- 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.
- 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.
- 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.
IGALMI IMPORTANT SAFETY INFORMATION
IGALMI can cause serious side effects, including:
- Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure, and older patients. IGALMI is taken under the supervision of a healthcare provider who will monitor vital signs (like blood pressure and heart rate) and alertness after IGALMI is administered to help prevent falling or fainting. Patients should be adequately hydrated and sit or lie down after taking IGALMI and instructed to tell their healthcare provider if they feel dizzy, lightheaded, or faint.
- Heart rhythm changes (QT interval prolongation). IGALMI should not be given to patients with an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, or taking other drugs that could affect heart rhythm. Taking IGALMI with a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Patients should be instructed to tell their healthcare provider immediately if they feel faint or have heart palpitations.
- Sleepiness/drowsiness. Patients should not perform activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI.
- Withdrawal reactions, tolerance, and decreased response/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours.
The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing.
These are not all the possible side effects of IGALMI. Patients should speak with their healthcare provider for medical advice about side effects.
Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids.
Everyone is encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You can also contact BioXcel Therapeutics, Inc. at 1-833-201-1088 or medinfo@bioxceltherapeutics.com.
Please see full prescribing information at Igalmi.com.
About Teva Advisors
Guggenheim Securities, LLC served as financial advisors and Ropes & Gray LLP served as legal advisors to Teva.
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. To learn more about how, visit www.tevapharm.com.
Teva Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause Teva’s future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. All statements other than statements of historical fact are, or may be deemed to be, forward-looking statements. In some cases, you can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “developing,” “target,” “may,” “expand,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future performance. Important factors that could cause or contribute to such differences include risks and uncertainties relating to: our ability to successfully complete the acquisition of certain assets from BioXcel Therapeutics, Inc., which remains subject to bankruptcy court approval, potential higher bids and customary closing conditions; our ability to obtain regulatory approval for and successfully commercialize the novel dexmedetomidine sublingual film; our ability to successfully compete in the marketplace including our ability to develop and commercialize ecopipam and additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to execute on our organizational transformation and to achieve expected cost savings; our significant indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments; and other factors discussed in this press release and in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the section captioned “Risk Factors” and “Cautionary Note Regarding Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
Teva Media Inquiries
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