Intra-Cellular receives FDA Fast Track designation

 Intra-Cellular receives FDA Fast Track designation for lumateperone

Intra Cellular Therapies receives FDA's fast track designation. See for details

Intra-Cellular (ITCI) announced that the FDA has granted Fast Track designation for lumateperone for the treatment of schizophrenia.

Lumateperone (INN; developmental code names ITI-007ITI-722) is an investigational atypical antipsychotic which is currently under development by Intra-Cellular Therapies, licensed from Bristol-Myers Squibb, for the treatment of schizophrenia.  It is also being developed by Intra-Cellular Therapies for the treatment of bipolar disorder, depression, and sleep and behavioral disturbance in dementia, autism, and other neuropsychiatric disorders.

The company requested Fast Track designation for lumateperone based on clinical evidence that lumateperone has the potential to address the unmet medical need for the treatment of schizophrenia with significant improvements on several clinically significant safety parameters, including with respect to metabolic, motor and cardiovascular issues associated with many currently available antipsychotic agents.

The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drug candidates to treat serious and life-threatening conditions.

Fast Track designation may allow for more frequent meetings and communications with the FDA to discuss a drug candidate’s development plans and review process.

Drug candidates with Fast Track designation may also qualify for priority review to expedite the FDA review process, if relevant criteria are met.

ITCI closed at $15.32.


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