ITI-214

Intra-Cellular Therapies seeks FDA approval for Caplyta as an adjunct treatment for major depressive disorder (MDD), potentially expanding its market to over $1 billion. Caplyta, already approved for schizophrenia and bipolar disorder, saw Q3 sales of $175 million, with Q4 projections at least $193 million. The MDD submission is based on Phase III trials showing symptom improvement when paired with an antidepressant. Jefferies estimates a 90–95% approval likelihood, predicting a company valuation of $9–12 billion. Intra-Cellular is also exploring Caplyta for autism and developing ITI-214 for Parkinson’s and ITI-333 for opioid use.