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SIGA,
It is interesting that Jet Capital Investors L.P.,in a 13G filing,has increased their ownership from 3.47% to 5.42%,just as SIGA is appealing the win by PIP.
Seems very bullish.
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=8670566
Here is the 3.47% ownership info:
Jet Capital Investors, L.P. 1,793,350 3.47
http://finance.yahoo.com/q/mh?s=SIGA+Major+Holders
Manny
SIGA,
It is interesting that Jet Capital Investors L.P.,in a 13G,has increased their ownership from 3.47% to 5.42%,just as SIGA is appealing the win by PIP.
Seems very bullish.
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=8670566
Here is the 3.47% ownership info:
Jet Capital Investors, L.P. 1,793,350 3.47
http://finance.yahoo.com/q/mh?s=SIGA+Major+Holders
Manny
Could you tell me how I can change my password?
TIA,
Manny
Posted on IV:
VHC: '181 Patent Reexam - Standard Process - No Reason for Concern
Subject: VHC: '181 Patent Reexam - Standard Process - No Reason for Concern
The patent reexamination of '181 should not come as a surprise - claims 1-29
being "rejected" was expected (in our opinion) and is similar to all other
patent reexams that have occurred. It is a non-final action and all claims
being "rejected" simply means they will be reviewed - it does not imply the
patent is invalid or will be invalidated.
As we have indicated in prior research approximately 95% of all reexam requests
are granted.
Despite reexamination filings related to VirnetX's patents (causing concern for
approximately 2 years), we emphasize all are standard processes that have not
had any negative repercussions.
Any information disseminated that implies this document is a "negative" should
be disregarded, in our opinion.
Please refer to our recent updated report dated January 11th.
Thank you.
Robert V. Tango, Jr.
Gilford Securities, Inc.
777 Third Avenue
New York, NY 10017
Shouldn't the price be around 1.75-2 dollars based on this news?
Manny
OPK,
I only have approximately 2.5% of my portfolio in this stock,so I am waiting to see if he keeps buying.
The CEO is a billionaire,and sold IVAX for 7.6 billion,so he has a very good track record.
This article is amazing.
http://seekingalpha.com/article/1113511-opko-s-frost-the-ceo-who-keeps-buying-his-company-s-stock?source=nasdaq
Manny
OPK,
CEO adds another 35,000 shares for 5.704.Stock is up 3.5% to 5.92,a 52 week high.
This guy owns over 120 million shares of OPK,and just keeps adding.
http://www.secform4.com/insider-trading/944809.htm
Manny
OPK,
CEO adds another 35,000 shares for 5.704.Stock is up 3.5% to 5.92,a 52 week high.
This guy owns over 120 million shares of OPK,and just keeps adding.
http://www.secform4.com/insider-trading/944809.htm
Manny
OPK,
They are buying a company for that 100 million,so they are getting value.
Opko Health signed a deal to acquire Canadian drug company Cytochroma, which has two products in Phase 3 clinical trials, for $100 million.
The Miami-based pharmaceutical and biotechnology company (NYSE: OPK) would issue shares of its stock as compensation for the deal, its second acquisition in the past two months after buying a pharmaceutical company in Brazil in December.
Both of Cytochroma’s products involve patients with kidney problems. Replidea is a vitamin D prohormone to treat secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease in addition to vitamin D insufficiency. More than eight million patients have stage 3 or 4 chronic kidney disease, according to the National Kidney Foundation. About 70 to 90 percent of such patients have vitamin D insufficiency and 40 to 60 percent of them have SHPT.
Alpharen is a non-absorbed phosphate binder to treat hyperphosphatemia, or elevated serum phosphorus, in dialysis patients, who commonly experience this program.
“OPKO intends to market Replidea along with our proprietary point-of-care vitamin D diagnostic test currently in development,” Opko Chairman and CEO Dr. Phillip Frost stated in a news release. “We envision these remarkable products as part of the foundation for a new and markedly improved standard of care for chronic kidney disease patients having SHPT and/or hyperphosphatemia.”
Following the acquisition, Cytochroma CEO Charles W. Bishop and business manager Eric J. Messner will join Opko.
Opko will issue 20.5 million shares, at $4.87 per share, as part of the $100 million price for Cytochroma. The sellers could receive an additional $190 million in cash of additional shares should the acquired drugs meet certain milestones in both development and revenue.
According to Yahoo Finance, Opko has 298 million shares outstanding. The company's shares were selling for $5.30 at market close on Jan. 8. They have a 52-week low of $4 and a high of $5.53.
OPK,
Look at this constant buying by CEO,even though he owns over 120 million shares,and stock has a market cap of 1.6 billion.
http://www.secform4.com/insider-trading/944809.htm
Company had news today.
MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (OPK) announced that it has expanded its collaboration with Bristol-Myers Squibb Company (BMY) relating to OPKO’s diagnostic test technology. OPKO’s simple blood tests are being developed, based on its proprietary platform technology, to identify biomarkers for a wide variety of diseases, including neurodegenerative disorders and various malignancies.
In December 2010, OPKO and Bristol-Myers Squibb entered into a multi-year collaboration agreement to investigate the utility of OPKO's novel technology for the diagnosis of Alzheimer's disease and for identifying individuals with early stage cognitive impairment that are likely to progress to Alzheimer's disease.
Under the expanded collaboration, work will continue on the Alzheimer’s project and additional investigations will use OPKO’s technology in an attempt to identify biomarkers that are predictive of drug response(s) in several therapeutic areas.
Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO, stated, "We are pleased to expand our relationship and look forward to utilizing our novel diagnostic technology to help Bristol-Myers Squibb identify novel biomarkers predictive of drug response."
About OPKO Health, Inc.
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies.
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "could," "intends," "estimates," and other words of similar meaning, including statements regarding our product development efforts, including our ability to develop and commercialize diagnostic tests for Alzheimer's and other diseases and malignancies, our ability to utilize our technology to identify biomarkers that are predictive of drug responses, and our ability to perform and complete clinical studies required for regulatory approval, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors, including those described in our filings with the Securities and Exchange Commission, could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. In addition, forward-looking statements may also be adversely affected by risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
OPK,
Look at this constant buying by CEO,even though he owns over 120 million shares,and stock has a market cap of 1.6 billion.
http://www.secform4.com/insider-trading/944809.htm
Company had news today.
MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (OPK) announced that it has expanded its collaboration with Bristol-Myers Squibb Company (BMY) relating to OPKO’s diagnostic test technology. OPKO’s simple blood tests are being developed, based on its proprietary platform technology, to identify biomarkers for a wide variety of diseases, including neurodegenerative disorders and various malignancies.
In December 2010, OPKO and Bristol-Myers Squibb entered into a multi-year collaboration agreement to investigate the utility of OPKO's novel technology for the diagnosis of Alzheimer's disease and for identifying individuals with early stage cognitive impairment that are likely to progress to Alzheimer's disease.
Under the expanded collaboration, work will continue on the Alzheimer’s project and additional investigations will use OPKO’s technology in an attempt to identify biomarkers that are predictive of drug response(s) in several therapeutic areas.
Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO, stated, "We are pleased to expand our relationship and look forward to utilizing our novel diagnostic technology to help Bristol-Myers Squibb identify novel biomarkers predictive of drug response."
About OPKO Health, Inc.
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies.
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "could," "intends," "estimates," and other words of similar meaning, including statements regarding our product development efforts, including our ability to develop and commercialize diagnostic tests for Alzheimer's and other diseases and malignancies, our ability to utilize our technology to identify biomarkers that are predictive of drug responses, and our ability to perform and complete clinical studies required for regulatory approval, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors, including those described in our filings with the Securities and Exchange Commission, could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. In addition, forward-looking statements may also be adversely affected by risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
CUR-Aegis capital raises price target to 4 from 3.5 (Schwab news)
Neuralstem Receives FDA Approval To Commence Spinal Cord Injury Trial
ROCKVILLE, Md., Jan. 14, 2013 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) announced that it received approval from the United States Food and Drug Administration (FDA) to commence a Phase I safety trial of its lead cell therapy candidate, NSI-566, in chronic spinal cord injury patients. This open-label, multi-site study, will enroll up to eight patients with thoracic spinal cord injuries (T2-T12), who have an American Spinal Injury Association (AIS) A level of impairment, between one and two years after injury. AIS A impairment refers to a patient with no motor or sensory function in the relevant segments at and below the injury, and is considered to be complete paralysis.
(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO)
The primary objective of the study is to determine the safety and toxicity of human spinal stem cell transplantation for the treatment of paralysis and related symptoms due to chronic spinal cord injury (SCI). The secondary objectives of the study are to evaluate graft survival in the transplant site by MRI, as well as the effectiveness of transient immunosuppression. Additionally, the study will look at exploratory objectives to evaluate the ability of human spinal cord stem cell (HSSC) transplantation to positively affect AIS level, ISNC SCI motor and sensory index scores, bowel and bladder function, pain, UAB IMR scores, SCIM scores, evoked sensory and motor potentials, and electromyogram (EMG).
All patients in the study will receive six injections in, or around, the injury site. The first four patients will receive 100,000 cells per injection, the second four patients will receive 200,000 cells per injection. All patients will also receive physical therapy post surgery, as well as immunosuppressive therapy, which will be for three months, as tolerated. The trial study period will end six months post-surgery for each patient.
"The company is both pleased and excited to begin this long-awaited trial to treat spinal cord injury patients with our spinal cord cells, NSI-566," said Karl Johe, Ph.D., Neuralstem Chairman of the Board and Chief Scientific Officer. "In August, in the peer-reviewed journal 'Cell,' compelling evidence was presented that the cells can 'bridge the gap' in a severed spinal cord model and return functionality.
This will be the first stem cell trial to attack the problem that way, as well as the first to treat chronic spinal cord injury patients," Dr. Johe went on to say. "In addition to the pre-clinical animal data, we have conducted 18 successful surgeries using the same cells and surgical device in our ALS trial. That trial has demonstrated that the surgical route of administration and the cells are safe and, well-tolerated and that the cells survive long-term in the patients. The successes of our human clinical experience, combined with the compelling data from the preclinical spinal cord injury animal studies gives us confidence that we are prepared to move into this additional indication for NSI-566."
"This is another critical milestone for the company," said Richard Garr, Neuralstem President and CEO. "We believe the FDA approval of a trial for a second indication for our NSI-566 cells demonstrates an increasing level of comfort at the FDA with our technology and acknowledges the positive strides being made in the ALS trial. Our goal for this SCI trial is to transplant and collect the 6 month data for all patients within a one-year timeframe.
The approval of this trial is also a demonstration of our product development strategy," Mr. Garr continued. "While we can create cell products from various regions of the CNS that might be applicable to all manner of indications, we have chosen to address multiple indications where the same cell product is applicable. This allows us to leverage the product manufacturing and safety data created in each trial with the next. Along those lines, we will begin dosing patients with NSI-566 to treat paralysis from stroke in the next month, in China, and we are preparing for a trial with NSI-566 to treat acute spinal cord injury patients in Korea this summer. We are also currently in discussions with the FDA over the design and scope of our Phase II trial for ALS with NSI-566. As we begin to create proof-of-principle data in multiple indications, we are also creating additional NSI-556 safety data across indications and borders."
In a September study published in the journal CELL (http://www.cell.com/abstract/S0092-8674(12)01018-5), paralyzed rats transplanted with NSI-566 stem cells recovered significant locomotor function, regaining movement in all lower extremity joints. Additionally, the transplanted neural stem cells turned into neurons which grew multiple axons. These axons extended over 17 spinal segments above and below the point of severance, where made reciprocal synaptic connectivity with the host spinal cord neurons, improving electrophysiological and functional outcome
About Chronic Spinal Cord Injury
There are more than 10,000 new spinal cord injuries (SCI) in the US each year. At the time of a recent survey done by the Christopher & Dana Reeve Foundation, there were approximately 840,000 people living with chronic SCI, which are patients in whom paralysis persists and becomes permanent. According to the National Spinal Cord Injury Association, 85% of SCI patients who survive the first 24 hours are still alive 10 years later.
About Neuralstem
Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem completed dosing of the last patient in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, in August 2012; the trial ends six months after that last surgery. Neuralstem has been awarded orphan status designation by the FDA for its ALS cell therapy.
In addition to ALS, the company is also targeting major central nervous system conditions with its NSI-566 cell therapy platform, including spinal cord injury, ischemic stroke and glioblastoma (brain cancer). The company received approval to commence a Phase I safety trial in chronic spinal cord injury in January, 2013.
Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate new neurons, possibly reversing the pathologies of some central nervous system conditions. The company is in a Phase Ib safety trial evaluating NSI-189, its first neurogenic small molecule compound, for the treatment of major depressive disorder (MDD). Additional indications could include chronic traumatic encephalopathy (CTE), Alzheimer's disease, and post-traumatic stress disorder (PTSD).
CUR-Aegis capital raises price target to 4 from 3.5 (Schwab news)
Neuralstem Receives FDA Approval To Commence Spinal Cord Injury Trial
ROCKVILLE, Md., Jan. 14, 2013 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) announced that it received approval from the United States Food and Drug Administration (FDA) to commence a Phase I safety trial of its lead cell therapy candidate, NSI-566, in chronic spinal cord injury patients. This open-label, multi-site study, will enroll up to eight patients with thoracic spinal cord injuries (T2-T12), who have an American Spinal Injury Association (AIS) A level of impairment, between one and two years after injury. AIS A impairment refers to a patient with no motor or sensory function in the relevant segments at and below the injury, and is considered to be complete paralysis.
(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO)
The primary objective of the study is to determine the safety and toxicity of human spinal stem cell transplantation for the treatment of paralysis and related symptoms due to chronic spinal cord injury (SCI). The secondary objectives of the study are to evaluate graft survival in the transplant site by MRI, as well as the effectiveness of transient immunosuppression. Additionally, the study will look at exploratory objectives to evaluate the ability of human spinal cord stem cell (HSSC) transplantation to positively affect AIS level, ISNC SCI motor and sensory index scores, bowel and bladder function, pain, UAB IMR scores, SCIM scores, evoked sensory and motor potentials, and electromyogram (EMG).
All patients in the study will receive six injections in, or around, the injury site. The first four patients will receive 100,000 cells per injection, the second four patients will receive 200,000 cells per injection. All patients will also receive physical therapy post surgery, as well as immunosuppressive therapy, which will be for three months, as tolerated. The trial study period will end six months post-surgery for each patient.
"The company is both pleased and excited to begin this long-awaited trial to treat spinal cord injury patients with our spinal cord cells, NSI-566," said Karl Johe, Ph.D., Neuralstem Chairman of the Board and Chief Scientific Officer. "In August, in the peer-reviewed journal 'Cell,' compelling evidence was presented that the cells can 'bridge the gap' in a severed spinal cord model and return functionality.
This will be the first stem cell trial to attack the problem that way, as well as the first to treat chronic spinal cord injury patients," Dr. Johe went on to say. "In addition to the pre-clinical animal data, we have conducted 18 successful surgeries using the same cells and surgical device in our ALS trial. That trial has demonstrated that the surgical route of administration and the cells are safe and, well-tolerated and that the cells survive long-term in the patients. The successes of our human clinical experience, combined with the compelling data from the preclinical spinal cord injury animal studies gives us confidence that we are prepared to move into this additional indication for NSI-566."
"This is another critical milestone for the company," said Richard Garr, Neuralstem President and CEO. "We believe the FDA approval of a trial for a second indication for our NSI-566 cells demonstrates an increasing level of comfort at the FDA with our technology and acknowledges the positive strides being made in the ALS trial. Our goal for this SCI trial is to transplant and collect the 6 month data for all patients within a one-year timeframe.
The approval of this trial is also a demonstration of our product development strategy," Mr. Garr continued. "While we can create cell products from various regions of the CNS that might be applicable to all manner of indications, we have chosen to address multiple indications where the same cell product is applicable. This allows us to leverage the product manufacturing and safety data created in each trial with the next. Along those lines, we will begin dosing patients with NSI-566 to treat paralysis from stroke in the next month, in China, and we are preparing for a trial with NSI-566 to treat acute spinal cord injury patients in Korea this summer. We are also currently in discussions with the FDA over the design and scope of our Phase II trial for ALS with NSI-566. As we begin to create proof-of-principle data in multiple indications, we are also creating additional NSI-556 safety data across indications and borders."
In a September study published in the journal CELL (http://www.cell.com/abstract/S0092-8674(12)01018-5), paralyzed rats transplanted with NSI-566 stem cells recovered significant locomotor function, regaining movement in all lower extremity joints. Additionally, the transplanted neural stem cells turned into neurons which grew multiple axons. These axons extended over 17 spinal segments above and below the point of severance, where made reciprocal synaptic connectivity with the host spinal cord neurons, improving electrophysiological and functional outcome
About Chronic Spinal Cord Injury
There are more than 10,000 new spinal cord injuries (SCI) in the US each year. At the time of a recent survey done by the Christopher & Dana Reeve Foundation, there were approximately 840,000 people living with chronic SCI, which are patients in whom paralysis persists and becomes permanent. According to the National Spinal Cord Injury Association, 85% of SCI patients who survive the first 24 hours are still alive 10 years later.
About Neuralstem
Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem completed dosing of the last patient in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, in August 2012; the trial ends six months after that last surgery. Neuralstem has been awarded orphan status designation by the FDA for its ALS cell therapy.
In addition to ALS, the company is also targeting major central nervous system conditions with its NSI-566 cell therapy platform, including spinal cord injury, ischemic stroke and glioblastoma (brain cancer). The company received approval to commence a Phase I safety trial in chronic spinal cord injury in January, 2013.
Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate new neurons, possibly reversing the pathologies of some central nervous system conditions. The company is in a Phase Ib safety trial evaluating NSI-189, its first neurogenic small molecule compound, for the treatment of major depressive disorder (MDD). Additional indications could include chronic traumatic encephalopathy (CTE), Alzheimer's disease, and post-traumatic stress disorder (PTSD).
Anyone concerned about this?
In this amended filing for selling stockholders Robert Roskamp of the Roskamp Institute is selling approximately 250,000 shares out of about 1.2 million.Why would he sell if positive news is coming shortly?
Of course he might need the money.
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=8653954
Shares of Common Stock
Beneficially Owned Prior Number of Shares Shares Beneficially Owned
After the Offering
Selling Stockholder to the Offering Being Offered Number Percentage
Robert G. Roskamp 1,023,682 (1) 65,770 (2) 769,230 (3) *
SCW Communities, LLC 188,682 (4) 188,682 (4) — —
TLON,
Talon Therapeutics Announces Review of Strategic Alternatives
TLON has hired Goldman Sachs to pursue strategic alternatives.
Talon Therapeutics (OTCBB:TLON), a biopharmaceutical company focused on expert and efficient clinical development of product candidates targeting hematologic malignancies and solid tumors, as well as a product candidate for the treatment-limiting skin toxicities of the EGFR-inhibitor class of cancer therapeutics, today announced that the Board has authorized a review of strategic alternatives. Goldman Sachs has been engaged to provide financial advisory services. The review of strategic alternatives may lead to a possible transaction, including the merger, business combination, or sale of the company.
No decision has been made to enter into a transaction at this time, and there can be no assurance that Talon will enter into a transaction in the future. The company does not plan to disclose or comment on developments regarding the strategic review process until further disclosure is deemed appropriate.
About Talon Therapeutics
Talon Therapeutics, Inc. is a biopharmaceutical company dedicated to seizing upon medical opportunities, efficiently and expertly leading product candidates through clinical development, and transferring value to patients, patient care providers, shareholders, corporate partners, and employees.
In addition to Marqibo® (vincCRIStine sulfate LIPOSOME injection) which received accelerated approval from the US FDA in August 2012, Talon has additional pipeline opportunities some of which, like Marqibo, have the potential to improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity.
Additional information on Talon Therapeutics can be found at www.talontx.com.
The Talon Therapeutics, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290
TLON,
Talon Therapeutics Announces Review of Strategic Alternatives
TLON has hired Goldman Sachs to pursue strategic alternatives.
Talon Therapeutics (OTCBB:TLON), a biopharmaceutical company focused on expert and efficient clinical development of product candidates targeting hematologic malignancies and solid tumors, as well as a product candidate for the treatment-limiting skin toxicities of the EGFR-inhibitor class of cancer therapeutics, today announced that the Board has authorized a review of strategic alternatives. Goldman Sachs has been engaged to provide financial advisory services. The review of strategic alternatives may lead to a possible transaction, including the merger, business combination, or sale of the company.
No decision has been made to enter into a transaction at this time, and there can be no assurance that Talon will enter into a transaction in the future. The company does not plan to disclose or comment on developments regarding the strategic review process until further disclosure is deemed appropriate.
About Talon Therapeutics
Talon Therapeutics, Inc. is a biopharmaceutical company dedicated to seizing upon medical opportunities, efficiently and expertly leading product candidates through clinical development, and transferring value to patients, patient care providers, shareholders, corporate partners, and employees.
In addition to Marqibo® (vincCRIStine sulfate LIPOSOME injection) which received accelerated approval from the US FDA in August 2012, Talon has additional pipeline opportunities some of which, like Marqibo, have the potential to improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity.
Additional information on Talon Therapeutics can be found at www.talontx.com.
The Talon Therapeutics, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290
CORT,
I have it in my Schwab news.
I can't get a url from this site.
Manny
CORT,
Piper Jaffray initiates coverage on Corcept Therapeutics ( NASDAQ : CORT ) with an Overweight rating.
Price target of 4 dollars.
Stock was up 10.13% today to 1.63,after this rating yesterday
Janney starts Corcept with Buy rating and fair value of 3 dollars.
Manny
CORT,
Piper Jaffray initiates coverage on Corcept Therapeutics ( NASDAQ : CORT ) with an Overweight rating.
Price target of 4 dollars.
Stock was up 10.13% today to 1.63,after this rating yesterday
Janney starts Corcept with Buy rating and fair value of 3 dollars.
Manny
CORT,
Piper Jaffray initiates coverage on Corcept Therapeutics ( NASDAQ : CORT ) with an Overweight rating.
Price target of 4 dollars.
Manny
NAVB,
Navidea Biopharmaceuticals Reaches Interim Analysis Point of Phase 3 Head and Neck Cancer Study of Lymphoseek(R)
Last update: 1/3/2013 9:00:05 AM
Company to conduct planned interim analysis of available clinical data
DUBLIN, Ohio, Jan 03, 2013 (BUSINESS WIRE) -- Navidea Biopharmaceuticals, Inc. (nyse mkt:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals today announced that it has accrued sufficient subjects in its NEO3-06 study in patients with head and neck cancer to enable the Company to conduct a pre-planned interim analysis. This Phase 3 trial of Lymphoseek(R) (technetium Tc 99m tilmanocept) Injection, a novel intraoperative lymphatic mapping (ILM) agent, is designed to demonstrate the performance of Lymphoseek in identifying sentinel lymph nodes in subjects with squamous cell carcinoma on the head or in the mouth. The interim analysis will compare the pathological analysis of the sentinel lymph nodes localized using Lymphoseek with that of all the lymph nodes removed during a full nodal dissection surgery of the head and neck. This full dissection surgery is considered the gold standard for determining the presence and extent of cancer and staging of the disease in such patients. A total of 82 subjects who underwent pre-planned, full dissection surgery were enrolled and represent the interim analysis cohort. Results from the interim statistical analysis and reporting of the findings will be available upon completion of full site and data audits planned for later in 2013.
"We believe this study is unique because it compares Lymphoseek's performance to a pathological 'truth standard' obtained from a head and neck cancer procedure in which the entire regional lymph node population is removed," commented Fred Cope, Ph.D., Navidea's Senior Vice President of Pharmaceutical Research and Drug Development. "In 2012, positive data from three sites participating in this study were presented at medical meetings by independent investigators characterizing the performance of Lymphoseek at their individual study centers in identifying sentinel lymph nodes in head and neck squamous cell carcinoma. The results appeared very promising. These investigators reported that, for patients accrued up to that date, Lymphoseek had a 0% false negative rate and was 100% predictive of the pathological status of the patient."
Dr. Cope added, "In head and neck cancer it is not uncommon to remove 40, 50, or even 100 regional lymph nodes during full dissection surgery, which can result in substantial and long-term morbidity for patients. An effective sentinel lymph node mapping agent could markedly limit the number of lymph nodes required to conduct pathological assessment and determine whether the cancer has spread. We believe that the NEO03-06 study may provide additional data to demonstrate Lymphoseek's usefulness in characterizing this important type of cancer, and potentially support its use as a sentinel lymph node mapping agent that can facilitate accurate cancer staging and decrease the extent of surgery for some patients, thereby reducing possible serious morbidity."
"This study is part of Navidea's strategy to expand the utilization of Lymphoseek into multiple cancer types to assist physicians and patients in improving the accuracy of cancer diagnosis and staging," said Thom Tulip, Ph.D., Executive Vice President and Chief Business Officer. "We believe that Lymphoseek fills an important unmet need as an ideal agent to enable lymphatic mapping in cancers where the procedure may be highly useful, but for which a suitable agent has not yet been developed. Lymphoseek targets key predictive lymph nodes through its specifically-designed, receptor-based mechanism, which we believe can enhance diagnostic accuracy through rapid injection site clearance, stable target binding, and fewer false negative results. We believe these characteristics can enable more accurate staging of cancer in patients undergoing lymphatic mapping procedures, while affording scheduling flexibility."
About the Lymphoseek NEO3-06 Trial
Navidea's NEO3-06 clinical trial is an open-label, multicenter study of Lymphoseek(R) (technetium Tc 99m tilmanocept) Injection. The study is designed to identify Sentinel Lymph Nodes (SLNs) and determine the false negative rate (FNR) associated with Lymphoseek-identified SLNs relative to the pathological status of non-SLNs in head and neck and intraoral squamous cell carcinoma. This study is a supplement to the previously conducted Phase 3 trials of Lymphoseek in breast cancer and melanoma designed to establish Lymphoseek as an effective radiopharmaceutical agent to be used in the intraoperative localization of lymph nodes in the lymphatic pathway draining the primary site of a tumor which have the highest probability of harboring cancer.
NAVB,
Navidea Biopharmaceuticals Reaches Interim Analysis Point of Phase 3 Head and Neck Cancer Study of Lymphoseek(R)
Last update: 1/3/2013 9:00:05 AM
Company to conduct planned interim analysis of available clinical data
DUBLIN, Ohio, Jan 03, 2013 (BUSINESS WIRE) -- Navidea Biopharmaceuticals, Inc. (nyse mkt:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals today announced that it has accrued sufficient subjects in its NEO3-06 study in patients with head and neck cancer to enable the Company to conduct a pre-planned interim analysis. This Phase 3 trial of Lymphoseek(R) (technetium Tc 99m tilmanocept) Injection, a novel intraoperative lymphatic mapping (ILM) agent, is designed to demonstrate the performance of Lymphoseek in identifying sentinel lymph nodes in subjects with squamous cell carcinoma on the head or in the mouth. The interim analysis will compare the pathological analysis of the sentinel lymph nodes localized using Lymphoseek with that of all the lymph nodes removed during a full nodal dissection surgery of the head and neck. This full dissection surgery is considered the gold standard for determining the presence and extent of cancer and staging of the disease in such patients. A total of 82 subjects who underwent pre-planned, full dissection surgery were enrolled and represent the interim analysis cohort. Results from the interim statistical analysis and reporting of the findings will be available upon completion of full site and data audits planned for later in 2013.
"We believe this study is unique because it compares Lymphoseek's performance to a pathological 'truth standard' obtained from a head and neck cancer procedure in which the entire regional lymph node population is removed," commented Fred Cope, Ph.D., Navidea's Senior Vice President of Pharmaceutical Research and Drug Development. "In 2012, positive data from three sites participating in this study were presented at medical meetings by independent investigators characterizing the performance of Lymphoseek at their individual study centers in identifying sentinel lymph nodes in head and neck squamous cell carcinoma. The results appeared very promising. These investigators reported that, for patients accrued up to that date, Lymphoseek had a 0% false negative rate and was 100% predictive of the pathological status of the patient."
Dr. Cope added, "In head and neck cancer it is not uncommon to remove 40, 50, or even 100 regional lymph nodes during full dissection surgery, which can result in substantial and long-term morbidity for patients. An effective sentinel lymph node mapping agent could markedly limit the number of lymph nodes required to conduct pathological assessment and determine whether the cancer has spread. We believe that the NEO03-06 study may provide additional data to demonstrate Lymphoseek's usefulness in characterizing this important type of cancer, and potentially support its use as a sentinel lymph node mapping agent that can facilitate accurate cancer staging and decrease the extent of surgery for some patients, thereby reducing possible serious morbidity."
"This study is part of Navidea's strategy to expand the utilization of Lymphoseek into multiple cancer types to assist physicians and patients in improving the accuracy of cancer diagnosis and staging," said Thom Tulip, Ph.D., Executive Vice President and Chief Business Officer. "We believe that Lymphoseek fills an important unmet need as an ideal agent to enable lymphatic mapping in cancers where the procedure may be highly useful, but for which a suitable agent has not yet been developed. Lymphoseek targets key predictive lymph nodes through its specifically-designed, receptor-based mechanism, which we believe can enhance diagnostic accuracy through rapid injection site clearance, stable target binding, and fewer false negative results. We believe these characteristics can enable more accurate staging of cancer in patients undergoing lymphatic mapping procedures, while affording scheduling flexibility."
About the Lymphoseek NEO3-06 Trial
Navidea's NEO3-06 clinical trial is an open-label, multicenter study of Lymphoseek(R) (technetium Tc 99m tilmanocept) Injection. The study is designed to identify Sentinel Lymph Nodes (SLNs) and determine the false negative rate (FNR) associated with Lymphoseek-identified SLNs relative to the pathological status of non-SLNs in head and neck and intraoral squamous cell carcinoma. This study is a supplement to the previously conducted Phase 3 trials of Lymphoseek in breast cancer and melanoma designed to establish Lymphoseek as an effective radiopharmaceutical agent to be used in the intraoperative localization of lymph nodes in the lymphatic pathway draining the primary site of a tumor which have the highest probability of harboring cancer.
CORT- CORCEPT THERAPEUTICS INC: JANNEY STARTS WITH BUY RATING
FAIR VALUE ESTIMATE OF $ 3
Manny
SIGA,
Up 18.32% to 3.10 on 401,000 shares.
This is almost 3.5 times the 10 day average volume.
No news.
Manny
SIGA,
Up 18.32% to 3.10 on 401,000 shares.
This is almost 3.5 times the 10 day average volume.
No news.
Manny
Nobody saw this "We may offer and sell, from time to time in one or more offerings, any security or combination of securities described in this prospectus having an aggregate initial offering price not exceeding $100,000,000 on terms to be determined at t
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=8632477
Manny
IMSC,
Implant Sciences Announces Receipt of $5.654M From the India Ministry of Defence
Implant Sciences Corporation (OTCQB: IMSC), a high technology supplier of systems and sensors for homeland security and defense markets, today announced it has received payment of approximately $5,654,000 or 95% of the amount due from the India Ministry of Defence. Implant Sciences announced the shipment of its Quantum Sniffer™ QS-H150 handheld explosives trace detectors to the Ministry on November 29, 2012. The funds will be applied to reduce the Company's obligation for accrued interest and borrowings under its credit facility with DMRJ Group, LLC.
"The receipt of the funds from the India Ministry of Defence substantially completes all of the requirements under the agreement, and will be used to improve our balance sheet," stated Implant Sciences' President and CEO, Glenn D. Bolduc. "Our Field Service and Technical Training team, under the leadership of Marc Edgeworth, will be onsite in India in the near term to provide training to the end-users. Successful completion of our contract with the India Ministry of Defence provides us with momentum in India, which we intend to capitalize on in the pursuit of additional business in this significant market."
About the Quantum Sniffer™ QS-H150 Handheld Explosives Trace Detector
The Quantum Sniffer QS-H150 utilizes Ion Mobility Spectrometry (IMS) technology, providing fast, accurate detection of trace amounts of a wide variety of military, commercial, and homemade explosives. Built with no radioactive materials and featuring a low-maintenance, self-calibrating, and self-clearing design, the QS-H150 provides very high levels of operational availability. The QS-H150 has been proven to perform well in a wide variety of temperatures and challenging environments, from humid jungles to dry, sand swept deserts.
About Implant Sciences
Implant Sciences develops, manufactures and sells sophisticated sensors and systems for Security, Safety, and Defense (SS&D) markets. The Company has developed proprietary technologies used in its commercial explosive and narcotics trace detection systems which ship to a growing number of locations domestically and internationally. Implant Sciences' QS-H150 portable explosives trace detector has received Qualified Anti-Terrorism Technology Designation and the Company's QS-B220 desktop explosives and drugs trace detector has received a Developmental Testing & Evaluation (DT&E) Designation by the U.S. Department of Homeland Security under the Support Anti-terrorism by Fostering Effective Technology Act of 2002 (the SAFETY Act). For further details on the Company and its products, please visit the Company's website at www.implantsciences.com.
5:30 pm Navidea Biopharma: Platinum-Montaur Life Sciences announces it has increased its common stock position in NAVB (NAVB) : Platinum-Montaur Life Sciences LLC (Montaur), a New York-based investment fund, announced that it has exercised Series W warrants to purchase 6 million shares of common stock in Navidea Biopharmaceuticals, Inc. (NAVB). The warrants were originally issued in December 2007 as a part of Montaur's original investment in Navidea.
"Montaur also wishes to correct an inaccuracy regarding its investment in Navidea that was contained in an article posted earlier today on the Seeking Alpha investor website. The article indicated that Montaur had sold 3 million shares of common stock of Navidea on November 27, 2012. In fact, Montaur converted the 3 million shares of common stock back into shares of Preferred Stock of Navidea, paving the way for Montaur to exercise the Series W warrants. On a fully diluted basis, Montaur continues to hold a position that represents over 42 million shares of Navidea common stock."
Looks like ARNA will get takeover speculation at some point also.
VVUS-Shares of Vivus (VVUS) are active in the post session on speculation that Johnson & Johnson (JNJ) and AstraZeneca (AZN) are considering a takeover of the drug developer due to the company's obesity drug Qsymia. Pfizer (PFE) may also take an interest should VVUS come under takeover attack, because obestity drugs are a hot item at present - with over 78M obese adults in the U.S. alone. Deal-watchers are skeptical however, noting that any deal with a chance of success would need to be in the $30-plus per share range. VVUS +1.3% AH.
Manny
FDA Seeks to Balance Opioid Pain Needs With Addict Risks:
. http://bloom.bg/V4cP6f
Manny
ZGNX,
Thanks to both of you for the quick response.
I think the stock should move higher,hopefully despite the Market Maker EDGX,who seems to be a favorite of the Shorts,trying to sell a bunch of shares as the stock has moved higher.
Manny
ZGNX,
Can you post where you found the news?
I can't find it on the company website,or anywhere else.
TIA,
Manny
ZGNX,
An Insider buy play,is now up 10.48% to 1.37
Look at this chart;
http://finviz.com/quote.ashx?t=zgnx&ty=c&ta=1&p=d
This info showed up on Sheff's IHub thread.It has not come up on Schwab News yet.
ZGNX..Zogenix (ZGNX +8.1%) moves up after saying the FDA has scheduled two days of hearings February 7-8 after receiving "comments, petitions, and informal inquiries concerning the extent to which opioid drugs should be used in the treatment of pain." Last week A panel of non-FDA medical experts shot down ZGNX's Zohydro, a hydrocodone pill for chronic pain.
Manny
ZGNX,
Is now up 10.48% to 1.37
This info showed up on Sheff's thread.It has not come up on Schwab News yet.
ZGNX..Zogenix (ZGNX +8.1%) moves up after saying the FDA has scheduled two days of hearings February 7-8 after receiving "comments, petitions, and informal inquiries concerning the extent to which opioid drugs should be used in the treatment of pain." Last week A panel of non-FDA medical experts shot down ZGNX's Zohydro, a hydrocodone pill for chronic pain.
Manny
ZGNX,
An insider buy play,is now up 10.48% to 1.37
This info showed up on Sheff's thread.It has not come up on Schwab News yet.
ZGNX..Zogenix (ZGNX +8.1%) moves up after saying the FDA has scheduled two days of hearings February 7-8 after receiving "comments, petitions, and informal inquiries concerning the extent to which opioid drugs should be used in the treatment of pain." Last week A panel of non-FDA medical experts shot down ZGNX's Zohydro, a hydrocodone pill for chronic pain.
Manny
CHTP,
There has been a 10% holder, El Coronado Holdings, who has sold about 20% of their holdings,with 688,557 shares at .9278 sold today.
http://www.secform4.com/insider-trading/1333763.htm
Manny
VHC,
An explanation for why Siemen's has removed one of their 2 lawyer firms
Re: PACER (377) Unopposed MOTION to Withdraw as Attorney and for Termination of Electronic Notices by Siemens Enterprise
V-Man
“All this means is that instead of two law firms representing Siemens, now one is doing so. Can we all calm down and just hold on for Thursday. It could be interesting.”
The court motion itself apparently does not raise the possibility of a Seimens settlement but other factors could. I rarely try to predict future events because I am usually wrong about 98 percent of the time. But this could be one of the 2 percent.
Siemens is the technical consultant to the FCC for the FirstNet program, a two billion dollar project to upgrade the communications and internet capabilities of first responders. Because of that role it seems almost essential that Seimens settle the suit sometime in the near future for the following reasons.
Seimens is under contract to the FCC to help write the specification for FirstNet and VirnetX technology is essential to FirstNet per 3GPP spec TS 33.401. In addition, I believe that SAIC would be a major candidate to win the FirstNet competition, and SAIC would no doubt have VirnetX as a subcontractor (or licensee) for security.
Also, Flyers provided this as well “A public-safety committee (of the FCC) recently (in February 2012) selected Science Applications International Corp. (SAIC) to serve as the common numbering administrator for public-safety waiver recipients seeking to develop 700 MHz LTE networks.”
It would a much smoother relationship if Siemens, SAIC and VirnetX were all on good working relations for the contract award of FirstNet. Siemens’ low profile in the litigation recently suggests to me that a settlement is possible. IMHO.
Best regards to all.
That paragraph is inside the article I posted.
http://ih.advfn.com/p.php?pid=nmona&article=55508722
Manny
ZGNX,
A beautiful buy off the bottom.Now at 1.30,up 4.845%.
http://finviz.com/quote.ashx?t=zgnx&ty=c&ta=1&p=d
Big insider buys around 1.20 and lower.
http://www.secform4.com/insider-trading/1375151.htm
Manny
ZGNX,
A beautiful buy off the bottom.Now at 1.30,up 4.845%.
http://finviz.com/quote.ashx?t=zgnx&ty=c&ta=1&p=d
Big insider buys around 1.20 and lower.
http://www.secform4.com/insider-trading/1375151.htm
Manny