NEW YORK (AP) -- Shares of Repros Therapeutics jumped Thursday after the company said it doesn't think it will have to run additional safety studies of its testosterone drug Androxal.
After a meeting with the Food and Drug Administration, Repros said it is still on pace to file for approval of Androxal before the end of 2014. Repros said the FDA wants more details about the ways Repros will confirm patients' fertility in two ongoing clinical trials. The company said it will provide that information to the FDA and enrollment of patients won't be interrupted.
The Woodlands, Texas, company started two trials of Androxal in January.
Shares of Repros Therapeutics Inc. had stumbled in October after the company delayed its filing for approval of Androxal. It said the FDA wanted it to provide year of study data on the effects of the highest dose of Androxal. The stock had fallen 34.7 percent since then through Wednesday.
Its shares rose $1.86, or 12 percent, to $17.33 in midday trading Thursday.