The Food and Drug Administration canceled an advisory committee meeting concerning an investigational drug to treat schizophrenia Tuesday, sending shares of the company developing it tumbling.
New York-based Intra-Cellular Therapies said Tuesday that the FDA had canceled the Psychopharmacologic Drugs Advisory Committee meeting scheduled for July 31 for the drug lumateperone. The company said the agency had canceled the AdCom meeting in order to allow for enough time to review new and any forthcoming information with regard to the company’s regulatory approval application for lumateperone. The FDA had requested additional information from the company about non-clinical studies of the drug.
The company added that it has a meeting scheduled with the agency “shortly” and would provide an update afterwards, and the additional information it provided may extend the deadline for the FDA to reach an approval decision beyond the current Sept. 27 date.
Shares of Intra-Cellular Therapies closed down 31 percent on the Nasdaq following the news Tuesday, falling from $11.94 to $8.19, but rose about 5 percent after markets opened Wednesday.
The company’s announcement did not provide further details. Referring to Intra-Cellular’s head of communications as “one of the nicest people in biotech,” investor Brad Loncar wrote on Twitter, “Bet he’s been biting his tongue all day. Too bad companies can’t comment on these things in real time.”
It’s the second time this month that Intra-Cellular’s stock has seen a significant drop. On July 8, its shares fell more than 20 percent after it announced that in one of two Phase III studies of lumateperone in bipolar disorder, the drug had failed to show superiority over placebo, while the other study was positive.
At the time, Cowen analyst Ritu Baral wrote in a note to investors that it was unclear why the rate of patients who responded to placebo differed so much between the two studies, though a number of factors may explain the discrepancy. Nevertheless, in a note four days later, Baral wrote that Cowen would discontinue coverage of Intra-Cellular “because of finite research capacity.”
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