Repros Says FDA Recommends Pivotal Study ZA-301 of Androxal to be Completed as Originally Planned

Repros Therapeutics Inc.^® RPRX today provided a clinical update of its Androxal^® Phase 3 program following receipt of written guidance from the FDA. The FDA has informed Repros to proceed with the analysis of ZA-301 as previously planned, and that data should be evaluated both with and without patients from the high enrolling site where the patients' baseline characteristics appeared different from other sites in the study. Additionally, the FDA accepted Repros' plan regarding study ZA-302 to enroll additional patients. They also noted that Repros should revise the statistical analysis plan and sample size to reflect increased enrollment. Study ZA-302 will also be analyzed with and without patients from the high enrolling site where the patients' baseline characteristics appeared different from other sites in the study. Per the guidance from the FDA, the Special Protocol Assessment (SPA) will remain intact with the revised trial parameters outlined above. Top line data from study ZA-301 will be reported when available, as per the Company's guidance given at the beginning of the year.