Welcome to our dedicated page for BioXcel Therapeutics SEC filings (Ticker: BTAI), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
BioXcel Therapeutics filings document regulatory, financing, governance, and operating disclosures for a Nasdaq-listed biopharmaceutical company focused on AI-supported drug re-innovation in neuroscience. The company’s Form 8-K reports include IGALMI regulatory updates, business and financial results, and exhibits tied to press releases and material corporate events.
The filing record also covers registered direct offerings, common stock, pre-funded warrants and accompanying warrants, credit agreement amendments, registration rights, unregistered equity issuances, and retention or milestone-based compensation arrangements. These disclosures describe BioXcel’s capital structure, contractual obligations, Nasdaq-listed common stock, and formal updates connected to its approved IGALMI product and BXCL501 development program.
BioXcel Therapeutics (BTAI) filed an 8-K to disclose completion of the “last-patient-last-visit” milestone in its SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 120 mcg for the acute treatment of agitation in bipolar disorder and schizophrenia.
- Randomized, double-blind, placebo-controlled design; >200 patients treated across 22 U.S. sites, with no site >11 % of enrollment.
- Patient mix was balanced between the two indications and the “vast majority” completed the 12-week study.
- >2,200 agitation episodes were captured, providing a sizable safety data set.
- Top-line results are expected later this month; management reiterates plans for a subsequent sNDA submission.
No financial metrics were provided. The filing consists mainly of forward-looking statements outlining regulatory intentions and associated risks.
BioXcel Therapeutics (BTAI) filed an 8-K announcing it has submitted a pre-supplemental NDA (pre-sNDA) package to the FDA seeking to expand IGALMI’s label to cover at-home treatment of acute agitation in schizophrenia or bipolar disorders. The FDA has scheduled the pre-sNDA meeting for 20 Aug 2025; BioXcel aims to confirm alignment on data requirements and formatting before filing the full sNDA. Management also intends to reconfirm guidance from a 6 Mar 2024 Type C meeting, in which the FDA deemed the company’s development plan a reasonable path to support the proposed 120 mcg BXCL501 outpatient indication.
No financial metrics were disclosed. The filing consists primarily of regulatory updates and forward-looking statements reminding investors of associated risks. Successful FDA agreement could open a materially larger market by allowing IGALMI to be self-administered outside clinical settings, but approval is still contingent on future FDA review.