Repros’ Proellex under FDA microscope (RPRX)

Repros Therapeutics Inc. (NASDAQ:RPRX) has received a verbal warning from the Food and Drug Administration of the United States of America about their drug Proellex. The FDA has informed Repros Therapeutics to resolve all the outstanding issues related with Proellex before they lift the clinical hold on the drug. The Food and Drug Administration panel has asked Repros’ for providing more clinical data on their experimental drug Proellex that is used for treating the symptoms of uterine fibroids and endometriosis. Around two months ago, the use of Proellex was suspended by Repros Therapeutics when they saw elevated liver enzymes in those patients who were a part of their clinical trial. Repros Therapeutics detected this dangerous side effect that could further lead to permanent liver damage and decided to stop the clinical trials. Soon after this news that FDA has given a verbal warning to Repros about their clinical drug, the shares of Repros Therapeutics plunged down and many market analysts and regulators now doubt that Repros will be able to prove or determine that a dose of Proellex can be safe and effective for the patients suffering from endometriosis and symptoms of uterine fibroids. The Food and Drug Administration panel has asked Repros to follow up with the patients who had suffered from elevated liver enzymes and to check for the dosing regime to further investigate the effectiveness of Proellex drug. The FDA also mentioned that they are not sure if Repros will be able to prove that Proellex is safe considering the fact that Repros Therapeutics lacks the resources to conduct a clinical trial and to arrange a new dose-finding study. Repros Therapeutics have clearly stated that they are short of cash and therefore the best option they have is to license the Proellex drug to another company who could finance the clinical study and continue with the development of Proellex.