Min­er­va's shares sink on re­jec­tion of schiz­o­phre­nia drug

The FDA has once again turned away Min­er­va’s schiz­o­phre­nia drug rolu­peri­done, re­quest­ing “at least one” ad­di­tion­al well-con­trolled study.

While rolu­peri­done met the pri­ma­ry end­point in a Phase IIb study for neg­a­tive symp­toms in pa­tients with schiz­o­phre­nia, reg­u­la­tors said in a com­plete re­sponse let­ter that the tri­al was “in­suf­fi­cient on its own” to es­tab­lish ef­fi­ca­cy. A Phase III read­out in 2020 failed to meet sta­tis­ti­cal sig­nif­i­cance. Reg­u­la­tors al­so want to see a safe­ty re­view in­clud­ing more pa­tients at the pro­posed 64 mg dose, as well as da­ta on con­comi­tant use with oth­er an­tipsy­chotics, Min­er­va an­nounced on Tues­day.

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