Is the FDA Canceling This Schizophrenia Treatment?
Intra-Cellular Therapies Inc. (NASDAQ: ITCI) shares dipped on Tuesday after the firm gave an update from the U.S. Food and Drug Administration (FDA).
Essentially, the FDA informed Intra-Cellular that it does not have plans to schedule an Advisory Committee meeting in connection with its review of the company’s New Drug Application (NDA) for lumateperone for the treatment of schizophrenia. The lumateperone Prescription Drug User Fee Act (PDUFA) goal date is December 27, 2019.
Additionally, the firm recently submitted to the FDA the results of nonclinical analyses Intra-Cellular previously announced it had agreed to conduct related to toxicology findings in animal studies.
The company believes the results of these analyses provide additional support for its position that the metabolic pathway, and the metabolites formed, are different in animals and humans and therefore toxicity findings in animals are not relevant to humans.
Dr. Sharon Mates, board chair and chief executive of Intra-Cellular, commented:
We have been working diligently to address the FDA requests for information and are optimistic that the additional non-clinical information we submitted addresses those requests. There is an ongoing unmet need for new treatments for schizophrenia and we look forward to continuing our work with the FDA to bring lumateperone to patients.
Shares of Intra-Cellular traded down about 5% to $9.78 on Tuesday. The 52-week range is $7.41 to $23.62, and the consensus price target is $25.89.