miércoles, 24 de julio de 2019

Is the market misreading Intra-Cellular Therapies?

The Readout
Damian Garde

Is the market misreading Intra-Cellular Therapies?


Yesterday afternoon, the FDA canceled a meeting of outside experts scheduled for July 31 that was expected to review Intra-Cellular’s schizophrenia drug lumateperone. Why cancel? Because the FDA received “new information regarding the [lumateperone] application,” the agency said.

Investors were quick to interpret the nixed advisory panel meeting — and the vague explanation — as a negative. Intra-Cellular shares fell 30% on fears that FDA was leaning toward rejecting lumateperone.

But as Adam Feuerstein noted, there might also be a more benign explanation: The “new information” might have convinced the FDA to approve lumateperone, thereby making hearing from the advisory panel meeting moot.

Without further details, we’re all just guessing, but biotech is never boring.

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