| Drug / Therapy | lumateperone |
| Indication | bipolar I maintenance |
| Decision Type | PDUFA |
| Conditions | bipolar I maintenance |
| Interventions | lumateperone |
Intra-Cellular Therapies (ITCI) operates in the Neuroscience sector. The current BTS Score is 29 (Grade: F).
Biotech companies frequently raise capital through secondary offerings, ATM programs, and convertible notes. Before or after major FDA decisions, dilution events are common. Understanding a company's dilution history is critical for managing risk around catalyst dates.
The PDUFA date for lumateperone by Intra-Cellular Therapies (ITCI) is scheduled for December 8, 2026. This is the target date for the FDA to make a decision on this application.
lumateperone is being developed by Intra-Cellular Therapies for the treatment of bipolar I maintenance. It is under FDA review.
If lumateperone receives FDA approval, Intra-Cellular Therapies (ITCI) would be able to market the drug in the United States for bipolar I maintenance. This typically leads to significant stock price movement for biotech companies. Investors should monitor the PDUFA date closely.
Biotech companies often raise capital through share offerings, which can dilute existing shareholders. You can check the current dilution risk for ITCI on DilutionWatch at dilutionwatch.com/stock/ITCI.html.
You can view the full BiotechSigns company profile for Intra-Cellular Therapies (ITCI) at biotechsign.com/app/company/ITCI, which includes the BTS Score, signal history, clinical trial data, and insider trading activity.
This page is for informational purposes only and does not constitute investment advice. FDA decision dates are subject to change. Clinical trial outcomes are inherently uncertain. Biotech stocks are highly volatile — past performance does not guarantee future results. Always consult a qualified financial advisor before making investment decisions. BiotechSigns is not a registered investment advisor.