Repros Therapeutics Inc. (NASDAQ: RPRX) is surging on clinical update news this Thursday. The company’s Androxal Phase 3 program has been given a receipt of written guidance from the Food & Drug Administration. This is effectively notice that the FDA is accepting its study plans. The company said:
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 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.
Investors will want to know that Androxal is in Phase II studies and is only one of two programs listed in the drug pipeline on the company’s website.
Repros shares are trading up a whopping 32% at $13.45 in early Thursday trading. This is a very volatile stock as the 52-week trading range is $3.68 to $19.12. Its new adjusted market cap is still very small at about $320 million. Repros has been public since the early 1990s and this remains a pre-revenue stage company.