Teva Acquires Worldwide Rights to BXCL501, Further Expanding Innovative Neuroscience Pipeline

The acquired portfolio includes hospital-use IGALMI, while BXCL501 remains under FDA review for potential at-home treatment.

Rhea-AI Summary

Teva (TEVA) has completed its acquisition of BioXcel Therapeutics’ neuroscience assets, including worldwide rights to BXCL501, for $57.5 million upfront. The asset purchase also carries up to $67.5 million in contingent payments, linked to regulatory approval timing, including potential delays, and specified sales milestones.

BXCL501 is an investigational, orally dissolving dexmedetomidine film under FDA review for at-home treatment of acute agitation associated with schizophrenia or bipolar I or II disorder in adults. Teva said approval would make it the first FDA-approved treatment patients could use at home for this condition. The acquired assets also include worldwide rights to IGALMI, an FDA-approved dexmedetomidine film for treatment in a hospital setting. The court-supervised asset sale closed after U.S. Bankruptcy Court approval and satisfaction of other closing conditions; Teva did not acquire BioXcel Therapeutics itself.

Positive

• Minor pointWorldwide rights to BXCL501 add a late-stage investigational asset to Teva’s neuroscience pipeline.
• Minor pointWorldwide rights to IGALMI add an FDA-approved treatment for agitation in a hospital setting.

Negative

• Minor point$57.5 million upfront is the acquisition’s initial cost to Teva.
• Minor point. Forward-looking: it has not happened yet and may not happen.Up to $67.5 million in contingent payments are linked to regulatory approval timing and specified sales milestones.
• Minor pointBXCL501’s at-home use remains under FDA review; approval is still pending.

Key Figures

Upfront payment: $57.5 million Contingent payments: Up to $67.5 million Acute agitation prevalence: 25%–40% of patients

Upfront payment

$57.5 million

Acquisition consideration

Contingent payments

Up to $67.5 million

Payments tied to regulatory timing and sales milestones

Acute agitation prevalence

25%–40% of patients

Across schizophrenia or bipolar I or II disorder

Previous Acquisition Reports

1 past event · Latest: Aug 28

Same Type 1 event

1. Aug 28

   Acquisition proposal

   24h Move

   -3.1%

   Teva proposed a court-supervised purchase of the same BXCL501 rights on matching payment terms.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

sublingual, supplemental new drug application (nda), alpha-2 adrenergic receptor agonist

3 terms

sublingual medical

"a dexmedetomidine sublingual film under FDA review"

Sublingual describes a way to take a drug or supplement by placing it under the tongue so active ingredients are absorbed through the thin tissue there directly into the bloodstream. Like taking a shortcut compared with swallowing a pill, this can produce faster effects, simpler dosing and sometimes more predictable delivery. Investors watch for sublingual formulations because they can affect a product’s market appeal, regulatory pathway, pricing and competitive positioning.

supplemental new drug application (nda) regulatory

"submitted as a supplemental New Drug Application (NDA)"

An application submitted to the U.S. Food and Drug Administration to request approval for a change to an already approved New Drug Application (NDA). Common uses include adding a new indication, changing dosage or dosing instructions, updating the drug label for safety information, modifying the formulation or manufacturing process, or seeking approval for a new route of administration; the agency reviews the supplement and may require additional data or clinical trials depending on the nature of the change. It is not a new drug approval but a regulatory petition to alter or expand an existing approval, often called an sNDA or NDA supplement.

alpha-2 adrenergic receptor agonist medical

"a selective alpha-2 adrenergic receptor agonist"

A drug that binds to and activates alpha-2 adrenergic receptors, a type of protein on nerve cells in the brain and elsewhere, producing a biological response. Activating these receptors reduces the release of the neurotransmitter norepinephrine and dampens sympathetic nervous system activity, which can lead to effects such as lowered blood pressure, slowed heart rate, and sedation depending on where the receptors are located and the drug's properties.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• BXCL501, a dexmedetomidine sublingual film, is under FDA review for first-ever at-home use for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults
• Acquisition adds differentiated late-stage investigational asset with potential to address a significant unmet need for patients
• Transaction supports Teva’s Pivot to Growth strategy and the company’s disciplined approach to business development

TEL AVIV, Israel, Oct. 27, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that it has completed the acquisition of assets from BioXcel Therapeutics, Inc., including worldwide rights to BXCL501. BXCL501 is an investigational dexmedetomidine sublingual film under FDA review for at-home use in the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. If approved, BXCL501 would be the first FDA-approved treatment patients could use at home for this condition. The acquisition expands Teva’s innovative neuroscience pipeline with a late-stage asset with the potential to address a significant unmet patient need.

“Business development plays an important role in accelerating our Pivot to Growth strategy by bringing targeted external innovation into Teva,” said Evan Lippman, Executive Vice President, Business Development at Teva. “BXCL501 is a strong strategic fit with our neuroscience portfolio and reflects our disciplined focus on differentiated, late-stage opportunities that address unmet patient needs and create long-term value for Teva’s shareholders.”

Acute agitation associated with schizophrenia or bipolar I or II disorder affects between 25% and 40%¹ of patients across these conditions. Acute agitation can escalate quickly, creating significant challenges for patients, families and caregivers and, in some cases, resulting in an emergency department visit or hospitalization. Acute treatment options remain limited, particularly outside healthcare settings.

“Agitation can escalate quickly, which is why the ability to intervene early matters,” said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer at Teva. “If approved, BXCL501 could give adults living with schizophrenia or bipolar I or II disorder the ability to treat agitation at home, closer to the moment symptoms emerge and before they could become more difficult to manage.”

About the Transaction
Teva acquired the neuroscience assets of BioXcel Therapeutics, Inc. and its affiliates through a court-supervised sale process under Section 363 of the U.S. Bankruptcy Code. The assets include worldwide rights to BXCL501 and IGALMI® (dexmedetomidine), an FDA-approved dexmedetomidine sublingual film for the treatment of agitation associated with schizophrenia or bipolar I or II disorder in a hospital setting. The application for the approval of BXCL501 has been submitted as a supplemental New Drug Application (NDA) to the IGALMI® NDA. The transaction does not involve the acquisition of BioXcel Therapeutics.

The transaction closed following Teva’s selection as the successful bidder, approval by the U.S. Bankruptcy Court and satisfaction of other closing conditions.

Teva acquired the assets for $57.5 million upfront and up to $67.5 million in contingent payments. These include a range of time-based payments linked to regulatory 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. BXCL501 is a proprietary, investigational, orally dissolving film formulation currently under FDA review for potential at-home use in the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

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 integrate and realize the anticipated benefits of the acquired assets from BioXcel Therapeutics, Inc.; resolution of any applicable appeals to the bankruptcy sale order approving the transaction; ability to obtainability to obtain regulatory approval for and successfully commercialize the novel dexmedetomidine sublingual film; 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: TevaCommunicationsNorthAmerica@tevapharm.com
Teva Investor Relations Inquiries: TevaIR@Tevapharm.com

¹ Teva Market Research via Trinity Partners, March 2026.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Teva acquire from BioXcel Therapeutics, and how much did it pay?

Teva acquired neuroscience assets, including worldwide rights to BXCL501 and IGALMI, for $57.5 million upfront and up to $67.5 million in contingent payments. The completed transaction was an asset purchase, not an acquisition of BioXcel Therapeutics itself.

What is the FDA approval status of Teva’s acquired BXCL501?

BXCL501 is under FDA review for potential at-home treatment of acute agitation associated with schizophrenia or bipolar I or II disorder in adults. Its application was submitted as a supplemental New Drug Application to the existing IGALMI application.