Kitov Pharma (KTOV) Reports FDA Filing for New Drug Application for KIT-302
- Dow, S&P futures inch higher as banks, energy stocks jump
- EV Company Polestar To Go Public Via $20 Billion SPAC Deal
- Amazon (AMZN) Price Target Lowered at Morgan Stanley Amid Rising Logistics Workforce Costs, Analyst Expects Stock to be Range Bound in Near Term
- Brent oil nears $80 a barrel amid supply constraints
- Some Apple (AAPL) and Tesla (TSLA) Suppliers Suspend Production in China For a Few Days
News and research before you hear about it on CNBC and others. Claim your 1-week free trial to StreetInsider Premium here.
Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV today announced that the U.S. Food and Drug Administration (FDA) filed the Company's New Drug Application (NDA) for KIT-302, its lead drug candidate, thereby accepting the NDA for a full review. KIT-302 is a patented combination of celecoxib and amlodipine, and is intended to treat osteoarthritis pain and hypertension simultaneously. In connection with its determination that Kitov's application is sufficiently complete to permit a substantive review, the FDA, under the Prescription Drug User Fee Act (PDUFA), has set a target date of May 31, 2018 to complete its review.
"The acceptance of filing of our NDA for KIT-302 represents a key achievement toward commercialization of our lead drug candidate. We intend to work closely with FDA as it reviews the NDA," stated J. Paul Waymack, M.D., Sc.D., Kitov's Chairman of the Board and Chief Medical Officer. "We look forward to FDA rendering a decision on approval for marketing of KIT-302 during the second quarter of 2018."
Dr. Waymack added, "We are extremely proud of the high-quality NDA package that has now been filed by FDA. We appreciate the hard work of our internal regulatory team in the preparation of NDA package, the participation of various clinics and hospitals in the United Kingdom in the trial, and the European Contract Research Organizations that collected, stored, and performed statistical analysis of the data. Most importantly, the data from KIT-302's pivotal Phase III clinical trial demonstrated that the study met its primary endpoint with statistical significance of p=0.001."
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Intra-Cellular Therapies (ITCI) Announces Publication of Lumateperone Pivotal Phase 3 Study in Bipolar Depression in The American Journal of Psychiatry
- Athenex (ATNX) Announces Phased European Launch of Klisyri for Treatment of Actinic Keratosis
- Phathom Pharmaceuticals Inc. (PHAT) Announces Results VONO-103 Phase 1 Trial
Create E-mail Alert Related CategoriesCorporate News, FDA, Hot Corp. News, Hot FDA News, Management Comments
Related EntitiesPDUFA, FDA
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!