Keyword: Intra-Cellular Therapeutics
Caplyta was originally slated for an FDA decision in September but weathered the cancellation of an advisory committee meeting and a three-month review extension before the agency finally OK’d it in December.
Intra-Cellular Therapies’ lead asset hit a snag Tuesday afternoon as the FDA canceled an advisory panel meeting scheduled for next Wednesday.
Intra-Cellular Therapies raised its target of $150 million, which will help it prepare for an FDA filing for lumateperone in schizophrenia next year.
Intra-Cellular Therapies shed about $1.2 billion in market cap on the top-line data on a Phase III trial for its ITI-007 to treat schizophrenia that missed the primary endpoint.