FDA endorses Repros plan for pivotal study to move forward; shares soar
This article was originally published in Scrip
Executive Summary
Shares of Repros Therapeutics soared as high as 45% on 21 February on word the US FDA gave its blessing for the company's analysis of its pivotal ZA-301 study of its oral testosterone drug Androxal to move forward as previously planned, with the special protocol assessment agreement entered into with the agency remaining intact.