Intra-Cellular Therapies (ITCI -30.9%) plummets on more than a 7x surge in volume in reaction to the cancellation of an FDA advisory committee meeting to review and discuss its marketing application for lumateperone for adults with schizophrenia citing “new information” pertaining to the filing. The meeting was scheduled for Wednesday, July 31.
The FDA says that it will “continue evaluating the application” and announce future meeting dates “as needed” in the Federal Register. The agency’s action date for its review is September 27.
On July 8, the company announced results from two Phase 3 studies, one successful and one not.
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