The FDA recommended that Repros conduct an additional Phase 3 study into its enclomiphene drug. The drug is intended to treat a reproductive disorder, known as secondary hypogonadism, in overweight men.
The FDA also said it was concerned regarding the study's entry criteria, titration and bioanalytical method validation.
"We are disappointed that the FDA has taken this position without the benefit of an advisory committee recommendation," Repros CEO Joseph Podolski said in a statement. "We plan to work closely with the agency to gain more information to determine the appropriate next steps regarding the enclomiphene application."
So far today, 4.13 million shares of Repros have traded, versus its 30-day average of 1.45 million shares.