- 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.