| Drug / Therapy | IGALMI |
| Indication | BTAI PDUFA |
| Decision Type | PDUFA |
| Conditions | BTAI PDUFA |
| Interventions | IGALMI |
BioXcel Therapeutics (BTAI) operates in the Neuroscience sector. The current BiotechSign Score is 41 (Grade: D).
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 IGALMI by BioXcel Therapeutics (BTAI) is scheduled for November 14, 2026. This is the target date for the FDA to make a decision on this application.
IGALMI is being developed by BioXcel Therapeutics for the treatment of BTAI PDUFA. It is under FDA review.
If IGALMI receives FDA approval, BioXcel Therapeutics (BTAI) would be able to market the drug in the United States for BTAI PDUFA. 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 BTAI on DilutionWatch at dilutionwatch.com/stock/BTAI.html.
You can view the full BiotechSign company profile for BioXcel Therapeutics (BTAI) at biotechsign.com/app/company/BTAI, which includes the BiotechSign 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. BiotechSign is not a registered investment advisor.