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BioXcel Therapeutics (BTAI)

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Earnings summaries and quarterly performance for BioXcel Therapeutics.

Recent press releases and 8-K filings for BTAI.

BioXcel Therapeutics Submits sNDA for IGALMI® Label Expansion
BTAI
Product Launch
New Projects/Investments
  • BioXcel Therapeutics (Nasdaq: BTAI) submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) on January 14, 2026, for IGALMI® to expand its label for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting.
  • The sNDA seeks to allow IGALMI® use in an outpatient setting without the supervision of a healthcare provider, addressing a current unmet medical need.
  • This submission is supported by positive results from the Phase 3 SERENITY At-Home safety trial, which met its primary endpoint of being well-tolerated.
  • The company anticipates potential FDA approval for this label expansion as early as year-end 2026.
Jan 20, 2026, 12:00 PM
BioXcel Therapeutics, Inc. Appoints Interim CCO and Plans IGALMI sNDA
BTAI
Management Change
New Projects/Investments
Product Launch
  • BioXcel Therapeutics, Inc. announced on January 12, 2026, the appointment of Mark Pavao as Interim Chief Commercial Officer.
  • Mr. Pavao's role is to support the potential launch of IGALMI for at-home use.
  • The company plans to submit a supplemental New Drug Application (sNDA) this month for FDA approval of IGALMI for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia.
Jan 12, 2026, 12:02 PM
BioXcel Therapeutics Stockholders Approve Reverse Stock Split and Elect Directors
BTAI
Proxy Vote Outcomes
Delisting/Listing Issues
  • At its 2025 Annual Meeting of Stockholders on December 12, 2025, BioXcel Therapeutics' shareholders approved the election of three Class I directors, ratified Ernst & Young LLP as the independent auditor for 2025, and approved the advisory compensation for named executive officers.
  • Shareholders also approved an amendment to the company's certificate of incorporation to effect a reverse stock split at a ratio of 1 for 2 to 1 for 20, intended as a precautionary measure to maintain Nasdaq Capital Market minimum bid price compliance.
  • The company confirmed that its drug, Serenity, was originally approved in April 2022 with 120 microgram and 180 microgram doses, and currently carries no black box warning on its label.
  • Management addressed questions regarding $4.9 million raised through ATM sales in Q3 and clarified discrepancies in reported share counts between Q2 and Q3, attributing them to different filing dates.
Dec 12, 2025, 2:00 PM
BioXcel Therapeutics Reports Q3 2025 Financial Results and Provides Clinical Program Update
BTAI
Earnings
New Projects/Investments
Guidance Update
  • BioXcel Therapeutics reported a net loss of $30.9 million for the third quarter of 2025, with net revenue from IGALMI® at $98 thousand for the same period.
  • The company plans to submit a supplemental New Drug Application (sNDA) in early Q1 2026 for FDA approval of IGALMI® for at-home use in treating agitation associated with bipolar disorders or schizophrenia.
  • As of September 30, 2025, cash and cash equivalents and restricted cash totaled $37.3 million.
  • The company estimates the total addressable at-home market for agitation episodes to be 57 to 77 million annually in the U.S..
Nov 12, 2025, 12:11 PM
BioXcel Therapeutics Reports Q3 2025 Financial Results and Clinical Program Updates
BTAI
Earnings
New Projects/Investments
  • BioXcel Therapeutics reported a net loss of $30.9 million for the third quarter of 2025, compared to a net loss of $13.7 million for the same period in 2024, with net revenue from IGALMI® at $98 thousand for Q3 2025.
  • The company plans to submit a supplemental New Drug Application (sNDA) early in the first quarter of 2026 seeking FDA approval for the at-home use of IGALMI® for the acute treatment of agitation associated with bipolar disorders or schizophrenia.
  • BioXcel Therapeutics is advancing steps toward the initiation of the TRANQUILITY In-Care Phase 3 Trial evaluating BXCL501 in agitation associated with Alzheimer’s dementia.
  • The total addressable market for at-home agitation is now estimated to be 57 to 77 million annual episodes in the U.S., which is significantly higher than the previously anticipated 23 million annual episodes.
  • As of September 30, 2025, cash and cash equivalents and restricted cash totaled $37.3 million.
Nov 12, 2025, 12:00 PM