BioXcel Therapeutics Completes Market Opportunity Assessment and Advances Commercialization Plans for IGALMI® in the At-Home Setting

Rhea-AI Summary

BioXcel Therapeutics (Nasdaq: BTAI) completed an updated market opportunity assessment for IGALMI in the at-home treatment of acute agitation related to bipolar disorder or schizophrenia.

The study estimated ~2.3 million treated patients with up to 1.8 million eligible and as many as 86 million annual addressable episodes; an sNDA for at-home use was submitted in January 2026.

Positive

• 2.3M treated patients estimated with frequent at-home agitation
• 1.8M potentially eligible patients for IGALMI treatment
• 86M annual episodes identified as addressable in updated analysis
• High prescriber interest projecting ~70% patient use
• Strong patient demand with prior research showing ~80% episode use
• Positive payer feedback expecting broad formulary coverage

Negative

• sNDA pending with FDA; approval for at-home use is not yet granted
• Market estimates rely on limited prescriber (15) and payer (5) interviews

News Market Reaction

-4.94%

1 alert

-4.94% News Effect

On the day this news was published, BTAI declined 4.94%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Prescriber interviews: 15 prescribers Payer interviews: 5 payers Patient & caregiver research: N=80 +5 more

8 metrics

Prescriber interviews 15 prescribers Qualitative market research sample for IGALMI at-home assessment

Payer interviews 5 payers Leaders at large health plans in commercial assessment

Patient & caregiver research N=80 Previously reported patient and caregiver market research sample

Treated bipolar/schizophrenia patients 2.3 million U.S. patients with frequent at-home acute agitation episodes

Eligible IGALMI patients 1.8 million U.S. bipolar and schizophrenia patients potentially eligible for IGALMI

Addressable annual episodes 86 million Updated estimate of at-home agitation episodes potentially requiring treatment

Prior episode TAM 57–77 million Earlier estimate of addressable U.S. at-home agitation episodes

Expected IGALMI use 80% of episodes Patients’ stated expected IGALMI use in acute agitation episodes

Market Reality Check

Price: $1.54 Vol: Volume 299,299 is at 0.61...

low vol

$1.54 Last Close

Volume Volume 299,299 is at 0.61x the 20-day average of 488,674, indicating subdued trading interest ahead of this update. low

Technical Shares at $1.62 are trading below the $2.27 200-day MA and sit well under the $8.08 52-week high, despite today’s positive at-home IGALMI market assessment.

Peers on Argus

BTAI fell 2.41% while peers were mixed: JUNS gained 4.1%, MAIA and ATNM declined...

BTAI fell 2.41% while peers were mixed: JUNS gained 4.1%, MAIA and ATNM declined 2.75% and 2.61%, and PDSB and VTVT were modestly positive. With multiple peers also down, today’s move has elements of broader biotech pressure alongside company-specific news.

Historical Context

5 past events · Latest: Jan 20 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 20	sNDA submission	Positive	+2.7%	Filed sNDA to expand IGALMI label for at-home treatment setting.
Jan 12	Leadership change	Positive	+0.5%	Appointed acting CCO and detailed launch prep for at-home IGALMI.
Jan 07	sNDA planning	Positive	+17.2%	Outlined plan to submit sNDA and potential 2026 at-home approval.
Dec 03	Medical roundtable	Positive	+2.1%	Sponsored expert roundtable on at-home treatments for acute agitation.
Nov 12	Earnings and pipeline	Negative	-15.3%	Reported Q3 losses while updating late-stage agitation programs and TAM.

Pattern Detected

Recent IGALMI-related and corporate updates have generally seen the stock move in the same direction as the news tone, with both positive sNDA milestones and negative earnings aligning with price reactions.

Recent Company History

Over the last few months, BioXcel has focused on expanding IGALMI into the at-home setting. On Nov 12, 2025, Q3 2025 results highlighted positive SERENITY At-Home Phase 3 safety data and a revised U.S. agitation TAM of 57–77M episodes. Subsequent news in Dec 2025 and Jan 2026 emphasized educational initiatives, sNDA planning, leadership additions, and the actual sNDA submission on Jan 14, 2026. Today’s market opportunity assessment builds directly on those clinical and regulatory steps, refining the commercial outlook for at-home IGALMI use.

Market Pulse Summary

This announcement refines the commercial picture for IGALMI in the at-home setting, citing about 2.3...

Analysis

This announcement refines the commercial picture for IGALMI in the at-home setting, citing about 2.3 million treated bipolar and schizophrenia patients and up to 86 million addressable annual agitation episodes, of which up to 1.8 million patients may be eligible for IGALMI. It follows recent sNDA submission and launch-preparation updates. Investors may watch for FDA feedback, final launch design, payer coverage decisions, and how prescriber and patient adoption ultimately track against these market research estimates.

Key Terms

supplemental new drug application, snda, target product profile, benzodiazepines, +1 more

5 terms

supplemental new drug application regulatory

"The Company submitted a supplemental New Drug Application (sNDA) last month"

A supplemental new drug application is a request submitted to regulatory authorities to make changes to an existing approved medication, such as adding new uses, strengths, or formulations. For investors, it signals that a pharmaceutical company is seeking approval for new product developments or expanded applications, which can impact the company's future sales, market potential, and stock value.

snda regulatory

"The Company submitted a supplemental New Drug Application (sNDA) last month"

A SNDA (Subordination, Non‑Disturbance and Attornment Agreement) is a legal pact among a property owner’s lender, the owner’s tenants, and sometimes the landlord that sets who keeps lease rights if the property is sold or a mortgage is enforced. Think of it as a rulebook that decides whether a tenant can stay and keep paying rent or must answer to a new owner after a foreclosure. For investors, an SNDA matters because it protects predictable rental income, clarifies who has priority on claims against a property, and therefore affects a property’s value and the security of related loans.

target product profile medical

"market research leveraging an updated Target Product Profile based on results"

A target product profile is a strategic blueprint that lists the desired attributes of a drug or medical device—who it will treat, how well it must work, acceptable side effects, dosing and delivery, and the regulatory goal it must meet. For investors, it summarizes the product’s commercial potential and the clinical and regulatory hurdles to clear, much like a building plan that shows whether a project is feasible and worth funding.

benzodiazepines medical

"IGALMI would most frequently replace benzodiazepines, which may cause dependence"

A class of prescription drugs that calm the brain and nervous system, commonly used to treat anxiety, insomnia, and seizures; they act like a dimmer switch that reduces overactive mental or physical responses. Investors care because benzodiazepines shape demand for certain drug makers, influence regulatory and safety scrutiny, affect prescription trends and patent lifecycles, and can drive liability, pricing and market-share shifts in the pharmaceutical and healthcare sectors.

key opinion leader (kol) medical

"augmented by a series of prior Company-sponsored Key Opinion Leader (KOL) initiatives"

A key opinion leader (KOL) is a person who is highly trusted and influential in a specific area, like fashion, technology, or health. Their opinions can shape what many people think or buy, making them important for brands or companies that want to reach a wide audience.

AI-generated analysis. Not financial advice.

Third party commercial assessment shows larger than expected potential total addressable market for IGALMI^® in the at-home setting

Strong prescriber interest, patient demand, and positive payer feedback on formulary coverage

NEW HAVEN, Conn., Feb. 12, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today announced the completion of an updated market opportunity assessment for IGALMI^® for acute agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting, informed by results from the SERENITY At-Home clinical study. The assessment represents a key milestone in the Company’s commercial preparation initiatives for IGALMI, with findings intended to inform launch planning activities. A comprehensive launch plan for IGALMI in the at-home setting is in development. The Company submitted a supplemental New Drug Application (sNDA) last month seeking the FDA’s approval of IGALMI for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia.

Overview of Market Opportunity Assessment

The commercial opportunity assessment was based on recently completed market research leveraging an updated Target Product Profile based on results from the SERENITY At-Home clinical study. The assessment incorporated interviews with 15 prescribers and 5 payers with leadership responsibility at large health plans as well as survey responses from 180 prescribers with extensive relevant experience. In addition, patient-level claims analyses were used to estimate the number of diagnosed and treated patients who may be candidates for IGALMI.

Current agitation landscape insights:

• Prescribers reported a moderate to high unmet need, noting that current treatment options are not indicated for at-home use, may be sedating, are slow to take effect, and/or are controlled substances with the potential to cause dependence.
  
• Analyses of market research and claims data identified approximately 2.3 million treated bipolar disorder and schizophrenia patients experiencing frequent episodes of acute agitation in the at-home setting in the United States, of whom up to 1.8 million may be eligible for IGALMI treatment. This represents up to 86 million addressable annual episodes that may require treatment. This updated estimate is generally consistent with prior estimates of approximately 57-77 million addressable annual episodes,^1-4 with further refinement based on the additional insights from market research.

IGALMI opportunity in the at-home setting:

• Prescribers reported moderate to high interest in IGALMI for the treatment of acute agitation in the at-home setting, projecting use in approximately 70% of their schizophrenia and bipolar disorder patients, regardless of agitation severity.
  
• Prescribers anticipated that IGALMI would be used either alone or in combination with existing off-label treatments for acute agitation, and that IGALMI would most frequently replace benzodiazepines, which may cause dependence.
  
• Payers indicated expectations for broad formulary coverage with standard adjudication controls.
  
• Previously reported patient and caregiver research (N=80) indicated that patients with schizophrenia and bipolar disorder would expect to use IGALMI in approximately 80% of their acute agitation episodes.

“This assessment further validates IGALMI’s commercial opportunity in the at-home setting,” said Mark Pavao, Interim Chief Commercial Officer of BioXcel Therapeutics. “The strong prescriber and patient interest, as well as positive payer feedback on potential formulary coverage, reinforce our confidence in launch planning and represent a critical step as we advance our commercial strategy. We will build on these insights as we develop and finalize a comprehensive launch plan.”

To view the updated market opportunity assessment, visit the Investors page on the BioXcel Therapeutics corporate website at www.ir.bioxceltherapeutics.com.

Additional Insights from Patient Interview and KOLs

As part of increasing awareness around agitation, the Company conducted an interview with Gabe Howard, a patient advocate who struggles with acute agitation episodes due to underlying bipolar disorder and shared his experience about the high unmet need for a therapy in the at-home setting. As observed in the patient interview and in the market assessment, there is an urgent need for an effective at-home treatment option for this condition.

The video interview is available below.

A Media Snippet accompanying this announcement is available by clicking on this link.

The updated market opportunity assessment is further augmented by a series of prior Company-sponsored Key Opinion Leader (KOL) initiatives designed to increase awareness and advance dialogue around acute agitation, including:

• December 8, 2025: A virtual expert roundtable discussing emerging approaches and the potential role of self-administered at-home treatments for acute agitation. It featured Leslie Citrome, M.D., M.P.H., Clinical Professor of Psychiatry and Behavioral Sciences at New York Medical College, Marc A. Milano, M.D., FACEP, Chair of Emergency Medicine at Newark Beth Israel Medical Center and Children’s Hospital of New Jersey, and Leon Ravin, M.D., Statewide Psychiatric Medical Director for the Division of Public and Behavioral Health, State of Nevada. A replay is available at this link.
• September 10, 2025: A live webcast and Q&A session focused on clinical data from the SERENITY At-Home trial, featuring Leslie Citrome, M.D., M.P.H., Clinical Professor of Psychiatry and Behavioral Sciences at New York Medical College. A replay is available at this link.

About IGALMI^® (dexmedetomidine) sublingual film

INDICATION

IGALMI^® (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children.

IMPORTANT SAFETY INFORMATION 

IGALMI can cause serious side effects, including: 

• Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure, and older patients. IGALMI is taken under the supervision of a healthcare provider who will monitor vital signs (like blood pressure and heart rate) and alertness after IGALMI is administered to help prevent falling or fainting. Patients should be adequately hydrated and sit or lie down after taking IGALMI and instructed to tell their healthcare provider if they feel dizzy, lightheaded, or faint. 
• Heart rhythm changes (QT interval prolongation). IGALMI should not be given to patients with an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, or taking other drugs that could affect heart rhythm. Taking IGALMI with a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Patients should be instructed to tell their healthcare provider immediately if they feel faint or have heart palpitations. 
• Sleepiness/drowsiness. Patients should not perform activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI. 
• Withdrawal reactions, tolerance, and decreased response/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours. 

The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing. 

These are not all the possible side effects of IGALMI. Patients should speak with their healthcare provider for medical advice about side effects. 

Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids. 

Everyone is encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You can also contact BioXcel Therapeutics, Inc. at 1-833-201-1088 or medinfo@bioxceltherapeutics.com. 

Please see full prescribing information at Igalmi.com. 

About BXCL501

Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI^® (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer’s dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia.

About BioXcel Therapeutics, Inc.

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit bioxceltherapeutics.com.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to: the approval of IGALMI for use in the at-home setting; bringing IGALMI^® directly to patients in the at-home setting; the approval of IGALMI for use in the at-home setting; bringing IGALMI^® directly to patients in the at-home setting; use of IGALMI in approximately 70% of schizophrenia and bipolar disorder patients, regardless of agitation severity; prescribers using IGALMI either alone or in combination with existing off-label treatments for acute agitation; IGALMI replacing benzodiazepines, which may cause dependence; broad formulary coverage of IGALMI with standard adjudication controls; patients with schizophrenia and bipolar disorder using IGALMI in approximately 80% of their acute agitation episodes; evaluating go-to-market options; reimagining existing medicines and accelerating the development of innovative therapies; transforming the standard of care in neuropsychiatry and improve lives around the world. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; the impact of the reprioritization; its significant indebtedness, ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual obligations; the Company has identified conditions and events that raise substantial doubt about its ability to continue as a going concern; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY program; its dependence on the success and commercialization of IGALMI^®, BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; the number of episodes of agitation and the size of the Company’s total addressable market may be overestimated, and approval that the Company may obtain may be based on a narrower definition of the patient population; its lack of experience in marketing and selling drug products; the risk that IGALMI^® or the Company’s product candidates may not be accepted by physicians or the medical community in general; the Company still faces extensive and ongoing regulatory requirements and obligations for IGALMI^®; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by the Company’s product candidates; its novel approach to the discovery and development of product candidates based on EvolverAI; the significant influence of and dependence on BioXcel LLC; its exposure to patent infringement lawsuits; its reliance on third parties; its ability to comply with the extensive regulations applicable to it; impacts from data breaches or cyber-attacks, if any; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; risks associated with federal, state or foreign health care “fraud and abuse” laws; and its ability to commercialize its product candidates, as well as the important factors discussed under the caption “Risk Factors” in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at and the Investors section of the Company’s website at. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.

Contact Information:

Corporate/Investors
Russo Partners
Nic Johnson
nic.johnson@russopartnersllc.com
1.303.482.6405

Media
Russo Partners
David Schull
david.schull@russopartnersllc.com
1.858.717.2310

Source: BioXcel Therapeutics, Inc.

References

1. Wu EQ, Shi L, Birnbaum H, et al. Annual prevalence of diagnosed schizophrenia in the USA: a claims data analysis approach. Psychol Med. 2006;36(11):1535-1540.
2. National Institute of Mental Health. Bipolar Disorder. Accessed April 5, 2022. https://rb.gy/lqz4rn

3. Kwong, M et al., Presented at the Academy of Managed Care Pharmacy Nexus 2021, October 18-21, 2021; Symphony claims data.

4. Roberts et al. BMC Psychiatry (2018) 18:104.

FAQ

What did BioXcel Therapeutics (BTAI) estimate for IGALMI's at-home patient pool in February 2026?

The company estimated about 2.3 million treated bipolar and schizophrenia patients may experience frequent at-home agitation. According to the company, claims analyses and market research refined eligibility to up to 1.8 million potential IGALMI candidates.

How many annual at-home agitation episodes did BioXcel report for IGALMI (BTAI)?

BioXcel reported up to 86 million addressable annual episodes of acute agitation in the at-home setting. According to the company, this figure reflects updated claims analyses and prescriber/patient survey inputs.

What regulatory step has BioXcel (BTAI) taken for IGALMI at-home use as of Feb 12, 2026?

BioXcel submitted a supplemental New Drug Application (sNDA) seeking FDA approval for at-home use. According to the company, the sNDA was submitted last month and a decision from the FDA is pending.

How much prescriber and patient interest did BioXcel (BTAI) report for IGALMI at-home use?

Prescribers projected IGALMI use in roughly 70% of their schizophrenia and bipolar patients; prior patient research indicated ~80% episode use. According to the company, these figures came from surveys and interviews.

What payer coverage expectations did BioXcel (BTAI) report for IGALMI in the at-home setting?

Payers indicated expectations for broad formulary coverage with standard adjudication controls. According to the company, feedback came from five payers with leadership responsibility at large health plans.

What data sources supported BioXcel's IGALMI market assessment (BTAI)?

The assessment used the SERENITY At-Home study results, interviews with prescribers and payers, surveys of 180 prescribers, and patient-level claims analyses. According to the company, these combined sources informed the updated estimates.