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BioXcel Therapeutics (BTAI) FDA Events

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FDA Events for BioXcel Therapeutics (BTAI)

This section highlights FDA-related milestones and regulatory updates for drugs developed by BioXcel Therapeutics (BTAI). Over the past two years, BioXcel Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as BXCL501, BXCL501, BXCL501, BXCL701, and IGALMI™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

BioXcel Therapeutics' Drugs in FDA Review

BXCL501 (dexmedetomidine) - FDA Regulatory Timeline and Events

BXCL501 (dexmedetomidine) is a drug developed by BioXcel Therapeutics for the following indication: For dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

BXCL501 (SERENITY) - FDA Regulatory Timeline and Events

BXCL501 (SERENITY) is a drug developed by BioXcel Therapeutics for the following indication: Schizophrenia and bipolar disorders. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

BXCL501 (TRANQUILITY) - FDA Regulatory Timeline and Events

BXCL501 (TRANQUILITY) is a drug developed by BioXcel Therapeutics for the following indication: Agitation Associated with Dementia. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

BXCL701 + KEYTRUDA (pembrolizumab) - FDA Regulatory Timeline and Events

BXCL701 + KEYTRUDA (pembrolizumab) is a drug developed by BioXcel Therapeutics for the following indication: Neuroendocrine Prostate Cancer (NEPC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

IGALMI™ - FDA Regulatory Timeline and Events

IGALMI™ is a drug developed by BioXcel Therapeutics for the following indication: Sublingual film. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

BioXcel Therapeutics FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, BioXcel Therapeutics (BTAI) has reported FDA regulatory activity for the following drugs: BXCL501 (SERENITY), BXCL501 (TRANQUILITY), IGALMI™, BXCL501 (dexmedetomidine) and BXCL701 + KEYTRUDA (pembrolizumab).

The most recent FDA-related event for BioXcel Therapeutics occurred on July 1, 2025, involving BXCL501 (SERENITY). The update was categorized as "Top-line data," with the company reporting: "BioXcel Therapeutics, Inc announced that Topline data expected in Q3 2025."

Current therapies from BioXcel Therapeutics in review with the FDA target conditions such as:

  • Schizophrenia and bipolar disorders - BXCL501 (SERENITY)
  • Agitation Associated with Dementia - BXCL501 (TRANQUILITY)
  • Sublingual film - IGALMI™
  • For dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist - BXCL501 (dexmedetomidine)
  • Neuroendocrine Prostate Cancer (NEPC) - BXCL701 + KEYTRUDA (pembrolizumab)

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:BTAI) was last updated on 7/10/2025 by MarketBeat.com Staff
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