Back to top
Zacks' 7 Best Strong Buy Stocks (New Research Report)
Valued at $99, click below to receive our just-released report
predicting the 7 stocks that will soar highest in the coming month.
We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Valued at $99, click below to receive our just-released report
predicting the 7 stocks that will soar highest in the coming month.
Image: Bigstock
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.
REPROS THERAPEU Price
REPROS THERAPEU Price | REPROS THERAPEU Quote
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>>