Last $9.49 USD
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Volume 288.1K
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repros therapeutics inc (RPRX) Snapshot

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09/2/14 - $22.55
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repros therapeutics inc (RPRX) Details

Repros Therapeutics Inc., a development stage biopharmaceutical company, focuses on the development of new drugs to treat hormonal and reproductive system disorders in the United States. Its product portfolio includes Androxal, an oral therapy, which is in Phase III clinical trials for the treatment of low testosterone due to secondary hypogonadism; and Proellex that is in Phase II clinical trials for the treatment of symptoms associated with uterine fibroids and endometriosis. The company has a license agreement with the National Institutes of Health to develop and commercialize Proellex. Repros Therapeutics Inc. was founded in 1987 and is based in The Woodlands, Texas.

28 Employees
Last Reported Date: 11/10/14
Founded in 1987

repros therapeutics inc (RPRX) Top Compensated Officers

Chief Executive Officer, President and Direct...
Total Annual Compensation: $521.0K
Chief Financial Officer, Chief Accounting Off...
Total Annual Compensation: $275.0K
Senior Vice President of Clinical & Regulator...
Total Annual Compensation: $191.3K
Chief Medical Officer
Total Annual Compensation: $181.1K
Vice President of Research & Development
Total Annual Compensation: $183.3K
Compensation as of Fiscal Year 2013.

repros therapeutics inc (RPRX) Key Developments

Repros Therapeutics Inc. Submits New Drug Application to FDA for Androxal

Repros Therapeutics Inc. reported that it has electronically submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Androxal, the company's lead product candidate. Androxal is a single isomer of clomiphene citrate and an orally active proprietary small molecule compound. The company is developing Androxal for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. Men with secondary hypogonadism exhibit low testosterone levels due to under stimulated testes but they are generally fertile. Androxal is designed to treat the underlying mechanism, insufficient stimulation of the testes by the pituitary, which causes secondary hypogonadism. Secondary hypogonadism due to being overweight or obese is the single great cause of hypogonadism in general.

Repros Initiates Two Phase 2B Uterine Fibroid Studies

Repros Therapeutics Inc. announced it has initiated two Phase 2B efficacy studies of Proellex® in the treatment of uterine fibroids in women that experience heavy vaginal bleeding as a result of these benign tumors. The two studies both have the same FDA suggested endpoints but test two different routes of administration, oral and vaginal. The Company had previously tested both routes using similar doses and found that Proellex® exhibited significant effects on bleeding due to uterine fibroids with each route of administration. In addition to significant effects on bleeding due to Proellex® administration, tumor size was significantly reduced. As a result of reduced tumor burden, bulk symptoms improved to the point where the majority of subjects reported to be symptom free using the Uterine Fibroid Symptom Quality of Life survey (UFSQoL). The UFSQoL is a validated survey that was used to approve uterine artery embolization and ultrasound focusing. In earlier Phase 2 studies, both oral and vaginal administration of Proellex® stopped menses and hence, in this study, on recommendation from the FDA, Repros has chosen amenorrhea as the primary efficacy endpoint. The studies both have three double blind arms: placebo and Proellex® at 6 mg and 12 mg doses. The two studies are powered to achieve the desired impact on menstrual bleeding with only 15 subjects per arm. In addition to investigating the incidence of amenorrhea, actual menstrual blood loss will be estimated by the alkaline hematin method from used sanitary products. The studies are designed to treat women for two 4-month dosing courses separated by an off drug interval to allow for menses. Following the second course, the FDA instructed the Company to follow the women for six additional menstrual events to investigate the duration of benefit. The Company plans to request a Type C meeting after all the subjects have experienced the menstrual event following the first course of treatment. An interim assessment of efficacy and safety is part of the analysis plan. Assuming enrollment proceeds according to plan, the Company believes it can schedule a Type C meeting with the FDA around year end 2015. The purpose of this meeting will be to discuss the overall FDA proposed size of the safety database required for an NDA.

Repros Therapeutics Inc. Presents at The Trout Group 's Annual 1x1 Management Access Event, Jan-12-2015

Repros Therapeutics Inc. Presents at The Trout Group 's Annual 1x1 Management Access Event, Jan-12-2015 . Venue: The Handlery Hotel, 351 Geary Street, Union Square, San Francisco, California, United States.


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