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Galena Biopharma, Inc. Message Board

zahnd9898 222 posts  |  Last Activity: 15 hours ago Member since: Sep 28, 1999
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  • Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced it has entered into a definitive agreement to license the U.S. rights for the commercial product Zuplenz® (ondansetron) oral soluble film. The asset was licensed from MonoSol Rx, LLC, the developer of the oral soluble film technology, PharmFilm®, and manufacturer of the product.

    Zuplenz was approved in 2010 by the U.S. Food and Drug Administration (FDA) in adult patients for the prevention of highly and moderately emetogenic chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV). Zuplenz is also approved in pediatric patients for moderately emetogenic CINV. Nausea and vomiting are two of the most common side-effects experienced by post-surgery patients and patients receiving chemotherapy or radiation. It is estimated that up to 90% of chemotherapy and up to 80% of radiotherapy patients will experience CINV and RINV respectively.

    The active pharmaceutical ingredient in Zuplenz, ondansetron, is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Ondansetron belongs to a class of medications called serotonin 5-HT3 receptor antagonists and works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting. According to data from Wolters Kluwer, the oral 5-HT3 market exceeds $1 billion in the U.S.

    Zuplenz utilizes MonoSol Rx's proprietary PharmFilm® technology, an oral soluble film that dissolves on the tongue in less than thirty seconds. This rapidly dissolving, oral soluble film eliminates the burden of swallowing pills during periods of emesis and in cases of oral irritation, therefore increasing patient adherence and reducing emergency room visits and hospitalization due to a lack o

    Sentiment: Strong Buy

  • zahnd9898 by zahnd9898 Jun 25, 2014 3:02 PM Flag

    Great info listen to the call!
    DO THE HOMEWORK,DD!

    Sentiment: Strong Buy

  • THE WINDOW IS CLOSING On Shorty!

    Sentiment: Strong Buy

  • GO HALO GO!

    Sentiment: Strong Buy

  • TAKE A LOOK!
    Pipeline
    NeuVax™
    PRESENT
    NeuVax + trastuzumab, HER2 1+ 2+
    NeuVax + trastuzumab, HER2 3+
    Gastric Cancer
    GALE-301 (Folate Binding Protein)
    GALE-401 (Anagrelide CR)
    RELIEF Registry

    Pipeline
    Product Candidate Indication IND Phase 1 Phase 2 Phase 3 NDA Approved

    Approved
    In Progress
    Planned
    Abstral® (fentanyl) Sublingual Tablets Breakthrough Cancer Pain (BTcP)
    NeuVax™ (nelipepimut-S) Breast Cancer Node Positive, HER2 IHC 1+/2+

    NeuVax™ + Herceptin® (trastuzumab) Breast Cancer Node Positive & Negative, HER2 IHC 1+/2+

    NeuVax™ + Herceptin® (trastuzumab) Breast Cancer Neoadjuvant, Node Positive & Negative, HER2 IHC 3+

    NeuVax™ (nelipepimut-S) Gastric Cancer HER2 IHC 1+/2+ or 3+

    GALE-301 (Folate Binding Protein(FBP)) Ovarian & Endometrial Cancers
    GALE-401 (Anagrelide CR) Essential Thrombocythemia (ET)

    Sentiment: Strong Buy

  • Take a look!
    With the exception of HYLENEX® recombinant, all product candidates are not approved for sale in the United States.

    Our proprietary product development portfolio consists of HYLENEX® recombinant, an FDA-approved 150 USP Units dose of rHuPH20 in a single use vial plus three product development programs. The diabetes program consists of Insulin-PH20 and Analog-PH20, which applies our rHuPH20 enzyme to currently approved and marketed mealtime insulin products. The oncology franchise consists of PEGPH20, a new molecular entity administered intravenously that targets the external environment of solid tumor cells. Our lead enzyme within dermatology is HTI-501, a molecule which degrades collagen. It may have applications in both medical and aesthetic dermatology and other potential therapeutic categories as well. Our programs aim to be best-in-class, which will help to ensure their acceptance by patients, healthcare providers and payors.

    Our product development pipeline also includes partnered programs with Roche, Pfizer and Baxter. These partnered programs validate our technology and may generate clinical and commercial milestone revenue based on the achievement of pre-specified events along with sales royalties when products reach the comercial stage. We utilize the non-dilutive cash milestone payments generated from the partnered programs as a source of development funding for our proprietary pipeline projects.

    Sentiment: Strong Buy

  • THIS IS GETTING BETTER and BETTER!

    Sentiment: Strong Buy

  • If you listen to cramer COVER NOW BEFORE HE DOES!

    Sentiment: Strong Buy

  • NICE, POLITICAL SCIENCE????
    I THINK I WILL LISTEN TO THE DOCTORS!!!!!!!!!!!!

    Sentiment: Strong Buy

  • YOU CAN GET THEM, HOLD YOUR OWN!
    DON'T HELP FRAUDSTAIN and the street or cramer and his missing link!

    Sentiment: Strong Buy

  • zahnd9898 zahnd9898 Jun 27, 2014 3:42 PM Flag

    MONEY!
    $$$$$$$$$$$$$$$$$$$$ $$$$$$$$$$$$$$$!!!!!!!!!!!

    Sentiment: Strong Buy

  • DON'T LOOK A GIFT HORSE IN THE MOUTH!

    Sentiment: Strong Buy

  • Reply to

    SUPER PIPELINE.......

    by zahnd9898 Jun 25, 2014 3:02 PM
    zahnd9898 zahnd9898 Jun 26, 2014 2:44 PM Flag

    Pipeline
    Product Candidate Indication IND Phase 1 Phase 2 Phase 3 NDA Approved

    Approved
    In Progress
    Planned
    Abstral® (fentanyl) Sublingual Tablets Breakthrough Cancer Pain (BTcP)
    NeuVax™ (nelipepimut-S) Breast Cancer Node Positive, HER2 IHC 1+/2+

    NeuVax™ + Herceptin® (trastuzumab) Breast Cancer Node Positive & Negative, HER2 IHC 1+/2+

    NeuVax™ + Herceptin® (trastuzumab) Breast Cancer Neoadjuvant, Node Positive & Negative, HER2 IHC 3+

    NeuVax™ (nelipepimut-S) Gastric Cancer HER2 IHC 1+/2+ or 3+

    GALE-301 (Folate Binding Protein(FBP)) Ovarian & Endometrial Cancers
    GALE-401 (Anagrelide CR) Essential Thrombocythemia (ET)

    Sentiment: Strong Buy

  • Reply to

    Feuerstein Bash Articles are like Clockwork

    by doogp1 Jun 13, 2014 10:34 AM
    zahnd9898 zahnd9898 Jun 13, 2014 10:36 AM Flag

    S.E.C. WILL GET ALL OF THEM!
    A former senior editor at TheStreet Inc has agreed to pay $10,225 to resolve claims he participated in an insider trading ring involving a group of high school friends, the U.S. Securities and Exchange Commission said Tuesday.

    The SEC's case against Michael Baron, 43, followed a related criminal prosecution of six other men involved in an insider trading scheme focused on pharmaceutical and medical technology stocks.

    Sentiment: Strong Buy

  • Title Replies Latest Post

    $gale is under consolidation with breakout building pennant ascending daily chart 1 day.
    1 hour 43 minutes ago by ugt_92251 3/0 2 16 minutes ago by quorthon_rip

    MUST READ!
    28 minutes ago by zahnd9898 0/0 0 28 minutes ago by zahnd9898

    Guys only 3 hours left to get your APPY shares before potential 510(k) approval PR!
    2 hours 9 minutes ago by thebiospecialist 3/0 2 33 minutes ago by zahnd9898

    The question "Are everybody that is short GALE a Tranny?"
    4 hours ago by xrayez 1/1 6 54 minutes ago by xrayez

    Question for shorts
    1 hour 31 minutes ago by xrayez 0/0 2 1 hour 22 minutes ago by xrayez

    Patient Approval is HUGE!
    1 hour 40 minutes ago by bigal.saunders 2/0 1 1 hour 35 minutes ago by whiskey8860
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    Sentiment: Strong Buy

  • The news is great!
    THIS IS THE BUY OF A LIFE TIME!

    Sentiment: Strong Buy

  • Reply to

    Motley fool at it again

    by ny.investor Jun 11, 2014 6:49 PM
    zahnd9898 zahnd9898 Jun 11, 2014 9:47 PM Flag

    WHAT COULD THESE TWO KNOW ABOUT GALENA, WHAT I HEARD WAS MORE ABOUT STOCK and NOTHING ABOUT GALENA BIOPHARMA!
    NAMES Michael Douglass and David Williamson ! 6/11/14

    Sentiment: Strong Buy

  • Shorty in big trouble here!

    Sentiment: Strong Buy

  • zahnd9898 by zahnd9898 Jul 24, 2014 11:17 AM Flag

    84% of patients chose to continue taking ABSTRAL for relief of breakthrough pain5

    Prospective, multicenter, open-label, Phase 4 study of 181 opioid-tolerant adult cancer patients with breakthrough pain. Patients received ABSTRAL sublingual tablets with a median dose of 401.4 mcg in the course of routine clinical practice. Patients completed questionnaires over a 28-day observation period. Efficacy wasassessed using measures of maximum breakthrough pain intensity and time to first effect and maximum effect of ABSTRAL.5

    Sentiment: Strong Buy

  • Time to buy buy buy!

    Sentiment: Strong Buy

GALE
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