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Ironwood Pharmaceuticals, Inc. Message Board

galaberge 2096 posts  |  Last Activity: May 27, 2016 8:09 AM Member since: Mar 5, 2002
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  • KTOV an innovative biopharmaceutical company focused on late-stage drug development, today announced the completion of manufacturing by Dexcel Pharma of pivotal batches required for registration of KIT-302 with the U.S. Food and Drug Administration (FDA). This follows Kitov's announcement in December 2015, that KIT-302's pivotal Phase III trial successfully met its primary efficacy endpoint.

    "We are fortunate to have Dexcel as our manufacturing partner for KIT-302. Dexcel's state-of-the-art manufacturing capabilities enabled us to reach this CMC milestone in record time, and bring KIT-302 one step closer to the NDA submission and marketing approval," stated Kitov CEO Isaac Israel."

    GLTA and see you @$100

    Long and strong KTOV

  • ........The owners won't sell shares if anything they would buy more. "

    GLTA and see you @$20

    Sentiment: Strong Buy

  • and 2 hours of trading to go. We should see a good rebound here on New York

    Long and strong KTOV

    Sentiment: Strong Buy

  • JohnWaymack
    Chairman of the Board & Chief Medical Officer
    Dr. John Paul Waymack serves as Chairman of the Board and Chief Medical Officer at Kitov Pharmaceuticals Holdings Ltd since July 11, 2013. Dr. Waymack has over 20 years of experience in the bio-pharma field. Dr. Waymack is a former academic transplant surgeon and a former FDA medical officer, with over 15 years of experience in drug development as a consultant to major pharmaceutical companies, including Pfizer, Roche, Pharmacia, Warner Lambert and Searle. During his 10 years of academic career, Dr. Waymack published over 100 scientific essays, mainly in the fields of prostaglandins and immunology. In addition, Dr. Waymack volunteered to the U.S. army, where he was commissioned and served as a Major in the Medical Corp. in the position of Chief of Surgical Research in the U.S. Army’s Institute for Surgical Research. Dr. Waymack was also an associate professor of surgery at the University of Texas Medical Branch and at the University of Medicine and Dentistry of New Jersey.

    Chief Executive Officer, Director
    Mr. Itzhak Israel serves as Chief Executive Officer and Director at Kitov Pharmaceuticals Holdings Ltd since October 31, 2012. Mr. Israel's work experience includes the following roles: Director at Ducant Connecting To Medicine Ltd, Uneri Capital Ltd, Lithotec Medical Ltd, Nextgen Biomed Ltd, Dermipsor Ltd, and at Ofakim Ventures Ltd., Founder and Chief Executive Officer of B Contact Communication, Vice President-Business Development at Ofakim Ventures Ltd and Meytag Hi-Tech Ventures Ltd, and Chief Executive Officer of Dermipsor Ltd, Einspein Medical Ltd.

    Chief Financial Officer, Director


  • Currently there are no combination drugs on the market that treat both osteoarthritis and hypertension together. If approved, KIT-302 would be the first. Kitov indicates that most pain medications, including Celebrex, have worldwide sales of about $2.7 billion as of 2014. In the U.S. alone there are about 27 million people diagnosed with osteoarthritis.

    “KIT-302 has the potential to address the multi-billion dollar market for the treatment of osteoarthritis pain and hypertension with one drug that reduces patients’ risk of suffering a heart attack or stroke, while also reducing cost for payers,” said Paul Waymack, Kitov’s chairman of the board and chief medical officer, in a statement. “There is currently no single medication on the market that treats both osteoarthritis pain and hypertension and thus, KIT-302 will be the only NSAID indicated both to treat pain and to reduce the risk of heart attack, stroke and death.”

    Sentiment: Strong Buy

  • galaberge galaberge May 13, 2016 9:35 PM Flag

    What is DexcelPharma , the partner of KTOV ?

    I quote

    " Dexcel Pharma is Israel’s largest private pharmaceutical
    company. Founded in 1968, we develop, manufacture
    and market value-added branded and generic
    pharmaceuticals. With a diverse product portfolio that
    spans more than 55 branded and generic products in
    over 140 dosage forms, our products are sold in the US,
    the UK and Germany, via subsidiaries and through a
    trusted network of partners in more than 30 countries worldwide."

    Long and strong KTOV

  • I quote :

    "On April 1, 2014 Kitov entered into a strategic agreement with Dexcel Ltd. for the development of the formulation of KIT-302 and the subsequent manufacture of adequate supplies of KIT-302 to submit a New Drug Application (NDA) to the FDA. The agreement calls for Dexcel to develop the final formulation of the drug, including chemical development, analytical methods and validation, stability testing, and production of batches for pharmacokinetics and bioequivalence studies and scale-up for submission of the NDA.

    Kitov will pay Dexcel $2 million in cash and $1.5 million in newly issued shares of Kitov in exchange for these services, based on milestones during the development and manufacturing period.

    In addition, Dexcel will pay Kitov $500,000 in exchange for a right of first negotiation with regard to future marketing rights for KIT-302 and for an option to negotiate the future commercial manufacture of KIT-302 .
    Dexcel is a global pharmaceutical company active in more than 30 countries including the U.S., the U.K., and Germany. Dexcel’s portfolio includes some 55 drug products, both branded and generic, and Dexcel produces some 5 billion tablets and capsules in its Israeli manufacturing facilities, which meet cGMP standards with routine oversight by the FDA " (see the link "
    " evaluategroupDOTcom/Universal/ViewDOTaspx?type=Story&id=516109 "

    So forget about the fools like " matt2400 " and "hitdahomerun " with their wrong statements.

    GLTA and long and strong KTOV

  • Michael S. Okun, MD, also author of the Parkinson bestseller, Parkinson's Treatment: 10 Secrets to a Happier Life, is considered a world's authority on Parkinson's disease treatment, and his publications provide a voice and an outlet to empower people living all over the world. He is currently Administrative Director and Co-director of the University of Florida Center for Movement Disorders and Neurorestoration. The center he runs is unique in that it is comprised of over 45 interdisciplinary faculty members from diverse areas, all of whom are dedicated to care, outreach, education and research. Dr. Okun has been dedicated to this interdisciplinary care concept, and since his appointment as the National Medical Director for the National Parkinson Foundation in 2006, he has worked with the 43 international NPF centers of excellence to help foster the best possible environments for care, research and outreach in Parkinson disease, dystonia, Tourette, and movement disorders. Dr. Okun has been supported by grants from the National Parkinson Foundation, the National Institutes of Health, the Parkinson Alliance, and the Michael J. Fox Foundation for Parkinson’s Disease Research, and he currently runs the online international “Ask The Expert” forums, on the National Parkinson Foundation website. The forum is a free service that answers questions from every continent (except Antartica) and has over 10,000 postings in the last 3 years alone. Dr. Okun has dedicated much of his career to the development of care centers for people suffering with movement disorders, but has also has enjoyed a prolific research career exploring non-motor basal ganglia brain features, and he has participated in pioneering studies exploring the cognitive, behavioral, and mood effects of deep brain stimulation (DBS).....continued

    Sentiment: Strong Buy

  • Reply to

    FDA Panel Backs Approval of Pimavanserin

    by galaberge Apr 20, 2016 4:06 PM
    galaberge galaberge Apr 20, 2016 4:30 PM Flag

    The author is....the Dr. Michael S. Okun himself, NPF's National Medical Director ! He wrote as if it was a done fact.

    Sentiment: Strong Buy

  • Here is an article found in the National Parkinson Foundation

    I quote :" What's Hot in PD?: As a New Drug Gains FDA Approval for Parkinson’s Disease Psychosis (Nuplazid), Should We Fear Using it? "

    Here is the link : " parkinsonDOTorg/find-help/blogs/whats-hot/april-2016 "

    Good reading


    Sentiment: Strong Buy

  • Here is a link stating the purchases of the BB: " edgarDOTsecDOTgov/Archives/edgar/data/1070494/000163859916000776/xslF345X03/doc4_3894DOTxml "


    Sentiment: Strong Buy

  • Reply to

    Baker Brothers are buying again

    by hawkihop1 Apr 2, 2016 5:44 PM
    galaberge galaberge Apr 3, 2016 7:50 PM Flag


  • ........(takes a little while to open post - a lot in here).

    Here is the link; " investorvillageDOTcom/smbd.asp?mb=523&mn=634&pt=msg&mid=13575176 "

    You will enjoy reading this excellent compilation. Enjoy and GLTA next coming days and weeks.

    Sentiment: Strong Buy

  • galaberge by galaberge Mar 26, 2016 4:24 PM Flag

    I quote "Fortune " and the link " fortuneDOTcom/2016/03/25/new-blockbuster-drugs-to-watch/ "

    7 New Blockbuster Drugs to Watch in 2016 by Laura Lorenzetti @lauralorenzetti March 25, 2016, 8:06 AM EDT

    "ACADIA Pharmaceuticals

    Drug: Nuplazid

    Indication: Parkinson’s disease psychosis

    2020 Forecast Sales: $1.41 billion

    ACADIA’s ACAD 0.30% nuplazid could be the first and only drug on the market to help treat Parkinson’s disease psychosis, which affects up to 40% of Parkinson’s patients. Clinical trials have shown that the drug does not worsen motor symptoms, a vital factor for these patients, while improving night-time sleep, daytime wakefulness, and caregiver burden. Nuplazid may also work in other psychosis settings, such as schizophrenia and Alzheimer’s disease psychosis. The combination of those three diseases means ACADIA’s drug has a potentially massive and therefore lucrative market."

    GLTA in the next days and weeks

    Sentiment: Strong Buy

  • Fourth-Quarter 2015 Net Sales of $244.5 Million, Up 135 Percent; Fourth-Quarter 2015 Adjusted EBITDA of $122.5 Million; GAAP Net Income of $24.0 Million; Fourth-Quarter 2015 Adjusted Operating Cash Flow of $154.0 Million; GAAP Operating Cash Flow of $134.9 Million; Full-Year 2015 Net Sales of $757.0 Million, Up 155 Percent; Full-Year 2015 Adjusted EBITDA of $362.1 Million; GAAP Net Income of $39.5 Million; Full-Year 2016 Net Sales Guidance of $1.025 to $1.050 Billion and Full-Year 2016 Adjusted EBITDA Guidance of $505 to $520 Million

    Sentiment: Strong Buy

  • galaberge galaberge Feb 19, 2016 3:28 PM Flag

    Mule-Excellent findings and explamations. Congrats


    Sentiment: Strong Buy

  • Aquinox is currently developing AQX-1125 as treatment in bladder pain syndrome/interstitial cystitis (BPS/IC)

    Potential market for BPS/IC is estimated to affect between 5 and 12 million people in the United States per year. Most BPS/IC patients continue to suffer this debilitating condition, despite treatment with existing therapies. Most current therapies and those in development are focused solely on symptomatic relief of BPS/IC.

    AQX-1125 could reach in U.S. alone peak revenue of $1.5-billion

    Pfizer and Johnson & Johnson own a significant amount in the company's shares.

    About AQX-1125

    All the clinical development utilize AQX-1125 tablets in an once-a-day dosing and has low plasma protein binding,being not metabolized and easily excreted unmetabolized in both urine and feces as per the first 7 clinical trials.

    -AQX-1125, Aquinox's lead drug candidate, is a small molecule activator of SHIP1, which is a regulating component of the PI3K cellular signaling pathway. By increasing SHIP1 activity

    -AQX-1125 accelerates a natural mechanism that has evolved to maintain homeostasis of the immune system and reduce immune cell activation and migration to sites of inflammation

    -AQX-1125 has demonstrated preliminary safety and favorable drug properties for once daily oral administration in multiple preclinical studies and seven completed clinical trials.

    Sentiment: Strong Buy

  • and is the first system that could be used by blood banks to destroy viruses and bacteria in donated blood plasma, potentially making transfusions safer.

    The U.S. Food and Drug Administration (FDA) has approved the INTERCEPT Blood System for platelets. The INTERCEPT platelet system is approved for ex vivo preparation of pathogen-reduced apheresis platelet components in order to reduce the risk of transfusion-transmitted infection (TTI), including sepsis, and to potentially reduce the risk of transfusion-associated graft versus host disease (TA-GVHD).

    The approval marks the first time that a system to inactivate pathogens in platelet components will be available in the United States. The FDA approved the INTERCEPT Blood System for plasma on December 16. The INTERCEPT systems for both plasma and platelets use the same illumination device, the same active compound (amotosalen) and very similar production steps.

    Long and strong CERS

    Sentiment: Strong Buy

  • “We are probably at a point where the individual company fundamentals matter,” she says. “We will see bifurcation: those with good fundamentals, a good pipeline, will continue to do well; the others less so.”

    “It will increasingly be a stockpicker’s market,” she adds

    That suits specialist investors such as Mr Borho. “Going into January, the biotech sector is not going to be a consensus long for generalist investors,” he says. “That’s a set-up I like, because there’s the opportunity for lots of surprise on the upside....”

    Long and strong HZNP

    Sentiment: Strong Buy

  • Reply to

    New gout treatment, Zurampic by AstraZeneca

    by shirazi2001us Dec 23, 2015 3:00 PM
    galaberge galaberge Dec 23, 2015 3:51 PM Flag

    Zurampic is not a competitor of

    Just check this :"An advisory committee to the US Food and Drug Administration (FDA) voted 10 to 4 to recommend lesinurad (Zurampic, AstraZeneca) 200 mg once daily for the treatment of gout-associated hyperuricemia, in combination with a xanthine oxidase inhibitor (XOI).

    The advisory committee voted unanimously that the company presented substantial evidence in favor of the drug's efficacy; the panel voted with narrow margins (7 yes, 6 no, 1 abstention) in favor of the drug's safety."The Committee's positive recommendation for lesinurad is an encouraging step for patients suffering from the debilitating effects of gout," Sean Bohen, MD, PhD, Executive vice president of Global Medicines Development and chief medical officer, AstraZeneca, said in a news release. "We look forward to the outcome of the FDA's review and the opportunity to provide a new treatment option that, when combined with a xanthine oxidase inhibitor, addresses both the under-excretion and over-production of uric acid, the underlying causes of gout."


    "The narrow therapeutic index of this drug really does concern me. If we have it out in general use, we're either going to learn that it's safe, or we'll learn that it's not safe and take it off the market later," said temporary voting committee member Peter J. Kaboli, MD, FACPP, FHM, from University of Iowa Carver College of Medicine and Iowa City Veterans Affairs Healthcare System, both in Iowa City, Iowa. Dr Kaboli said that he's concerned that it may help some patients but harm others. There were a total of 17 deaths...."

    Read carefully the full article: " medscapeDOTcom/viewarticle/853201 "

    Long and strong HZNP

    Sentiment: Strong Buy

14.27+0.43(+3.11%)Jul 22 4:00 PMEDT