Intra-Cellular Therapies (NASDAQ: ITCI) shares resumed trading after the company released mixed study results from two Phase 3 clinical trials evaluating lumateperone as monotherapy in the treatment of major depressive episodes associated with bipolar depression.
Intra-Cellular Therapies is a company focused on the development of therapeutics for central nervous system (CNS) disorders. According to the group in the trials, lumateperone demonstrated a favorable safety profile and was generally well-tolerated.
“We consider today’s positive results to be a significant milestone in our bipolar depression program. The distinct pharmacological profile of lumateperone and positive clinical results in schizophrenia and bipolar depression further support the potential for benefits in a broad range of neuropsychiatric conditions, including major depressive disorder,” said Sharon Mates CEO of Intra-Cellular Therapies.
Intra-Cellular Therapies prepares for the launch of lumateperone for the treatment of schizophrenia, pending FDA approval.
Intra-Cellular Therapies shares traded lower by 13.3% at $11.66 in Monday's pre-market session.
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