Acor­da preps FDA fil­ing af­ter Parkin­son’s drug hits the pri­ma­ry end­point in PhI­II

Acor­da’s $525 mil­lion gam­ble on a Phase III Parkin­son’s drug has paid off. The biotech $ACOR an­nounced ear­ly Thurs­day that the late-stage study of an in­haled res­cue for­mu­la­tion of lev­odopa was a suc­cess, open­ing the door to a fast-ap­proach­ing FDA ap­pli­ca­tion for mar­ket­ing ap­proval.

Acor­da is re­port­ing this morn­ing that CVT-301 hit the pri­ma­ry end­point in the study, demon­strat­ing a sig­nif­i­cant im­prove­ment in mo­tor skills over a place­bo. CEO Ron Co­hen scooped up the drug in an all-cash deal to ac­quire Civ­i­tas in late 2014.

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