Intra-Cellular to submit additional preclinical data; FDA date delay to Dec 27

Per FDA feedback, Intra-Cellular Therapies (NASDAQ:ITCI) will submit additional preclinical data to the FDA related to its marketing application seeking approval for lumateperone for the treatment of schizophrenia. The additional results constitute a major amendment to the filing so the agency’s action date has been extended three months to December 27 to allow for review.

The company believes that the additional data should be sufficient to address the FDA’s questions.

Management hosted a conference call this morning at 8:30 am to discuss the matter.

On July 24, the company announced that the agency canceled the planned advisory committee meeting to allow for the full review of the new information. Shares initially sold off on the news.

Shares were up 13% premarket on light volume.

https://seekingalpha.com/news/3486700-intra-cellular-submit-additional-preclinical-data-lumateperone-nda-fda-action-date-extended