BioXcel Therapeutics, Inc. 8-K

What Happened

• On February 12, 2026 BioXcel Therapeutics (BTAI) reported completion of an updated market opportunity assessment for IGALMI® for acute agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting. The assessment was informed by results from the SERENITY At-Home clinical study. The company also noted it submitted a supplemental New Drug Application (sNDA) to the FDA in January 2026 seeking approval of IGALMI for at-home use.

Key Details

• Market research included interviews with 15 prescribers and 5 payers, plus survey responses from 180 experienced prescribers.
• Patient-level claims analysis estimated ~2.3 million treated bipolar and schizophrenia patients experience frequent at-home acute agitation; up to 1.8 million may be eligible for IGALMI.
• Company estimates up to 86 million addressable annual episodes (previously estimated ~57–77 million episodes).
• Prescribers projected use of IGALMI in ~70% of their schizophrenia and bipolar patients; prior patient/caregiver research (N=80) indicated expected use in ~80% of acute agitation episodes. Payers indicated expectations for broad formulary coverage with standard controls.

Why It Matters

• The sNDA and this market assessment signal BioXcel’s push to make IGALMI available for at-home treatment—a potential expansion beyond in-clinic use that could materially increase the drug’s commercial opportunity if approved.
• The filing provides concrete uptake and eligibility estimates (patients, episodes, prescriber interest) and indicates payer openness to coverage, all key factors for revenue potential.
• These figures are company estimates and forward-looking; FDA approval, actual prescribing, coverage decisions, and other risks (described in the 8-K) will determine real outcomes.