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Kitov Pharmaceuticals Holdings Ltd (KTOV.OQ)

KTOV.OQ on NASDAQ Stock Exchange Capital Market

2.31USD
15 Dec 2017
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Latest Key Developments (Source: Significant Developments)

Kitov pharmaceuticals announces receipt of FDA's favorable response to NT219's pre-ind meeting package
Wednesday, 1 Nov 2017 09:15am EDT 

Nov 1 (Reuters) - Kitov Pharmaceuticals Holdings Ltd :Kitov Pharmaceuticals announces receipt of FDA's favorable response to NT219's pre-ind meeting package.Kitov Pharmaceuticals - U.S. ‍FDA agreed to proposed Chemistry Manufacturing, Controls (CMC), preclinical, clinical development plans for NT219​.Kitov Pharmaceuticals Holdings Ltd - U.S. ‍FDA further agreed that one-month animal toxicology studies for NT219 would be sufficient to support ind​.Kitov Pharmaceuticals Holdings Ltd - U.S. ‍FDA further agreed that no toxicology studies of NT219 together with Gemcitabine would be necessary​.Kitov Pharmaceuticals Holdings Ltd - ‍expect to submit ind with FDA for NT219​ during first half of 2019.  Full Article

Kitov Pharmaceuticals announces phase III/IV clinical trial for KIT-302 successfully meets primary endpoint
Thursday, 26 Oct 2017 02:00pm EDT 

Oct 26 (Reuters) - Kitov Pharmaceuticals Holdings Ltd :Kitov pharmaceuticals announces phase iii/iv clinical trial for kit-302 successfully meets primary endpoint, and also demonstrates drug candidate improves renal function.Kitov pharmaceuticals holdings - ‍study demonstrated that treatment with kit-302 led to a statistically significant reduction of serum creatinine​.Kitov pharmaceuticals- ‍randomized double-blind, placebo-controlled renal function clinical trial for kit-302, met primary efficacy endpoint​.Kitov pharmaceuticals holdings ltd - ‍anticipates completion and submission of kit-302​ report to fda by january 2018.Kitov pharmaceuticals - ‍data from trial demonstrated kit-302 lowered systolic blood pressure a comparable amount to widely used antihypertension drug​.  Full Article

Kitov boosts ownership in Tyrnovo and Oncology platform
Friday, 6 Oct 2017 08:21am EDT 

Oct 6 (Reuters) - Kitov Pharmaceuticals Holdings Ltd :Kitov boosts ownership in Tyrnovo and Oncology platform through exchange of shares for stock.Kitov Pharmaceuticals Holdings Ltd - ‍Acquires an additional 27% ownership stake in Tyrnovo and NT219, its oncology therapeutic candidate​.Kitov Pharmaceuticals Holdings-‍After closing of transaction, Kitov will hold approximately 92% of Tyrnovo's issued and outstanding ordinary shares​.Kitov - ‍Acquires additional ownership stake in Tyrnovo and NT219 in exchange for Kitov stock at a value of $2.50 per ads​.Kitov - To acquire Tyrnovo shares from unaffiliated minority shareholders​ based on agreed upon Tyrnovo valuation of $7 million.  Full Article

Kitov posts filing by FDA of New Drug Application for KIT-302
Monday, 2 Oct 2017 07:00am EDT 

Oct 2 (Reuters) - Kitov Pharmaceuticals Holdings Ltd :Kitov announces filing by FDA of New Drug Application for KIT-302.Kitov Pharmaceuticals - co has set a target PDUFA date of May 31, 2018 to complete its substantive review​.  Full Article

Kitov submits new drug application to FDA for KIT-302
Monday, 31 Jul 2017 03:20pm EDT 

July 31 (Reuters) - Kitov Pharmaceuticals Holdings Ltd ::Kitov submits new drug application to FDA for KIT-302.Says ‍company expects that within 60 days FDA will determine whether NDA is complete and acceptable for filing​.Says on track to meet anticipated PDUFA dates with respect to FDA filing NDA in Q3 2017.Says on track to meet anticipated dates with respect to rendering decision on approval for marketing of KIT-302 during Q2 2018.  Full Article

Kitov announces results of study demonstrating NT-219 enhanced efficacy of keytruda in immune-oncology preclinical model
Tuesday, 18 Jul 2017 08:36am EDT 

July 18 (Reuters) - Kitov Pharmaceuticals Holdings Ltd ::Kitov announces results of study demonstrating NT-219 enhanced efficacy of keytruda in immune-oncology preclinical model.Kitov Pharmaceuticals Holdings-Mice treated concomitantly with combination of keytruda and NT-219 demonstrated complete blockage of tumor progression.Kitov Pharmaceuticals Holdings Ltd - no response was observed with keytruda alone or with NT-219 alone, and tumors aggressively progressed in study.  Full Article

Kitov Pharma enters agreements with investors
Tuesday, 11 Jul 2017 09:20am EDT 

July 11 (Reuters) - Kitov Pharmaceuticals Holdings Ltd :Kitov Pharmaceuticals - entered agreements with investors providing for issuance of 2.4 million ads at purchase price of $1.45 per ADS - SEC filing‍​.Kitov Pharmaceuticals - offering is expected to result in gross proceeds of approximately $3.5 million.  Full Article

Kitov Pharmaceuticals discloses additional details of Israeli Securities Authority investigation
Monday, 1 May 2017 11:43am EDT 

May 1 (Reuters) - Kitov Pharmaceuticals Holdings Ltd ::Investigation by Israeli Securities Authority related to data monitoring committee appointed in relation to KIT-302 phase III trial.Continuing with process of completing new drug application for KIT-302, which is expected to be submitted to FDA during Q2 2017.Company appointed independent statistician, orthopedist to serve as DMC to review preliminary results of initial patient group.ISA investigating circumstances surrounding actual dissemination of statistical analysis to members of DMC - SEC filing.ISA also investigating if dissemination of statistical analysis led to misleading disclosures in company's public filings - SEC filing."This matter had no impact whatsoever on the validity of the statistical analysis of the KIT-302 phase III clinical trial data".  Full Article

Kitov announces settlement agreement with minority shareholder of recently acquired Tyrnovo
Friday, 10 Feb 2017 12:23pm EST 

Kitov Pharmaceuticals Holdings Ltd : Kitov announces settlement agreement with minority shareholder of recently acquired Tyrnovo . As a result of settlement, we expect to be able to reduce financial resources required to be funded by Kitov in Tyrnovo . As part of settlement Kitov agreed to invest in Tyrnovo up to an aggregate amount of US$ 1.0 million . Settlement agreement between Kitov, Tyrnovo, minority shareholder of Tyrnovo was finalized and final ruling was issued by Israeli Court . As part of settlement minority shareholder agreed to invest in Tyrnovo up to an aggregate amount of US$ 1.75 million .Co,Tyrnovo, minority shareholder signed agreement dismissing all legal claims against co, Tyrnovo in connection with deal.  Full Article

Kitov provides further update on formal investigation by Israeli Securities Authority
Thursday, 9 Feb 2017 09:33am EST 

Kitov Pharmaceuticals Holdings Ltd : Kitov provides further update on formal investigation by israeli securities authority . Kitov is continuing with process of completing preparations for submitting a new drug application for kit-302 . To best of co's knowledge, focus of investigation is on data monitoring committee appointed in connection with phase iii trial of kit-302 . Expects nda for kit-302 to be submitted to u.s. Food and drug administration at end of q1 2017 . During isa investigations and enforcement proceedings, kitov's CEO, was detained and subsequently released on same day .Continuing with other ongoing activities, including ongoing research and development activities in connection with kit-302, tyrnovo's nt 219.  Full Article