Repros Therapeutics Inc. (RPRX)

Repros Therapeutics Inc. is an advanced development stage bio-pharmaceutical company focusing on the treatment of hormonal/endocrine-related disorders. The major focus of the company’s diseases includes secondary hypogonadism, endometriosis and uterine fibroid.  The company’s lead value driver, Androxal, recently completed Phase III clinical trials in secondary hypogonadism and met study endpoints.  Both studies are with a Special Protocol Assessment (SPA) designation. The FDA recently also suggested the company potentially to conduct comparative pivotal studies vs. marketed testosterone gel for potential approval and the company plans to start the trials in 1Q14 with potential completion in 4Q14 and NDA filing shortly after.  According to this timeline, Androxal could potentially enter the market in 2016.  Overall, although risks for the development has increased modestly due to the uncertainty of clinical path and slight increase of development time, we believe the accumulative robust clinical data that support the notion of Androxal is potentially superior to testosterone gels has not changed.

The second product, Proellex, with a vaginal delivered version (Proellex-V) and a low dose oral regimen are about to undergo two separate Phase II studies in uterine fibroids, while a low dose orally administrated form is undergoing Phase II in endometriosis study and data from all studies

Published Reports

RPRX-2017-07-18-Proellex FDA feedback rev
RPRX-2017-04-11-Proellex FDA meeting rev
RPRX-2017-04-03-4Q16 rev
RPRX-2017-03-27-Management updates rev2
RPRX-2017-01-30-EOP2 meeting for Proellex in UF to come rev
RPRX-2016-12-08-Buying opportunity after Adcom decision rev
RPRX-2016-08-10-2Q16 rev
RPRX-2016-05-19-Low dose oral Proellex P2 positive rev
RPRX-2016-05-10-1Q16 rev
RPRX-2016-04-13-Positive Proellex-V P2 data
RPRX-2016-03-14-4Q15 rev
RPRX-2016-02-17-Enclomiphene Phase II trial started
RPRX-2016-02-09-Androxal development updates rev
RPRX-2015-12-22-Proellex development update rev (2)
RPRX-2015-12-01-CRL for Androxal rev
RPRX-2015-10-30-AdCom cancelation
RPRX-2015-08-11-2Q15 rev
RPRX-2015-07-16-Mgnt update rev2
RPRX-2015-05-07-1Q15 rev
RPRX-2015-04-01-NDA moves forward rev
RPRX-2015-03-16-4Q14 rev
RPRX-2014-11-24-Mgnt meeting rev
RPRX-2014-11-07-FDA feedback rev
RPRX-2014-11-03-Analyst day rev
RPRX-2014-10-20-Type C FDA meeting rev
RPRX-2014-09-29-Robust 304 results rev2
RPRX-2014-09-18-AdCom meeting on TRT v3 rev
RPRX-2014-09-04-AdCom meeting on TRT rev2
RPRX-2014-08-28-Conference call update rev
RPRX-2014-08-28-Robust 305 results rev
RPRX-2014-08-11-2Q14 rev
RPRX-2014-07-17-FDA feedback
RPRX-2014-05-20-TRT CV benefit rev
RPRX-2014-05-12-1Q14 rev
RPRX-2014-05-08-More update on 305 study
RPRX-2014-05-01-Sperm endpoint modified
RPRX-2014-04-14-305 pt enrollment completed
RPRX-2014-03-17 Proellex P2 update
RPRX-2014-02-06 Positive FDA feedback rev
RPRX-2014-01-27-Top pick ’14
RPRX-2014-01-08-Commencement of 2 trials
RPRX-2013-11-25-FDA discussion in Feb 14 rev