Shares of Intra-Cellular Therapies (ITCI) were down 42.1% to $8 in premarket trading on Monday after the New York firm said the U.S. Food and Drug Administration had requested additional information regarding its lumateperone development program in schizophrenia.
Intra-Cellular said it has requested guidance from the FDA on the acceptability of the two clinical studies - ITI-007-005 and ITI-007-301 - with supportive evidence from Study ITI-007-302, as the basis for the submission of a new drug application for schizophrenia treatment. The company said the FDA confirmed that the results of ITI-007-302 do not preclude Intra-Cellular from submitting an NDA.
"The FDA has raised questions, however, relating to certain findings observed in nonclinical animal toxicology studies of lumateperone and has requested additional information to confirm that the nonclinical findings are not indicative of a safety risk associated with long term exposure in humans," the company said.
Intra-Cellular said it believes the findings "are not indicative of a safety risk for humans due to species differences in the metabolism of lumateperone." The company said it is preparing to respond to the FDA's request for additional information and plans to proceed with its long-term safety study of lumateperone in patients that have schizophrenia.
Meanwhile, shares of Organovo Holdings (ONVO - Get Report) were up 5.2% to $3.05. The San Diego firm said Monday it has teamed up with the University of Virginia to develop three-dimensional bioprinted tissues for volumetric muscle loss injury.