Seeking Alpha

Repros Therapeutics plunges as Androxal NDA timing in question

  • Repros Therapeutics (RPRX) tumbles 32% premarket after outlining new FDA guidance for Androxal.
  • The regulator wants a meeting to discuss Site 9's inclusion in the ZA-301 analysis. RPRX notes that "ZA-302 was powered for analysis with or without Site 9 and met the co-primary endpoints in both instances." (PR)
  • Ultimately, RPRX is now guiding for an H2 2014 NDA submission — that looks like a delay from previous guidance of mid-2014.
  • The sell-side is already moving to defend the shares, with Lazard first up to bat, saying the delay is worth it, and reiterating a Buy rating. Brean is apparently also out positive.
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