sNDA submission supports the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting with IGALMI® Submission timeline supports potential approval of IGALMI® label expansion as early as year-end 2026 NEW HAVEN, Conn., Jan. 20, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today announced it submitted a supple ...

Core Insights - BioXcel Therapeutics is highlighted as a promising penny stock due to its late-stage pipeline progress, increasing market potential, and an upcoming FDA milestone, making it a company to watch for 2026 [1] Company Overview - BioXcel Therapeutics is a biopharmaceutical company that utilizes artificial intelligence (AI) and machine learning to discover and develop innovative treatments, particularly in neuroscience [2] - The company's lead product, IGALMI, is an FDA-approved sublingual film formulation of BXCL501 designed for the immediate treatment of severe agitation in individuals with schizophrenia and bipolar disorder [2] Regulatory Developments - BioXcel has conducted a Phase 3 SERENITY At-Home trial with 246 patients to evaluate the safety of BXCL501 in a home-use setting, collecting data on over 2,600 agitation episodes [3] - The trial results showed no discontinuations due to tolerability, no major adverse events related to the drug, and no new safety signals, prompting the company to submit a supplemental New Drug Application (sNDA) to the FDA for at-home use of IGALMI [3] - The company anticipates FDA approval within the year and is preparing for pre-launch and commercial activities [3] Market Potential - BioXcel is advancing its TRANQUILITY In-Care Phase 3 program to address agitation associated with Alzheimer's dementia, having received FDA feedback on the clinical protocol [4] - The company estimates that the at-home agitation market in the U.S. represents between 57 million and 77 million episodes annually, significantly higher than previous estimates of 23 million episodes [5] - If approved, at-home IGALMI could fulfill a substantial unmet need by transitioning treatment from institutional settings to patients' homes, benefiting the patients [5]

Mark Pavao to Join BioXcel Therapeutics as Interim Chief Commercial Officer Mr. Pavao Brings Deep Experience in Neuroscience Sales and Marketing to Support Potential Launch of IGALMI® in At-Home Setting as Early as Year-End 2026 BioXcel Therapeutics on Track to Submit a sNDA for IGALMI® this Month NEW HAVEN, Conn., Jan. 12, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscienc ...

Core Viewpoint - BioXcel Therapeutics plans to submit a supplemental New Drug Application (sNDA) for IGALMI® to the FDA for at-home use in treating agitation associated with bipolar disorders or schizophrenia, with potential approval as early as 2026 [1][2]. Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience [10]. - The company’s approach involves leveraging existing approved drugs and big data to identify new therapeutic indications [10]. Product Information - IGALMI® (dexmedetomidine) is a sublingual film used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults, administered under healthcare supervision [4]. - BXCL501, the investigational formulation of dexmedetomidine, is being studied for treating agitation in Alzheimer's dementia and bipolar disorders in the at-home setting [3]. Regulatory Status - IGALMI has received Breakthrough Therapy designation for agitation associated with dementia and Fast Track designation for agitation related to schizophrenia and bipolar disorders [3]. - The safety and efficacy of IGALMI have not been established beyond 24 hours from the first dose, and its use in children is not known [4]. Market Potential - The company is focused on launch planning for IGALMI, aiming to provide a treatment option in the at-home setting where no FDA-approved alternatives currently exist [2].

Financial Data and Key Metrics Changes - The company raised $4.9 million through ATM sales in the third quarter, with reported shares increasing from approximately 14.4 million in Q2 to approximately 21.8 million in Q3, a difference of 7.3 million shares [9][10] Business Line Data and Key Metrics Changes - The drug Serenity was originally approved in April 2022, with two doses approved: 120 micrograms and 180 micrograms [10] Market Data and Key Metrics Changes - There is no specific market data or key metrics changes mentioned in the provided content Company Strategy and Development Direction and Industry Competition - The company is currently in compliance with the minimum bid price requirements at the Nasdaq Capital Market and has proposed a reverse stock split as a precautionary measure to provide additional flexibility for future compliance [8][13] Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook in the provided content Other Important Information - The company has approved the appointment of Ernst & Young LLP as its independent registered public accounting firm for the fiscal year ending December 31, 2025 [13] - The advisory vote on the compensation of named executive officers has been approved [13] Q&A Session Summary Question: What was the average cost per share traded, and how many shares did the company sell? - The 14.4 million shares in Q2 were as of the filing date, not the end of the quarter, and the 21.8 million shares in Q3 were also as of the filing date, which is mid-November [9][10] Question: When was the drug Serenity approved, and how many doses have been issued? - The drug was originally approved in April 2022, with two doses approved, and there is no black box warning on the current label [10]

Financial Data and Key Metrics Changes - The company raised $4.9 million through ATM sales in the third quarter, with reported shares increasing from approximately 14.4 million in Q2 to approximately 21.8 million in Q3, a difference of 7.3 million shares [9] - The low trade price during this period was $1.18, which would have returned over $8 million [9] Business Line Data and Key Metrics Changes - The drug SERENITY was originally approved in April 2022, with two doses approved: 120 micrograms and 180 micrograms [10] Company Strategy and Development Direction - The company is currently in compliance with the minimum bid price requirements at the Nasdaq Capital Market and has proposed a reverse stock split as a precautionary measure to provide additional flexibility for future compliance [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's current compliance status and the strategic measures being taken to ensure future flexibility in operations [8] Other Important Information - The company has appointed Ernst & Young LLP as its independent registered public accounting firm for the fiscal year ending December 31, 2025, which has been ratified by stockholders [13] - The advisory vote on the compensation of named executive officers has also been approved [13] Q&A Session Summary Question: Average cost per share traded and number of shares sold - The average cost per share traded was not disclosed, but the company clarified that the share counts reported were as of the filing dates, not the end of the quarters [9] Question: Approval and dosage information for the drug SERENITY - The drug SERENITY was approved in April 2022, with no black box warning on the current label, and two doses are available [10]

Financial Data and Key Metrics Changes - The company raised $4.9 million through ATM sales in the third quarter, with reported shares increasing from approximately 14.4 million in Q2 to approximately 21.8 million in Q3, a difference of 7.3 million shares [9][10] Business Line Data and Key Metrics Changes - The drug Serenity was originally approved in April 2022, with two doses approved: 120 micrograms and 180 micrograms [10] Market Data and Key Metrics Changes - There is no mention of specific market data or key metrics changes in the provided content Company Strategy and Development Direction and Industry Competition - The company is currently in compliance with the minimum bid price requirements at the Nasdaq Capital Market and has proposed a reverse stock split as a precautionary measure to provide additional flexibility for future compliance [8] Management's Comments on Operating Environment and Future Outlook - Management has indicated that they are open to communication with shareholders and are willing to address any questions through their investor relations [10] Other Important Information - The company has approved several proposals during the meeting, including the election of directors and the ratification of Ernst & Young LLP as the independent registered public accounting firm for fiscal year 2025 [13] Q&A Session Summary Question: What was the average cost per share traded, and how many shares did the company sell? - The company clarified that the 14.4 million shares in Q2 were as of the filing date, not the end of the quarter, and that the 21.8 million shares in Q3 were also as of the filing date [9][10] Question: When was the drug Serenity approved, and does it have a black box warning? - The drug Serenity was approved in April 2022, with no black box warning on the current label [10]

Core Viewpoint - The discussion focuses on addressing acute agitation associated with schizophrenia and bipolar disorders, emphasizing the need for patient-centered innovations in non-clinical settings [1][3]. Group 1: Company Mission and Commitment - BioXcel Therapeutics aims to transform patient care by advancing solutions that alleviate the burden of acute agitation on patients, caregivers, and the healthcare system [3]. - The company recognizes the significant challenges posed by episodes of acute agitation, particularly outside clinical environments, highlighting the urgency for practical innovations [3]. Group 2: Event Structure and Participants - The event features a roundtable discussion moderated by Anjalee Khemlani, an award-winning journalist known for her in-depth reporting on healthcare [2]. - The participation of clinical experts is intended to provide valuable insights into the management of agitation in real-world settings [2].

Core Insights - The upcoming virtual roundtable hosted by BioXcel Therapeutics will focus on self-administered treatments for acute agitation associated with bipolar disorder and schizophrenia, highlighting the shift in treatment paradigms towards home care [1][3]. Group 1: Event Details - The event is scheduled for December 8, 2025, at 10 a.m. EST and will be hosted by Anjalee Khemlani, a recognized healthcare journalist [2]. - Pre-registration for the event is currently open [2]. Group 2: Industry Context - There are an estimated 57 to 77 million episodes of agitation related to bipolar disorders and schizophrenia occurring annually in the U.S. home setting, indicating a significant need for innovative treatment solutions [3]. - The roundtable aims to provide insights to clinicians, caregivers, investors, and healthcare professionals on how treatment approaches are evolving and what innovations may redefine patient care outside traditional healthcare settings [3]. Group 3: Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, with a focus on drug re-innovation [5]. - The company’s subsidiary, OnkosXcel Therapeutics, is dedicated to developing medicines in immuno-oncology, showcasing its broad therapeutic focus [5].

Core Insights - BioXcel Therapeutics, Inc. reported a quarterly loss of $2.18 per share, which was worse than the Zacks Consensus Estimate of a loss of $1.54, representing an earnings surprise of -41.56% [1] - The company generated revenues of $0.1 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 34.67% and down from $0.21 million a year ago [2] - BioXcel shares have declined approximately 66.2% year-to-date, contrasting with the S&P 500's gain of 16.4% [3] Financial Performance - The company has surpassed consensus EPS estimates two times over the last four quarters [2] - The current consensus EPS estimate for the upcoming quarter is -$0.82 on revenues of $0.2 million, while for the current fiscal year, it is -$6.93 on revenues of $0.64 million [7] Market Outlook - The earnings outlook and estimate revisions will significantly influence the stock's immediate price movement [3][4] - The Zacks Rank for BioXcel is currently 3 (Hold), indicating expected performance in line with the market in the near future [6] - The Medical - Biomedical and Genetics industry is ranked in the top 34% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]