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.
Last month Repros Therapeutics hoisted a red flag for investors, saying that investigators had spotted an odd bulge in its late-stage study for their lead drug Androxal, being studied for the treatment of secondary hypogonadism.
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
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
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
Repros Therapeutics saw its badly battered stock price (RPRX) jump 30 percent this morning after the developer asked the FDA to drop a clinical hold on its late-stage lead therapy, insisting that it
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
The FDA has informed Repros Therapeutics (RPRX) that it will need to resolve a number of outstanding issues with its drug Proellex before the clinical hold on the drug can be lifted. In August,
Two weeks ago, when Repros Therapeutics suspended late stage trials of Proellex after researchers saw signs of spiking liver enzymes in patients, the company said it would have to keep a close eye on