FDA accepts for review supplemental New Drug Application for lumateperone (Caplyta) for the treatment of depressive episodes associated with bipolar I or II disorder

Lumateperone, an atypical antipsychotic currently licensed for treatment of schizophrenia in US, demonstrated a favourable tolerability and safety profile in two Phase 3 global placebo-controlled studies consistent with findings in previous studies in schizophrenia.

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Biospace Inc.