Teva’s Data on AUSTEDO® (deutetrabenazine) tablets and AUSTEDO XR® (deutetrabenazine) extended-release tablets Highlight Long-Term Advances in Tardive Dyskinesia Treatment and Care

• New analysis from the IMPACT-TD Registry demonstrates that treatment with AUSTEDO and AUSTEDO XR led to reductions in Abnormal Involuntary Movement Scale (AIMS) scores in all participants, which were associated with improved activities of daily living.
• Further data from the 3-year RIM-TD study reinforces the importance of sustained treatment, showing >50% of patients achieve a clinically meaningful response to AUSTEDO by week 15, with additional patients achieving response with continued treatment.
• The comprehensive data package presented at Psych Congress Elevate advances clinical understanding of TD from diagnosis to long-term management, underscoring Teva's commitment to improving outcomes for the full spectrum of individuals living with TD.
  

PARSIPPANY, N.J. and TEL AVIV, Israel, June 08, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new data that highlight the comprehensive tardive dyskinesia (TD) symptom improvement from treatment with AUSTEDO^® and AUSTEDO XR^®. The new findings, drawn from three separate studies, were presented at Psych Congress Elevate, held June 3 – 6, 2026, in Las Vegas, NV.

“The data presented at Psych Congress Elevate represent Teva’s pursuit to better understanding the full human experience of tardive dyskinesia,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. "We are dedicated to not only advancing science but also striving to close critical gaps in diagnosis and clinical management of tardive dyskinesia. By generating robust evidence for a broader range of patients, including those with mild TD, and providing insights that guide optimal long-term treatment strategies, we are working to deliver innovations that make a meaningful difference in the day-to-day lives of those living with this condition.”

The new findings from Teva’s latest research revealed:

• Benefit in Mild TD (IMPACT-TD): New real-world insights from the IMPACT-TD Registry, the largest real-world study of TD,¹ evaluated patients with mild symptoms who were starting AUSTEDO or AUSTEDO XR treatment. At three months, all participants showed reductions in their Abnormal Involuntary Movement Scale (AIMS) score while maintaining their psychiatric stability; and participants with a clinically meaningful baseline burden in areas such as activities of daily living, psychosocial functioning, speech and communication reported improvement in these domains due to the reduction of TD movements.
• Value of Sustained Treatment (RIM-TD): An analysis from the 3-year RIM-TD open-label study found that an increasing percentage of patients responded to treatment over the course of the study. While >50% showed AIMS improvement within 15 weeks, an additional 23% saw improvement after week 15. This underscores the possibility of increasing improvement when patients stay on treatment.
• Closing the Diagnosis Gap: A study focused on caregiver education found that providing TD-specific educational content developed in collaboration with patient advocacy groups via online platforms prompted crucial conversations with healthcare professionals. Within six months, 53% of care recipients at risk of TD discussed TD with a provider, and 34% received a TD diagnosis, highlighting an effective strategy to improve disease recognition.
  
  

"These findings are significant because they add to the real-world evidence supporting treatment benefit for patients with mild tardive dyskinesia," said Richard Jackson, MD, Assistant Clinical Adjunct Professor at the University of Michigan School of Medicine’s Department of Psychiatry and IMPACT-TD principal investigator. "In clinical practice, we know that even so-called 'mild' involuntary movements can have a profound, multidimensional impact on a person's quality of life. These data give clinicians greater confidence to identify and treat TD early, offering the potential to improve outcomes for patients who might have previously been overlooked."

Teva remains deeply committed to advancing the science of tardive dyskinesia and supporting the full needs of the TD community.

About Tardive Dyskinesia (TD)
Tardive dyskinesia (TD) is a highly debilitating, chronic movement disorder that affects one in four people who take certain mental health treatments and is characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts, which may be disruptive and negatively impact individuals.^2,3,4

About AUSTEDO XR Extended-Release Tablets and AUSTEDO Tablets
AUSTEDO XR and AUSTEDO are the first vesicular monoamine transporter 2 (VMAT2) inhibitors approved by the U.S. Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease. Safety and effectiveness in pediatric patients have not been established. AUSTEDO XR is the once-daily formulation of AUSTEDO.

INDICATIONS AND USAGE
AUSTEDO XR (deutetrabenazine) extended-release tablets and AUSTEDO (deutetrabenazine) tablets are indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia.

IMPORTANT SAFETY INFORMATION 

Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidality and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation. AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression. 

Contraindications: AUSTEDO XR and AUSTEDO are contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO XR and AUSTEDO are also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine or valbenazine.   

Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO XR or AUSTEDO in their patients by assessing the effect on chorea and possible adverse effects. 

QTc Prolongation: AUSTEDO XR and AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO XR or AUSTEDO is administered within the recommended dosage range. AUSTEDO XR and AUSTEDO should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.  

Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex reported in association with drugs that reduce dopaminergic transmission, has been observed in patients receiving tetrabenazine. The risk may be increased by concomitant use of dopamine antagonists or antipsychotics. The management of NMS should include immediate discontinuation of AUSTEDO XR and AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.   

Akathisia, Agitation, and Restlessness: AUSTEDO XR and AUSTEDO may increase the risk of akathisia, agitation, and restlessness. The risk of akathisia may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops akathisia, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy. 

Parkinsonism: AUSTEDO XR and AUSTEDO may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy. 

Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO XR and AUSTEDO. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, until they are on a maintenance dose of AUSTEDO XR or AUSTEDO and know how the drug affects them. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence. 

Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO XR and AUSTEDO.   

Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and could accumulate in these tissues over time. Prescribers should be aware of the possibility of long-term ophthalmologic effects. 

Common Adverse Reactions: The most common adverse reactions for AUSTEDO (>8% and greater than placebo) in a controlled clinical study in patients with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue. The most common adverse reactions for AUSTEDO (4% and greater than placebo) in controlled clinical studies in patients with tardive dyskinesia were nasopharyngitis and insomnia.  Adverse reactions with AUSTEDO XR extended-release tablets are expected to be similar to AUSTEDO tablets. 

Please see accompanying full Prescribing Information, including Boxed Warning. 

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 our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize AUSTEDO and AUSTEDO XR for the treatment of tardive dyskinesia; our ability to successfully compete in the marketplace, including our ability to develop and commercialize 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 other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors” and “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.

References:

1. Data on file. Parsippany, NJ: Teva Neuroscience, Inc.
2. Carbon M, Hsieh CH, Kane JM, Correll CU. Tardive Dyskinesia Prevalence in the Period of Second-Generation Antipsychotic Use: A Meta-Analysis. J Clin Psychiatry. 2017;78(3):e264-e278. doi: 10.4088/JCP.16r10832.
3. Waln O, Jankovic J. An Update on Tardive Dyskinesia: From Phenomenology to Treatment. Tremor Other Hyperkinet Mov. 2013;3:1-11.
4. Tardive dyskinesia. National Alliance on Mental Illness website. https://www.nami.org/Learn-More/Treatment/Mental-Health-Medications/Tardive-Dyskinesia. Accessed May 4, 2026.

Teva Media Inquiries	TevaCommunicationsNorthAmerica@tevapharm.com
Teva Investor Relations Inquiries	TevaIR@Tevapharm.com

source: Teva Pharmaceutical Industries Ltd