BXY News - Candlesense

BioXcel Therapeutics Announces Database Lock in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia

Data from more than 2,600 agitation episodes collected

How does BioXcel's SERENITY trial compare to competitor pipelines targeting agitation in bipolar disorder and schizophrenia? What are the expectations for regulatory approval timelines based on the SERENITY trial data? How will the database lock and upcoming results affect BXY's valuation in the short term?

Clinical trials

4 days ago

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

Achieved alignment with the FDA on sNDA package to expand the IGALMI label for the At-Home (Outpatient) setting

What competitive threats exist for BXCL501 in the agitation treatment market for bipolar disorder and schizophrenia? How significant is the expansion of the IGALMI label to the At‑Home setting in terms of potential revenue growth? What is the expected timeline for FDA approval of the sNDA and how might that affect BXY's valuation?

Regulatory

5 days ago

BioXcel Therapeutics Reports Second Quarter 2025 Financial Results and Recent Business Updates

Topline data from SERENITY At-Home Phase 3 trial for acute treatment of agitation associated with bipolar disorders or schizophrenia expected in August

How does the expected data release align with broader market sentiment toward biotech earnings and macro‑economic conditions? What are the potential regulatory implications if the trial meets its endpoints, and how could that affect the timeline to market and revenue forecasts? How might the trial outcomes influence analyst coverage, earnings estimates, and forward‑looking guidance for BioXcel?

Earnings

11 days ago