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Repros Provides Update on Phase IIb Study on Proellex

Zacks Equity Research

Repros Therapeutics Inc. RPRX announced that it has completed randomization in a phase IIb study on its pipeline candidate, Proellex (vaginal administration). The candidate is being developed for the treatment of women suffering from symptomatic uterine fibroids.

While the primary endpoint is the incidence of amenorrhea induced following four months of treatment with two dose levels of Proellex compared to placebo, Repros is also collecting an assessment of blood loss by a validated alkaline hematin method at baseline and during off-drug intervals, based on discussions with the FDA.

Repros expects top-line data from the first four-month course of treatment in the second quarter of 2016.

Meanwhile, a sister study evaluating low doses of oral Proellex in the same patient population has finished screening with randomization expected to be completed before the end of Jan 2016. Top-line data from the oral study is expected later than the vaginal study data.

Considering the number of women suffering from uterine fibroids that later requires hysterectomy, there is significant unmet need for drugs addressing this disease. Once successfully developed and commercialized, Proellex could cater to a huge population of women.

We remind investors that the company has a key regulatory event coming up later this month (Nov 30) with the FDA expected to render a decision on its lead pipeline candidate, enclomiphene. The candidate is under FDA review for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function.

However, chances of approval look low considering the FDA cancelled an advisory panel meeting with the Division of Bone, Reproductive and Urologic Products that was scheduled for Nov 3 citing concerns related to the bio-analytical method validation that could affect interpretability of certain pivotal study data.

We expect investor focus to remain on the FDA action date.

Repros is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Actelion Ltd. ALIOF, Achillion Pharmaceuticals, Inc. ACHN and Anika Therapeutics Inc. ANIK. All three hold a Zacks Rank #1 (Strong Buy).

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ACTELION LTD (ALIOF): Free Stock Analysis Report
 
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