Shares of small-cap biopharma Intra-Cellular Therapies Inc (NASDAQ: ITCI) were nearly doubling Monday after a binary event panned out in favor of the company.
The SHARES are trading at their highest level since late 2016.
FDA Approves Lumateperone
Intra-Cellular said the FDA has approved its lumateperone for treating schizophrenia.
Lumateperone, which goes by the trade name Caplyta, is an oral, once-daily medicine. Its efficacy is mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine receptors.
Intra-Cellular Developing Drug For Other Indications
Schizophrenia, a chronic disease often accompanied by depression and gradual deterioration of social functioning and cognitive ability, affects about 2.4 million adults in the U.S.
Most patients often discontinue treatment due to side effects such as weight gain and movement disorders.
"We believe Caplyta provides health care providers a new, safe and effective treatment option to help the millions of adult patients with schizophrenia," CEO Dr. Sharon Mates said in a statement.
Intra-Cellular is also developing Caplyta for bipolar depression; behavioral disturbances in patients with dementia, including Alzheimer's disease; depression and other neuropsychiatric and neurological disorders.
The company said it expects to commercially launch Caplyta late in the first quarter of 2020.
Intra-Cellular shares were jumping 181.03% to $34.96 at the time of publication.