Repros Therapeutics (RPRX) soars 26% premarket.
Androxal topline results from ZA-302 (pivotal efficacy) and ZA-300 (six-month safety) show the secondary hypogonadism treatment met both primary endpoints and is generally well tolerated.
ZA-302 results are "almost identical" to the first pivotal efficacy study. (PR)
Expect an NDA in mid-2014.
RPRX says it expects to have "launch drug product available for an anticipated approval during 2015."
It's worth noting that back in July, BofA's Steve Byrne said peak 2022 sales could reach $450M.