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Kitov Pharmaceuticals Hldgs L Sponsored ADR (KTOV)

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Last Post: 7/26/2017 5:01:42 AM - Followers: 118 - Board type: Free - Posts Today: 1




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
http://kitovpharma.investorroom.com/news-releases?item=50

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
http://kitovpharma.investorroom.com/download/KitovPresentation+June+2017+FINAL.pdf

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
https://baystreet.ca/articles/research_reports/lifesci/Kitov062717.pdf

 
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
http://kitovpharma.investorroom.com/news-releases?item=46

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.

 

Products

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.

Market

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
http://jewishbusinessnews.com/2015/12/16/kitov-pharmas-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
http://www.prnewswire.com/news-releases/kitov-pharmaceuticals-reports-additional-data-from-its-phase-iii-trial-on-the-beneficial-blood-pressure-effects-of-kit-302-300194664.html



November 20, 2015 : Kitov Pharmaceuticals Holdings Announces Pricing of U.S. Initial Public Offering and NASDAQ Listing
http://www.prnewswire.com/news-releases/kitov-pharmaceuticals-holdings-announces-pricing-of-us-initial-public-offering-and-nasdaq-listing-552301701.html



October 21, 2015 : Kitov Pharma Announces Completion of Patient Recruitment for the Phase III Clinical Trial for KIT-302
http://www.prnewswire.com/news-releases/kitov-pharma-announces-completion-of-patient-recruitment-for-the-phase-iii-clinical-trial-for-kit-302-535035241.html





 

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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
KTOV News: Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) 07/13/2017 05:29:10 PM
KTOV News: Report of Foreign Issuer (6-k) 07/13/2017 05:09:16 PM
KTOV News: Report of Foreign Issuer (6-k) 07/11/2017 09:04:44 AM
PostSubject
#5860   The sun is shining on TASE this morning.....very nice. Locke1 07/26/17 05:01:41 AM
#5859   this is just a guess - it may nsomniyak 07/25/17 02:15:00 PM
#5858   As I'am not an insider I have no Locke1 07/25/17 02:01:41 PM
#5857   any reason for the low insider ownership? madras50 07/25/17 01:49:47 PM
#5856   Could not more agree. It's time... Locke1 07/25/17 12:32:30 PM
#5855   The general trend however midastouch017 07/25/17 12:26:21 PM
#5854   Well, this sucks. Weird. Locke1 07/25/17 12:21:21 PM
#5853   Methinks KTOV is suffering an midastouch017 07/25/17 11:18:33 AM
#5852   Even more as i post! midastouch017 07/25/17 07:02:46 AM
#5851   10% up on heavy volume. Very nice Locke1 07/25/17 05:25:57 AM
#5850   Bullish move after recent financing.Limited downside risk from tmeier 07/24/17 02:40:28 PM
#5848   Well done, Sir Locke1 07/24/17 01:54:36 PM
#5847   Charts confirm a big upward move. Fundamentals very biotechnician 07/24/17 01:40:43 PM
#5846   See my previous #msg-133244748! midastouch017 07/24/17 01:06:40 PM
#5845   up she goes again BioSpecialist 07/24/17 12:57:51 PM
#5844   The ClayTrader effect worked midastouch017 07/24/17 10:19:28 AM
#5843   People think nasdaq follows tase. Tase still had zj3001 07/24/17 09:55:31 AM
#5842   What the heck is going on? Locke1 07/24/17 09:28:57 AM
#5841   Nice. ;-) Locke1 07/23/17 09:44:50 AM
#5840   Here we go: midastouch017 07/23/17 09:31:46 AM
#5839   Will be up 13-15% oil export 07/22/17 01:11:53 AM
#5838   * * $KTOV Video Chart Analysis 7/21/17 * * ClayTrader 07/21/17 05:53:26 PM
#5837   Hopefully uptrend continues next week.The NDA filing Should tmeier 07/21/17 04:49:50 PM
#5836   Another crazy trading session. Looking forward for TASE Locke1 07/21/17 04:32:50 PM
#5835   Yes amazing preclinical results on rats.Its a long tmeier 07/21/17 04:15:11 PM
#5834   So we wait for TASE on Sunday! midastouch017 07/21/17 12:39:21 PM
#5833   I'm sorry, but in Israel the stock fell oil export 07/21/17 12:35:13 PM
#5832   Kitov clawing back from equity offering-related down move; midastouch017 07/21/17 12:10:18 PM
#5831   KTOV's drug combined with MRK's Keytruda had AMAZING biotechnician 07/21/17 12:04:56 PM
#5828   Hit $2 today and market cap is still BioSpecialist 07/21/17 10:55:55 AM
#5827   With no Claytrader in midastouch017 07/21/17 10:13:57 AM
#5826   On fire $$ stock1ace1 07/21/17 10:02:29 AM
#5825   Too much to say for helping you to EM 07/21/17 09:08:22 AM
#5824   If so, why were they diluted at 1.45 oil export 07/21/17 08:50:11 AM
#5823   What would be a good buy in price Wyldone87 07/20/17 08:59:17 PM
#5821   The $2 Mark is coming closer and closer BioSpecialist 07/20/17 03:26:20 PM
#5820   Very Undervalued,I think the market is waiting for tmeier 07/20/17 12:07:54 PM
#5819   Up 7% looking good so far BioSpecialist 07/20/17 11:21:36 AM
#5818   I expect NDA submission within this month. FDA EM 07/20/17 10:12:48 AM
#5817   6-26-17 PR, KTOV expects that the formal filing stock1ace1 07/20/17 10:08:17 AM
#5816   Let's hope KTOV doesn't have to do a tmeier 07/19/17 07:56:59 PM
#5815   Yeah. Sold at 1.86 and thought it was Locke1 07/19/17 02:24:46 PM
#5814   Watch AEZS move today after NDA resubmission thats BioSpecialist 07/19/17 02:23:17 PM
#5813   Question marks are the sunglasses emoji...lol Locke1 07/19/17 02:15:04 PM
#5812   So why your question marks? midastouch017 07/19/17 02:01:33 PM
#5811   Same here.....?? Locke1 07/19/17 01:59:33 PM
#5810   For this reason i am chewing midastouch017 07/19/17 12:34:37 PM
#5809   FDA Approval News To Submit NDA For Kit302 stock1ace1 07/19/17 12:24:35 PM
#5808   This is history in the making!!! midastouch017 07/19/17 11:29:10 AM
#5807   Actually float available is less than 8mm ADSs EM 07/19/17 10:17:28 AM
PostSubject