The Kitov Pharmaceutical Holdings Ltd. (TASE: KTOV)(Nasdaq: KTOV) share price leaped 50% today, after the company reported success in a trial of a drug it is developing.
The company's announcement indicates that a statistical analysis of the interim Phase III trial results for KIT-302, a drug for relieving osteoarthritic pain and hypertension, found that the main goal of the trial had been fully achieved, with significant statistical results.
Because the trial target was fully achieved, there is no need to recruit additional patients, and the trial results have been declared final. The company plans to submit the drug for FDA approval in the second half of 2016.
Kitov CEO Isaac Israel said, "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… We are very pleased with the successful and final outcome of our pivotal Phase III trial and we look forward to meeting with the FDA in the near future to finalize plans for our NDA submission. We believe we will be ready to submit the NDA for KIT-302 in the second half of 2016. Should the NDA meet with the FDA's approval, we would expect to receive marketing approval in 2017."
Published by Globes [online], Israel business news - www.globes-online.com - on December 15, 2015
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