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A biopharmaceutical company focused on the development of new drugs to treat hormonal and reproductive system disorders.
Repros is a difficult stock to predict both in the short-term and in the long-term. There are numerous potential short-term catalysts that have the potential to move the share price dramatically. Topline results of the ZPV-200 trial of vaginally-administered Proellex are expected before the end of 2012. The company has never released the final results of the dose escalation trial of oral Proellex, despite having completed dosing in the final cohort in January. The company has scheduled a teleconference with the FDA in the last week of August to discuss a proposed phase II trial protocol for oral Proellex for endometriosis. Two pivotal phase III trials of Androxal in male secondary hypogonadism will soon be initiated, and the company has projected an NDA submission around the end of 2013. Meanwhile, the company is very short of cash as always and they have never been shy about dipping into the secondary markets.Regarding the long-term, both Proellex and Androxal have the potential for substantial commercial success yet each carries troubling baggage. Proellex has had toxicity issues that nearly caused Repros to go bankrupt in 2010. While the company may have solved liver toxicity with low-dose and vaginally administered formulations of Proellex, they have yet to face the wrath of the FDA regarding the side effect of endometrial hyperplasia that doomed Schering's late stage SPRM candidate asoprisnil. Meanwhile, Androxal has not clearly differentiated itself from generic clomid in terms of raising testosterone levels through testicular stimulation. This may significantly reduce Androxal revenues in terms of pricing and market share.I could have green thumbed Repros today on a substantial decline without a clear catalyst, but instead the stock moved in the opposite direction. A very high risk play, to be sure, and not one I'm likely to maintain for long if dilution comes before data as I expect.
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