FDA Cancels Panel Review Of Intra-Cellular Therapies' Schizophrenia Drug

(RTTNews) - Intra-Cellular Therapies Inc. (ITCI) said that the U.S. Food and Drug Administration has cancelled the Psychopharmacologic Drugs Advisory Committee meeting scheduled for July 31, 2019 to discuss the New Drug Application or NDA for lumateperone for the treatment of schizophrenia.

ITCI closed Tuesday's regular trading at $8.19, down $3.79 or 31.64 percent. But, in the after-hours tare, the stock gained $0.61 or 7.45 percent.

The company said it recently provided additional information to the FDA in response to information requests relating to non-clinical studies.

The FDA cancelled the Advisory Committee meeting to allow sufficient time to review this new and any forthcoming information as they continue the NDA review. The information may result in an extension of the September 27, 2019 Prescription Drug User Fee Act target action date for the lumateperone NDA.