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BioXcel Therapeutics develops AI-enabled biopharmaceutical programs in neuroscience and, through its wholly owned OnkosXcel Therapeutics subsidiary, immuno-oncology. Its news centers on IGALMI, the FDA-approved sublingual film formulation of dexmedetomidine for acute agitation associated with schizophrenia or bipolar I or II disorder in adults, and on BXCL501 development across additional neuropsychiatric settings.
Recurring updates include FDA interactions and label-expansion activity for IGALMI, commercial planning for broader use settings, financial results, and capital-raising transactions. Company announcements also cover investigator-led and funded studies of BXCL501 in areas such as acute agitation in Alzheimer’s dementia, opioid withdrawal, and acute stress reactions, alongside disclosures tied to its drug re-innovation approach using big data and machine learning.
BioXcel Therapeutics (BTAI) announced that the FDA has closed its inspection of a single site in the TRANQUILITY II Phase 3 trial for BXCL501, their treatment for acute agitation in Alzheimer's dementia patients. The FDA designated the site as 'Voluntary Action Indicated' and released the Establishment Inspection Report.
This development, combined with positive findings from an independent audit announced in October 2023, supports the data integrity from the site. The company plans to include these results in a potential supplemental New Drug Application (sNDA). BioXcel has also received FDA feedback on the protocol for their upcoming TRANQUILITY In-Care Phase 3 trial for BXCL501.
BioXcel Therapeutics (BTAI) has successfully regained compliance with Nasdaq's minimum bid price requirement. The company, which focuses on developing AI-driven neuroscience medicines, had received a non-compliance notice on September 16, 2024, after failing to maintain a minimum closing bid price of $1.00 per share for 30 consecutive business days. To meet Nasdaq's Listing Rule 5550(a)(2), BTAI was required to maintain a minimum closing bid price of $1.00 per share for at least 12 consecutive trading days, which it achieved on February 26, 2025.
BioXcel Therapeutics (BTAI) has announced a 1-for-16 reverse stock split of its common stock, effective February 7, 2025, with split-adjusted trading beginning February 10, 2025. The company will continue trading on Nasdaq under the symbol 'BTAI' with a new CUSIP number (09075P204).
This strategic move aims to regain compliance with Nasdaq's minimum bid price requirement. The split will uniformly affect all stockholders, converting every 16 shares into one share, while maintaining the $0.001 par value. Stockholders entitled to fractional shares will receive cash payments instead. The company will also adjust the terms of outstanding stock options and equity incentive plans proportionately.
The split was approved by stockholders on January 28, 2025, allowing for a ratio between 1-for-5 and 1-for-30, with the Board ultimately selecting 1-for-16.
BioXcel Therapeutics (NASDAQ: BTAI) provided updates on its clinical programs and business developments. The company is advancing its SERENITY At-Home Phase 3 trial of BXCL501 for acute agitation in bipolar disorders and schizophrenia, with most trial sites now open and enrollment progressing. They have also developed plans for the TRANQUILITY In-Care Phase 3 trial for Alzheimer's-related agitation.
The company enhanced its financial position through a credit agreement amendment and raised $7 million in equity funding in November 2024. BioXcel will continue supplying IGALMI® through existing distribution channels without commercial support. The company also strengthened its Board with two key appointments: Dr. Rajiv Patni, current CEO of Judo Bio with extensive pharmaceutical development experience, and David Mack, who brings 25+ years of financial and legal expertise.
BioXcel Therapeutics (BTAI) has announced the pricing of a $7.0 million public offering, consisting of 5,600,000 shares of common stock and warrants to purchase up to 5,600,000 additional shares, along with pre-funded warrants for up to 9,000,000 shares and accompanying warrants. The combined offering price is set at $0.48 per share and accompanying warrant. The accompanying warrants will be exercisable immediately upon issuance, expire after five years, and have an exercise price of $0.48 per share. Canaccord Genuity is serving as the sole book-running manager, with the offering expected to close around November 25, 2024.
BioXcel Therapeutics (BTAI) has announced a public offering of its common stock and accompanying warrants, along with pre-funded warrants for certain investors. The company plans to use the proceeds to fund the SERENITY At-Home trial, prepare for the TRANQUILITY In-Care trial, and for working capital and general corporate purposes. Canaccord Genuity is acting as the sole book-running manager. The offering is being made through a shelf registration statement that became effective on November 13, 2023.
BioXcel Therapeutics (BTAI) reported Q3 2024 financial results, highlighting progress in two pivotal Phase 3 trials of BXCL501. Net revenue from IGALMI was $214,000 in Q3 2024, down from $341,000 in Q3 2023, though nine-month revenue increased 89% to $1.9 million. The company reported a net loss of $13.7 million, improved from $50.5 million in Q3 2023. R&D expenses decreased to $5.1 million from $19.6 million, while SG&A expenses reduced to $7.7 million from $24.3 million. Cash position stood at $40.4 million as of September 30, 2024.
BioXcel Therapeutics (BTAI) announced progress in two pivotal Phase 3 trials for BXCL501. The first patient has been randomized in the SERENITY At-Home trial, evaluating a 120 mcg dose for at-home treatment of agitation in bipolar disorders or schizophrenia. The company also received FDA feedback on the TRANQUILITY In-Care trial protocol, testing a 60 mcg dose for Alzheimer's-related agitation. The SERENITY trial aims to enroll 200 patients over 9-12 months, while TRANQUILITY targets 150 patients aged 55+ across various dementia severity levels. Both conditions currently lack FDA-approved acute therapies, with an estimated 140 million annual acute agitation episodes.
BioXcel Therapeutics (BTAI) has scheduled its third quarter 2024 financial results release for Thursday, November 14, 2024, before U.S. financial markets open. The company will host a conference call and webcast at 8:00 AM ET the same day, featuring management's discussion of results and business updates. The webcast will be available on the company's website under the Investors & Media section, with a replay accessible for 90 days following the event.
BioXcel Therapeutics (Nasdaq: BTAI), an AI-focused biopharmaceutical company specializing in neuroscience medicines, has announced its upcoming presentation at the ThinkEquity Conference in New York City. CEO Vimal Mehta and Executive VP Vincent O'Neill will deliver the presentation on Wednesday, October 30 at 2 p.m. ET.
The presentation will be accessible via live webcast on the company's website under the Events & Presentations page in the Investors & Media section. The webcast recording will remain available for 90 days following the event.