What's In The Cards For Repros (RPRX) This Earnings Season?
Zacks Investment Research | May 04, 2017 11:02PM ET
Repros Therapeutics Inc. (NASDAQ:RPRX) is expected to report first-quarter 2017 results this month. Let’s see how things are shaping up for this quarter.
Repros Therapeutics’ share price has decreased 28.8% year to date, while the Zacks classified Medical-Biomed/Genetics industry gained 4.7%.
Repros is a development-stage biotech company focused on the development of treatments for hormonal and reproductive system disorders. With no approved products in its portfolio yet, investors are expected to remain focused on pipeline-related updates by the company. Repros’ pipeline presently comprises enclomiphene and Proellex.
The most advanced candidate in Repros’ pipeline is enclomiphene, which is currently under review in the EU. The company intends to get the candidate approved for the treatment of secondary hypogonadism. A decision on the approval status of the candidate should be out in 2017.
Moreover, Repros is evaluating enclomiphene for the treatment of low testosterone level in overweight men. The drug was approved in the EU in 2016 for this indication while the phase II study data is under review in the U.S.
Proellex is being evaluated in phase II orally administered trials for the treatment of endometriosis and uterine fibroids under partial clinical hold with low oral dosage. Repros held a discussion with the FDA in April regarding its progress and the next steps in the development of Proellex for the treatment of uterine fibroids. As per the discussion, the FDA will continue to maintain partial clinical hold as the agency internally reviews data related to the effect of the same on the liver. Repros Therapeutics and its panel of liver experts said that they will submit additional information to the FDA and offer a proposed clinical protocol in a month. We expect update on the data at the first quarter conference call.
The company is also evaluating Proellex in a phase IIb study for uterine fibroids by vaginal delivery. However, this study has no clinical hold issues. The company presented positive topline data from this study in November last year.
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