Canada News Beep
  • News Beep
  • Canada
  • Headlines
  • Business
  • Entertainment
  • Health
  • Science
  • Sports
  • Technology
Canada News Beep
Canada News Beep
  • News Beep
  • Canada
  • Headlines
  • Business
  • Entertainment
  • Health
  • Science
  • Sports
  • Technology

Browsing Tag

acute treatment

5 posts
HHealthcare
BioXcel Therapeutics Announces Positive FDA Pre-sNDA Meeting Comments for sNDA Submission for BXCL501 in Agitation Associated with Bipolar Disorders or Schizophrenia
Read More

BioXcel Therapeutics Reports Third Quarter 2025 Financial Results and Provides Update on Late-Stage Clinical Programs for Agitation in Bipolar, Schizophrenia, and Alzheimer’s Disease

  • November 12, 2025
BioXcel Therapeutics sNDA submission expected in early Q1 2026 for expanded usage of IGALMI® in home setting based…
HHealthcare
BioXcel Therapeutics Announces Positive FDA Pre-sNDA Meeting Comments for sNDA Submission for BXCL501 in Agitation Associated with Bipolar Disorders or Schizophrenia
Read More

BioXcel Therapeutics Reports Positive Topline Exploratory Efficacy Data from SERENITY At-Home Pivotal Phase 3 Safety Trial for Agitation Associated with Bipolar Disorders or Schizophrenia

  • September 10, 2025
BioXcel Therapeutics BXCL501 demonstrated a significant mean reduction in mCGI-S score from baseline compared to placebo at 2…
HHealthcare
BioXcel Therapeutics Announces Positive FDA Pre-sNDA Meeting Comments for sNDA Submission for BXCL501 in Agitation Associated with Bipolar Disorders or Schizophrenia
Read More

BioXcel Therapeutics Announces SERENITY At-Home Pivotal Phase 3 Safety Trial Met its Primary Endpoint in Support of sNDA Submission for Label Expansion of IGALMI®

  • August 30, 2025
BioXcel Therapeutics BXCL501 achieved SERENITY At-Home’s primary endpoint of being well tolerated in the at-home treatment of agitation…
HHealthcare
BioXcel Therapeutics Announces Positive FDA Pre-sNDA Meeting Comments for sNDA Submission for BXCL501 in Agitation Associated with Bipolar Disorders or Schizophrenia
Read More

BioXcel Therapeutics To Announce Topline Results from SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia on August 27, 2025

  • August 26, 2025
BioXcel Therapeutics Company to host conference call at 8 a.m. ET, August 27, 2025 NEW HAVEN, Conn., Aug.…
HHealthcare
BioXcel Therapeutics Announces Positive FDA Pre-sNDA Meeting Comments for sNDA Submission for BXCL501 in Agitation Associated with Bipolar Disorders or Schizophrenia
Read More

BioXcel Therapeutics Announces Positive FDA Pre-sNDA Meeting Comments for sNDA Submission for BXCL501 in Agitation Associated with Bipolar Disorders or Schizophrenia

  • August 18, 2025
BioXcel Therapeutics Achieved alignment with the FDA on sNDA package to expand the IGALMI label for the At-Home…
Canada News Beep
www.newsbeep.com