Intra-Cellular takes another beating after the FDA raises a red flag on schizophrenia drug safety
Intra-Cellular Therapeutics is digging in deep to defend the troubling late-stage data its researchers gathered on a lead drug for schizophrenia. But now the FDA has raised questions about tox issues seen in an animal study, and the biotech execs appear to have lost another big group of once-faithful investors.
The biotech’s share price $ITCI was already subjected to a severe beating last fall, when company execs tried to explain why their second Phase III study for lumateperone (ITI-007) flopped badly against a placebo and an active control arm. Part of their case centered on the improved safety profile they touted at the time.
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