Repros shares rally on move to get FDA clinical hold lifted

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 has learned enough now to develop a safe, low-dose oral therapy.

Repros will need to use all its powers of persuasion to get the agency to budge, though. Last August the FDA put a clinical hold on Proellex, a new therapy for uterine fibroids and endometriosis, after seeing signs of elevated liver enzymes--a classic red flag for toxicity--in patients taking the drug in a late-stage trial. Regulators asked Repros to follow those patients to help study the safety issue, but made clear last fall that it doubts whether Proellex can find a dosing regimen that is both safe and effective. Adding to its woes, Repros has been strapped for cash.

"Repros believes doses of Proellex at 12.5 mg or less will provide a safe and efficacious treatment for both uterine fibroids and endometriosis," the company said in a release today. "Repros requests a lift of the full clinical hold on the Company's Proellex program to conduct a single study to determine the potential for developing a "low dose" oral anti-progestin therapy based on telapristone acetate or Proellex."

Shares of Repros, which is based in The Woodlands, TX, jumped to 80 cents on the company's move today.  By mid-morning, though, Repros shares had slid back down to 69 cents. Its stock dropped 60 percent last August, falling to $1.02, when the company announced the trial hold.

- read the Repros release
- here's the Reuters story

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