Edition:
United Kingdom

Kitov Pharmaceuticals Holdings Ltd (KTOV.OQ)

KTOV.OQ on NASDAQ Stock Exchange Capital Market

2.02USD
3:43pm GMT
Change (% chg)

$-0.01 (-0.49%)
Prev Close
$2.03
Open
$2.03
Day's High
$2.04
Day's Low
$2.01
Volume
11,419
Avg. Vol
68,136
52-wk High
$3.49
52-wk Low
$1.27

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 

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 

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 Pharmaceuticals files for mixed shelf of up to $200 mln
Monday, 12 Dec 2016 

Kitov Pharmaceuticals Holdings Ltd :Kitov pharmaceuticals holdings ltd - files for mixed shelf of up to $200 million - sec filing.  Full Article

Kitov's KIT-302 meets FDA bioequivalence standards for 2.5 mg amlodipine dose
Tuesday, 27 Sep 2016 

Kitov Pharmaceuticals Holdings: Reports successful results for additional KIT302 pharmacokinetic bioequivalence study . KIT-302 successfully meets U.S. Food and Drug Administration bioequivalence standards for 2.5 mg amlodipine dose .Working towards submitting new drug application to FDA for KIT-302 "as planned".  Full Article

Kitov announces issuance of U.S. patent securing long-term exclusivity for KIT-302
Wednesday, 10 Aug 2016 

Kitov : Term exclusivity for KIT-302 ahead of new drug application to the FDA .Company expects to submit KIT-302 for a new drug application to U.S. FDA by end of 2016.  Full Article

Kitov Pharmaceuticals announces pricing of $12 mln follow-on public offering
Wednesday, 29 Jun 2016 

Kitov Pharmaceuticals Holdings Ltd : Kitov pharmaceuticals announces pricing of $12 million follow-on public offering in the U.S.A. . Kitov Pharmaceuticals says pricing for its public offering of 2.4 million Class A units, with each Class A unit consisting of one American Depositary Share, . Kitov Pharmaceuticals Holdings Ltd says each class a unit will be sold at a negotiated price of $3.40 per unit, including ADS issuance fee of $0.01 per ADS . Plans to use net proceeds to fund possible acquisition of new therapeutic candidates . Says each Class B unit will be sold at a negotiated price of $3.40 per unit, including pre-listed, pre-funded warrant to purchase one ads .Funded warrant exercise price of $0.01 per full ADS.  Full Article

Kitov completes manufacture of pivotal batches for FDA registration of KIT-302
Friday, 27 May 2016 

Kitov Pharmaceuticals Holdings Ltd : Announces completion of manufacturing by Dexcel Pharma of pivotal batches required for registration of KIT-302 with U.S. FDA .Plans to file New Drug Application for KIT-302 with U.S. FDA at end of 2016.  Full Article

Kitov receives pre-NDA meeting response from FDA for KIT-302
Thursday, 12 May 2016 

Kitov Pharmaceuticals Holdings Ltd : Receives pre-NDA meeting response from FDA for KIT-302, supporting its NDA submission . Kitov is on track to submit NDA for marketing approval of KIT-302 by end of 2016 .FDA confirmed advisory committee review should not be required for review, and FDA may accept 6 months data of long term stability.  Full Article