Intra-Cellular Therapy Inc. (NASDAQ: ITCI) shares practically doubled on Monday after the firm announced that the U.S. Food and Drug Administration (FDA) has approved Caplyta for the treatment of schizophrenia in adults.

Schizophrenia is a serious mental illness affecting roughly 2.4 million adults in the United States. The clinical presentation of schizophrenia is diverse. Acute episodes are characterized by psychotic symptoms, including hallucinations and delusions, often requiring hospitalization. The disease is chronic and lifelong, often accompanied by depression and gradual deterioration of social functioning and cognitive ability. Patients with schizophrenia often discontinue treatment as a result of side effects such as weight gain and movement disorders.

The efficacy of Caplyta at the 42 mg dose was demonstrated in two placebo-controlled trials, showing a statistically significant separation from placebo on the primary endpoint, the Positive and Negative Syndrome Scale total score.

Additionally, the most common adverse reactions (≥5% and twice the rate of placebo) for the recommended dose of Caplyta versus the placebo were somnolence/sedation (24% versus 10%) and dry mouth (6% versus 2%).

Jeffrey A. Lieberman, M.D., Lawrence C. Kolb Professor and Chairman of Psychiatry, Columbia University, College of Physicians and Surgeons and Director, New York State Psychiatric Institute, commented:

Schizophrenia is a complex disease that severely impacts patients and their families. Effective treatment provided in a timely fashion can be game-changing for people living with schizophrenia. The efficacy and safety profile of CAPLYTA approved by the FDA, offers healthcare providers an important new option for treating people living with schizophrenia.

Shares of Intra-Cellular were last seen up about 118% to $27.09, in a 52-week range of $6.75 to $28.60. The consensus price target is $25.22

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