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BTAI News
BTAI Events
BioXcel Therapeutics Enters Asset Sale Agreement with Teva
BioXcel Therapeutics (BTAI) announced that it has entered into an asset sale agreement with Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries (TEVA), for substantially all of the company's assets. This includes IGALMI sublingual film and the related pending supplemental New Drug Application of BXCL501 for potential at-home use for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. Concurrent with the execution of the asset sale agreement, BioXcel Therapeutics and its subsidiaries, OnkosXcel Therapeutics, LLC and OnkosXcel Employee Holdings, LLC, have commenced voluntary Chapter 11 proceedings in the U.S. Bankruptcy Court for the District of Delaware to facilitate a court-supervised sale process, which is expected to include the auction of substantially all of the company's assets. To anchor the sale process, Teva will serve as the sole "stalking horse bidder" for the sale of the assets contemplated by the asset sale agreement. A stalking horse asset sale agreement establishes a strong baseline offer and is intended to help maximize value for all stakeholders through the Chapter 11 auction process.
Teva Bids to Acquire Innovative Neuroscience Product from BioXcel
Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries (TEVA) announced it has made a bid to acquire an innovative neuroscience product from BioXcel Therapeutics (BTAI) through a court-supervised sale process. The novel dexmedetomidine sublingual film is under U.S. FDA review for potential at-home use for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. If approved, it could become the first FDA-approved at-home treatment for this condition. If the transaction is completed, the asset would expand Teva's psychiatry portfolio and, pending FDA approval, could help address a meaningful unmet need for people living with complex mental health conditions. Teva has entered into an agreement with BioXcel Therapeutics, Inc., to serve as the "stalking horse bidder" in a court-supervised auction process, pursuant to Section 363 of Chapter 11 of the U.S. Bankruptcy Code, for the purchase of certain assets from BioXcel Therapeutics and its affiliates, including IGALMI, its dexmedetomidine sublingual film. As the stalking horse bidder, Teva's proposal establishes the initial bid for the assets. The proposed transaction does not involve the acquisition of BioXcel Therapeutics as a whole. Teva would acquire the agreed-upon assets if Teva is selected as the successful bidder during the auction, required conditions are satisfied, and the transaction is approved by the Bankruptcy Court. If Teva is not the successful bidder, Teva would be entitled to a break-up fee and expense reimbursement, subject to the terms of the agreement. Under the terms of the Agreement, Teva would acquire worldwide rights to the assets including dexmedetomidine sublingual film for an upfront payment of $57.5M and up to an additional $67.5M in contingent payments. These include a range of time-based payments linked to the timing of the pending FDA approval, including potential delays in approval, as well as payments tied to the achievement of specified sales milestones.
BioXcel Therapeutics Q1 Revenue $206,000
Reports Q1 revenue $206,000, consensus $381,490. "The first quarter was marked by tremendous progress, achieving a major regulatory milestone and developing the IGALMI commercial launch plan for the at-home setting," said Vimal Mehta, CEO of BioXcel Therapeutics. "We are very pleased with the recent approval of another product in Alzheimer's agitation, in an area adjacent to our focus on the acute treatment of agitation in Alzheimer's dementia with BXCL501. Our first-in-class mechanism has the potential to make a transformative impact on the lives of a large patient population in this disease area. We are actively pursuing strategic options to maximize shareholder value for the IGALMI franchise."
BioXcel Therapeutics Begins U.S. War Department-Funded Clinical Trial
BioXcel Therapeutics announced the enrollment of the first patients in a U.S. Department of War-funded Phase 2a clinical trial evaluating BXCL501 for the treatment of acute stress reactions, also known as acute stress disorder. The trial is being led by the University of North Carolina at Chapel Hill Institute of Trauma Recovery and marks a significant milestone in the collaboration between BioXcel Therapeutics and UNC.
BioXcel Therapeutics' Igalmi sNDA Accepted by FDA
BioXcel Therapeutics announced that the FDA has accepted its supplemental new drug application, or sNDA, for approval of Igalmi for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia. The FDA has assigned a Prescription Drug User Fee Act target action date of November 14.
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