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