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.
Is Your Money Earning the Best Possible Rate? (Sponsor)
Let’s face it: If your money is just sitting in a checking account, you’re losing value every single day. With most checking accounts offering little to no interest, the cash you worked so hard to save is gradually being eroded by inflation.
However, by moving that money into a high-yield savings account, you can put your cash to work, growing steadily with little to no effort on your part. In just a few clicks, you can set up a high-yield savings account and start earning interest immediately.
There are plenty of reputable banks and online platforms that offer competitive rates, and many of them come with zero fees and no minimum balance requirements. Click here to see if you’re earning the best possible rate on your money!
Thank you for reading! Have some feedback for us?
Contact the 24/7 Wall St. editorial team.
Latest from 24/7
