BioPharmSignal logoBioPharmSignal

Biotech News

BioXcel Therapeutics Announces Food & Drug Administration Acceptance of Supplemental New Drug Application for Use of IGALMI® in the At-Home Setting

BioXcel (BTAI)BioXcelFDA / regulatory

PDUFA target action date of November 14, 2026 Potential first FDA-approved treatment option for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting NEW HAVEN, Conn., April 01, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc.

Related news

BMYBMYBristol-Myers Squibb Company2026-07-13 10:59 EST

U.S. Food and Drug Administration Accepts Bristol Myers Squibb's New Drug Application for Mezigdomide in Patients with Relapsed or Refractory Multiple Myeloma

COGTCogent Biosciences2026-05-28 12:00 EST

Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST

REPLReplimune Group2026-06-26 12:00 EST

Replimune Announces FDA Acceptance of RP1 Biologics License Application Resubmission for Advanced Melanoma

RVMDRevolution Medicines2026-07-22 20:05 EST

Revolution Medicines’ New Drug Application for Daraxonrasib Accepted for Review by U.S. FDA for Previously Treated Metastatic Pancreatic Cancer

BTAIBioXcel2026-05-28 11:00 EST

BioXcel Therapeutics Presents New Data from SERENITY At-Home Phase 3 Trial for Agitation Associated with Bipolar Disorders or Schizophrenia at 2026 ASCP Annual Meeting

INBXInhibrx2026-06-15 13:15 EST

Inhibrx Announces U.S. FDA Acceptance of BLA for Ozekibart in Patients with Conventional Chondrosarcoma

REGNRegeneron Pharmaceuticals2026-06-22 11:00 EST

Cemdisiran Regulatory Submissions Accepted for Review by FDA and EMA for the Treatment of Generalized Myasthenia Gravis (gMG)

ELVNEnliven Therapeutics2026-06-11 12:00 EST

Enliven Therapeutics Announces Updated Positive Phase 1 Clinical Data and Alignment with FDA on Key Phase 3 Trial Design Components

REPLReplimune Group2026-08-06 20:00 EST

Replimune Announces FDA Accelerated Approval of TUDRIQEVTM in Combination with Nivolumab for Unresectable Advanced Cutaneous Melanoma After Progression on an anti-PD-1 Based Regimen

BMYBMYBristol-Myers Squibb Company2026-06-01 10:59 EST

U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Supplemental New Drug Application for Camzyos (mavacamten) to Treat Adolescents with Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

View all latest news

BioXcel

BioXcel Therapeutics is a neuroscience and immuno-oncology company focused on using artificial intelligence to identify therapeutic candidates. Its story combines data-driven discovery with development-stage biotech execution.

Recent company news

BTAIBioXcel2026-05-28 11:00 EST

BioXcel Therapeutics Presents New Data from SERENITY At-Home Phase 3 Trial for Agitation Associated with Bipolar Disorders or Schizophrenia at 2026 ASCP Annual Meeting

BTAIBioXcel2026-05-15 11:00 EST

BioXcel Therapeutics Provides Business Update and Reports First Quarter 2026 Financial Results

BTAIBioXcel2026-04-17 11:00 EST

BioXcel Therapeutics Announces Virtual Event to Discuss Commercial Launch Plan Based on Market Opportunity Assessment for IGALMI® in the At-Home Setting

BTAIBioXcel2026-04-08 11:00 EST

BioXcel Therapeutics Announces Enrollment of First Patients in U.S. Department of War-Funded Study of BXCL501 (Sublingual Dexmedetomidine) for Treatment of Acute Stress Reactions

BTAIBioXcel2026-04-01 11:00 EST

BioXcel Therapeutics Announces Food & Drug Administration Acceptance of Supplemental New Drug Application for Use of IGALMI® in the At-Home Setting

Stock data

Close
0.83 USD
Market cap
36.74M USD
Exchange
NASDAQ
Sector
Biopharma
Location
United States