The Wall Street Journal: Repros Therapeutics shares drop on drug application setback

Recommended by Dr. Michael White, Updated on October 25th, 2018
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Repros Therapeutics Inc. said it was notified by the U.S. Food and Drug Administration that there isnt enough clinical information to hold a planned pre-investigational new drug application meeting in November.

Its shares RPRX, -39.96% dropped 43% in premarket trade in response. The stock had already lost more than half its value through Thursdays close in the past 12 months.

The company in September said it had been granted a type B, pre-investigational new-drug application meeting with the FDA in the first half of November, when Repros planned to seek guidance on its planned new drug application for Androxal for the treatment of secondary hypogonadism. At the time, it said it expected to file the new drug application for Androxal around the end of this year.

Instead, the company said it will have a type C guidance meeting with the FDA next month. A type C meeting is any meeting other than a type A meetingwhich is used to help a stalled product-development program proceedor a type B meeting, which typically occurs at the end of certain clinical trials or center on pre-investigational new drug applications.

An expanded version of this report appears at WSJ.com.

See original here:

The Wall Street Journal: Repros Therapeutics shares drop on drug application setback

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