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Kitov Pharmaceuticals Hldgs L Sponsored ADR (KTOV)

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Last Post: 9/21/2018 2:02:34 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

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) 09/19/2018 04:18:04 PM
KTOV News: Kitov Pharma Updates on Motions in USA Initiated by Kitov Chairman 09/18/2018 12:57:48 PM
KTOV News: Amended Report of Foreign Issuer (6-k/a) 09/17/2018 07:05:15 AM
KTOV News: Report of Foreign Issuer (6-k) 08/29/2018 08:01:57 AM
KTOV News: Kitov Pharma Provides Corporate Update and Reports First Half 2018 Financial Results 08/29/2018 08:00:00 AM
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#6634  Sticky Note Little Chart Update w/ Sabby Plunge finesand 09/21/18 12:57:09 PM
#6119  Sticky Note KITOV PHARMACEUTICALS - FULL DD EM 10/27/17 09:14:36 AM
#6635   Good summary of the possible catalysts in the EM 09/21/18 02:02:34 PM
#6634   Little Chart Update w/ Sabby Plunge finesand 09/21/18 12:57:09 PM
#6633   Little Chart & Value Overview finesand 09/20/18 12:22:39 AM
#6632   EM- yeah, Waymack is pretty p1ssed probably. finesand 09/20/18 12:01:58 AM
#6631   What is the future of this Co, with dream_maker 09/19/18 05:09:05 PM
#6630   That's a legit question. EM 09/19/18 10:25:30 AM
#6629   Why not just send them what they need zj3001 09/19/18 09:22:54 AM
#6628   Hopefully a non event. I personally think so too. midastouch017 09/19/18 08:34:54 AM
#6627   I fully support dr Waymack and Kitov. Two EM 09/19/18 04:44:36 AM
#6626   SEC assisting ISA's old Investigation for Information - finesand 09/18/18 10:19:51 PM
#6625   $2.04 for the EOW fwb 08/31/18 04:17:44 PM
#6624   Like to see $2.00 by Friday. fwb 08/29/18 06:27:12 PM
#6623   The real nice move will occur only if midastouch017 08/28/18 09:11:39 AM
#6622   Nice move today. Not great but in the fwb 08/27/18 10:56:21 PM
#6621   Sounds reasonable. Thanks for your input. EM 08/25/18 06:26:15 PM
#6620   (Edited) EM- 13F must disclose their complete stock holding finesand 08/25/18 06:25:04 PM
#6619   this should give the all clear signal? fwb 08/25/18 02:47:50 PM
#6618   Sabby filed 13G not 13F .... are you EM 08/24/18 07:47:29 AM
#6617   Thanks for sharing EM 08/24/18 04:17:48 AM
#6616   Sabby out; NASDAQ/TASE Divergence -8%; 9/9 Event finesand 08/23/18 07:29:55 PM
#6615   Or a Japanese or a European. Any one midastouch017 08/21/18 04:15:56 PM
#6614   So any upward move depends on an US Partnership? fwb 08/21/18 04:08:48 PM
#6613 midastouch017 08/21/18 02:05:17 PM
#6612   KTOV PR dated Feb 2016: Gil Ben-Menachem becomes VP of midastouch017 08/21/18 02:00:52 PM
#6611   FDA has had its short term upwards run midastouch017 08/21/18 01:53:11 PM
#6610   What is wrong with this Stock? fwb 08/21/18 01:44:29 AM
#6609   Thus far I see, US FDA approval on Consensi, Spideyboy 08/16/18 12:58:20 PM
#6608   Sure as it seemed FDA would have not EM 08/12/18 10:31:51 AM
#6607   Seems the people who matter do not consider Amatuer17 08/11/18 10:06:02 PM
#6606   Sad you are still sharing your ideas with EM 08/11/18 05:45:11 PM
#6605   They still have an approved FDA drug fwb 08/11/18 10:23:57 AM
#6604   I will repeat what I said before “ Everyone knows Amatuer17 08/11/18 10:03:51 AM
#6603   Market does not believe in this stock fwb 08/10/18 03:33:37 PM
#6602   It looks like no near-term catalysts is hurting EM 08/09/18 03:11:22 PM
#6601   Looks like they went out instead of in. fwb 08/03/18 04:13:49 PM
#6600   Lets see it the rush to buy shares fwb 08/03/18 01:20:42 PM
#6599   KTOV Evaluation Update finesand 08/01/18 11:24:33 PM
#6598   Wants to go above $2.00 but keeps getting fwb 08/01/18 05:33:30 PM
#6597   Very nice. Best result possible it seems scottsmith 07/30/18 09:31:29 AM
#6596   Kitov announces settlement! EM 07/30/18 08:10:15 AM
#6595   Stock should move higher if this was what fwb 07/29/18 06:12:05 PM
#6594   I sold some as well, still holding good EM 07/29/18 03:25:50 PM
#6593   EM- to be honest as you know, I finesand 07/29/18 01:50:45 PM
#6592   A17- the short after approval w/ Sabby along finesand 07/29/18 01:45:38 PM
#6591   First thing first - just because I express Amatuer17 07/29/18 10:21:06 AM
#6590   Can’t count how many times he has been EM 07/29/18 09:33:30 AM
#6589   A17- you are wrong again w/ your timing here finesand 07/29/18 08:59:32 AM
#6588   It is interesting to see that a company Amatuer17 07/29/18 07:13:41 AM
#6587   More probable the funds which have warrants at EM 07/29/18 06:26:53 AM
#6586   Settlement for Lawsuits Done finesand 07/29/18 12:07:33 AM