Saturday, November 14, 2026
172 days away
Drug Information
- Drug Name
- IGALMI →
- Application Type
- sNDA
- Indication
- acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting
Filing Details
- Company
- BioXcel Therapeutics, Inc. →
- Stock Ticker
- BTAI
- SEC CIK
- 0001720893
Active Phase 3 Trials
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What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Explore BioXcel Therapeutics, Inc.
View BioXcel Therapeutics, Inc.'s full pipeline, approved drugs, and clinical trials.
Data sourced from SEC EDGAR filings. Last updated: 2026-05-10. Report an issue