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BXCL501, a novel dexmedetomidine sublingual film, is under FDA review for potential at-home (outpatient) use for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
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Agreement is part of a court-supervised sale process with BioXcel Therapeutics, Inc. and remains subject to bankruptcy court approval, potential higher bids, and customary closing conditions.
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Transaction reflects Teva’s targeted business development approach focused on strategic fit, patient needs, and potential long-term value.
TEL AVIV, Israel, Aug. 28, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA) today announced it has made a bid to acquire an innovative neuroscience product from BioXcel Therapeutics, Inc. through a court-supervised sale process. The novel dexmedetomidine sublingual film is under U.S. Food and Drug Administration (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.
“Business development plays a critical role in accelerating our Pivot to Growth strategy,” said Evan Lippman, Executive Vice President, Business Development at Teva. “This opportunity strengthens our neuroscience portfolio and reflects our disciplined approach to pursuing innovative assets with a clear strategic fit, the potential to make a meaningful difference for patients and attractive long-term growth potential, while balancing risk and value creation."
For people living with schizophrenia or bipolar I or II disorder, agitation episodes can be unpredictable, disruptive, and distressing for patients, families, and caregivers. In some cases, these episodes may lead to escalation of care, including emergency department visits or hospitalization. Despite this burden, acute treatment options specifically designed for agitation remain limited, particularly options that may be used outside healthcare and hospital settings.
About the Proposed Transaction
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 $57.5 million and up to an additional $67.5 million 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.
About dexmedetomidine sublingual film (BXCL501)
Dexmedetomidine is a selective alpha-2 adrenergic receptor agonist. Dexmedetomidine sublingual film is a proprietary, investigational, orally dissolving film formulation currently under FDA review for at-home use in the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 14, 2026.
About IGALMI®
IGALMI® (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a healthcare provider, which is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI have not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children. IGALMI® is a registered trademark of BioXcel Therapeutics, Inc.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars, and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health.