patent). After a thorough assessment, the Board of Directors of the Company (Board) unanimously adopted the merger agreement. The merger agreement permits the Board to solicit, receive, evaluate and enter into negotiations with respect to alternative proposals through July 25, 2011. The Board, with the assistance of its advisors, will actively solicit alternative proposals during this period. There can be no assurance that this process will result in a superior offer. If there is no superior offer, the transaction is expected to close in the second half of calendar 2011. Vector has secured committed debt financing from Fortress Credit Corporation. RA Capital Advisors is acting as financial advisor and Cravath, Swaine & Moore LLP is acting as legal advisor to the Board.
( Source: Reuters )
( Source: Reuters )
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.
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.
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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