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Kitov Pharmaceuticals Hldgs L Sponsored ADR (KTOV)

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Last Post: 12/15/2017 8:02:10 AM - Followers: 119 - 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) 12/14/2017 04:04:41 PM
KTOV News: Report of Foreign Issuer (6-k) 12/04/2017 04:17:59 PM
KTOV News: Report of Foreign Issuer (6-k) 11/29/2017 10:47:52 AM
KTOV News: Report of Foreign Issuer (6-k) 11/07/2017 04:17:46 PM
KTOV News: Report of Foreign Issuer (6-k) 11/01/2017 04:52:10 PM
#6119  Sticky Note KITOV PHARMACEUTICALS - FULL DD EM 10/27/17 09:14:36 AM
#6173   The Company has applied to the United States midastouch017 12/15/17 08:02:10 AM
#6172   Another step in the right direction. midastouch017 12/14/17 10:36:06 AM
#6171   Nice! As mentioned in my full DD, this EM 12/14/17 10:30:06 AM
#6170   Thanks for the thoughts! scottsmith 12/14/17 10:13:44 AM
#6169   Kitov Announces Consensi™ as Brand Name for KIT-302 midastouch017 12/14/17 09:44:25 AM
#6168   Ktov $2.10 stock1ace1 12/07/17 11:06:20 AM
#6167   My guess is deal (not sure what kind EM 12/07/17 02:19:09 AM
#6166   Any new thoughts regarding timing on partnership or scottsmith 12/06/17 08:18:45 PM
#6165   New presentation here. Very nice job. EM 11/29/17 11:17:42 AM
#6164   * * $KTOV Video Chart 11-21-17 * * ClayTrader 11/21/17 05:06:09 PM
#6163   This indeed is usually the case, midastouch017 11/21/17 11:52:43 AM
#6162   It never stays this high It will come down Amatuer17 11/21/17 11:34:19 AM
#6161   Kitov Pharmaceuticals up 20% premarket midastouch017 11/21/17 08:36:27 AM
#6160   KTOV running up pre-market [SMART MONEY] 11/21/17 08:33:41 AM
#6159   Very nice! Very cheap at this pps! EM 11/21/17 07:44:20 AM
#6158   H.C. Wainright initiates coverage and a buy with Endorfinaholic 11/21/17 07:33:25 AM
#6157   Some good action this morning, what don’t we know? doncamel 11/21/17 07:17:42 AM
#6156   SHARE STRUCTURE UDPATE EM 11/14/17 05:04:32 AM
#6155   Not random at all - tHink of Happy nsomniyak 11/07/17 08:59:34 PM
#6154   That's one of the most random rules I've Endorfinaholic 11/07/17 08:45:26 PM
#6153   If you aren’t a premium member, you can scottsmith 11/07/17 08:29:42 PM
#6152   How can I send you a private message. Endorfinaholic 11/07/17 08:12:08 PM
#6151   My pleasure. EM 11/07/17 03:58:03 AM
#6150   Thx - tried few sources but not getting Amatuer17 11/06/17 10:32:55 PM
#6149   Check my DD, point 6) Tutes now owning 38% EM 11/03/17 07:29:51 AM
#6147   See this link - it shows all data Amatuer17 11/03/17 07:23:15 AM
#6146   Their interest is actual. We saw a concrete EM 11/02/17 11:49:40 AM
#6145   American bulls ~> stock1ace1 11/02/17 08:35:18 AM
#6144   Huge bid @$2.24 ~ wowzer stock1ace1 11/02/17 07:38:24 AM
#6143   So when will the US institutional interest be scottsmith 11/02/17 06:56:35 AM
#6142   NICE SUMMARY BY DR. WAYMACK EM 11/02/17 05:57:32 AM
#6141   They are being responsible and not hyping timelines. Millstone 11/01/17 08:45:31 PM
#6140   Yes - that os good news but look Amatuer17 11/01/17 08:41:56 PM
#6139   Phase 3 drug “kit302” is PENDING for approval stock1ace1 11/01/17 01:17:11 PM
#6138   Today's news is superb. If you look at Millstone 11/01/17 01:15:59 PM
#6137   Let them play with the “weak hands” investors EM 11/01/17 11:41:47 AM
#6136   It seems shorts trying to bring it down stock1ace1 11/01/17 11:34:42 AM
#6135   *** FDA News Out Today ~> Kitov Pharmaceuticals stock1ace1 11/01/17 10:50:57 AM
#6134   Pending FDA approval for Phase 3 Drug Kit302 stock1ace1 11/01/17 10:49:58 AM
#6133   Kitov Pharmaceuticals Announces Receipt of FDA's Favorable Response EM 11/01/17 09:25:12 AM
#6132   You're Welcome. midastouch017 10/31/17 12:46:17 PM
#6131   Thx for sharing! Locke1 10/31/17 12:35:29 PM
#6130   Kitov Pharmaceuticals: An Update midastouch017 10/31/17 12:23:22 PM
#6129   A great overview for newbies! Thanks for your Ironman1106 10/29/17 02:22:38 AM
#6128   Wow. Well said. It Actually got RBNEWS 10/28/17 04:47:47 PM
#6127   Very nice DD, thanks EM 10/28/17 03:39:02 PM
#6126   KIT-302 / (ENSEDAPINE or CONSENSI) will be the Endorfinaholic 10/28/17 11:58:29 AM
#6125   Haha, this would be great. lol rofl Locke1 10/28/17 02:23:24 AM
#6124   Or we could have a bunch of idiots zj3001 10/27/17 02:17:21 PM
#6123   Yep. Lol. The amount of flippers is insane zj3001 10/27/17 02:14:41 PM