BioXcel Therapeutics Announces 33% Enrollment in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia
Portfolio Pulse from
BioXcel Therapeutics has announced that it has reached 33% enrollment in its SERENITY At-Home Pivotal Phase 3 Safety Trial. This trial is focused on the acute treatment of agitation associated with bipolar disorders or schizophrenia. The data from this trial could support a potential supplemental New Drug Application (sNDA) for label expansion of IGALMI® for use in home settings.
March 07, 2025 | 12:15 pm
News sentiment analysis
Sort by:
Ascending
POSITIVE IMPACT
BioXcel Therapeutics has achieved 33% enrollment in its Phase 3 trial for IGALMI®, targeting agitation in bipolar and schizophrenia patients. This progress could lead to a sNDA for home use, potentially expanding the drug's market.
The announcement of 33% enrollment in a pivotal Phase 3 trial is a significant milestone for BioXcel Therapeutics. If successful, the trial could lead to a sNDA submission, allowing IGALMI® to be used in home settings. This would expand its market and potentially increase revenue, positively impacting BTAI's stock price.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100