Logotype for BioXcel Therapeutics Inc

BioXcel Therapeutics (BTAI) investor relations material

BioXcel Therapeutics Study Result summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Logotype for BioXcel Therapeutics Inc
Study Result summary10 Sep, 2025

Study background and clinical need

  • Acute agitation in bipolar disorder and schizophrenia is a major burden, often leading to ED visits and hospitalization if not managed early.

  • No FDA-approved therapies currently exist for at-home agitation management in these populations.

  • IGALMI (dexmedetomidine sublingual film/BXCL501) is FDA-approved for institutional use; the SERENITY At-Home Phase III trial evaluated its safety and efficacy for self-administration at home, aiming for label expansion.

Study design and patient population

  • SERENITY At-Home was a double-blind, placebo-controlled, 12-week trial with 246 randomized patients and over 2,600 treated agitation episodes.

  • Included adults aged 18–75 with schizophrenia, schizoaffective, schizophreniform, or bipolar I/II disorder, stable on psychotropic regimens, and with recent agitation history.

  • Excluded those with serious or unstable medical illness, certain personality disorders, or recent substance use disorder.

  • Patients self-administered the film as needed, with or without a co-resident informant, and could use alternative coping strategies.

  • Patients or caregivers completed a modified CGI-S assessment two hours after dosing.

Safety and tolerability results

  • BXCL501 was well tolerated with no drug-related serious adverse events, falls, or syncopes reported.

  • No patients discontinued due to treatment-emergent adverse events in the BXCL501 arm.

  • Adverse event profile was consistent with prior institutional studies and the approved IGALMI label; most events were mild.

  • Most common side effects: somnolence (22% first dose, 14% all doses vs. 17%/8% placebo), oral paresthesia/hypoesthesia, dizziness, dry mouth; incidence did not increase with repeat dosing.

  • No new or unexpected safety signals emerged with repeated use.

Partial view of Summaries dataset, powered by Quartr API
Research faster. Power your platform.

Next BioXcel Therapeutics earnings date

Logotype for BioXcel Therapeutics Inc
Q3 202513 Nov, 2025
Your earnings 
season toolkit.
Download
Free on both iOS & Android.

Next BioXcel Therapeutics earnings date

Logotype for BioXcel Therapeutics Inc
Q3 202513 Nov, 2025

The essential earnings season companion

The #1 app for live earnings calls, transcripts, analyst estimates, and more. All for free.

Live calls and transcripts

Listen to earnings calls, CMDs, investor conferences, and more – with a podcast-like experience.

Find what you need faster

Search for any keyword across all transcripts simultaneously.

Easily store key findings

Capturing important takeaways is as simple as it gets. Even during your lunch run or commute.

Your watchlist. Your dashboard.

Follow the companies that matter to you. Get a personalized feed with real-time updates.

Be the first to know

Set keyword alerts for any company, product, or competitor. Get notified the moment they're mentioned.

Consensus estimates

Access analyst consensus estimates, valuation multiples, and revenue segments splits.

All IR material in one place

The easiest way to stay updated during earnings season.

Global coverage

All events from public companies. Live and recorded.

Just click and listen

No webcast links. No manual registrations.

Research anytime, anywhere

Built for professionals. Loved by everyone. Try our free mobile app.

excellent app, it gives me free access to company earnings calls and annual reports. I also love the convenience of calls being available offline so I can listen in whilst doing other things and even when internet or WiFi isn't available.
App-store-avatar.png play-store-avatar.png
Leroy DaleyApp Store
One of the very few apps you could call perfect. If something was to add to it, maybe the share price of the company when you search for it, but it's already excellent.
play-store-avatar
Eferix Drawings Google Play
This is genuinely one of the cleanest and fastest finance apps out there to track the market.
App-store-avatar.png play-store-avatar.png
anuj283App Store
excellent app, it gives me free access to company earnings calls and annual reports. I also love the convenience of calls being available offline so I can listen in whilst doing other things and even when internet or WiFi isn't available.
App-store-avatar.png play-store-avatar.png
Leroy DaleyApp Store
One of the very few apps you could call perfect. If something was to add to it, maybe the share price of the company when you search for it, but it's already excellent.
play-store-avatar
Eferix Drawings Google Play
This is genuinely one of the cleanest and fastest finance apps out there to track the market.
App-store-avatar.png play-store-avatar.png
anuj283App Store
I can't remember the last time an app had such a positive impact on my investment process.
x-avatar
@ankurshah47_ x.com
Love the app! Quartr makes it really easy to keep track of earnings calls. It also includes the reports and slides to make it easier to follow along.
App-store-avatar.png play-store-avatar.png
Amina0781App Store
Quartr is amazing, no way around it. It is the best right now for earnings calls, presentations, and the like.
x-avatar
@theshortbearx.com
I can't remember the last time an app had such a positive impact on my investment process.
x-avatar
@ankurshah47_ x.com
Love the app! Quartr makes it really easy to keep track of earnings calls. It also includes the reports and slides to make it easier to follow along.
App-store-avatar.png play-store-avatar.png
Amina0781App Store
Quartr is amazing, no way around it. It is the best right now for earnings calls, presentations, and the like.
x-avatar
@theshortbearx.com

Frequently asked questions

BioXcel Therapeutics, Inc. is a biopharmaceutical company focused on utilizing artificial intelligence to discover and develop new therapies in neuroscience and immuno-oncology. The company leverages its proprietary AI platform to identify and advance drug candidates for the treatment of complex conditions, including psychiatric disorders and cancers. BioXcel Therapeutics is engaged in both clinical and preclinical development. The company is headquartered in New Haven, United States, and its shares are listed on the NASDAQ.

Quartr provides global coverage of all investor relation material from public companies.

  • Mobile app: Research anytime, anywhere with the #1 app for live earnings calls, transcripts, analyst estimates, and more. All for free.

  • Desktop (Quartr Pro): The leading platform for qualitative research, used daily by top firms and financial institutions.

  • Quartr API: Build custom solutions powered by live earnings calls, live transcripts, filings and reports, slide presentations, and more.

Yes, the Quartr mobile app is free on both iOS and Android.

Yes. Quartr provides global, industry-leading live coverage of company events such as regular earnings calls, capital markets days, M&A announcements, and investor conferences. Live with zero delays. Just click and listen.

Yes, capturing important takeaways is as simple as it gets. Even during your lunch run or commute.

Yes. Follow the companies that matter to you. Get a personalized feed with real-time updates, a tailored earnings calendar, and instant alerts when earnings calls go live.

Yes. Set keyword alerts for any company, product, or competitor. Get notified the moment they're mentioned, regardless of who's talking.

Explore our global coverage