After years of clinical and regulatory setbacks, Repros Therapeutics was finally on the path to submitting its testosterone treatment to the FDA, scheduling a prefiling meeting for November with hopes of handing the drug in by year's end. But the agency has had some second thoughts, changing the agenda for the meeting and indefinitely delaying Repros' plans.
Repros Therapeutics got a boost from its announcement that its late-stage testosterone treatment beat out the topical Androgel in helping patients with low testosterone, or hypogonadism.
Repros has again swung southward in its up-and-down development of the testosterone drug Androxal, pushing back its proposed NDA filing and revealing that the FDA is taking a hard look at its Phase III results, news that hammered its shares by about 30%.
Shares of Repros Therapeutics rocketed up 78% this morning after the Texas-based biotech announced that its roller coaster ride in a Phase III study for its experimental testosterone-boosting therapy Androxal ended on a positive note on a pair of co-primary endpoints.
Regulators at the FDA have told Repros Therapeutics ($RPRXD) that its testosterone drug Androxal is not ready for Phase III. Instead, the developer says the agency has asked for a fresh Phase IIb
Repros Therapeutics got a badly needed lift this morning after it announced that a small study of Androxal demonstrated its ability to restore sperm count and boost testosterone levels in men with