UPDATE 1-FDA approves Intra-Cellullar's schizophrenia treatment, shares soar [Reuters]
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Source: Reuters
UPDATE 1-FDA approves Intra-Cellullar's schizophrenia treatment, shares soar (Adds background, shares, company comment) Dec 23 (Reuters) - The U.S. Food and Drug Administration has approved Intra-Cellular Therapies Inc’s investigational drug to treat schizophrenia, the company said on Monday, sending its shares soaring 40%. The treatment, Caplyta, is the drug developer’s lead candidate that has shown to regulate three neurotransmitter systems — serotonin, dopamine and glutamate — linked to severe mental illnesses. The approval comes with a boxed warning, FDA’s harshest, saying the drug is not for the treatment of patients with dementia-related psychosis. Schizophrenia is a chronic mental disorder that causes distortion in thoughts, hallucinations and feelings of fright and paranoia. “We have a strong commercial team and are fully prepared to launch the drug in the first quarter of 2020,” Intra-Cellular Chief Medical Officer Dr. Andrew Satlin said, ahead of the approval, also highlight
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