Ax­some cel­e­brates mi­graine PhI­II win, shift­ing eyes to­ward a pair of Q4 sub­mis­sions

One week af­ter re­port­ing a late-stage fail­ure for its lead drug, Ax­some is back with pos­i­tive news: In the 302-per­son Phase III IN­TER­CEPT tri­al, its ex­per­i­men­tal mi­graine drug hit both pri­ma­ry end­points: Stop­ping mi­graine pain en­tire­ly and pre­vent­ing pain from pro­gress­ing be­yond ”mild in­ten­si­ty.”

The tri­al win sets up a big fourth quar­ter for the 8-year-old com­pa­ny and keeps them on track to file for ap­proval for the mi­graine drug, known as AXS-05. And de­spite the late-stage fail­ure, they plan to file for ap­proval on their lead de­pres­sion drug, known as AXS-07, cit­ing sec­ondary end­points and the high place­bo rates that have long cloud­ed de­pres­sion tri­al re­sults.

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