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Kitov Pharmaceuticals Hldgs L Sponsored ADR (KTOV)

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Last Post: 7/16/2018 12:11:51 PM - Followers: 117 - Board type: Free - Posts Today: 0




Kitov Pharma (KTOV)

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

Shares Out: 10.6 Million


Kitov Announces FDA Acceptance of NDA for KIT-302..........October 3, 2017
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

¦Additional marketing agreements for the distribution of KIT-302
¦Q4 2017 – Top-line results from Phase III kidney function trial.
¦Q2 2018 – Expected FDA approval decision for KIT-302.




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 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.

 

Products

Kitov’s current pipeline products, KIT-301 and KIT-302, are combination drugs that treat OA pain and HTN simultaneously. In December 2015, KIT-302 successfully achieved the primary efficacy endpoint for its Phase III clinical trial. In August 2016, the United States Patent Office issued a patent covering KIT-302.

Market

Of the 27 million Americans with OA, 50% also suffer from HTN, which is also a common side effect of stand-alone OA drugs. With no single medication currently treating both conditions, KIT-301 and KIT-302 are targeting this multi-billion dollar market.



Kitov Pharma’s Arthritis Drug Meets Main Goal in Late-Stage Study
http://jewishbusinessnews.com/2015/12/16/kitov-pharmas-arthritis-drug-meets-main-goal-in-late-stage-study/

“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.





Dec. 17, 2015 :  Kitov Pharmaceuticals Reports Additional Data from its Phase III Trial on the Beneficial Blood Pressure Effects of KIT-302
http://www.prnewswire.com/news-releases/kitov-pharmaceuticals-reports-additional-data-from-its-phase-iii-trial-on-the-beneficial-blood-pressure-effects-of-kit-302-300194664.html



November 20, 2015 : Kitov Pharmaceuticals Holdings Announces Pricing of U.S. Initial Public Offering and NASDAQ Listing
http://www.prnewswire.com/news-releases/kitov-pharmaceuticals-holdings-announces-pricing-of-us-initial-public-offering-and-nasdaq-listing-552301701.html



October 21, 2015 : Kitov Pharma Announces Completion of Patient Recruitment for the Phase III Clinical Trial for KIT-302
http://www.prnewswire.com/news-releases/kitov-pharma-announces-completion-of-patient-recruitment-for-the-phase-iii-clinical-trial-for-kit-302-535035241.html





 

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KTOV News: Securities Registration (foreign Private Issuer) (f-3) 07/16/2018 05:25:54 PM
KTOV News: Report of Foreign Issuer (6-k) 06/27/2018 09:29:16 AM
KTOV News: Report of Foreign Issuer (6-k) 06/18/2018 07:20:07 AM
KTOV News: Report of Foreign Issuer (6-k) 06/15/2018 11:38:29 AM
KTOV News: Statement of Ownership (sc 13g) 06/11/2018 05:28:31 PM
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#6119  Sticky Note KITOV PHARMACEUTICALS - FULL DD EM 10/27/17 09:14:36 AM
#6561   Again, for a BT that got Approval it's fwb 07/16/18 12:11:50 PM
#6560   I think there will be a settlement EM 07/13/18 09:43:37 AM
#6559   Bogus lawsuit final response date was 7/12 we bUrRpPPP! 07/13/18 07:49:59 AM
#6558   I honestly fail to see how can someone EM 07/12/18 08:48:19 AM
#6557   I might play the bear every once and zj3001 07/12/18 08:42:58 AM
#6556   Exactly but unfortunately in these public boards where EM 07/12/18 02:46:25 AM
#6555   I see just the opposite. Big hype on zj3001 07/11/18 08:59:30 PM
#6554   The point is if a BT gets FDA fwb 07/11/18 04:33:30 PM
#6553   Here you go. DD at your finger tips. Enjoy. https://www.biopharmcatalyst.com/ca zj3001 07/11/18 01:16:52 PM
#6552   I’m not sure the point of your reply. zj3001 07/11/18 01:15:08 PM
#6551   Lol rdhl .... doesn’t make any sense for EM 07/11/18 06:31:17 AM
#6550   The combination is patented - the drug is Amatuer17 07/11/18 06:22:26 AM
#6549   Insane that you are here since decades (we EM 07/11/18 02:37:12 AM
#6548   You are right - getting any drug approved Amatuer17 07/10/18 08:58:43 PM
#6547   TXMD The company has recently received FDA approval for fwb 07/10/18 04:47:56 PM
#6546   Txmd DOVA Those two come to mind as they zj3001 07/10/18 03:34:28 PM
#6545   "I could give you several examples about stock fwb 07/10/18 10:24:57 AM
#6544   Lol .... could be .... At least with a EM 07/09/18 11:04:54 AM
#6543   I meant the revenue from the Chinese upfront midastouch017 07/09/18 11:00:48 AM
#6542   I meant just approved in US but no EM 07/09/18 10:48:20 AM
#6541   "An approved drug but not revenues" There are midastouch017 07/09/18 10:46:24 AM
#6540   I could give you several examples about stock EM 07/09/18 10:36:12 AM
#6539   You make no sense. To get FDA approval fwb 07/09/18 10:32:10 AM
#6538   What you says doesn’t make any sense. EM 07/09/18 10:25:47 AM
#6537   You are correct, but don't say its a fwb 07/09/18 10:19:31 AM
#6536   Market is a democracy, you can sell buy EM 07/09/18 10:14:55 AM
#6535   Dead Money. fwb 07/09/18 09:55:35 AM
#6534   So far you are correct fwb 07/06/18 11:06:03 AM
#6533   Agree, up and down until US deal, hopefully EM 07/06/18 07:00:35 AM
#6532   Heard business update - nothing great 1. Received $1 Amatuer17 07/05/18 10:16:37 PM
#6531   Funds can manipulate wherever they want/like and they EM 07/04/18 03:50:28 AM
#6530   fwb- more like Sabby doing their asking. finesand 07/04/18 12:27:24 AM
#6529   Wish they would just sell the company and MTH4 07/02/18 08:49:39 PM
#6528   -----------------------------INDICATIONS AND USAGE--------------------------- CO EM 07/02/18 02:36:28 PM
#6527   There is a black box warning, however they Millstone 07/02/18 12:09:13 PM
#6526   I think the labeling is still confusing. They zj3001 07/02/18 12:03:07 PM
#6525   I guess the Market didn't like what they fwb 07/02/18 10:21:26 AM
#6524   Hope it is positive news - the tone Amatuer17 06/28/18 07:34:40 AM
#6523   Relax EM 06/28/18 04:46:58 AM
#6522   Should see higher PPS by Friday fwb 06/27/18 11:22:09 PM
#6521   Efforts are appreciated, inking a US partnership midastouch017 06/27/18 10:45:59 AM
#6520   Here is the Link fwb 06/27/18 10:39:11 AM
#6519   Efforts by KTOV to finalise US commercialization partnerships midastouch017 06/27/18 09:38:23 AM
#6517   Doesn't seem this stock is going anywhere for fwb 06/25/18 09:59:08 AM
#6516   That makes sense, this stock should have added fwb 06/21/18 09:50:03 PM
#6515   There is not much demand for the combo Amatuer17 06/21/18 09:21:18 PM
#6514   xtra true <- NT219 with p > 0.01 RollingWithTheFDA 06/21/18 06:00:25 PM
#6513   Upon receipt of marketing authorization in China, Changshan EM 06/21/18 04:39:04 PM
#6512   Dexcel in Israel. In China Changshan Biochemical. In South-Korea Kunhil. In EM 06/21/18 04:36:02 PM
#6511   Who's manufacturing it bmrobinson88 06/21/18 04:32:32 PM
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