PDUFAApproval decision

BXCL501

Acute agitation associated with schizophrenia & bipolar disorder

BTAIBioXcel Therapeutics Inc

Expected catalystNovember 14, 2026Company guidance: Nov 14, 2026

Catalyst overview

Event details

Drug or asset: BXCL501
Development stage: PDUFA
Event type: Approval decision
Indication: Acute agitation associated with schizophrenia & bipolar disorder

Research signalsHigh management interest

Research summary

What is being tracked?

This catalyst tracks a PDUFA approval decision for BXCL501 in Acute agitation associated with schizophrenia & bipolar disorder. The expected timing is based on the latest available company guidance and may change.

Development notes

05/15/26:- PDUFA date reiterated; at-home launch planning and strategic options continue. 05/28/26:- New SERENITY At-Home Ph3 exploratory efficacy analyses presented at ASCP 2026; PDUFA Nov 14, 2026 reiterated.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source