Repros Therapeutics announced that the FDA will continue to maintain partial clinical hold on its pipeline candidate Proellex for uterine fibroids indication as the agency internally reviews data related to the effect of the same on the liver. Regulators will be consulting agency experts on the liver effects of Proellex identified during the phase II study. Repros Therapeutics and its panel of liver experts will submit additional information to the FDA and offer a proposed clinical protocol in a month.
The meeting was supposed to be an end of phase II study and phase III requirement discussion but was later changed to a guidance meeting by the FDA.
We remind investors that Proellex studies on oral dose for the treatment of endometriosis and uterine fibroids were placed under clinical hold in 2009. But later the FDA allowed the studies to be conducted under partial clinical hold with low oral dosage.
We note that Repros' shares have outperformed the Zacks classified Medical - Biomedical and Genetics industry in the last one year. Repros shares returned 37.1% against a decline of 10.6% for the industry.
In a separate press release, the company announced that Larry Dillaha will become its permanent President and CEO effective Apr 10. She was working on an interim basis at the same position since Feb 1. Dillaha has experience in handling an inception stage biotechnology company as well as a specialty pharmaceutical company.
We note that 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.
Repros' other key pipeline candidate enclomiphene is being evaluated for the treatment of low testosterone level in overweight men. The drug was approved in the EU in 2016 while the phase II study data is under review in the U.S.
AbbVie Inc. (ABBV - Free Report) in collaboration with Neurocrine Biosciences, Inc. (NBIX - Free Report) is also developing a drug, elagolix for the treatment of endometriosis and uterine fibroids. We note that with AbbVie being a much bigger company, elagolix, if approved, may offer stiff competition to Repros’s Proellex in the long run.
Zacks Rank & Stock to Consider
Repros currently has a Zacks Rank #3 (Hold). Progenics Pharmaceuticals Inc. (PGNX - Free Report) is a better-ranked stock in the generic drug sector, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Progenics' loss estimates narrowed from 82 cents per share to 62 cents for 2017 over the last seven days. The company posted an average positive surprise of 8.45% for the trailing four quarters. . Its shares increased 72.6% in the last one year.
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