Shares of Intra-Cellular Therapies opened greater than 100% higher today after the company reported that the FDA approved its antipsychotic CAPLYTA® (lumateperone) drug for the treatment of schizophrenia in adults.
This morning a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, Intra-Cellular Therapies Inc. (ITCI:NASDAQ), announced that the U.S. Food and Drug Administration (FDA) has approved the company's CAPLYTA® (lumateperone) for the treatment of schizophrenia in adults. The company stated that it expects the commercial launch of CAPLYTA to commence in late Q1/20.
Intra-Cellular notes that CAPLYTA is a once daily oral medicine approved for the treatment of schizophrenia in adults. The firm advised that it is also currently developing and studying CAPLYTA for applications in the treatment of bipolar depression; behavioral disturbances in patients with dementia, including Alzheimer's disease; depression; and other neuropsychiatric and neurological disorders.
The company's Chairman and CEO Dr. Sharon Mates commented, "We believe CAPLYTA provides healthcare providers a new, safe and effective treatment option to help the millions of adult patients with schizophrenia...This approval represents the culmination of years of scientific research. We are especially grateful to the patients, their caregivers, and the healthcare professionals who have contributed to the development of CAPLYTA."
The firm explained in the report that schizophrenia is a chronic and lifelong mental illness that impacts approximately 2.4 million adults in the U.S. Acute episodes are typically characterized by psychotic symptoms, including hallucinations and delusions, frequently requiring hospitalization.
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, added, "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."
Intra-Cellular Therapies is headquartered in New York and states that its mission is "to develop innovative treatments to improve the lives of individuals suffering from neuropsychiatric and neurologic disorders, in order to reduce the burden on patients and their caregivers." In addition to the first product, CAPLYTA, Intra-Cellular is also utilizing its phosphodiesterase (PDE) platform and other proprietary chemistry platforms to develop drugs for the treatment of CNS and other disorders. The firm indicated that ITI-214, the lead molecule in its PDE1 portfolio, is being developed for treatment of Parkinson's disease symptoms and in treatment of heart failure.
Intra-Cellular Therapies began the day with a market capitalization of about $687.4 million with approximately 55.26 million outstanding shares and a short interest of around 19.5%. ITCI shares opened more than 100% higher today at $25.48 (+$13.04, +104.82%) over Friday's closing price of $12.44. Following the open, the firm's stock then proceeded even higher, setting a new 52-week high price this morning of $43.56/share. The stock has traded between $23.73 and $43.56 per share and is presently trading at $36.26 (+$23.82, +191.48%).
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