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Kitov Pharmaceuticals Hldgs L Sponsored ADR (KTOV)

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Last Post: 10/19/2017 8:58:32 AM - Followers: 120 - Board type: Free - Posts Today: 2

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) 10/06/2017 09:24:06 AM
KTOV News: Report of Foreign Issuer (6-k) 10/02/2017 11:06:39 AM
KTOV News: Report of Foreign Issuer (6-k) 09/29/2017 04:33:34 PM
KTOV News: Report of Foreign Issuer (6-k) 08/16/2017 05:01:31 PM
KTOV News: Small Company Offering and Sale of Securities Without Registration (d) 08/08/2017 02:52:10 PM
#6099  Sticky Note KITOV INSTITUTIONAL OWNERSHIP EM 10/19/17 08:58:32 AM
#6097   Shorts and MM doing their things, let them EM 10/18/17 01:41:35 PM
#6096   Reminder of the tantalizing potential of TyrNovo's NT219: Millstone 10/17/17 02:34:58 PM
#6095   While people wasting their time celebrating an useless EM 10/14/17 05:23:37 AM
#6094   Right. And, since he was stocks that have nsomniyak 10/14/17 01:50:46 AM
#6093   Agree. However, way more often then not he rnoutlaw21 10/14/17 01:13:13 AM
#6092   Nah. Clay is meaningless to the long nsomniyak 10/14/17 12:46:36 AM
#6091   When clay shows up, sell immediately if long rnoutlaw21 10/13/17 08:58:52 PM
#6090   Thanks again for offering up KTOV as a cjf913913 10/13/17 04:33:56 PM
#6089   My take is that the fair price midastouch017 10/13/17 11:02:34 AM
#6088   Where did you come up with 70mm to scottsmith 10/13/17 10:13:22 AM
#6087   But that would have no impact on what zj3001 10/13/17 10:06:45 AM
#6086   you are paying the $3.78 to kitov though ylama3 10/13/17 08:54:25 AM
#6085   Imagine if they announce a deal with a EM 10/13/17 08:50:33 AM
#6084   Some elements of that. But, was almost RBNEWS 10/13/17 08:24:31 AM
#6083   We might have seen a p&d but we EM 10/13/17 03:56:41 AM
#6082   Once again you found a big gainer, yesterday, cjf913913 10/12/17 09:32:23 PM
#6081   $100m buyout is $5/share. Warrants=0 You would have to convert zj3001 10/12/17 07:16:42 PM
#6080   Buy out price divided by all shares/warrants = zj3001 10/12/17 07:12:18 PM
#6079   here is what i was looking for, this ylama3 10/12/17 06:03:07 PM
#6078   Same here. Congrats to those who had fun yesterday. Locke1 10/12/17 03:32:11 PM
#6077   Nice call, wake me up in 7 more months...zzzzz rnoutlaw21 10/12/17 01:40:28 PM
#6076   Under 20m ads zj3001 10/12/17 12:49:22 PM
#6075   Can someone post the most updated information with ylama3 10/12/17 12:41:55 PM
#6074   Link for the catalysts! EM 10/12/17 11:43:54 AM
#6073   For me personally, it's a hold. midastouch017 10/12/17 09:17:41 AM
#6072   Is this still a buy at this point Dcab 10/12/17 09:14:51 AM
#6071   Nice start of Premarket midastouch017 10/12/17 07:54:18 AM
#6070   Kitov Pharmaceuticals Holdings Ltd. (KTOV) After Hours Trading midastouch017 10/12/17 12:55:55 AM
#6069   Check out after hours action today on KTOVW. Wow!!!!! MTH4 10/11/17 10:58:32 PM
#6068   Is that so critical? FDA already accepted NDA application Amatuer17 10/11/17 10:16:46 PM
#6067   P3 Results imminent if positive this low float BioSpecialist 10/11/17 09:49:36 PM
#6066   If no news yes. rnoutlaw21 10/11/17 08:30:54 PM
#6065   Seems so - PDUFA date is May 2018 KT-219 Amatuer17 10/11/17 08:18:02 PM
#6064   Patience, indeed. I've had 10850 shares from 3/16 tominvb 10/11/17 05:09:52 PM
#6063   Buyout or big partner? Can't be the renal results rnoutlaw21 10/11/17 04:55:07 PM
#6062   * * $KTOV Video Chart 10-11-17 * * ClayTrader 10/11/17 04:42:50 PM
#6061   Patience. In the green. BOOOOOM rnoutlaw21 10/11/17 04:30:41 PM
#6060   KTOVW 66%. ash111 10/11/17 04:21:36 PM
#6059   ENJOY MY DEAR LONGS! WE REALLY DESERVE IT. We EM 10/11/17 04:08:30 PM
#6058   Kitov Pharma latest biotech breakout, shares up 37% midastouch017 10/11/17 03:21:34 PM
#6057   Is there any word on the street there nsomniyak 10/11/17 03:11:03 PM
#6056   Not too many, LOL, but very midastouch017 10/11/17 03:09:49 PM
#6055   You folks have a lot of holidays.....but I Locke1 10/11/17 03:00:43 PM
#6054   Certainly is a a big move on a nsomniyak 10/11/17 02:50:54 PM
#6053   Hard to say. It is Holiday Eve midastouch017 10/11/17 02:40:17 PM
#6052   Leak? Locke1 10/11/17 02:18:33 PM
#6051   Nice gains today! Glad to see this moving. Piton 10/11/17 02:17:49 PM
#6050   As i said: at least $2.50! midastouch017 10/11/17 02:15:10 PM
#6049   This has been the value accepted by TyrNovo EM 10/11/17 02:06:21 PM