Phase 2ITCINCT06540833

A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease FDA Decision: Intra-Cellular Therapies (ITCI)

Decision Date
September 30, 2028
805 days away

Drug Overview

Drug / TherapyA Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease
Indication
Decision TypePhase 2
Trial PhasePhase 2
ClinicalTrials.govNCT06540833

Company Overview

Intra-Cellular Therapies (ITCI) operates in the Neuroscience sector. The current BTS Score is 50 (Grade: C).

Dilution Risk Assessment

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.

Frequently Asked Questions

Q:When is the Phase 2 date for A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease?

The Phase 2 date for A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease by Intra-Cellular Therapies (ITCI) is scheduled for September 30, 2028. This is the target date for the FDA to make a decision on this application.

Q:What is A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease used for?

A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease is being developed by Intra-Cellular Therapies for the treatment of its target indication. It is currently in Phase 2 clinical trials.

Q:What happens if A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease gets FDA approval?

If A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease receives FDA approval, Intra-Cellular Therapies (ITCI) would be able to market the drug in the United States for its target indication. This typically leads to significant stock price movement for biotech companies. Investors should monitor the Phase 2 date closely.

Q:What is the dilution risk for ITCI?

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.

Q:Where can I find more information about Intra-Cellular Therapies?

You can view the full BiotechSign 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.

Disclaimer

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. BiotechSign is not a registered investment advisor.