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Kitov Pharmaceuticals Hldgs L Sponsored ADR (KTOV)

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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

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

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

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.



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.


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

“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

November 20, 2015 : Kitov Pharmaceuticals Holdings Announces Pricing of U.S. Initial Public Offering and NASDAQ Listing

October 21, 2015 : Kitov Pharma Announces Completion of Patient Recruitment for the Phase III Clinical Trial for KIT-302


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KTOV News: Report of Foreign Issuer (6-k) 04/13/2018 11:52:47 AM
KTOV News: Small Company Offering and Sale of Securities Without Registration (d) 03/26/2018 08:02:09 AM
KTOV News: Report of Foreign Issuer (6-k) 03/15/2018 04:57:58 PM
KTOV News: Report of Foreign Issuer (6-k) 03/08/2018 09:16:26 AM
KTOV News: Report of Foreign Issuer (6-k) 03/05/2018 09:51:29 AM
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#6119  Sticky Note KITOV PHARMACEUTICALS - FULL DD EM 10/27/17 09:14:36 AM
#6230   My point is - the fda meetings for Amatuer17 04/20/18 01:22:01 PM
#6229   Good find but don’t see how the two EM 04/20/18 12:52:37 PM
#6228   That is a real possibility Amatuer17 04/20/18 11:20:04 AM
#6227   It’s like Pfizer knows they are about to zj3001 04/20/18 09:58:57 AM
#6226   PDUFA is May 2018 - this committee does Amatuer17 04/20/18 08:50:44 AM
#6225   If you look at link below an analyst MTH4 04/18/18 03:42:19 PM
#6224   2017 has been a frustrating year for Kitov EM 04/18/18 09:02:50 AM
#6223   need to hurry 2020 not too far away Dollar Bill 04/17/18 02:25:03 PM
#6222   Agree, Consensi needs marketing validation and some upfront EM 04/17/18 04:25:34 AM
#6221   What’s your scenario for getting to $10 just scottsmith 04/15/18 09:07:24 AM
#6220   $10-$3.78 + time premium that market decides for zj3001 04/15/18 12:15:05 AM
#6219   Thanks so if we get to $10 on MTH4 04/14/18 10:03:29 PM
#6218   $3.78 zj3001 04/14/18 12:01:12 PM
#6217   TyrNovo’s NT219 #AACR2018 abstract!/4562/pr EM 04/14/18 10:47:20 AM
#6216   Does anyone recall the strike price for the MTH4 04/14/18 02:30:33 AM
#6215   Fingers crossed for the upcoming May PDUFA. MTH4 04/14/18 02:28:21 AM
#6214   TyrNovo to Present at 2018 Annual Meeting of EM 04/13/18 10:05:15 AM
#6213   I hope so as well! Good luck! EM 04/10/18 03:01:35 AM
#6212   I hope it does receive the green light glengold47 04/09/18 08:19:47 PM
#6211   Yes here the main points to consider .... EM 04/08/18 05:46:02 PM
#6210   From the filing 20-F: Points to Consider: glengold47 04/08/18 01:46:46 PM
#6209   $7,4mm cash .... i think they could if EM 03/14/18 09:56:36 AM
#6208   Any worries of possible near term dilution? I grizzly2314 03/14/18 09:33:54 AM
#6207   Problem is you can’t rx NSAIDs to pts EM 03/05/18 07:35:43 AM
#6206   I’m not getting your question: why you should EM 03/04/18 04:26:43 PM
#6205   Even with BB warning - the sale of Amatuer17 03/03/18 07:38:19 PM
#6204   Generic Celebrex has blackbox warning. Presumably Consensi will EM 03/03/18 01:00:10 PM
#6203   This is the big gamble - Celebrex generic Amatuer17 03/03/18 06:43:27 AM
#6202   Hopefully partnership too. Anythinggi 03/03/18 05:51:14 AM
#6201   KTOV - PDUFA date is May 31st for Amatuer17 02/23/18 05:46:47 PM
#6199   Form 13/G - Rosalind Master Fund LP bought EM 02/01/18 10:20:17 AM
#6198   Not amended but integrated. Top-line results still to be EM 01/30/18 08:04:11 AM
#6197   Would they need to PR that? I am grizzly2314 01/30/18 07:57:54 AM
#6196   Expecting PR related to completion and submission of EM 01/30/18 07:35:59 AM
#6195   As mentioned in my previous post (link back) EM 01/25/18 05:35:13 PM
#6194   thank you CynicalObserver 01/25/18 01:43:45 PM
#6193   $3.78 is the current exercise price. royzim 01/25/18 01:16:48 PM
#6192   what is the current strike price of KTOVW? CynicalObserver 01/25/18 12:35:48 PM
#6191   No zj3001 01/23/18 11:59:36 PM
#6190   Did we hear anything on the investigation? mathew633 01/23/18 12:36:05 PM
#6189   Nice day and nice volume. Entering into PDFUA EM 01/05/18 04:21:10 PM
#6188   The warrants will be exercisable on the six EM 01/04/18 06:40:18 PM
#6187   Warrants in the Money Exercisable 1/15 finesand 01/04/18 05:48:14 PM
#6186 EM 01/03/18 11:01:35 AM
#6185   If we are cleared we should get a mathew633 12/28/17 01:29:08 PM
#6184   Still is...but all BS. I can’t find any zj3001 12/28/17 01:27:44 PM
#6183   What a punch to the gut that was! mathew633 12/28/17 12:44:30 PM
#6182   Jan 15th ISA investigation is forced to conclude zj3001 12/28/17 12:42:53 PM
#6181   May 31st 2018 for CONSENSI PDFUA (And we have EM 12/28/17 12:34:08 PM