Posts by vagnum

    DNDN 4.84$

    Aurum hat am 25.03.2013 - 09:16 folgendes geschrieben:

    Ich finde deine grundlegenden Überlegungen sehr gut. Wenn man von einer EU Zulassung ausgeht, dann ist es nur noch eine Frage des Timings. Jedoch kenne mich mit DNDN gar nicht aus und weiss auch nicht, warum die Aktie so stark gefallen ist.



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    JAZZ 55$

    Jazz Pharmaceuticals PLC : Jazz Pharmaceuticals Announces Pricing Of Public Offering Of Ordinary Shares By Selling Shareholders


    03/05/2013| 09:05am US/Eastern


    DUBLIN, March 5, 2013 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the pricing of a previously announced underwritten public offering of 5,375,000 of its ordinary shares held by certain of its existing shareholders, offered at a price to the public of $58.50 per share. Jazz Pharmaceuticals will not receive any proceeds from the sale of ordinary shares by the selling shareholders in the offering, and its total number of ordinary shares outstanding will not change as a result of the offering. The offering is expected to close on or about March 8, 2013, subject to customary closing conditions.


    Barclays Capital Inc. is acting as sole book-running manager and underwriter in this offering.


    A registration statement relating to the shares described above was previously filed with and has become effective by rule of the Securities and Exchange Commission ("SEC"). A final prospectus supplement relating to the offering will be filed with the SEC. Copies of the final prospectus supplement and related prospectus, when available, may be obtained from Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by telephone at 1-888-603-5847, or by email at Barclaysprospectus@broadridge.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the shares in any state or other jurisdiction which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.


    About Jazz Pharmaceuticals


    Jazz Pharmaceuticals plc is a specialty biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing innovative products that address unmet medical needs. The company has a diverse portfolio of products in the areas of narcolepsy, oncology, pain and psychiatry. The company's U.S. marketed products in these areas include: Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi), Prialt® (ziconotide) intrathecal infusion, FazaClo® (clozapine, USP) HD, FazaClo LD, and Luvox CR® (fluvoxamine maleate). Outside of the U.S., Jazz Pharmaceuticals also has a number of products marketed by its EUSA Pharma division.


    "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995


    This press release contains forward-looking statements, including, but not limited to, statements related to the public offering of ordinary shares of Jazz Pharmaceuticals. These forward-looking statements are based on Jazz Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties. Jazz Pharmaceuticals' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the public offering. Additional risks and uncertainties relating to the public offering, Jazz Pharmaceuticals and its business can be found under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including in its Annual Report on Form 10-K for the year ended December 31, 2012. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.


    SOURCE Jazz Pharmaceuticals plc


    http://bit.ly/W8tryP

    AAPL 440$

    http://evasi0n.com/


    :biggrin:


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    da steppt der Bär.


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    short seit 698$.

    Asterix hat am 07.02.2013 - 18:56 folgendes geschrieben:

    Quote

    Was passier eigentlich mit meinen Aktien bei Swissquote? Wann kann ich wieder darüber verfügen, jetzt sind sie ja gesperrt:shock:smiley

    Ich sass neulich auch über 2 Monate auf einer Position Fest wegen eines Splits, konnte dann aber erfolgreich sogar mit Gewinn verkaufen. Ich würde mir da keine grosse Sorgen machen, denn du bist nicht der einzige dem die Aktien zugefroren sind. ;)

    HPTX 18.90$

    Hyperion Therapeutics Inc. : Hyperion Therapeutics' RAVICTI(TM) (glycerol phenylbutyrate) Liquid Receives FDA Approval for Treatment of Urea Cycle Disorders

    02/01/2013| 03:35pm US/Eastern

    • Anticipated market launch by end of April 2013
    • Patent allowance extends coverage to 2032

    SOUTH SAN FRANCISCO, Calif., Feb. 1, 2013 (GLOBE NEWSWIRE) -- Hyperion Therapeutics, Inc. (Nasdaq:HPTX) today announced that the U.S. Food and Drug Administration (FDA) has approved RAVICTI for the treatment of Urea Cycle Disorders (UCD) in patients two years of age and older. The drug is expected to be commercially available by the end of April 2013.


    Separately, Hyperion announced it has received notification from the U.S. Patent & Trademark Office (USPTO) of the allowance of the claims of patent application number 13/417,137 entitled, METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING DRUGS, which discloses optimal measurement timing and target levels for blood ammonia in UCD patients. A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. The issued patent would have a term that expires in March 2032. After issuance, Hyperion plans to list this patent in FDA's Approved Drug Products with Therapeutic Equivalence, or Orange Book.


    "With FDA approval of RAVICTI, we are now in a position to commercialize Hyperion's first product. Furthermore we believe that the allowed claims, once issued, will provide important protection for the use of RAVICTI to treat UCD," said Donald J. Santel, Hyperion's chief executive officer. "We thank our clinical trial patients, their families, our investigators and study coordinators, the UCD Consortium, and the National Urea Cycle Disorders Foundation - in particular NUCDF Executive Director Cynthia Le Mons - for their collaboration and support of our development efforts."


    The FDA approval of RAVICTI was based on a New Drug Application (NDA) that included data from 10 clinical trials, including six in UCD patients, that involved 23 sites, over 50 investigators and sub-investigators, and approximately a dozen referring metabolic specialists throughout North America. As part of FDA approval, Hyperion agreed to post-marketing requirements that include: studies of RAVICTI safety, ammonia control, and pharmacokinetics in pediatric UCD patients in the first two months of life and from two months to two years of age; studies in healthy adults to examine drug-drug interaction and whether RAVICTI metabolites are present in breast milk; a randomized controlled clinical trial to assess the safety and efficacy of RAVICTI in treatment-naïve patients with UCD; and a UCD registry of approximately 10 years duration. Importantly, the FDA did not require a Risk Evaluation and Mitigation Strategy (REMS) program.


    "We believe the RAVICTI development program has brought not only a promising new drug to the UCD community, but also a much deeper understanding of UCD treatment," said Dr. Bruce F. Scharschmidt, M.D., Hyperion's chief medical officer and senior vice president. "The post-marketing studies and registry represent additional opportunities to expand our knowledge in areas that are important to the community, particularly in very young children, a population in which few systematic studies have been done."


    Hyperion intends to commercially launch RAVICTI by the end of April. As part of the commercialization of RAVICTI, Hyperion today announced the launch of a dedicated call center, Hyperion UCD Support Services, which will serve as an integrated resource for patients and their physicians in the areas of RAVICTI prescription intake, reimbursement adjudication, patient financial support, and ongoing compliance support. Together with distribution via two specialty pharmacies, the Company believes that its UCD Support Services program will provide better support to UCD patients, their families and their physicians and help them better manage their disease.


    RAVICTI Indications, Usage and Safety Information


    RAVICTI is indicated for use as a nitrogen-binding agent for chronic management of adult and pediatric patients


    http://bit.ly/XFT7Rg



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    IPXL 19.76$

    Impax Laboratories Inc : FDA Issues Complete Response Letter for RYTARY? (Carbidopa and Levodopa) Extended-Release Capsules (IPX066) New Drug Application


    01/21/2013| 08:05am US/Eastern


    Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for RYTARY? (IPX066), an extended-release capsule formulation of carbidopa-levodopa, a potential treatment for the symptomatic treatment of Parkinson's disease currently under review in the United States.


    The complete response letter indicates that the FDA requires a satisfactory re-inspection of the company's Hayward facility as a result of the warning letter issued in May 2011 before the company's NDA may be approved due to the facility's involvement in the development of RYTARY, and supportive manufacturing and distribution activities. During the assessment of the NDA, the company withdrew the Hayward site as an alternative site of commercial production at launch.


    "We will work with the FDA on the appropriate next steps for the RYTARY application," said Larry Hsu, Ph.D., president and CEO, Impax Laboratories, Inc. "We remain committed to resolving the warning letter and bringing this new treatment option to patients who are suffering from Parkinson's disease."


    A complete response letter is issued by the FDA's Center for Drug Evaluation and Research when the review cycle for a drug is complete and the application is not yet ready for approval.


    About RYTARY TM (IPX066)


    RYTARY is an investigational extended-release capsule formulation of carbidopa-levodopa for the treatment of idiopathic Parkinson's disease. It is not approved or licensed anywhere in the world. Results from the phase III studies of IPX066, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD) have previously been announced.


    RYTARY has been licensed to GlaxoSmithKline (GSK) for countries outside the U.S. and Taiwan for development and marketing.


    About the Impax GSK collaboration


    Impax Pharmaceuticals and GSK announced an agreement for the development and commercialization of IPX066 in December 2010. Under the terms of the agreement, GSK received an exclusive license to register and commercialize IPX066 throughout the world except in the U.S. and Taiwan.


    About Impax Laboratories, Inc.


    Impax Laboratories, Inc. (Impax) is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products. Impax markets its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division. Additionally, where strategically appropriate, Impax develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams and ointments. Impax Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward, Philadelphia and Taiwan facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.


    http://bit.ly/VkrUnv



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    CYCC 8.00$

    Cyclacel Pharmaceuticals Inc. : Cyclacel to Report New Sapacitabine Clinical Data at the American Society of Hematology Annual Meeting

    12/04/2012| 09:47am US/Eastern

    BERKELEY HEIGHTS, N.J., Dec. 4, 2012 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) (Cyclacel or the Company), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders announced today that updated Phase 3 clinical trial results for the treatment of elderly patients with newly diagnosed acute myeloid leukemia (AML) treated with sapacitabine and decitabine administered in alternating cycles will be presented at a poster presentation during the 54th Annual Meeting of the American Society of Hematology (ASH) in Atlanta, on Sunday, December 9, 2012.


    The poster's abstract details are as follows:

    Abstract:2630
    Title:Pooled Analysis of Elderly Patients with Newly Diagnosed AML Treated with Sapacitabine and Decitabine Administered in Alternating Cycles
    Date/Time:Sunday, December 9, 2012, 6:00 PM - 8:00 PM Eastern Time
    Hall B1-B2, Level 1, Building B (Georgia World Congress Center)
    Session:Acute Myeloid Leukemia - Therapy, excluding Transplantation: Poster II
    Poster board:The abstract is available online at: https://ash.confex.com/ash/2012/webprogram/start.html.

    About Cyclacel Pharmaceuticals, Inc.


    Cyclacel is a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases. The Company's most advanced oral product candidate, sapacitabine, is the subject of SEAMLESS, a Phase 3 trial being conducted under an SPA with the FDA as front-line treatment of acute myeloid leukemia (AML) in the elderly and Phase 2 studies for AML, myelodysplastic syndromes (MDS), chronic lymphocytic leukemia (CLL) and solid tumors including breast, lung, ovarian and pancreatic cancer. Cyclacel's pipeline includes seliciclib, a CDK inhibitor, in Phase 2 for lung and nasopharyngeal cancer and in Phase 1 in combination with sapacitabine; and CYC065, a second generation CDK inhibitor, in IND-directed development. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a development pipeline of novel drug candidates. Please visit www.cyclacel.com for additional information.


    bit.ly/SNwKZ6


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    bzzzzz

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    AFFY 16.00$

    Affymax Wins Approval of Drug for Anemic Kidney Patients

    By Anna Edney on March 27, 2012

    Affymax Inc. (AFFY) won U.S. approval for Omontys, an anemia-treatment competitor to Amgen Inc. (AMGN)medicines that have been the only option for patients with loss of kidney function for more than 20 years.

    The Food and Drug Administration cleared Omontys, also known as peginesatide, for patients with chronic kidney disease on dialysis, according to a statement from the agency today. The treatment will be Palo Alto, California-based Affymax’s first marketed product.

    Approval of the drug -- intended to be used once a month instead of as often as three times a week for Amgen’s Epogen -- may potentially save money for Medicare, the federal health program for the elderly and disabled. Peginesatide may generate as much as $700 million in peak sales by 2017, Ian Somaiya, an analyst at Piper Jaffray & Co. in New York, said in a telephone interview.

    “We’re dealing with a monopoly right now and that’s not ideal because it’s occurred for two decades,” Somaiya said of Epogen. “Small and medium dialysis centers are price sensitive. Peginesatide would be the choice for these dialysis providers.”

    Dialysis removes toxins from the blood when kidneys can’t.

    Amgen’s Epogen, approved in 1989, generated $2 billion in sales last year, down 19 percent from 2010, according to data compiled by Bloomberg. Peginesatide may compete to a lesser extent with Thousand Oaks, California-based Amgen’s Aranesp, which is primarily used on non-dialysis kidney patients. Aranesp had $2.3 billion in sales last year.

    JNJ’s Procrit Agreement

    Johnson & Johnson’s Procrit is the same drug as Epogen though is used only in patients who aren’t undergoing dialysis under an agreement the New Brunswick, New Jersey-based drugmaker has with Amgen, Somaiya said.

    Affymax has a profit-sharing agreement for peginesatide with Osaka, Japan-based Takeda Pharmaceutical Co. (4502)

    Medicare spent $6.8 billion on dialysis and drugs for kidney failure patients in 2007, according to a March 2010 report from the U.S. Government Accountability Office, the investigative arm of Congress. Medicare, which covers almost everyone with kidney failure regardless of age, began reimbursing for such services in one bundled payment last year to save money.

    DaVita Deal

    Like peginesatide, Epogen is for anemia in chronic kidney disease patients on dialysis while Aranesp can also treat patients not on dialysis. The medicines are part of a class of drugs known as erythropoiesis-stimulating agents that boost production of red blood cells. The FDA recommended in June that doctors use the lowest possible doses of the agents because of potential heart risks. The agency in 2006 first warned that high doses of the anemia drugs may cause heart attacks and strokes.

    Amgen, the world’s largest biotechnology company, has deals with the two largest dialysis providers DaVita Inc. (DVA) of Denver and Fresenius Medical Care AG (FME) in Bad Homburg, Germany. The deal with DaVita is exclusive and for seven years, while Fresenius’s agreement isn’t exclusive and is for an undisclosed amount of years.

    To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

    To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

    b00n hat am 24.03.2012 - 11:22 folgendes geschrieben:

    hast du AWYI absichtlich zuoberst gestellt? bin auch shcon ein paar mal darüber gestollpert. wär geil wenn da was kommen würde...


    hab noch CATA ECOS MEXP und GRNE gesehen....


    MEXP guck ich wie ein adler denke aber es gibt zuerst ein neues low?! vielleicht aber auch nicht, müsste aber wenn es in die NEOM SNDY ICPA Abteilung kommt. joooah



    nochmals gruss ;)

    STVF 1.30$

    2ter Stevia Play nach STEV. Ist mir heute aufgefallen, hab noch keie Posi der chart gefällt mir aber. Grösstes Kaufvolumen 0.75$. heue auch gutes Volumen und handelt zur Zeit bei 1.30$. Gaps unten bei 0.75$, 0.85$, 1.00$ und 1.14$. Tageshoch 1.48$ support sollte um die 1.14$ sein Ziel.


    Marketcap 55Mil bei 1.30$. auf 100mil spekulieren? eher ein längerfristiges play wie z.B NSRS denke ich.



    gruess

    b00n hat am 20.03.2012 - 16:14 folgendes geschrieben:

    Quote

    ASYI merger speculation..

    man man ich liebe diese kleinen dinger. wäre schön mal wieder einen von anfang an zu erwischen, sind ja im aufbau alle ziemlich gleich. SNDY NEOM ICPA ASYI etc..



    hmm möglicherweise GRNE next? sonst noch welche aufm radar?




    gruss