Woodlands, TX-based Repros Therapeutics Inc. (RPRX) is a development-stage biopharmaceutical company focused on the development of treatments for hormonal and reproductive system disorders.
Repro currently has two candidates in its pipeline: enclomiphene (previously known as Androxal) and Proellex. Enclomiphene is currently under FDA review for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. A response should be out by Nov 30. But before that, enclomiphene will be reviewed by the FDA’s Division of Bone, Reproductive and Urologic Products on Nov 3.
Repros’ second pipeline candidate, Proellex, is currently in a phase II development for the treatment of uterine fibroids and endometriosis.
With no approved product in its portfolio at the moment and enclomiphene being the company’s lead pipeline candidate, investor focus will remain on the upcoming advisory panel meeting and other pipeline related updates.
Overall, Repros has posted an average positive earnings surprise of 7.63% over the past two quarters. Estimate revisions are, however, flat for both 2015 and 2016.
Currently, Repros has a Zacks Rank #3 (Hold), but that could definitely change following the company’s earnings report which was just released. We have highlighted some of the key stats from this just-revealed announcement below:
Earnings: Repros reported a loss of 32 cents per share in the second quarter of 2015, narrower than the year-ago loss of 38 cents.
Revenues: Second-quarter revenues (which consisted entirely of interest income) decreased 50% from the year-ago quarter to $1 million.
Key Stats: During the second quarter of 2015, the European Medicines Agency informed the company that the centralized marketing authorization application for the candidate can be submitted as a new active substance (NAS). With the NAS designation in place, Repros is eligible to submit a supplementary protection certificate for the extension of the exclusivity period of the product. Repros intends to file for EU approval in the first quarter of 2016.
Check back later for our full write up on this RPRX earnings report later!
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