Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
mfging facility passed! $4.52
News News Alert: Protalix Announces Successful Manufacturing Facility Evaluation by Health Canada
strategic outlook
Protalix BioTherapeutics Provides Full-Year 2014 Strategic Outlook
Dr. Aviezer to Present at the 32nd Annual J.P. Morgan Healthcare Conference
CARMIEL, Israel, Jan. 13, 2014 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today that Dr. David Aviezer, the Company's President and Chief Executive Officer, will discuss the Company's corporate objectives and key milestones in a presentation at the 32nd Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2014 at 12:00 PM, Pacific Time. Dr. Aviezer's presentation will include a discussion of the Company's 2014 strategic outlook and clinical highlights. A live webcast of the presentation will be available at www.protalix.com on the event calendar page, and will be archived for 90 days.
"In 2014, Protalix anticipates achieving a number of milestones on both the commercial and clinical front that have the potential to add significant value," commented Dr. Aviezer. "We expect to see sales of ELELYSO® (taliglucerase alfa) increase across all approved and launched territories, primarily in the United States, Israel, Brazil, Chile and Mexico. Additionally, we expect ELELYSO to be approved in Canada, Australia and Argentina. On the clinical front, we plan to report data from two key clinical programs, Oral GCD for the treatment of Gaucher disease and PRX-102 for the treatment of Fabry disease, and to initiate clinical trials for our oral antiTNF and Dnase compounds."
2013 Highlights
ELELYSO/UPLYSO highlights
Approved in Brazil, Mexico and Chile; the drug was already approved in the United States, Israel and Uruguay.
In Israel, since the addition of ELELYSO to Israel's national healthcare reimbursement basket in early 2013, ELELYSO has become the drug of choice for naïve adult Gaucher patients. Substantially all newly treated adult Gaucher patients in Israel during 2013 received our drug.
In Chile, during the fourth quarter of 2013, all adult Gaucher patients previously treated with other enzyme replacement therapies were successfully switched to UPLYSO/ELELYSO.
An application for a pediatric indication of ELELYSO has been submitted to the U.S. Food and Drug Administration.
The Company entered into a supply and technology transfer agreement in Brazil for UPLYSO, whereby Fiocruz committed to purchase at least approximately $40 million worth of the drug during the first two years of the agreement and at least approximately $40 million worth of the drug each subsequent year under the agreement. The first shipment of the drug to Brazil under the agreement with Fiocruz has just been made. In addition, in accordance with the technology transfer agreement, Fiocruz has initiated the regulatory process with ANVISA for the registration of the drug, which is another step in progressing the agreement contingent to the progression of the commercial aspects. Fiocruz has notified the Company that it has purchased a lot in the Brazilian state of Ciera where it plans to erect its UPLYSO manufacturing site in the future.
Clinical highlights
The Company reported positive top-line phase I clinical trial results for Oral GCD in Gaucher patients.
The Company disclosed three new compounds in development: Oral PRX-106, an oral formulation of antiTNF alpha for the treatment of immune and inflammatory mediated disorders; PRX-110 for the treatment of Cystic Fibrosis; and PRX-107, an alpha1-antitrypsin for the treatment of emphysema.
The U.S. Patent and Trademark Office granted the Company a new patent entitled "Human lysosomal proteins from plant cell culture" (U.S. patent 8449876). This patent relates to plant cells expressing our GCD composition for oral treatment of Gaucher disease.
2014 Commercial and Clinical Milestones
ELELYSO/UPLYSO Milestones
In Israel, the Company anticipates continued growth, and that approximately 25% of adult Gaucher patients will be treated with ELELYSO.
In Brazil, in accordance with the technology transfer and supply agreement, the Company expects that a total of approximately $39 million will be invoiced through July 31, 2015.
The Company anticipates that its collaboration with Pfizer Inc. will continue to be profitable in 2014, with the Company's share in the collaboration to continually increase. ELELYSO has recently been selected as the drug of choice for Gaucher patients by certain regional insurance providers in the United States, and similar agreements with certain other national and regional providers are currently being discussed. The Company is hopeful that some of these agreements will materialize during 2014; such agreements should contribute to further growth in the Company's share in the collaboration.
Marketing approvals for ELELYSO/UPLYSO are currently pending in several countries, including Canada, Australia and Argentina. We are hoping to obtain approvals in 2014.
Clinical Milestones
Report interim results from the Company's phase I/II clinical trial of PRX-102 in Fabry patients during the second half of 2014; full results during the first half of 2015.
Report phase I clinical trial results for Oral GCD, including results from patients with low platelet counts, at the Lysosomal Storage Disease Network WORLD Symposium (LDN WORLD) in February 2014.
Initiate next phase clinical trial of Oral GCD in the second half of 2014.
Initiate phase I clinical trial of the Oral PRX-106 anti TNF for the oral treatment of autoimmune diseases in 2014.
File investigational new drug application (IND) enabling the initiation of a phase I clinical trial of PRX-110 for the treatment of Cystic Fibrosis in 2014.
About Protalix
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®. Protalix's unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner. Protalix's first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the U.S. Food and Drug Administration (FDA) in May 2012, by Israel's Ministry of Health in September 2012, by the Brazilian National Health Surveillance Agency (ANVISA) in March 2013, by the Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS) in April 2013 and by the regulatory authorities of other countries. Marketing applications for taliglucerase alfa have been filed in additional territories as well. Protalix has partnered with Pfizer Inc. for the worldwide development and commercialization of taliglucerase alfa, excluding Israel and Brazil, where Protalix retains full rights. Protalix's development pipeline includes the following product candidates: PRX-102, a modified version of the recombinant human alpha-GAL-A protein for the treatment of Fabry disease; PRX-112, an orally-delivered glucocerebrosidase enzyme that is produced and encapsulated within carrot cells, also for the treatment of Gaucher disease; pr-antiTNF, a similar plant cell version of etanercept (Enbrel®) for the treatment of certain immune and inflammatory diseases, such as rheumatoid arthritis, Crohn's disease, colitis, psoriasis and other autoimmune and inflammatory disorders; PRX-110 for the treatment of Cystic Fibrosis; PRX-107 for the treatment of emphysema due to hereditary alpha1-antitrypsin deficiency; and others.
Forward Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms "anticipate," "believe," "estimate," "expect," "project," "plan" and "intend" and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the progress of our various clinical trials, potential future sales of our product and additional marketing approvals of our product. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause material differences include, among others: risks related to the commercialization efforts for taliglucerase alfa in the United States, Israel, Brazil and other countries; the risk of significant delays in the commercial introduction of taliglucerase alfa in other markets as planned; risks related to the acceptance and use of taliglucerase alfa or any of our product candidates, if approved, by physicians, patients and third-party payors; the risk that we will not be able to develop a successful sales and marketing organization for any of our product candidates in a timely manner, if at all; failure or delay in the commencement or completion of our preclinical studies and clinical trials which may be caused by several factors, including: unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; slower than expected rates of patient recruitment; inability to monitor patients adequately during or after treatment; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; lack of sufficient funding to finance our clinical trials; the risk that the results of our clinical trials will not support the applicable claims of safety or efficacy, that our product candidates will not have the desired effects or includes undesirable side effects or other unexpected characteristics; our dependence on performance by third party providers of services and supplies, including without limitation, clinical trial services; delays in the approval or the potential rejection of any application filed with or submitted to the regulatory authorities reviewing taliglucerase alfa outside of the United States, Israel, Brazil and other countries in which taliglucerase alfa is already approved; our ability to establish and maintain strategic license, collaboration and distribution arrangements, and to manage our relationships with Pfizer Inc., Fiocruz or any other collaborator, distributor or partner; delays in our preparation and filing of applications for regulatory approval of our other product candidates in the United States, the European Union and elsewhere; our expectations with respect to the potential commercial value of our product and product candidates; the risk that products that are competitive to our product candidates may be granted orphan drug status in certain territories and, therefore, our product candidates may be subject to potential marketing and commercialization restrictions; the impact of the development of competing therapies and/or technologies; any lack of progress of our research and development activities and our clinical activities with respect to any product candidate; risks relating to our ability to make scheduled payments of the principal of, to pay interest on or to refinance our 2018 convertible notes, or any other indebtedness; potential product liability risks; risks related to the potential infringement of a third party's patents or other intellectual property rights; the uncertainty of obtaining patents covering our products and processes and in successfully enforcing our intellectual property rights against third parties; risks of securing adequate levels of product liability and clinical trial insurance coverage; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this release are valid only as of the date hereof and we disclaim any obligation to update this information.
CONTACT: Investor Contact
Marcy Nanus
The Trout Group, LLC
646-378-2927
mnanus@troutgroup.com
Media Contact
Kari Watson
MacDougall Biomedical Communications
781-235-3060
kwatson@macbiocom.com
positive results $11.35
Evoke Pharma study reports positive results of Metoclopramide nasal spray for Gastroparesis in Diabetics (EVOK) : Co announced the publication of a study that found intranasal delivery of metoclopramide to be more effective in managing symptoms of diabetic gastroparesis compared to the marketed oral tablet formulation of metoclopramide. The Phase 2b study, which was published online ahead-of-print for an upcoming issue of Neurogastroenterology & Motility, enrolled 89 patients from six study sites throughout the United States. The multicenter, randomized, open-label, parallel design study was the first to compare the efficacy and safety of metoclopramide nasal spray to oral tablets in diabetic patients with symptoms of gastroparesis when dosed four times a day for 6 weeks.
looks trending up.. $2.86
Karyopharm Therapeutics presents clinical data on Selinexor (KPT-330) in colorectal cancer from ongoing Phase 1 study and preclinical data on novel PAK4 inhibitors at American Society of Clinical Oncology 2014 Gastrointestinal Cancers Symposium; Data demonstrate preliminary evidence of anti-tumor activity of oral selinexor in colorectal cancer patients (KPTI) :
Data Demonstrate Preliminary Evidence of Anti-Tumor Activity of Oral Selinexor in Colorectal Cancer Patients
Potential Anti-Proliferative Activity of Novel PAK4 Inhibitor Seen in Preclinical Pancreatic Cancer Model
Co announced data from two poster presentations at the American Society of Clinical Oncology (TATD) 2014 Gastrointestinal (:GI) Cancers Symposium that took place January 16-18 in San Francisco, California.
The data presented included an update (as of December 16, 2013) from the ongoing Phase 1 study of oral Selinexor in solid tumors that show preliminary evidence of antitumor activity in metastatic colorectal cancer (:CRC) patients. Additionally, data were presented on novel, oral p21-activated kinase 4 (PAK4) inhibitors that show anti-proliferative activity and tolerability in a preclinical pancreatic cancer model.
"We are very pleased with these preliminary results showing that single agent oral Selinexor has the potential to provide disease control in a subset of patients with heavily pretreated CRC. We are currently continuing our Phase 1 dose expansion cohorts and expect to report more data at the annual ASCO conference in June," stated Sharon Shacham, Ph.D., founder, Chief Scientific Officer and President of Karyopharm. "In addition, the preliminary preclinical data on our compounds that selectively inhibit PAK4 support our continued development of these potential therapies towards first-in-human studies."
8:35 am Hemispherx Biopharma analysis of new data on protection from pulmonary damage associated with infection by highly pathogenic influenza virus (HEB) :
Co announced that Dr. William M. Mitchell of Vanderbilt University presented a research paper on January 21, 2014 at the Keystone Symposia Conference on Pathogenesis of Respiratory Viruses entitled "Protection from Pulmonary Tissue Damage Associated with Infection of Cynomolgus Macaques by Highly Pathogenic Avian Influenza Virus (H5N1) by Low Dose Natural Human IFN-a Administered to the Buccal Mucosa." This presentation is a collaborative project conducted at Viroclinics, Rotterdam, an internationally recognized research entity for the study of both seasonal and pandemic influenza viruses. The biohazard facilities are directed by Prof. Albert D.M.E. Osterhaus, an internationally known virologist specializing in the study of pandemic influenza.
Thus, both H5N1 influenza virus (the subject of collaboration with the Osterhaus group) and H7N9 influenza virus (the subject of ongoing collaboration with Prof. J. Richt's group at the Center of Excellence for Emerging and Zoonotic Animal Diseases (:CEEZAD), Kansas State University (please see Expert Review of Anti-infective Therapy (online edition, pages 1-5, 2014) are susceptible to Alferon N treatment in various model systems.
Both H5N1 influenza virus and H7N9 influenza virus have recently lead to an increased incidence of clinical disease in various parts of the world.
The new study shows the importance of the interferon induced pathways in controlling influenza viral infection. No deaths were observed in individuals with the wildtype genotype, compared to a 33% mortality rate in patients with the dysfunctional interferon pathway genotype.
Actavis comments on notification to Allergan (AGN) submission of application for Restasis; disagrees with FDA's refusal to receive its ANDA for filing and remains in discussions with FDA concerning the filing status of its application. (ACT) : Co confirmed that its subsidiary, Watson Laboratories, Inc., has submitted an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market a generic version of Allergan's (AGN) Restasis (cyclosporine ophthalmic emulsion) 0.05% product.
Actavis' ANDA was submitted prior to the issuance of FDA guidance related to approval of generic versions of Restasis products. Following issuance of FDA guidance in June 2013, FDA notified Actavis' subsidiary that it had refused to receive the ANDA for filing. Actavis disagrees with FDA's refusal to receive its ANDA for filing and remains in discussions with FDA concerning the filing status of its application.
On January 14, 2014, the U.S. Patent and Trademark Office issued a patent claiming a method of use related to Restasis. In accordance with applicable rules, Actavis' subsidiary amended its ANDA on that date to include a Paragraph IV certification to the newly issued patent and, in order to preserve its potential first-filer status, notified Allergan of its Paragraph IV certification. Actavis continues to work with the FDA to clarify the filing status of its ANDA.
Restasis is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation.
Response to ANCHOR SPA agrmnt reinstatement request will be delayed!
To be delayed!
where did pumpa dumpa low lives go?
NxStage Increases Revenue Guidance for Fourth Quarter and Full-Year 2013
Date : 01/13/2014 @ 4:05PM
Source : PR Newswire (US)
Stock : Nxstage Medical, Inc. (MM) (NXTM)
Quote : 11.31 -0.18 (-1.57%) @ 4:44PM
NxStage Increases Revenue Guidance for Fourth Quarter and Full-Year 2013
Print
Nxstage Medical (NASDAQ:NXTM)
Intraday Stock Chart
Today : Monday 13 January 2014
LAWRENCE, Mass., Jan. 13, 2014 /PRNewswire/ -- NxStage® Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today increased its revenue guidance for the fourth quarter and fiscal year ended December 31, 2013.
(Logo: http://photos.prnewswire.com/prnh/20110503/MM94799LOGO)
For the fourth quarter of 2013, the Company expects to deliver total revenue of approximately $69 million, above the top end of its previously announced guidance range for revenue to be between $67.0 to $68.5 million. This performance is expected to reflect approximately 12% growth in the Home when compared with the fourth quarter of 2012, as a result of solid domestic and international sales.
For the full-year 2013, the Company expects to deliver total revenue of approximately $263 million, above the top end of its previously announced guidance range for revenue to be between $261.0 to $262.5 million. Annual Home revenue growth for 2013 is expected to be approximately 7.5%, at the top end of the Company's previously announced guidance range of 6.5 to 7.5% growth.
The Company also expects net loss for the fourth quarter and the full-year 2013 to be within its previous announced guidance ranges of $5 to $6 million and $18.5 to $19.5 million, respectively, subject to adjustments, including recent litigation settlement costs and certain international tax matters.
"As a result of continued traction with our strategic growth initiatives, Home revenue increased slightly ahead of our expectations in the quarter and we continue to target 15% annual revenue growth in the Home in 2014," stated Jeffrey H. Burbank, Chief Executive Officer. "We also delivered solid revenue growth across our other businesses consistent with our guidance, and ended the year with over $80 million in cash."
Management will be presenting at the 32nd Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Wednesday, January 15th at 4:30 p.m. PST. A webcast of the presentation will be made available at http://ir.nxstage.com at the time of the presentation. The Company plans to announce its final audited financial results for the fourth quarter and fiscal year ended December 31, 2013 on Thursday, February 27, 2014 at 9:00 am ET.
About NxStage
NxStage Medical, Inc. (Nasdaq: NXTM) is a medical device company, headquartered in Lawrence, Massachusetts, USA, that develops, manufactures and markets innovative products for the treatment of ESRD and acute kidney failure. For more information on NxStage and its products, please visit the Company's website at www.nxstage.com.
NxStage Increases Revenue Guidance for Q4, expects to deliver total revenue of ~$69 mln, above the top end of its previously announced guidance range for revenue to be between $67-68.5 mln vs $67.7 mln Capital IQ Consensus Est. Co also expects net loss for Q4 to be within its previous announced guidance ranges of $5-6 mln ( NXTM ) : ...
AHs actions @ $1.47... Who is selling?
GLLs
Mast Therapeutics Provides Enrollment Update On Phase 3 "EPIC" Study Of MST-188
- Enrollment on-track at 6 months with 40 U.S. sites open in 2013 - First ex-U.S. sites to open Q1 2014 - Enrollment completion remains on target for YE 2015
SAN DIEGO, Jan. 8, 2014 /PRNewswire/ -- Mast Therapeutics, Inc. (NYSE MKT: MSTX) today provided an update on the status of EPIC, its pivotal phase 3 study of MST-188 in sickle cell disease. Consistent with prior guidance, the Company announced that 40 clinical sites were opened in the U.S. by year-end 2013. In addition, clinical sites are expected to open in at least three countries outside the U.S. in the first quarter of 2014, leading to a total of approximately 30 ex-U.S. sites open by the end of 2014. Overall study enrollment is consistent with internal projections and the Company affirmed prior guidance that it expects to complete full enrollment for the trial by the end of 2015.
"We are pleased to see early enrollment for EPIC proceeding in line with our projections," said Brian M. Culley, Chief Executive Officer of Mast Therapeutics. "With enrollment on track and over $44 million on our balance sheet to begin 2014, we continue to see MST-188 as well-positioned to become the first drug to treat an ongoing vaso-occlusive crisis in patients with sickle cell disease. Considering the limited number of comprehensive sickle cell centers with the infrastructure to conduct a clinical study, we believe our ability to rapidly establish EPIC at 40 sites reflects strong interest in the study among physicians who treat these patients."
Based in part on physician enthusiasm for the study and the identification of otherwise eligible adult patient candidates, Mast has decided to amend the study's entry criteria to expand the genotype and age range. In parallel, the Company will add a limited number of adult centers to the 40 pediatric-focused sites that already are open to generate additional safety and efficacy data on MST-188 in the adult population. This decision was made following a determination by disease experts and the EPIC steering committee that expansion will not compromise the ability to enroll a sufficiently homogenous patient population and conduct a successful study. Given that most of the study investigators will be pediatric hematologists, the Company expects the majority of enrolled subjects will be children and young adults.
About Mast Therapeutics
Mast Therapeutics, Inc. is a publicly traded biopharmaceutical company headquartered in San Diego, California. The Company is leveraging the MAST (Molecular Adhesion and Sealant Technology) platform, derived from over two decades of clinical, nonclinical and manufacturing experience with purified and non-purified poloxamers, to develop MST-188, its lead product candidate, for serious or life-threatening diseases with significant unmet needs. MST-188 is a cytoprotective, hemorheologic, anti-inflammatory and anti-thrombotic agent that has potential utility in diseases or conditions characterized by microcirculatory insufficiency (endothelial dysfunction and/or impaired blood flow).
The Company is enrolling subjects in EPIC, a pivotal phase 3 study of MST-188 in sickle cell disease. In early 2014, the Company plans to initiate a phase 2, clinical proof of concept study in acute limb ischemia that will evaluate whether MST-188 improves the effectiveness of existing thrombolytic agents. The Company also is evaluating development options in heart failure. More information can be found on the Company's web site at www.masttherapeutics.com. (Twitter: @MastThera)
Mast Therapeuticsâ„¢ and the corporate logo are trademarks of Mast Therapeutics, Inc.
WMGI $31 (WMGI) : MicroPort Scientific Corporation announced on January 9, 2014 the closing of the transaction to acquire the OrthoRecon business from Wright Medical Group (WMGI). The transaction establishes MicroPort Orthopedics as the sixth largest multinational hip and knee reconstruction company, with global headquarters in Arlington, Tennessee. As a result of the acquisition, MicroPort now holds U.S. manufacturing, global infrastructure, logistics and operations in the top four global orthopedic markets, as well as established hip and knee franchise brands.
Eco;
Good reversal sign with this sleepy..
Waz going on?
mlkrborn
GLLs
"undisclosed entity"
Give me a break.
Great manipulators.
SEC will/should look into this Co..
Greece passes new property-tax legislation
Dec. 21, 2013, 9:20 a.m. EST
By Nektaria Stamouli
ATHENS--Greek parliament Saturday passed a controversial new property tax that has been years in the making and demanded by international creditors, but the government lost one deputy, who failed to back the property bill.
The legislation was supported by the two-party coalition of the conservative New Democracy and the socialist, or Pasok, parties.
But lawmaker Byron Polydoras voted against the bill and was expelled from the government.
This reduces the already slim majority of the coalition government to 153 in the country's 300-seat parliament.
The new levy will provide a boost to Greece's budget revenues by rolling several taxes into one, but is also seen as harming the economy's expected rebound next year, driving dented property prices further lower.
By targeting revenues of some 2.6 billion euros per year, the law imposes a tax on residential housing, commercial properties, vacant property lots, farms and sports fields. At the same time, it slashes property transfer taxes by more than 50% and offers discounts to those who prove they cannot afford to pay it.
In September 2011, after facing a budget shortfall just months after receiving its first bailout from international creditors, Greece imposed a real estate tax that it placed on electricity bills and is collected by the country's power company.
Known as the haratsi, the tax has become one of the most unpopular measures Greece has undertaken in its bid to improve its fiscal health. Greece is now replacing this tax with a new one, which effectively shifts the tax burden onto the assets of tax payers rather than just assessing the income of those possessing the property.
The law has been given the nod by the country's international creditors, its euro zone partners and the International Monetary Fund, who are demanding that Greece moves ahead with a series of structural reforms to keep funding lines open to its EUR240 billion rescue package.
Property prices have fallen by an average of 32% since the country's crisis broke out four years ago, according to the Greek central bank. They are tipped to come under further pressure next year despite the economy's expected return to growth.
Alpha Bank argues that the tax is not being fairly imposed on all property owners across the country, excessively weighing down real estate located in the cities.
"It is absolutely certain that tax will amount to essential obstacles to a recovery of the property market and the economy in 2014, despite the very favourable consequence that the significant reduction in transfer tax may have," said Alpha Bank in a report.
Later Saturday, Greek parliament is expected to pass another law renewing a ban on some primary home foreclosures for one more year in 2014, without the full blessings of the troika on that.
"We are bringing a bill to parliament without having reached a full agreement with the troika but also without a stated objection from their part," Development Minister Kostis Hatzidakis told reporters earlier this week, while presenting the bill.
The Greek government is concerned that a wave of foreclosures would weigh on the already weakened property market of the crisis-battered country, as mortgage defaults alone are now running at a staggering 24%--about 17.4 billion euros in total.
The new legislation extends a freeze on home foreclosures for one more year, but only for primary properties valued at up to 200,000 euros and households with an annual net income of under 35,000 euros. The total value of the real estate and liquid assets cannot exceed 270,000 euros, while bank deposits, shares or bonds cannot exceed 15,000 euros.
Write to Nektaria Stamouli at nektaria.stamouli@wsj.com and Stelios Bouras at stelios.bouras@wsj.com
Sano
thnx~
Yes indeed nutsy! Thnx for correction.
HNY!
mlkrborn
Oh well. MMs didnt accept my $1.95 offers!
$3.30 pre-split after buying 20 generic drugs from TEVA. Still affordable. Question is why TEVA dumped those generics ?
Both down ;CANF $5.50 OPLI $3 Can-Fite BioPharma announces top-line results of Phase III Study with CF101 for dry eye syndrome; CF101 did not meet the primary efficacy endpoint (CANF) :
Co announced today that its subsidiary OphthaliX (OPLI) released results from a 24 week, placebo-controlled phase III study involving 237 patients with moderate-to-severe Dry Eye Syndrome who were treated with its licensed drug CF101, an A3 adenosine receptor agonist.
The patients were randomized to receive two oral doses of CF101 or a placebo, for a period of 24 weeks.
In the study, CF101 did not meet the primary efficacy endpoint of complete clearing of corneal staining, nor the secondary efficacy endpoints. Nonetheless, CF101 was found to be well tolerated.
Global Data estimates that the global market for rheumatoid arthritis therapeutics was $12 billion in 2010 and is projected to reach $18 billion by 2020. The global market for treating psoriasis was $3.3 billion in 2010 and is projected to reach $6.7 billion by 2018, according to Global Data.
OphthaliX is also developing CF101 for the treatment of Glaucoma and Uveitis. The interim data from the ongoing phase II study in Glaucoma is expected to be released during 2014.
Can-Fite BioPharma announces top-line results of Phase III Study with CF101 for dry eye syndrome; CF101 did not meet the primary efficacy endpoint (CANF) :
Co announced today that its subsidiary OphthaliX (OPLI) released results from a 24 week, placebo-controlled phase III study involving 237 patients with moderate-to-severe Dry Eye Syndrome who were treated with its licensed drug CF101, an A3 adenosine receptor agonist.
The patients were randomized to receive two oral doses of CF101 or a placebo, for a period of 24 weeks.
In the study, CF101 did not meet the primary efficacy endpoint of complete clearing of corneal staining, nor the secondary efficacy endpoints. Nonetheless, CF101 was found to be well tolerated.
Global Data estimates that the global market for rheumatoid arthritis therapeutics was $12 billion in 2010 and is projected to reach $18 billion by 2020. The global market for treating psoriasis was $3.3 billion in 2010 and is projected to reach $6.7 billion by 2018, according to Global Data.
OphthaliX is also developing CF101 for the treatment of Glaucoma and Uveitis. The interim data from the ongoing phase II study in Glaucoma is expected to be released during 2014.
Looking good. Will pay well for holding cost ones!
GLLs
Chartologist's prediction: $5.25 if it breaks tru $4.!
GLLs
set in motion ! short pricks will pay dearly!
Inching up!
ONTX $13.32
4:45 pm Onconova Therapeutics announces discontinuation of the Phase 3 ONTRAC study of intravenous rigosertib plus gemcitabine in front-line metastatic pancreatic cancerBriefing.com(Wed 3:09AM EST)
Onconova Announces Results of Interim Analysis of Metastatic Pancreatic Cancer StudyGlobeNewswire(Tue, Dec 17)
competion is severe in lucrative market
Akebia snags $41M financing in anemia-drug race with GlaxoSmithKline, others
June 4, 2013 | By Ryan McBride
fiercebiotech
In a race with rival programs from GlaxoSmithKline ($GSK) and Astellas Pharma, the biotech startup Akebia Therapeutics has rallied venture investors to fund its charge toward late-stage development of a novel anemia drug. Today the company disclosed a $41 million Series C financing amid plans for a Phase IIb study later this year for AKB-6548, which is among a potential blockbuster class of oral drugs that could serve as safer alternatives to EPO therapies for anemia patients such as Amgen's ($AMGN) Aranesp.
Akebia, which spun off from the former pharma unit of Procter & Gamble ($PG) in 2007, raised capital for the third-round financing from a bevy of backers. The syndicate for the round includes lead investors Satter Investment Management and Novo A/S as well as Novartis Venture Funds, AgeChem Venture, Athenian Venture Partners, Kearny Venture Partners, Venture Investors LLC, Triathlon Medical Ventures, and Sigvion Capital Fund.
The Series C round follows Akebia's 93-patient Phase IIa study of AKB-6548, which showed dose-related increases in hemoglobin and red blood cell levels. Patients required low doses of iron to hit hemoglobin targets, according to the company, and safety of the experimental treatment was on par with placebo. The compound belongs to a class of drugs, known as inhibitors of hypoxia-inducible factor prolyl hydroxylase, which includes Glaxo's candidate known as GSK 1278863 and ASP1517 from Astellas and its partner FibroGen.
Webinar: Mobile medical app regulation
DATE: DECEMBER 18TH, 2 PM ET/11 AM PT
The FDA has finally issued new guidance outlining requirements for mobile medical device apps. Are companies altering their app development in response to the new requirements, or can they continue as planned, business as usual? This webinar explores the issue. Register Today!
The drugs mimic the reaction of the body to hypoxia, or low levels of oxygen, to generate the glycoprotein EPO, which controls production of red blood cells. Astellas and Fibrogen launched a Phase III program for their contender in anemia patients with chronic kidney disease in December. Like Akebia's, GSK's compound is in midstage development.
Cincinnati-based Akebia, which previously disclosed a $22 million Series B round and $25 million Series A round, expects its third round of financing to fund its planned Phase IIb study and work required to launch a Phase III study in anemia associated with kidney disease. Like its rivals, the company aims to highlight the safety of its drug relative to existing EPO therapies.
Akebia and its rivals have targeted patients with kidney disease. Amgen and others have recorded billions of dollars in revenue from sales of EPO therapies to those patients, yet their fortunes have dwindled after warnings from the FDA about increased cardiovascular and cancer risks from the treatments.
Akebia CEO Joseph Gardner wasn't immediately available to comment on the latest financing found this morning. He and fellow P&G veteran Robert Shalwitz, Akebia's chief medical officer, co-founded the company in 2007.
- here's the company's release
Related Articles:
Akebia lands $22M round for lead anemia program
Cincy biotech spinoff snags $27M A round for vascular drug work
Pharma giants' oral EPO alternatives could cater to dopers
Read more: Akebia snags $41M financing in anemia-drug race with GlaxoSmithKline, others - FierceBiotech http://www.fiercebiotech.com/story/akebia-snags-41m-financing-anemia-drug-race-glaxosmithkline-others/2013-06-04#ixzz2nSuQkwYS
Subscribe at FierceBiotech
Intra-day's high of $2.92 signaled a significant move!
GLLs
$36! TODAY "Insys in hot water over marketing practices
Insys Therapeutics (NASDAQ: INSY ) is down nearly 20% pre-market this morning after word hit the Street late yesterday about the company being investigated for its marketing practices for Subsys.
Subsys was approved by the Food and Drug Administration in 2012 as a sublingual spray used for pain relief in opioid-tolerate cancer patients. Since coming on the market last year, sales have now risen nearly 1,000% , pushing Insys shares up an eye-popping 500% year to date. According to the company's statement on the matter, it's cooperating with the investigation.
Is this drop panic-worthy? My take is that the market is getting ready to overreact again to another investigation into marketing practices that may or may not result in anything. Similar allegations have been hanging over Questcor Pharmaceuticals for over a year now, and there are lessons from that case that can be applied to Insys today.
Firstly, these investigations typically take years to resolve. And in my experience, they generally result in a fine that isn't a major issue for drugs churning out hundreds of millions in sales. Although I'd like to see more details of the investigation before making a final call, Foolish investors should dig deeper into this legal matter to see if today's drop is creating a good buying opportunity. Buying fear is often a great long-term investing strategy."MOTLEY FOOL
Adamis Pharma prices public offering of 3.72 mln shares of common stock at $5.95 per share; announces listing on NASDAQ, reverse stock split (ADMP) : In connection with the offering, Adamis has completed a 1-for-17 reverse stock split of its common stock which is effective as of December 13, 2013. The common stock began trading, on a split-adjusted basis, on The NASDAQ Capital Market under the symbol "ADMP" on December 13, 2013. In connection with its listing on The NASDAQ Capital Market, the company's common stock will cease trading on the OTC QB.
UP a bit; Cormedix announces first sales of Neutrolin in the EU (CRMD 0.83 TODAY ) : Co announced that it has received approval to commence sales of its Neutrolin catheter lock solution in Germany from the Hessian District President. As previously disclosed, the Company has received orders from several dialysis centers and now has begun fulfilling these orders today. In conjunction with ongoing sales and marketing of Neutrolin in Germany, the Company's 2014 strategic plan includes expanding Neutrolin sales into other targeted EU countries and other markets. Additionally, CorMedix will pursue label expansion for Neutrolin beyond its primary indication of hemodialysis, oncology, ICU, total parenteral nutrition and peritoneal dialysis.
Marrone Bio Innovations announces Regalia Maxx Biofungicide received international registrations and certification (MBII) : Co announced FMC, the exclusive Latin America distributor for its Regalia Maxx Biofungicide, has received new product registrations in El Salvador, Guatemala, and Honduras. These countries join Panama and Mexico in approving the use of Regalia Maxx in Latin America to control a wide variety of bacterial and fungal diseases across an array of agricultural crops.
Smart
what is the story with this pick?
tia
mlkrbornn
Still holding on OCRX in green.
Ocera Therapeutics Announces Staffing Transition
4:00p ET December 11, 2013 (GlobeNewswire)
Ocera Therapeutics (Nasdaq:OCRX) today announced that David S. Moore, its chief business officer, will be leaving Ocera to pursue other opportunities. Mr. Moore was a former member of the management team at Tranzyme and continued his employment with Ocera following the merger of Ocera and Tranzyme, which closed in July 2013. "We are grateful to David for his leadership in overseeing several aspects of our post-merger integration and streamlining," said Linda Grais, M.D., chief executive officer of Ocera. "We wish him the best in his future endeavors."
"It has been exciting to be part of a successful merger process, from the initial concept through completion of full integration. OCR-002 has great therapeutic potential for patients with liver disease, which is an important and growing market," said David Moore. "However, my background lies in sales and marketing, and I plan to return to working with commercial stage products."
In addition, as part of the transition of Ocera's corporate headquarters to Palo Alto, CA, Rhonda L. Stanley, Ocera's controller and principal accounting officer will be leaving Ocera. Jeryl L. Hilleman, Ocera's chief financial officer will assume the role of principal accounting officer effective immediately and a controller has been hired in Palo Alto.
About Ocera
Ocera Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of OCR-002 (ornithine phenylacetate). OCR-002 is an ammonia scavenger which has been granted Orphan Disease and Fast Track status from the FDA to treat hyperammonemia and associated hepatic encephalopathy in patients with liver cirrhosis, acute liver failure and acute liver injury. For additional information, please see www.ocerainc.com.
pre-split $0.80 -1 for 8 shares..
STILL holding! $6.42
Hovnanian beats by $0.04, reports revs in-line (HOV) : Reports Q4 (Oct) earnings of $0.21 per share, $0.04 better than the Capital IQ Consensus Estimate of $0.17; revenues rose 21.5% year/year to $591.7 mln vs the $596.53 mln consensus.
Homebuilding gross margin percentage, before interest expense and land charges included in cost of sales, increased 430 basis points to 22.6% for the fiscal 2013 fourth quarter compared with 18.3% during the fourth quarter of 2012, and was up 230 basis points compared to the 20.3% reported for the third quarter of 2013.
Deliveries, including unconsolidated joint ventures, were 1,816 homes during the fourth quarter of 2013, up 3.8% compared with 1,750 homes in the same period of the prior year.
The dollar value of net contracts, including unconsolidated joint ventures, during the fiscal 2013 fourth quarter decreased 4.5% to $490.5 million compared with $513.4 million in last year's fourth quarter. The number of net contracts decreased 8.9% to 1,315 homes in the fiscal 2013 fourth quarter from 1,443 homes in the prior year's fourth quarter.
Contract backlog, as of October 31, 2013, including unconsolidated joint ventures, was $848.4 million for 2,392 homes, which was an increase of 14.3% and 11.5%, respectively, compared to October 31, 2012.
"Although our sales slowed from July through September due to the adverse impacts of higher mortgage rates, the sequester and the government shutdown, we are happy to report that our sales improved back to prior year levels in October and exceeded last year's levels in November. Entering 2014 with a higher backlog, gross margin and community count, gives us optimism that, excluding any expenses related to early retirement of debt, fiscal 2014 should result in greater levels of profitability and continued leveraging of our fixed costs. Further, we continue to believe that household formations, the primary driver of housing demand, will ultimately lead to increased demand for new homes and we continue to believe that our industry is still in the early stages of a housing recovery."
Smart;
And medicare reimbursement news released at same time along with secondary offer.
CEO a smart tuchie it seems!