Recent 8-K filings for BTAI

• May 15, 2026, 7:07 AM ET earnings materiality 0.75 neutral item 2.02item 9.01

  BioXcel reports Q1 net loss $12.7M; FDA sets Nov 14 PDUFA for at-home IGALMI

  FDA accepted sNDA for IGALMI at-home use in agitation associated with bipolar/schizophrenia; PDUFA date Nov 14, 2026.

• April 17, 2026, 7:59 PM ET debt materiality 0.60 neutral item 3.02item 9.01

  BioXcel Therapeutics issues warrants to purchase 1.35M shares at $0.01 per share under credit amendment

  On April 15, 2026, BioXcel Therapeutics granted lenders warrants to purchase up to 1,353,729 shares of common stock at an exercise price of $0.01 per share.

• April 1, 2026, 7:59 PM ET regulatory materiality 0.65 neutral item 8.01

  BioXcel announces FDA acceptance of sNDA for IGALMI in at-home agitation; PDUFA Nov 14, 2026

  FDA accepted supplemental New Drug Application for IGALMI (dexmedetomidine) for acute agitation in bipolar disorders or schizophrenia in outpatient setting.

• March 27, 2026, 7:59 PM ET earnings materiality 0.85 neutral item 2.02item 9.01 ◈ Earnings Releases

  BioXcel posts Q4 net loss $12.5M, IGALMI revenue falls; sNDA filed for at-home use

  Q4 2025 IGALMI revenue $256K vs $366K in Q4 2024; full year $642K vs $2.3M.

• March 11, 2026, 7:59 PM ET other material materiality 0.60 neutral item 1.01item 9.01 ◈ Material Agreements ×2

  BioXcel Therapeutics raises $7.8M in registered direct offering and amends prior warrants

  Sold 2,480,294 common shares and pre-funded warrants for 2,020,491 shares at combined $1.739/unit, plus accompanying warrants.

• February 12, 2026, 6:59 PM ET other material materiality 0.65 positive item 8.01

  BioXcel updates IGALMI at-home opportunity: up to 86M annual episodes, sNDA pending

  Updated market assessment for IGALMI at-home use identifies up to 86M addressable annual episodes, up from prior 57-77M estimate.

• January 20, 2026, 6:59 PM ET regulatory materiality 0.70 positive item 8.01

  BioXcel submits sNDA for at-home use of IGALMI for agitation in bipolar/schizophrenia

  Submitted sNDA to FDA on January 14, 2026 for IGALMI in the at-home setting.

• January 12, 2026, 6:59 PM ET leadership materiality 0.60 neutral item 8.01

  BioXcel names Mark Pavao Interim CCO; plans sNDA for IGALMI at-home use

  Mark Pavao appointed Interim Chief Commercial Officer to support potential IGALMI at-home launch.

• November 12, 2025, 6:59 PM ET earnings materiality 0.70 negative item 2.02item 9.01

  BioXcel Q3 net loss $30.9M; plans sNDA for IGALMI at-home use in Q1 2026

  Net revenue of $98K from IGALMI, down from $214K YoY; cost of goods sold fell to $11K.

• November 10, 2025, 6:59 PM ET other material materiality 0.70 positive item 8.01item 9.01

  BioXcel reports positive Phase 3 safety and efficacy results for BXCL501 agitation in home setting

  BXCL501 (sublingual dexmedetomidine) safe and well-tolerated in 12-week home-use study (SERENITY At-Home).

• October 30, 2025, 7:59 PM ET other material materiality 0.65 positive item 8.01

  BioXcel expects to submit IGALMI at-home sNDA early Q1 2026

  Completed SERENITY At-Home Phase 3 safety trial in August 2025; positive topline data.

• October 14, 2025, 7:59 PM ET regulatory materiality 0.75 positive item 8.01

  BioXcel Therapeutics reports strong correlation between clinician & caregiver agitation scales; sNDA planned Q1 2026

  Correlation study (N=33) shows ρ=0.89 (patient) and ρ=0.88 (informant) between PEC and mCGI-S scales, p<0.0001.

• September 10, 2025, 7:59 PM ET other material materiality 0.88 positive item 8.01

  BioXcel reports positive Phase 3 SERENITY At-Home data for BXCL501; agitation resolution significantly higher vs placebo

  SERENITY At-Home trial: 246 patients randomized; BXCL501 showed significant mean reduction in mCGI-S score vs placebo at 2 hours (p<.05).

• August 27, 2025, 7:59 PM ET other material materiality 0.85 positive item 8.01

  BioXcel Therapeutics' BXCL501 meets primary endpoint in SERENITY At-Home Phase 3 trial for agitation

  Phase 3 SERENITY At-Home trial met primary safety endpoint; no drug-related SAEs, syncope, or falls in 2,437 episodes treated with 120 mcg BXCL501.

• August 18, 2025, 7:59 PM ET regulatory materiality 0.65 positive item 8.01

  BioXcel receives positive FDA pre-sNDA comments for BXCL501 at-home use; sNDA on track for Q1 2026

  FDA provided positive written feedback on August 14, 2025 for BXCL501 sNDA in agitation associated with bipolar disorders or schizophrenia for outpatient setting.

• August 15, 2025, 7:59 PM ET regulatory materiality 0.70 positive item 8.01

  BioXcel receives positive FDA preliminary comments ahead of pre-sNDA meeting

  Positive preliminary FDA meeting comments received August 14, 2025.

• August 12, 2025, 7:59 PM ET earnings materiality 0.65 neutral item 2.02item 9.01

  BioXcel Q2 net loss $19.2M, cash $18.6M; SERENITY Phase 3 topline due August

  Q2 2025 IGALMI revenue $120K (down ~89% YoY from $1.1M); net loss $19.2M vs $8.3M in Q2 2024.

• August 11, 2025, 7:59 PM ET other material materiality 0.60 positive item 8.01item 9.01

  BioXcel presents at-home BXCL501 market opp: patients would use in 80% of episodes

  Market research shows ~3 episodes/month (36/year) per patient, vs prior 23M annual episodes estimate from claims data.

• August 11, 2025, 7:59 PM ET debt materiality 0.65 positive item 7.01item 9.01

  BioXcel Therapeutics raises $30.4M net, satisfies Oaktree financing covenant

  Raised $30.4M net from Nov 2024 ($6.2M), Mar 2025 ($13.0M), and ATM ($11.2M) financings, satisfying the Oaktree Financing Covenant.

• August 1, 2025, 7:59 PM ET other material materiality 0.65 neutral item 8.01

  BioXcel completes enrollment (last patient last visit) in SERENITY At-Home Phase 3 trial for BXCL501

  SERENITY At-Home Phase 3 safety trial for BXCL501 120 mcg to treat acute agitation in bipolar/schizophrenia.

• July 21, 2025, 7:59 PM ET regulatory materiality 0.65 neutral item 8.01

  BioXcel submits pre-sNDA package to FDA for IGALMI outpatient label expansion

  Pre-sNDA meeting package submitted July 21, 2025 for IGALMI (BXCL501) outpatient use.

• July 15, 2025, 7:59 PM ET other material materiality 0.80 positive item 8.01

  BioXcel Therapeutics receives USPTO allowance for key IGALMI patent expiring 2043

  USPTO allowed U.S. Patent Application No. 18/600,419 for single-dose oromucosal dexmedetomidine up to 120 mcg.

• May 27, 2025, 7:59 PM ET regulatory materiality 0.60 neutral item 8.01

  BioXcel Therapeutics granted Nasdaq listing extension to Sept 16, 2025

  Nasdaq Hearings Panel extended compliance deadline for MVLS Rule (minimum $35M market value for 10 consecutive days) to September 16, 2025.

• May 12, 2025, 7:59 PM ET earnings materiality 0.65 neutral item 2.02item 9.01

  BioXcel Q1 net loss $7.3M; SERENITY At-Home trial fully enrolled, data H2 2025

  Net revenue from IGALMI fell to $168K in Q1 2025 from $582K in Q1 2024.

• March 21, 2025, 7:59 PM ET other material materiality 0.80 negative item 3.01

  BioXcel Therapeutics receives Nasdaq delisting notice; intends to appeal

  Received Nasdaq delisting notice on March 20, 2025 for failing to meet $35M minimum MVLS requirement.

• March 4, 2025, 6:59 PM ET debt materiality 0.70 neutral item 1.01item 9.01

  BioXcel Therapeutics raises $14M in registered direct offering with warrants

  Total gross proceeds of $14M from sale of 188,383 shares and pre-funded warrants for up to 3,811,617 shares.

• March 3, 2025, 6:59 PM ET other material materiality 0.65 negative item 8.01

  BioXcel: FDA inspection closed with VAI; SERENITY trial enrolling; Nasdaq compliance regained; CMO resigns

  FDA closed TRANQUILITY II site inspection with 'Voluntary Action Indicated'; no regulatory action taken.

• January 29, 2025, 6:59 PM ET other material materiality 0.60 negative item 5.07

  BioXcel Therapeutics shareholders approve reverse stock split range of 1:5 to 1:30

  Proposal 1 passed with ~90.8% of votes cast in favor (27.6M for, 2.5M against, 0.3M abstain).

• January 8, 2025, 6:59 PM ET other material materiality 0.60 neutral item 5.02item 9.01

  BioXcel cuts CEO/CFO/CSO 2025 cash comp, grants stock options at $0.4713

  CEO Vimal Mehta's 2025 cash compensation reduced to $706,558; granted options for 660,000 shares at $0.4713.

• November 25, 2024, 6:59 PM ET other material materiality 0.80 negative item 1.01item 9.01

  BioXcel raises ~$6.2M in public offering of stock and warrants; cash runway into Q1 2025

  Issued 5.6M shares and warrants, plus 9M pre-funded warrants, at $0.48 per share (or $0.479 for pre-funded).

• November 21, 2024, 6:59 PM ET debt materiality 0.85 negative item 1.01item 3.02item 5.02item 8.01item 9.01 ◈ executive_change

  BioXcel Therapeutics amends Oaktree credit deal, waives covenants, sets capital raise milestones, appoints director

  Fifth Amendment waives going concern and minimum revenue covenants; removes prior $50M raise requirement.

• November 14, 2024, 6:59 PM ET earnings materiality 0.65 neutral item 2.02item 9.01

  BioXcel Therapeutics Q3 2024 net loss narrows to $13.7M; advances Phase 3 trials for agitation

  Net loss of $13.7M in Q3 2024 vs $50.5M loss in Q3 2023; operating cash use $16.3M.

• October 9, 2024, 7:59 PM ET leadership materiality 0.60 negative item 5.02item 9.01 ◈ executive_change

  BioXcel CCO Matthew Wiley departs; severance includes 9-mo salary, consulting through 2024

  Matthew Wiley (SVP, Chief Commercial Officer) separated on Oct 2, 2024; severance agreement signed Oct 3.

• September 20, 2024, 7:59 PM ET regulatory materiality 0.75 negative item 3.01

  BioXcel receives Nasdaq deficiency notices for bid price and market value; faces delisting risk

  On Sep 16, 2024, Nasdaq notified BTAI that bid price closed below $1.00 for 30 consecutive business days.

• September 19, 2024, 7:59 PM ET other material materiality 0.70 negative item 2.05item 5.02 ◈ executive_change

  BioXcel Therapeutics reduces workforce by 28% (~15 employees) to cut costs, prioritizes BXCL501; CCO Matt Wiley departs.

  Headcount reduction of 28% (~15 employees) approved Sept 17, 2024; charges ~$1.4M primarily in severance and benefits, expected Q4 2024.

• September 5, 2024, 7:59 PM ET other material materiality 0.65 neutral item 8.01

  BioXcel initiates patient enrollment in pivotal Phase 3 SERENITY At-Home trial for BXCL501

  Phase 3 trial evaluates safety of 120 mcg BXCL501 (dexmedetomidine ODF) for acute agitation in bipolar or schizophrenia in the at-home setting.

Executive changes

Earnings & guidance

Materiality & sentiment trend

Max materiality 0.88 · Median 0.65 · Most common event other_material

15 positive 11 negative 24 neutral

source · BTAI on sec.gov