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Kitov Pharmaceuticals Hldgs L Sponsored ADR (KTOV)

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Last Post: 9/13/2017 7:40:32 AM - Followers: 118 - 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 Updates on KIT-302 New Drug Application

Kitov expects that the formal filing of the NDA by the FDA will occur by the end of the third quarter of 2017.

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 Pharmaceuticals Initiates NDA Filing for KIT-302 as a Treatment for Osteoarthritis and Hypertension

On June 26th, Kitov Pharmaceuticals (NasdaqCM: KTOV) announced it has started assembling documents required for the NDA submission of its lead asset KIT-302. KIT-302 is a fixed dose combination of celecoxib plus amlodipine being developed as a treatment for patients who experience both osteoarthritis and hypertension. The Company hired Parexel International Corporation (NasdaqGS: PRXL) to digitalize and formally submit its NDA.Recall the Company completed a Phase III trial with KIT-302 in patients with hypertension and found that the therapy significantly reduced systolic pressure in the KIT-302 treatment arm compared to competing amlodipine treatment arm. Kitov expects to file an NDA for KIT-302 during the third quarter of 2017 and potentially receive FDA approval during the second quarter of 2018.

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) 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
KTOV News: Report of Foreign Issuer (6-k) 07/31/2017 05:29:27 PM
KTOV News: Report of Foreign Issuer (6-k) 07/18/2017 02:10:50 PM
KTOV News: Report of Foreign Issuer (6-k) 07/14/2017 04:48:30 PM
#5953   Thanks Amatuer17 09/13/17 07:40:32 AM
#5952   It is pretty clear here EM 09/13/17 07:37:22 AM
#5951   Actually dates for NDA are different -see below --- Many Amatuer17 09/13/17 07:09:42 AM
#5950   My pleasure. EM 09/12/17 04:35:21 PM
#5949   Thanks EM. So we should start to carp302 09/12/17 04:33:50 PM
#5948   NDA submitted on July 31, FDA takes 60 EM 09/12/17 04:30:58 PM
#5947   What's the estimated time frame of those? carp302 09/12/17 04:27:22 PM
#5946   Waiting for NDA acceptance (FDA formal filing) and EM 09/11/17 11:26:15 AM
#5945   Phase 3 drug Kit 302 NDA Submitted waiting stock1ace1 09/11/17 11:10:20 AM
#5944   Actually it's on the ABOUT section of every zj3001 09/05/17 08:32:33 AM
#5943   They have mentioned, and part of their presentation. zj3001 09/04/17 09:08:46 PM
#5942   Absolutely not. Fast track would have been mentioned by Amatuer17 09/03/17 10:17:05 AM
#5941   I believe they are going for fast track zj3001 09/03/17 10:02:35 AM
#5940   Many boards blame fda for delays but it Amatuer17 09/03/17 09:18:12 AM
#5939   Looking very good now in TASE midastouch017 08/30/17 09:40:56 AM
#5938   Yes indeed nice action, thanks for info. Doubletree 08/24/17 09:54:32 AM
#5937   Very nice action today in TASE: midastouch017 08/24/17 08:14:28 AM
#5936   Good. It's about time carp302 08/22/17 04:57:05 PM
#5935   Reversal pattern!!! homdance 08/22/17 10:49:51 AM
#5934   Agree. I still see value. Will RBNEWS 08/18/17 07:38:40 AM
#5933   But still, you really think this pill will zj3001 08/17/17 10:56:18 PM
#5932   Good point. Anyway they have been enough smart EM 08/17/17 01:57:15 PM
#5931   Agree. The market is going to have RBNEWS 08/17/17 01:26:55 PM
#5930   I hear you -- but my point is scottsmith 08/17/17 01:12:07 PM
#5929   I get that this will be a unique RBNEWS 08/17/17 01:04:51 PM
#5928   They announced major news on July 31. scottsmith 08/17/17 12:48:58 PM
#5927   We are Dealing with TEVA effect combined with RBNEWS 08/17/17 12:22:36 PM
#5926   A very quiet and lukewarm midastouch017 08/17/17 06:04:41 AM
#5925   Kitov Pharmaceuticals Provides Corporate Update and Reports First midastouch017 08/17/17 05:59:51 AM
#5924   Interesting time for company - the NDA approval Amatuer17 08/13/17 06:47:10 AM
#5922   Same to you. NDA has been delivered, so Locke1 08/07/17 07:56:32 AM
#5921   Nice uptick on TASE midastouch017 08/07/17 07:54:21 AM
#5920   Investigation brings uncertainty and panic to those who EM 08/07/17 07:53:23 AM
#5919   Me too. But those who sold in a Locke1 08/07/17 07:46:13 AM
#5918   Most sold in panic mode with a loss EM 08/07/17 07:36:01 AM
#5917   Investigation happened, do you really think that after EM 08/07/17 07:20:29 AM
#5916   Nevertheless, the drop was real. Probably a criminal act? Locke1 08/07/17 07:14:55 AM
#5915   More than a kick in the ass maybe EM 08/07/17 06:42:48 AM
#5914   Kitov says the investors have not provided "even EM 08/07/17 06:39:25 AM
#5913   Very interesting. Let the plaintiffs name names scottsmith 08/06/17 06:53:42 PM
#5912   Nice find on Stocktwits .... EM 08/06/17 03:39:21 PM
#5911   Patience will pay off here. Science works, approval Locke1 08/04/17 03:44:04 PM
#5910   It is extremely undervalued, can't figure out why tmeier 08/03/17 04:59:39 PM
#5909   You mean NDA? EM 08/03/17 10:14:54 AM
#5908   With IND filed and highly likely to be biotechnician 08/03/17 09:15:34 AM
#5907   My guess is within August. EM 08/03/17 08:40:10 AM
#5906   When? carp302 08/03/17 08:34:33 AM
#5905   Was expected in June, came in July. Expecting PR EM 08/02/17 10:06:37 AM
#5904   Completed July 21, why the delay? zj3001 08/02/17 10:04:01 AM
#5903   Nice find on ST. Renal study completed EM 08/02/17 09:39:46 AM