ITCI shares fall as FDA cancels panel review of schizophrenia drug

Drug Drop

The Food and Drug Administration (FDA) canceled an advisory committee meeting that had been scheduled for July 31 to review Intra-Cellular Therapies’ (ITCI) lead drug, lumateperone. When word of the cancellation was revealed, shares of ITCI fell sharply, according to an article by Adam Feuerstein in STAT News.

The FDA was convening the meeting of outside experts in order to review the drug lumateperone. The agency canceled the meeting, saying that there was “new information regarding the application,” according to an FDA statement. While no additional information was available, investors took the news about the lumateperone review badly. As a result, shares of Intra-Cellular stock dropped 30 percent.

Data supporting lumateperone’s application to the FDA had been mixed, with one positive and one negative Phase 3 clinical trial involving schizophrenia patients, Feuerstein reported. In early July, ITCI reported more mixed clinical data on efforts to expand lumateperone’s use for patients with bipolar depression. One Phase 3 study showed that the drug clearly outperformed placebo in improving the symptoms of bipolar depression. Another Phase 3 study revealed that the treatment was not distinguishable from placebo.

ITCI is developing lumateperone (also known as ITI-007) to treat schizophrenia, bipolar disorder, behavioral disturbances in patients with dementia, including Alzheimer’s disease, depression and other neuropsychiatric and neurological disorders. Lumateperone, which provides selective and simultaneous modulation of serotonin, dopamine, and glutamate, three neurotransmitter pathways implicated in severe mental illness, is a potent serotonin 5-HT2A receptor antagonist, a dopamine receptor phosphoprotein modulator (DPPM) acting as a presynaptic partial agonist and postsynaptic antagonist at dopamine D2 receptors, a dopamine D1 receptor-dependent indirect modulator of glutamate and a serotonin reuptake inhibitor.

As of this writing, it was not certain that the FDA requested to see the bipolar depression data as part of its review of lumateperone for schizophrenia. However, it is possible that those data, if shared with the FDA, triggered enough concerns to sway the FDA against approving the drug. That would have eliminated the need for an advisory panel meeting.

It is also possible that the FDA decided that those new lumateperone data made it necessary to extend the review beyond the current September 27 approval decision deadline. Should the review be extended, the canceled advisory panel meeting could be rescheduled for a later date.

A third explanation is possible as well. The FDA could have made the decision to approve lumateperone already. If that is the case, the discussion of the drug by outside panel experts would be moot. If that’s what’s happening, Tuesday’s selloff would be a huge misread by the market.

Because Intra-Cellular has not yet issued a statement on the subject of the canceled FDA advisory panel meeting, people can only speculate on the reason for it. The company has not yet replied to requests for comment.