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Repros Seeks EU Approval for Secondary Hypogonadism Drug
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Repros Therapeutics Inc. (RPRX - Free Report) announced that the company's UK subsidiary, Renable Pharma Limited, has submitted a marketing authorization application to the European Medicines Agency for one of its pipeline candidate, enclomiphene.
Repro is looking to get enclomiphene approved in the EU for the treatment of secondary hypogonadism. One of the most disabling but less recognized problems in obese men is low testosterone (secondary hypogonadism).
A decision on the approval status of the candidate should be out in 13-16 months.
We are encouraged by the company’s progress with enclomiphene. Per the company’s press release, prevalence of secondary hypogonadism is significantly greater than the occurrence of primary hypogonadism. Considering the EU adult male population being 165% of that in the US, its approval will be a huge boost for the company and for the eligible patient population.
We remind investors that Repros’ efforts to gain approval for enclomiphene in the U.S. for the treatment of secondary hypogonadism had suffered a setback with the FDA issuing a complete response letter in Dec 2015. Currently, the company is conducting a proof-of-concept phase II study (ZA-205) on enclomiphene in obese secondary hypogonadal men to assess its impact on metabolic parameters and quality of life under routine diet and exercise. Six-month interim data from this study were presented in Aug 2016.
Apart from enclomiphene, the company has Proellex in its pipeline. Repros plans to hold discussion with the FDA for phase III studies on Proellex for the treatment of women struggling with painful menstruation. The company is also evaluating Proellex for the treatment of uterine fibroids.
Repros currently carries a Zacks Rank #2 (Buy). Other favorably placed stocks in the health care sector include ANI Pharmaceuticals, Inc. (ANIP - Free Report) , Anika Therapeutics Inc. (ANIK - Free Report) and Cambrex Corporation . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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Repros Seeks EU Approval for Secondary Hypogonadism Drug
Repros Therapeutics Inc. (RPRX - Free Report) announced that the company's UK subsidiary, Renable Pharma Limited, has submitted a marketing authorization application to the European Medicines Agency for one of its pipeline candidate, enclomiphene.
Repro is looking to get enclomiphene approved in the EU for the treatment of secondary hypogonadism. One of the most disabling but less recognized problems in obese men is low testosterone (secondary hypogonadism).
A decision on the approval status of the candidate should be out in 13-16 months.
We are encouraged by the company’s progress with enclomiphene. Per the company’s press release, prevalence of secondary hypogonadism is significantly greater than the occurrence of primary hypogonadism. Considering the EU adult male population being 165% of that in the US, its approval will be a huge boost for the company and for the eligible patient population.
We remind investors that Repros’ efforts to gain approval for enclomiphene in the U.S. for the treatment of secondary hypogonadism had suffered a setback with the FDA issuing a complete response letter in Dec 2015. Currently, the company is conducting a proof-of-concept phase II study (ZA-205) on enclomiphene in obese secondary hypogonadal men to assess its impact on metabolic parameters and quality of life under routine diet and exercise. Six-month interim data from this study were presented in Aug 2016.
Apart from enclomiphene, the company has Proellex in its pipeline. Repros plans to hold discussion with the FDA for phase III studies on Proellex for the treatment of women struggling with painful menstruation. The company is also evaluating Proellex for the treatment of uterine fibroids.
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Zacks Rank & Key Picks
Repros currently carries a Zacks Rank #2 (Buy). Other favorably placed stocks in the health care sector include ANI Pharmaceuticals, Inc. (ANIP - Free Report) , Anika Therapeutics Inc. (ANIK - Free Report) and Cambrex Corporation . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks'' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand.Click to see them now>>