Earnings summaries and quarterly performance for BioXcel Therapeutics.
Executive leadership at BioXcel Therapeutics.
Vimal Mehta
Chief Executive Officer and President
Frank Yocca
Executive Vice President and Chief Scientific Officer
Javier Rodriguez
Senior Vice President, Chief Legal Officer and Corporate Secretary
Richard Steinhart
Senior Vice President and Chief Financial Officer
Board of directors at BioXcel Therapeutics.
Research analysts who have asked questions during BioXcel Therapeutics earnings calls.
Graig Suvannavejh
Mizuho Securities
4 questions for BTAI
Sumant Kulkarni
Canaccord Genuity
4 questions for BTAI
Alec Stranahan
Bank of America
3 questions for BTAI
Samir Devani
Rx Securities
3 questions for BTAI
Colin Bristow
United States
2 questions for BTAI
Raghuram Selvaraju
H.C. Wainwright & Co.
2 questions for BTAI
Avantika Joshi
Mizuho Securities
1 question for BTAI
Ram Selvaraju
H.C. Wainwright
1 question for BTAI
Robyn Karnauskas
Truist Securities
1 question for BTAI
Recent press releases and 8-K filings for BTAI.
- 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.
- 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.
- 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.
- 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..
- 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.
Quarterly earnings call transcripts for BioXcel Therapeutics.
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