$NERV -58%

Roluperidone NDA receives CRL from FDA 🙁

⚠️ FDA cited clinical deficiencies:
▪️ Insufficient substantial evidence of effectiveness
▪️ lacks data on concomitant antipsychotic admin.
▪️ lacks data to establish change in negative symptoms of schizophrenia
▪️ inadequate number of subjects exposed at proposed dose

ℹ️Add'l info on Roluperidone…
⇒ for negative symptoms of schizophrenia
⇒ NDA
⇒ PDUFA: 02/26/24