=Repros Therapeutics (RPRX)

Repros Therapeutics receives preliminary feedback from the FDA on the clinical development program for Proellex; program to remain on partial clinical hold :

The co announced that it received preliminary feedback from the FDA on the Company's clinical development program for Proellex, its oral delivery mechanism for telapristone acetate. The Proellex program will remain on partial clinical hold, and based upon the FDA's review of all the existing liver function safety data, the FDA has indicated that the Company will be required to compile a large pre-approval safety data base to support future development.

• In light of the FDA guidance, the Company is assessing increasing its focus on its uterine fibroid and endometriosis development program utilizing a vaginal drug delivery program for telapristone acetate, a selective progesterone modulator (:SPRM).
• Additionally, Repros has received notice that on August 2, 2017 it will be granted a European patent relating to the use of SPRMs, in particular Telapristone Acetate (Proellex) or Ulipristal Acetate, with an Off Drug Interval (:ODI) for the treatment of estrogen-dependent hyperproliferative uterine conditions, such as uterine fibroids and endometriosis. The European patent is related to the Company's recently granted U.S. Patent number 9,616,074, announced by the Company in April 2017.
• Finally, as previously announced, the Company submitted to the European Medicines Agency (:EMA) a marketing authorization application (MAA) for enclomiphene in the treatment of secondary hypogonadism in Europe in September of 2016. As part of the ongoing review process, the Company expects to file responses to the EMA in the third quarter of 2017.

***

Repros Therapeutics Inc., a biopharmaceutical company, focuses on the development of various drugs to treat hormonal and reproductive system disorders for male and female in the United States. Its product portfolio include Proellex that is in Phase III clinical trials for the treatment of symptoms associated with uterine fibroids, as well as in Phase II clinical trial for the treatment of endometriosis; and enclomiphene, a single isomer of clomiphene citrate, which is in Phase III clinical trials for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. The company was founded in 1987 and is based in The Woodlands, Texas.