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 the condition. Researchers plan to stick within the low-dose range to avoid any further toxicity issues.

The news was enough to send Repros' shares up by 44 percent even though some analysts are frankly puzzled by the developer's odds of success at this point. "It's difficult to predict and that's why they have to go through the test to establish the correct doses," said Ladenburg Thalmann & Co analyst Matthew Kaplan. After hitting a high of 69 cents Repros' shares settled back to a 19 percent jump. And by this morning the shares were back down to 50 cents.

Repros was able to raise more than $5 million after the FDA action, giving it enough money to get back into the clinic. But larger trials may necessitate a partnership with a bigger pharma company.

- see Repros' release
- here's the Reuters story
- and here's the report from the AP

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