Sage con­firms sus­pen­sion of 2 de­pres­sion tri­als af­ter PhI­II flop; Es­pe­ri­on fol­lows up maid­en ap­proval with com­bo OK

→ In the wake of a flop in the cru­cial Phase III MOUN­TAIN study, Sage Ther­a­peu­tics con­firmed in its quar­ter­ly up­date that it’s sus­pend­ed en­roll­ment in two oth­er piv­otal tri­als for the oral de­pres­sion drug SAGE-217 (or zu­ra­nolone) as it awaits guid­ance from the FDA. While RED­WOOD (mea­sur­ing re­lapse) and RAIN­FOR­EST (for pa­tients with both ma­jor de­pres­sive dis­or­der and in­som­nia) are on hold pend­ing amend­ments, though, the open-la­bel SHORE­LINE has com­plet­ed en­roll­ment. CEO Jeff Jonas re­mained tight-lipped about what spe­cif­ic tweaks they are con­sid­er­ing for the pro­gram, re­it­er­at­ing on­ly there have been is­sues with com­pli­ance and room for a high­er dose.

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