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BTAI BIOXCEL THERAPEUTICS INC US FDA Inspections 8-K Filing

BXCL

BT

BIOXCEL THERAPEUTICS INC

(BTAI)

2025 8-K

Summary

Summary

Drug Application Update

Positive Study Results

Clinical Trial Update

Positive Efficacy Results

Trial Success Announcement

Equity Offering Filed

Positive FDA Feedback

FDA Meeting Feedback

New Product Launches

Pre-Market Approval

Other Special Situation

Financial Statements

Equity Offering

Financial Results

Nasdaq Delisting Notice

Securities Agreement

FDA Inspection Update

Stock Split Announcement

Stock Split Approval

Board Appointment

Executive Compensation Changes

Credit Agreement Amendment

Financial Results

Management Change

Nasdaq Compliance Issues

Workforce Reduction

Trial Enrollment Initiated

Financial Results Announcement

Amendment to Commercial Sup...

Financial Results

Positive Study Results for ...

Annual Meeting and Stock Am...

Financial Results Announcement

Presentation and Trial Updates

Updates on TRANQUILITY In-C...

Securities Purchase Agreement

Financial Results Announcement

Presentation Update

Credit Agreement Amendment ...

BXCL501 Updates and Planned...

Patent Approvals

Patent Announcement

Update on Clinical Developm...

Credit Agreement Amendment ...

Financial Results Announcement

Update on Phase 2 trial of ...

Business Updates

Non-Compete Agreement

Patent Approval

Patent Approval

FDA Meeting Scheduled

FDA Meeting Granted for TRA...

Financial Results Announcement

Phase 3 Trial Results

Financial Results Announcement

Update on Clinical Trial Da...

Phase 3 Trial Enrollment Co...

Financial Results Announcement

KOL Day for BXCL701

Phase 2a trial results

External Links:

On August 14, 2025, BioXcel Therapeutics, Inc. received positive early comments from the FDA regarding their pre-sNDA meeting set for August 20, 2025, aiming to discuss the submission requirements.

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BIOXCEL THERAPEUTICS INC

2025

8 K

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