KTOV (MC $16 M) (Cash $17 M) US-NDA for Big Drug this Quarter

Discussion in 'Stock picks and trading strategies' started by DollarChamp, Jul 18, 2017.

  1. DollarChamp

    DollarChamp Member

    Another very hot and heavily undervalued FDA Gem ...

    KTOV (MC $16 M) (Cash $17 M) US-NDA Submission for their osteoarthritis pain and hypertension drug exptected this Quarter. This ultra low float stock will be one of the hottest and most underpriced FDA play i ever have seen in last 20 years in stock trading. KTOV has really more than 10 bagger potential the stock is trading at cash level and the valuation is ONLY $16 Million i cant believe it but please do your own dd and realize the brutal potential here .GL


    Kitov Pharma (KTOV)

    Market Cap: $16 Million
    Cash $17 Million
    Price: $1.44

    Shares Out: 10.6 Million


    Kitov Updates on KIT-302 New Drug Application http://kitovpharma.investorroom.com/news-releases?item=50

    Kitov expects that the formal filing of the NDA by the FDA will occur by the end of the third quarter of 2017.


    Presentation June 2017
    http://kitovpharma.investorroom.com/download/KitovPresentation+June+2017+FINAL.pdf

    KIT-302 is a combination drug that treats osteoarthritis pain and hypertension simultaneously

    Primary efficacy endpoint achieved Lead drug candidate KIT-302 achieved its primary efficacy endpoint in a pivotal Phase III trial

    Marketing potential Pipeline candidates address large, multi-billion dollar markets




    Kitov Pharmaceuticals Initiates NDA Filing for KIT-302 as a Treatment for Osteoarthritis and Hypertension
    https://baystreet.ca/articles/research_reports/lifesci/Kitov062717.pdf

    Kitov Expects to Submit an NDA for KIT-302 in the Third Quarter 2017.Kitov announced that it began the process of compiling the documents necessary to file an NDA for its lead asset KIT-302 as a treatment for patients who experience both osteoarthritis and hypertension. The Company hired Parexel International Corporation, a clinical research organization, to digitalize and formally submit its NDA application. Kitov expects the filing to occur during the third quarter of 2017, with a potential FDA approval during the second quarter of 2018.



    Kitov Received a $2 Million Filing Waiver from FDA http://kitovpharma.investorroom.com/news-releases?item=46

    Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV, TASE: KTOV), an innovative biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Kitov a waiver related to the $2,038,100 New Drug Application (NDA 210045) filing fee for KIT-302. KIT-302 is Kitov's patented combination of Amlodipine Besylate-Celecoxib tablets, intended to treat osteoarthritis pain and hypertension simultaneously.
     
  2. DollarChamp

    DollarChamp Member

  3. DollarChamp

    DollarChamp Member

    Can you believe that this low float stock has a terrible low valuation of just $21 million which is very close to the cash balance of $17 million ? This one could be a very very hot FDA play for the coming months .GL
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    “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. 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.”

    Pain medications for osteoarthritis account for billions of dollars in annual sales globally. Most pain medications for osteoarthritis, including celecoxib which had global sales of $2.7 billion in 2014, are non-steroidal anti-inflammatory drugs (NSAIDs) which have the side effect of elevating blood pressure, and increasing the risk of heart attacks, strokes and death. Of the 27 million Americans who live with osteoarthritis, 13.5 million also suffer from hypertension, which also increases the risk of heart attack, stroke, and death.

    http://jewishbusinessnews.com/2015/...tis-drug-meets-main-goal-in-late-stage-study/
     
  4. DollarChamp

    DollarChamp Member

    Still a dirt cheap stock with huge upside potential ...GL

    Kitov Announces FDA Acceptance of NDA for KIT-302
    https://www.baystreet.ca/articles/research_reports/lifesci/Kitov100317.pdf

    KIT-302 is a Treatment for Hypertension and Osteoarthritis Pain.
    KIT-302 is a fixed dose combination drug comprised of the nonsteroidal anti-inflammatory drug (NSAID)celecoxib, and the well-known antihypertensive agent, amlodipine besylate. Celecoxib
    monotherapy often leads to hypertension, which if uncontrolled, can increase the risk of heart attack and stroke. KIT-302 is designed to provide a solution for physicians who avoid prescribing NSAIDs for osteoarthritis pain due to their hypertensive side effects. There is currently no single drug for the treatment of pain and hypertension, so, if approved, KIT-302 could be a unique product in the multibillion-dollar osteoarthritis market.

    Expected Upcoming Milestones

    ■Q4 2017 – Top-line results from Phase III kidney function trial.
    ■Q2 2018 – Expected FDA approval decision for KIT-302.
     
  5. DollarChamp

    DollarChamp Member

    nice run today , phase 3 results coming anytime now
     
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