Repros' FDA meeting goes well, shares soar


After meeting with the FDA to discuss Phase 3 trial data requirements for the use of its Androxal drug to treat secondary hypogonadism, Repros Therapeutics (RPRX +12.9%) says it "expects to maintain its timeline for submitting an NDA prior to the end of 2014."

Repros adds it "understands that the safety of Androxal will stand on its own merits during NDA review and no additional safety assessments are currently planned prior to NDA submission."

Shares plunged in October after FDA guidance raised doubts about the timing of Androxal's NDA submission.

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