Wall Street is mulling Intra-Cellular Therapeutics Inc.’s chances of replicating with Caplyta (lumateperone) the path followed by Abbvie Inc. with Vraylar (cariprazine) in major depressive disorder (MDD), and possibly overtaking the latter in the difficult indication.

Robust top-line phase III data showed Intra-Cellular Therapies Inc.’s marketed oral atypical antipsychotic drug, Caplyta (lumateperone), achieved statistically significant and clinically meaningful best-in-class results, potentially expanding its reach into the billion-dollar major depressive disorder market. The company’s shares (NASDAQ:ITCI) surged to a 52-week high of $84.89 throughout the day, closing at $79.84, up 23.3%, or $15.08, on April 16.

Intra-Cellular Therapies Inc.’s phase III data with Caplyta (lumateperone) 42 mg in major depressive disorder (MDD) with mixed features (MF) and in patients with bipolar depression with MF may augur well for the ongoing, late-stage program with the compound as an adjunctive treatment in MDD.

Drugs targeting receptors of the neurotransmitter serotonin (5-hydroxytryptamine [5-HT]) are widely used in neuropsychiatry and some such agents, most notably psilocybin, have shown potential for further drug development, but hallucinogenic effects have limited their clinical use. The findings of a new multicenter Chinese structural pharmacology study may now provide a solid basis for the structure-based design of safe and nonhallucinogenic psychedelic analogues with therapeutic efficacy, the authors reported in the January 28, 2022, edition of Science.