Repros says testosterone drug meets main goals of second key study
Sept 17 (Reuters) - Shares of Repros Therapeutics Inc jumped 33 percent, a day after the company said its experimental drug Androxal met the main goals of a key study on men with low testosterone levels.
The drug increased testosterone levels and sperm concentration in patients with secondary hypogonadism, caused when parts of the brain that stimulate the testicles to produce testosterone don't work properly.
Repros said 81 percent of patients enrolled in the late-stage trial had normalized levels of testosterone after taking the drug, higher than the U.S. Food and Drug Administration's prescribed threshold of 75 percent.
The results were almost identical to those of a previous study reported in May, the company said.
Repros said the drug was well tolerated in a separate safety study. The company said 28 of 499 patients enrolled dropped out due to adverse events, which were mild to moderate and included upper respiratory tract infections and headaches.
There was one serious adverse event that could be related to Androxal, the company said. A patient developed thromboembolism, an obstruction of the blood vessel by a clot.
Repros said it was on track to file a marketing approval application for the drug in mid-2014. The company said it expects the drug to be approved in 2015.
The stock jumped to $28.30, its highest in four years, in morning trade on the Nasdaq. It was up 25.7 percent at $26.73.
Over 3.4 million shares had changed hands by 11:05 a.m. ET, more than six times their 10-day average volume.
(Reporting By Vrinda Manocha in Bangalore; Editing by Kirti Pandey)