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

Discussion in 'Stock Message Boards NYSE, NASDAQ, AMEX' started by Biotechmaster, Jul 18, 2017.

  1. Biotechmaster

    Biotechmaster Member

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    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. Biotechmaster

    Biotechmaster Member

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  3. Biotechmaster

    Biotechmaster Member

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    An older article but nice one which shows the massive potential here

    https://seekingalpha.com/article/3939596-kitov-pharmaceuticals-bullish-valuation-based-comparables

    Conclusion

    In my original article, I ballparked KTOV's valuation at $22.50 per share. That valuation assumed KTOV took KIT-302 to market on its own and therefore, included additional equity financings and a concomitant higher share count on which to base the per share price. It also assumed a weaker marketing capability and therefore, lower peak sales. In this article, I've estimated KTOV's valuation on the idea that it sells KIT-302 to a large pharmaceutical company and I've provided some comparables to ground this valuation. (Nonetheless, there are a lot of assumptions here, particularly the peak sales numbers and the DCF inputs.) The comparable valuation method gives a share price target range of $13 to $29 per share, which corroborates the initial $22.50 per share target. As a result, I continue to hold KTOV as one of my favorite longs, and am hoping for a big payoff within the next four years or so. Indeed, after performing this research, I think it's likely that one of the companies mentioned in the article will buy KTOV sooner rather than later - with Pfizer (Celebrex's developer) being my front-running candidate.
     
  4. Biotechmaster

    Biotechmaster Member

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    it could hit $2+ quickly if it breaks the MA(50) at $1.70

    [​IMG]
     
  5. Biotechmaster

    Biotechmaster Member

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    Hit $2 today and market cap is still very low with $22 milion which is close to cash balance of $17 million
     
  6. Biotechmaster

    Biotechmaster Member

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    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
    --------


    “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/
     
  7. Biotechmaster

    Biotechmaster Member

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    Love the huge Potential here especially because of its dirt low valuation of only $21 Million .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.
     
  8. Biotechmaster

    Biotechmaster Member

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    nice run today , phase 3 results coming anytime now
     
  9. MiguelHammond10

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    Share an idea on KTOV won't sell until price target of 8.50 is hit.
     

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