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RPRX Surges 57 Percent On FDA Guidance

January 28th, 2010
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Repros Therapeutics Inc. (NASDAQ:RPRX) gained 57.74% up to $1.09 on news Repros received guidance from  the Division of Reproductive and Urologic Products of the FDA on January 25th, 2010. The focus of the teleconference meeting was to know the FDA’s current position regarding the use of Repros’ oral Androxal for the treatment of men with secondary hypogonadism while preserving fertility. The company’s data supports the notion that the negative feedback of exogenous testosterone administered by any route suppresses the hypothalamic–pituitary axis and causes spermatogenesis. The FDA requested a label to better identify individuals Repros believes will benefit from the use of Androxal. The FDA also requested a review of the literature of the incidence of infertility associated with the use of exogenous testosterone as supportive of the Repros’ data.  If the FDA is satisfied by the submission, there will be no more additional clarifying meetings regarding Androxal. Based in The Woodlands, Texas, Repros Therapeutics is a development-stage biopharmaceutical company developing drug therapies for the treatment of serious female pelvic conditions, such as treatment of uterine fibroids, anaemia associated with excessive menstrual bleeding relating to uterine fibroids, and anaemia associated with uterine fibroids and endometriosis.  Repros Therapeutics has three late stage drug candidates in trials including Androxal, a hormone treatment of for low testosterone levels in men.  RPRX is surging on heavy volume with 9,850,267 shares moving actively, and is trading well above its 50 day moving average of $0.74.

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Jan
28
2010


One Response to “RPRX Surges 57 Percent On FDA Guidance”

  1. RPRX Surges 57 Percent On FDA Guidance | Health News Says:

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