Repros surges after FDA slowly backs off clinical hold

Shares of Repros Therapeutics (RPRX) temporarily soared on Friday after the FDA backed far enough away from its clinical hold on the Proellex program to allow for a low-dose study to go ahead. The agency had halted the program last year after signs of liver toxicity were spotted in its study of the uterine fibroid therapy. Researchers can now embark on a new trial that tests a 1 mg dose of the drug, with plans to raise the dosage in later trials as it looks for a safe but effective therapy for...

Repros: FDA may lift Proellex clinical hold

Repros Therapeutics (NASDAQ: RPRX) said today that following a teleconference with the FDA, the agency may be willing to lift the clinical hold status of Proellex if Repros can modify the study design. Clinical studies of the drug, which is under investigation for the treatment for uterine fibroids and endometriosis, were halted last year due liver enzymes changes at higher doses. Those changes were linked to serious adverse events. In early April Repros asked the FDA lift the clinical...