A month after taking a severe beating at the hands of disappointed investors, Repros Therapeutics has confirmed what company execs had already hinted at: The FDA has rejected its long-delayed testosterone therapy after regulators determined that the agency would need to see data from a new Phase III study before it could determine if the treatment is worth a green light.
Repros Therapeutics is facing yet another setback for its long-delayed testosterone treatment as the FDA has backed out of a preapproval meeting and raised serious questions about the company's pivotal data.
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.
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