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Kitov Pharmaceuticals Holdings Ltd (KTOV.OQ)

KTOV.OQ on NASDAQ Stock Exchange Capital Market

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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 

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

Kitov Pharmaceuticals Holdings Ltd reports additional data from its phase iii trial on the beneficial blood pressure effects of KIT-302
Thursday, 17 Dec 2015 

Kitov Pharmaceuticals Holdings Ltd:Reports additional data from its phase iii trial on the beneficial blood pressure effects of KIT-302.Says phase III study successfully met the primary efficacy endpoint.Determined blood pressure reduction synergy seen in combining celecoxib, amlodipine present in other blood pressure variables.  Full Article

Kitov Pharmaceuticals Holdings Ltd's pivotal phase III trial successfully meets primary efficacy endpoint
Tuesday, 15 Dec 2015 

Kitov Pharmaceuticals Holdings Ltd:Announced that the Phase III, double-blind, placebo-controlled clinical trial for its leading drug candidate, KIT-302, successfully met the primary efficacy endpoint of the trial protocol as approved by the U.S. Food & Drug Administration.Data from the trial further revealed that KIT-302 was more efficacious at reducing hypertension than the widely used hypertension drug amlodipine besylate.  Full Article