BioXcel Therapeutics, Inc.
2.0700-0.11 (-5.05%)
Oct 29, 4:00:02 PM EDT · NasdaqCM · BTAI · USD
Key Stats
Market Cap
40.67MP/E (TTM)
-Basic EPS (TTM)
-11.90Dividend Yield
0%Recent Filings
8-K
Positive BXCL501 correlation study results
BioXcel Therapeutics announced positive results from a correlation study on October 14, 2025, validating the modified CGI-S scale against the standard PEC for assessing BXCL501's efficacy in treating acute agitation at home. The strong correlation (ρ=0.89; p<0.001) supports its use in outpatient settings, bolstering the sNDA submission planned for Q1 2026. This bridges clinic-to-home care effectively. Yet regulatory approval remains uncertain amid clinical risks.
8-K
Trial enrollment complete, funds raised
BioXcel Therapeutics wrapped up enrollment in its open-label study on September 13, 2025, assessing correlations between patient-reported mCGI-S and PEC scales in about 30 patients, with results slated for Q4 2025 to bolster the sNDA filing in Q1 2026. Meanwhile, the company raised $37.3 million from July 1 to September 15, 2025, via ATM share sales and warrant exercises, extending cash runway into Q1 2026. Cash burn hinges on clinical progress. Forward-looking plans carry risks from regulatory hurdles.
8-K
Positive BXCL501 at-home trial data
BioXcel Therapeutics announced positive topline exploratory efficacy data from the SERENITY At-Home Phase 3 trial on September 10, 2025, showing BXCL501 significantly reduced agitation severity in 2,433 episodes among 208 patients with bipolar disorders or schizophrenia over 12 weeks. All patients self-administered the sublingual film successfully, with 81% completing the trial despite an average of 11.7 episodes per patient. This reinforces BXCL501's potential for outpatient use, building on its FDA-approved institutional efficacy.
8-K
Trial meets tolerability endpoint
BioXcel Therapeutics announced on August 27, 2025, that its SERENITY At-Home Phase 3 trial met the primary tolerability endpoint for BXCL501, a 120 mcg sublingual film treating agitation in bipolar disorders or schizophrenia at home. The study involved 246 patients across 2,628 episodes, with 81% completing 12 weeks and no discontinuations due to tolerability; adverse events matched the IGALMI label, including 13.9% somnolence. This supports an sNDA submission in Q1 2026 for at-home label expansion. Full data analysis continues.
8-K
ATM program prospectus filed
BioXcel Therapeutics filed a prospectus supplement on August 18, 2025, enabling sales of up to $80 million in common stock via its at-the-market program established April 3 with Canaccord Genuity. This setup allows flexible share issuance without fixed pricing, backed by a legal opinion on share validity. It bolsters liquidity amid biotech funding pressures. No sales have occurred yet.
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