BioXcel Therapeutics Announces Food & Drug Administration Acceptance of Supplemental New Drug Application for Use of IGALMI® in the At-Home Setting BioXcel Therapeutics (Nasdaq: BTAI) announced FDA acceptance of a supplemental New Drug Application for IGALMI for at-home treatment of agitation associated with bipolar disorders or schizophrenia. The FDA set a PDUFA target action date of November 14, 2026.According to the company, this filing targets a potential first FDA-approved at-home option and addresses up to 86 million annual episodes while the company advances commercial and launch planning.

#BTAI BioXcel Therapeutics Announces Food & Drug Administration Acceptance of Supplemental New Drug Application for Use of IGALMI® in the At-Home Setting

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BioXcel Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results as Company Prepares for Potential IGALMI® Approval in Outpatient Setting BioXcel Therapeutics (Nasdaq: BTAI) reported Q4 and full‑year 2025 results and progress toward potential IGALMI at‑home approval. The company submitted an sNDA in January 2026 supported by the SERENITY At‑Home Phase 3 trial and targets potential approval as early as year‑end 2026.Full‑year 2025 net revenue from IGALMI was $642,000; cash and restricted cash totaled $28.8M at year‑end. R&D, SG&A, operating loss and net loss figures were disclosed, and commercial launch preparations continue.

#BTAI BioXcel Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results as Company Prepares for Potential IGALMI® Approval in Outpatient Setting

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BioXcel Therapeutics Announces Approximately $8.0 Million Registered Direct Offering BioXcel Therapeutics, Inc. (the “Company”) (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence to develop transformative medicines in neuroscience, today announced that it has entered into a securities purchase

#BTAI BioXcel Therapeutics Announces Approximately $8.0 Million Registered Direct Offering

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BioXcel Therapeutics Announces Positive Phase 2 Topline Results from Columbia University-Led Study of BXCL501 for Treatment of Opioid Withdrawal BioXcel Therapeutics (Nasdaq: BTAI) announced positive Phase 2 topline results (Mar 5, 2026) from a NIDA-funded Columbia University-led IST of BXCL501 for opioid withdrawal during a seven-day methadone taper. The 80-patient trial reported a >30% reduction in SOWS-Gossop scores with BXCL501 240 µg BID and lower rates of orthostatic hypotension versus lofexidine (18% vs 50%, p<0.05).BXCL501 showed no sedation in treatment arms, a favorable tolerability profile, and may offer a twice-daily orally dissolving thin-film alternative for managing withdrawal, including fentanyl/xylazine-exposed patients.

#BTAI BioXcel Therapeutics Announces Positive Phase 2 Topline Results from Columbia University-Led Study of BXCL501 for Treatment of Opioid Withdrawal

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BioXcel Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for IGALMI® Label Expansion in the At-Home Setting BioXcel Therapeutics (Nasdaq: BTAI) submitted a supplemental New Drug Application (sNDA) to the U.S. FDA on January 14, 2026 seeking label expansion of IGALMI® to allow at-home (outpatient) treatment of acute agitation associated with bipolar disorders or schizophrenia without healthcare provider supervision. The sNDA is supported by the Phase 3 SERENITY At-Home safety trial, which met its primary endpoint of being well-tolerated with a safety profile consistent with the approved IGALMI label, and by positive FDA pre-sNDA feedback. The company cited a potential approval timeline as early as year-end 2026 and noted estimated U.S. patient and episode burdens.

#BTAI BioXcel Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for IGALMI® Label Expansion in the At-Home Setting

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BioXcel Therapeutics Planning to Submit sNDA This Month Seeking FDA Approval for At-Home Use of IGALMI® BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical

#BTAI BioXcel Therapeutics Planning to Submit sNDA This Month Seeking FDA Approval for At-Home Use of IGALMI®

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BioXcel Therapeutics Announces Positive Results from Correlation Study Supporting SERENITY At-Home Exploratory Efficacy Outcomes BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in

#BTAI BioXcel Therapeutics Announces Positive Results from Correlation Study Supporting SERENITY At-Home Exploratory Efficacy Outcomes

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BioXcel Therapeutics Announces SERENITY At-Home Pivotal Phase 3 Safety Trial Met its Primary Endpoint in Support of sNDA Submission for Label Expansion of IGALMI® BioXcel Therapeutics (Nasdaq: BTAI) announced positive results from its SERENITY At-Home Pivotal Phase 3 safety trial for BXCL501 (IGALMI®) in treating agitation episodes for bipolar disorders or schizophrenia patients at home. The trial met its primary endpoint, demonstrating favorable tolerability with no discontinuations in the treatment arm.The study treated 2,437 agitation episodes across 208 patients, with 81% completing the full 12-week trial. The safety profile remained consistent with the approved IGALMI® label, showing no drug-related serious adverse events. Based on these results, BioXcel plans to submit a supplemental New Drug Application (sNDA) in Q1 2026 for label expansion to include at-home use without healthcare provider supervision.The company estimates a significantly larger market opportunity of 57-77 million annual agitation episodes in the U.S., notably higher than previously reported 23 million episodes.

#BTAI BioXcel Therapeutics Announces SERENITY At-Home Pivotal Phase 3 Safety Trial Met its Primary Endpoint in Support of sNDA Submission for Label Expansion of IGALMI®

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First-Ever At-Home Agitation Drug: BioXcel's IGALMI Moves Closer to Outpatient Bipolar/Schizophrenia Use BioXcel receives positive FDA feedback for IGALMI outpatient sNDA submission planned for Q1 2026. Phase 3 SERENITY trial data expected this month for bipolar/schizophrenia agitation treatment.

#BTAI BioXcel Therapeutics Announces Positive FDA Pre-sNDA Meeting Comments for sNDA Submission for BXCL501 in Agitation Associated with Bipolar Disorders or Schizophrenia

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BioXcel Therapeutics Reports Second Quarter 2025 Financial Results and Recent Business Updates BioXcel Therapeutics (Nasdaq: BTAI) reported Q2 2025 financial results and provided key updates on its clinical programs. The company completed its SERENITY At-Home Phase 3 trial for treating agitation in bipolar disorders and schizophrenia patients, with topline results expected in August. The trial enrolled over 200 patients across 22 sites, collecting data from more than 2,200 agitation episodes.Financial results showed IGALMI® revenue of $120,000 in Q2 2025, down from $1.1M in Q2 2024. The company reported an operating loss of $15.9M and a net loss of $19.2M. Cash position stood at $18.6M as of June 30, 2025, with additional post-quarter funding of $15.1M through ATM sales and warrant exercises.

#BTAI BioXcel Therapeutics Reports Second Quarter 2025 Financial Results and Recent Business Updates

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🚨 FeetrAI Alert: #BTAI is trading at $1.37 with bearish signals! 📉 Oversold RSI, negative MACD, and below moving averages suggest caution. SERENITY Phase 3 trial results could be a game-changer. Short entry at $1.37, targets: $1.25 & $1.15. Stop loss: $1.50. Stay sharp! 🔍📊

🚀 Exciting times for #BTAI! With Phase 3 trial results for BXCL501 on the horizon, this biotech gem is showing oversold signals. A low float and high short interest could spark a short squeeze. Targeting $1.50-$1.65 with a stop at $1.25. High-risk, high-reward! 📈 #Biotech #Stocks

🚀 Exciting times for #BTAI! Trading at $1.37, BioXcel just wrapped up its SERENITY At-Home Phase 3 trial. A breakout above $1.40 could target $1.50-$1.60, but watch out for broader market pressure. Stay tuned for trial results that could shake things up! 📈 #FeetrAI

🚀 Excitement is building around #BTAI as we await phase 3 trial results for BXCL501! 📈 Despite recent surges, it's oversold with potential for a rebound. Watch for a breakout above $1.50 with targets at $1.70 & $1.90. Stay alert for news—volatility ahead! #Stocks #Biotech

BioXcel Therapeutics Submits Pre-Supplemental New Drug Application Meeting Package in Support of Potential Label Expansion for IGALMI® BioXcel Therapeutics (NASDAQ: BTAI) has submitted a pre-supplemental New Drug Application (pre-sNDA) meeting package to the FDA for IGALMI®, seeking potential label expansion for outpatient use in treating acute agitation associated with bipolar disorders or schizophrenia.The company has scheduled a pre-sNDA meeting with the FDA for August 20, 2025, following a previous Type C meeting on March 6, 2024. BioXcel is nearing completion of the SERENITY At-Home Pivotal Phase 3 trial, with top-line results expected this quarter. The development addresses a significant unmet need, as approximately 23 million annual episodes of agitation occur in the at-home setting in the U.S., with no current FDA-approved therapies available.

#BTAI BioXcel Therapeutics Submits Pre-Supplemental New Drug Application Meeting Package in Support of Potential Label Expansion for IGALMI®

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Why Bittensor Is AI’s Best Next-Gen Incubator With competing AI projects and performance-based rewards, Bittensor represents a shift from speculation-driven to utility-driven tokenomics, says Arrash Yasavolian, Founder and CEO, Taoshi (Subnet 8 on Bittensor).

Why Bittensor Is AI’s Best Next-Gen Incubator With competing AI projects and performance-based rewards, Bittensor represents a shift from speculation-driven to utility-driven tokenomics, says Arrash Yasavolian, Founder and CEO... @cosmicmeta.io #BTAI

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BioXcel Gets Critical Nasdaq Reprieve: 4-Month Extension as Phase 3 Trial Results Near BioXcel receives Nasdaq extension through September 2025, advances SERENITY trial for IGALMI label expansion. See compliance roadmap and strategic initiatives.

#BTAI BioXcel Therapeutics Granted Extension to Regain Compliance with Nasdaq Continued Listing Requirement

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BioXcel Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update BioXcel Therapeutics (NASDAQ: BTAI) has announced the completion of enrollment in its SERENITY At-Home Phase 3 safety trial for BXCL501, testing acute treatment of agitation in bipolar disorders or schizophrenia patients. The trial has enrolled 200 patients, with over 165 patients dosed and 115 receiving multiple doses over 12 weeks. Topline data is expected in H2 2025. For Q1 2025, BTAI reported IGALMI® revenue of $168,000, down from $582,000 in Q1 2024. The company's net loss improved to $7.3 million from $26.8 million year-over-year, with R&D expenses decreasing to $4.6 million from $11.4 million. Cash position stands at $31 million as of March 31, 2025, with $12 million used in Q1 operations.

#BTAI BioXcel Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update

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