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Repros Presents 6-Month Interim Data on Enclomiphene
Repros Therapeutics Inc. (RPRX - Free Report) provided six month interim results from its ongoing 15 month study that is evaluating enclomiphene in obese secondary hypogonadal men. Repros is developing enclomiphene for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function.
The study has two active arms (12.5 mg of enclomiphene and 25 mg enclomiphene) and a placebo arm. Repros reported that six month interim assessment of testosterone (T) levels showed statistically and clinically significant increases in total T and free T superior to placebo. The company said that effects of diet and exercise and enclomiphene treatment were additive. Enclomiphene treatment plus diet and exercise increased lean body mass over baseline while higher weight loss was observed in the placebo group.
We note that the company had received a Complete Response Letter (CRL) from the FDA in Dec 2015 for enclomiphene. The FDA had stated that the design of the enclomiphene phase III studies were no longer adequate to demonstrate clinical benefit based on recent scientific developments, and recommended that Repros should conduct an additional late-stage study or studies to support approval in the target population.
The company is currently working on gaining EU approval for enclomiphene where Repros expects to submit a marketing application in Fall 2016. The European Medicines Agency (EMA) has assigned UK as the primary rapporteur and France as the co-rapporteur for the application review.
Meanwhile, Repros’ other pipeline candidate, Proellex, is in mid-stage development for the treatment of symptoms associated with uterine fibroids and endometriosis.
REPROS THERAPEU Price
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Repros is a Zacks Rank #2 (Buy) stock. Some better-ranked stocks in the health care sector include companies like Geron Corporation (GERN - Free Report) , ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Anika Therapeutics Inc. (ANIK - Free Report) – all three are Zacks Rank #1 (Strong Buy) stocks.
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