Repros Therapeutics Inc. RPRX is expected to report second-quarter 2015 results on Aug 10. Overall, the company has posted an average positive earnings surprise of 7.63%. Let’s see how things are shaping up for this announcement.
Factors at Play
Repros, a development-stage biopharmaceutical company, is focused on the development of treatments for hormonal and reproductive system disorders. The company currently has two candidates in its pipeline: enclomiphene (previously known as Androxal) and Proellex.
Enclomiphene, Repros’ lead pipeline candidate, 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 has also made some progress in the EU. During the second quarter, 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.
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.
Meanwhile, Repros’ second pipeline candidate, Proellex, is being developed for the treatment of uterine fibroids and endometriosis. Proellex is currently in a couple of phase IIb efficacy studies (both oral and vaginal administration) for the treatment of uterine fibroids in women who experience heavy vaginal bleeding due to these benign tumors. The company expects to complete the first course of treatment in both studies by the end of 2015. Additionally, the company expects the phase II study on Proellex (low-dose oral administration) for endometriosis to be fully enrolled by the end of 2015.
This Zacks Rank #3 (Hold) stock is currently looking for partnerships for funding its pipeline development activities and commercialization of its products, if approved.
Stocks to Consider
Here are some companies in the broader health care sector you may want to consider as our model shows that they have the right combination of elements –- a positive Zacks Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 – to post an earnings beat this quarter.
Inovio Pharmaceuticals, Inc. INO has an Earnings ESP of +275.00% and carries a Zacks Rank #3. The company is scheduled to release second-quarter results on Aug 10.
The Earnings ESP for BioDelivery Sciences International, Inc. BDSI is +6.45% and it carries a Zacks Rank #3. The company is scheduled to release second-quarter results on Aug 10.
Immune Design Corp. IMDZ has an Earnings ESP of +20.41% and carries a Zacks Rank #3. The company is scheduled to release second-quarter results on Aug 12.
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