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.

• February 6, 2026, 6:59 PM ET other material materiality 0.45 neutral item 5.02item 9.01

  BioXcel enters retention bonus agreements with key employees, CEO gets $650K after sNDA submission

  CEO receives $650K bonus ($325K initial, $325K final); other key employees get $225K ($150K initial, $75K final).

• 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.

• December 15, 2025, 6:59 PM ET other materiality 0.50 neutral item 5.07

  BioXcel stockholders approve reverse stock split authorization and elect directors

  All five proposals passed at Dec 12 annual meeting; 44.68% of shares voted.

• 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 15, 2025, 7:59 PM ET other material materiality 0.55 neutral item 7.01item 8.01

  BioXcel completes enrollment for mCGI-S/PEC study; sNDA submission expected Q1 2026

  Open-label study of ~30 patients evaluating mCGI-S vs PEC scale enrolled on Sept 13, 2025; results due Q4 2025.

• 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 18, 2025, 7:59 PM ET other material materiality 0.55 neutral item 8.01item 9.01

  BioXcel Therapeutics files prospectus supplement for up to $80M ATM stock offering

  Filed prospectus supplement to sell up to $80M of common stock via ATM program with Canaccord Genuity.

• 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 6, 2025, 7:59 PM ET other material materiality 0.30 positive item 8.01

  BioXcel announces publication of non-clinical study on dexmedetomidine in Frontiers in Pharmacology

  Study shows dexmedetomidine potently and reversibly regulates stress-mediated behaviors.

• 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.

• April 3, 2025, 7:59 PM ET other material materiality 0.50 negative item 1.01item 9.01

  BioXcel Therapeutics enters ATM equity distribution agreement for up to $8.135M

  Entered Equity Distribution Agreement with Canaccord Genuity LLC on April 3, 2025.

• March 27, 2025, 7:59 PM ET earnings materiality 0.55 neutral item 2.02item 9.01

  BioXcel Therapeutics Q4 net loss $10.9M; SERENITY Phase 3 trial 63% enrolled; cash ~$35M

  Net loss $10.9M in Q4 2024 vs $22.3M Q4 2023; full-year net loss $59.6M vs $179.1M.

• March 21, 2025, 7:59 PM ET other material materiality 0.55 neutral item 8.01

  BioXcel Therapeutics reaches 50% enrollment in SERENITY At-Home Phase 3 trial for BXCL501

  100 patients enrolled out of 200 expected (50% of total); 24 sites open as of March 20, 2025.

• 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.

• February 6, 2025, 6:59 PM ET other material materiality 0.55 negative item 5.03item 9.01

  BioXcel Therapeutics effectuates 1-for-16 reverse stock split effective Feb 7, 2025

  Board approved 1-for-16 reverse split on Jan 29; stockholders approved at Jan 28 special meeting.

• 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 16, 2025, 6:59 PM ET leadership materiality 0.35 neutral item 5.02 ◈ executive_change

  BioXcel Therapeutics appoints Dr. Rajiv Patni to Board of Directors

  Board increased from seven to eight directors on January 15, 2025.

• 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 9, 2024, 7:59 PM ET regulatory materiality 0.50 neutral item 8.01

  BioXcel submits Phase 3 protocol for BXCL501 in Alzheimer's agitation to FDA

  Submitted TRANQUILITY In-Care Phase 3 protocol for 60 mcg BXCL501 to FDA on Sept 5, 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.

• August 6, 2024, 7:59 PM ET earnings materiality 0.55 neutral item 2.02item 9.01

  BioXcel Q2 2024 IGALMI net revenue up 141% YoY to $1.1M; net loss narrows to $8.3M

  IGALMI net revenue $1.1M (+141% YoY, +90% sequentially) on increased psychiatric clinic contracting.

• July 17, 2024, 7:59 PM ET other material materiality 0.25 positive item 1.01

  BioXcel Therapeutics amends ARx supply agreement to reduce minimum annual payments over next three years

  Amendment reduces specified minimum annual payment due to ARx for next three years starting 2024.

• July 16, 2024, 7:59 PM ET earnings materiality 0.55 positive item 2.02item 9.01

  BioXcel reports preliminary Q2 2024 IGALMI net revenue of $1.1M, up 90% QoQ

  Preliminary Q2 2024 net revenue from IGALMI approximately $1.1M, up 90% from Q1 2024 and 141% from Q2 2023.

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