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WELTRUZA™ (olanzapine) for extended-release injectable suspension is the first and only once-monthly subcutaneous long-acting injectable (LAI) formulation of olanzapine for the treatment of schizophrenia in adults with no loading doses, no oral supplementation and no post-injection monitoring requiredThe approval is based on results from the pivotal Phase 3 SOLARIS trial, which demonstrated overall symptom improvement, significant reduction in illness severity and improvement in personal and social functioning, with a systemic safety profile consistent with oral olanzapine1As Teva drives forward its Pivot to Growth strategy, the company continues to deliver on its commitment to patient-centered innovation in neuroscience, including a differentiated long-acting injectable franchiseTeva will hold an investor call and live webcast on Friday, October 9, 2026, 8:00 a.m. ET

PARSIPPANY, N.J. and TEL AVIV, Israel, Oct. 09, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved WELTRUZA™ (olanzapine) for extended-release injectable suspension, a new, once-monthly, subcutaneous long-acting injectable (LAI) for the treatment of schizophrenia in adults. WELTRUZA clinical trial results demonstrated improvement in symptoms (PANSS), significant reduction in illness severity (CGI-S), as well as improvement in personal and social functioning (PSP).1 In the coming weeks, WELTRUZA will be available in three different strengths (318 mg, 425 mg, 531 mg) with no loading doses, no oral supplementation and no post-injection monitoring required.1

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“WELTRUZA offers the proven efficacy of olanzapine in an innovative long-acting subcutaneous injectable, helping to fill a major, long-standing gap in the schizophrenia treatment landscape,” said Chris Fox, Executive Vice President, U.S. Commercial and Head of Innovative Franchise at Teva. “WELTRUZA was developed with the patient in mind from day one and it is a powerful demonstration of what is possible when the needs of the patient guide the development of a truly innovative medicine. This important milestone also helps further Teva’s Pivot to Growth strategy.”

Olanzapine is the most widely prescribed atypical antipsychotic for schizophrenia as a daily oral treatment.2 However, it is well documented that daily options may make it difficult to sustain long-term symptom improvement due to challenges with adherence, increasing the risk for instability and relapse.1 WELTRUZA was developed to address this significant unmet need by offering the established efficacy of olanzapine in a once-monthly subcutaneous injectable formulation.1

“This approval reflects the strength of patient-centric innovation at Teva and what our R&D organization can deliver,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “WELTRUZA combines proven science and novel formulation innovation to eliminate the need for monitoring after each injection, addressing a significant barrier to treatment and advancing care for people living with schizophrenia.”

WELTRUZA will be available in once-monthly subcutaneous injectable doses of 318 mg, 425 mg and 531 mg that correspond to the approved daily dose range of oral olanzapine of 10 mg, 15 mg and 20 mg, respectively.1

“Olanzapine has been a trusted and foundational treatment option for people living with schizophrenia for more than 30 years, but adherence continues to be a major barrier to stability, particularly for those who rely on daily oral medications,” said Christoph Correll, MD, Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY. “By offering a subcutaneous long-acting injectable formulation with achievement of therapeutic blood levels without oral cotreatment, loading doses or booster injections, this new treatment option can help empower patients, support their care partners and provide clinicians with an important new tool to assist in managing this complex condition more effectively.”

In the Phase 3 SOLARIS trial, all three doses of WELTRUZA were similarly tolerated, with the most common reported adverse events (AEs) inclusive of increased weight, somnolence, headache, constipation and injection site reactions.1 Weight gain and metabolic changes were observed and were consistent with the systemic safety profile of oral olanzapine, including clinically significant weight gain.1 Discontinuations of WELTRUZA due to common AEs were consistent with placebo at 5% and 4% of trial participants, respectively.1 Please refer to the Important Safety Information below for additional safety information.

An estimated 2.1 million people are currently diagnosed with schizophrenia in the U.S. It is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and behaves.3 Schizophrenia is a complex medical condition that may require switching from oral options or between long-acting injectable options during the treatment journey.

WELTRUZA utilizes SteadyTeq™, a copolymer technology proprietary to Medincell that provides a controlled steady, sustained release of olanzapine.

WELTRUZA will be available in the U.S. in the coming weeks.

The European Medicines Agency (EMA) accepted the Marketing Authorization Application (MAA) for olanzapine long-acting injectable (TEV-‘749) for the treatment of schizophrenia in adults in May 2026. The EMA submission is supported by an extensive clinical development program, including the Phase 3 SOLARIS study. TEV-‘749 is not approved by the EMA at this time.

Teva Investor Call
Teva will hold an investor call and live webcast today, Friday, October 9, 2026, at 8:00 a.m. ET/ 2:00 p.m. CET. To participate, please register in advance here. To access a live webcast of the presentation, visit Teva’s Investor Relations website. An archived version of the webcast will be available 24 hours after the end of the live discussion.

APPROVED USE

WELTRUZA™ (olanzapine) for extended-release injectable suspension is a prescription medicine used in adults for the treatment of schizophrenia.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about WELTRUZA?

WELTRUZA can cause serious side effects, including an increased risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). WELTRUZA is not for the treatment of people with dementia-related psychosis.

WELTRUZA may cause serious side effects, including:

Post-injection delirium/sedation syndrome (PDSS) is a serious problem that can happen when too much olanzapine enters the bloodstream too quickly. PDSS has happened in people who received another extended-release olanzapine medicine by injection into their muscles (intramuscularly). WELTRUZA is injected under the skin (subcutaneously). It is not known whether PDSS can happen with WELTRUZA. PDSS with an extended-release intramuscular injection has led to hospitalization, has happened within the first 3 hours of injection, but also happened after 3 hours of injection, and has the risk each time an injection is received. Tell your healthcare provider right away or go to the nearest emergency room if you get signs or symptoms of PDSS, including more sleepiness than usual, dizziness, confusion or disorientation, trouble walking or talking, stiff muscles or shakiness, weakness, feeling grouchy or angry, feeling anxious or nervous, increased blood pressure, seizures (convulsions), or passing out.Strokes in elderly people (cerebral problems) that can lead to death.Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Seek medical attention right away if you have any of these symptoms: high fever, stiff muscles, confusion, changes in pulse, heart rate, or blood pressure, increased sweating.Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS is an allergic reaction that can cause death that may affect your skin or other parts of your body including your liver, kidney, lungs, or heart. Contact your healthcare provider right away if you experience any signs or symptoms of DRESS, including fever, skin rash or blistering or peeling skin, swelling of face, glands, or other body parts, cough or trouble breathing, chest pain, yellowing of the skin or eyes, dark urine or changes in urination.Problems with your metabolism that may include high blood sugar (hyperglycemia), diabetes mellitus, changes in the fat levels in your blood (dyslipidemia), and weight gain. Extremely high blood sugar can lead to coma or death. If you have diabetes or are at risk of diabetes (e.g., obesity, family history of diabetes), your healthcare provider should check your blood sugar before you start and during treatment with WELTRUZA. Call your healthcare provider if you have symptoms of high blood sugar, including feeling very thirsty, hungry, sick to your stomach, weak or tired, or confused; needing to urinate more than usual; or your breath smells fruity.Uncontrolled facial or body movements (tardive dyskinesia) that may not go away, even if you stop receiving WELTRUZA. Tell your healthcare provider if you get any body movements that you cannot control.Decreased blood pressure (orthostatic hypotension). You may feel dizzy or lightheaded, get a fast or slow heartbeat, or faint, when you rise too quickly from a sitting or lying position. Drinking alcohol and using other medicines that make you dizzy can increase your risk for orthostatic hypotension. Avoid drinking alcohol during treatment with WELTRUZA.Falls. WELTRUZA may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.Low white blood cell counts. Your healthcare provider may do white blood cell count tests during your first few months of treatment with WELTRUZA.Difficulty swallowing that can cause food or liquid to get into your lungs.Seizures (convulsions). Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. Do not drive, operate machinery, or do other dangerous activities until you know how WELTRUZA affects you.Problems controlling your body temperature so that you feel too warm. Avoid getting overheated or dehydrated.Certain side effects from the way WELTRUZA works in your body such as constipation, dry mouth, fast heartbeat, urinary retention, or prostate and bowel problems. Your risk is increased if you take other medicines that also cause these side effects.Increased prolactin levels in your blood (hyperprolactinemia). WELTRUZA can cause a rise in the blood levels of a hormone called prolactin that may cause side effects including missed menstrual periods, a reversible reduction in fertility in females who are able to become pregnant, leakage of milk from the breasts, development of breasts in men, or problems with erection.The most common side effects of olanzapine in patients with schizophrenia include weight gain, sleepiness, headache, and constipation. Injection site reactions, including hardness, pain, redness, itching, and swelling, were reported with WELTRUZA.

These are not all the possible side effects with WELTRUZA. Tell your healthcare provider if you have any side effect that does not go away. For more information, ask your healthcare provider or pharmacist.

Before receiving WELTRUZA, tell your healthcare provider about all of your medical conditions, including if you:

have or had diabetes or high blood sugarhave or had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low HDL levels in your bloodhave or had low or high blood pressurehave or had heart problems or strokeare dehydratedhave or had a low white blood cell counthave or had seizures (convulsions)have or had problems with urination or prostate problemshave Alzheimer’s diseasehave or had constipation or bowel obstructionhave or had breast cancerare pregnant or plan to become pregnant. WELTRUZA may harm your unborn baby. Receiving WELTRUZA during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms such as agitation, stiffness or floppiness, tremors, sleepiness, and breathing or feeding problems after birth. Talk to your healthcare provider about the risks to your baby if you receive WELTRUZA during pregnancy.If you become pregnant during treatment with WELTRUZA, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.are breastfeeding or plan to breastfeed. WELTRUZA passes into breast milk. If you breastfeed during treatment with WELTRUZA, tell your healthcare provider if your baby is very sleepy, irritable, is feeding poorly, or gets tremors or abnormal muscle movements. Talk to your healthcare provider about the best way to feed your baby during treatment with WELTRUZA.Tell your healthcare provider about all the medicines you take or plan to take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take: blood pressure medicines, levodopa or dopamine, or other olanzapine medicines. Your healthcare provider can tell you if it is safe to receive WELTRUZA with your other medicines.

Do not start or stop any medicines during treatment with WELTRUZA without talking to your healthcare provider first. 

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For more information about WELTRUZA, see the full Prescribing Information, including Medication Guide and Boxed WARNING, or talk to your healthcare provider.

About Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS)
SOLARIS was an 8 week, multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of olanzapine extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 18-64 years) with schizophrenia.1 For period one of the study (first 8 weeks), 675 patients were randomized to receive a subcutaneous injection of once-monthly olanzapine LAI (WELTRUZA) (low, medium or high dose) or placebo in a 1:1:1:1 ratio.1 For period two (next 48 weeks), patients who completed period one on placebo were re-randomized and equally allocated to one of the three olanzapine LAI (WELTRUZA) treatment groups, while patients who completed period one on active olanzapine LAI (WELTRUZA) remained on their established dose strength.1 The end-of-treatment and follow-up visits were 4 and 8 weeks after administration of the last treatment dose, respectively.1 The primary objective of the Phase 3 SOLARIS study was to evaluate the efficacy of olanzapine LAI (WELTRUZA) in adult patients with schizophrenia, as measured by PANSS.1 A key secondary objective was to further evaluate the efficacy of olanzapine LAI (WELTRUZA) based on additional parameters in adult patients with schizophrenia, as measured by CGI-S and PSP.1 A secondary objective of period two of the study was to evaluate the safety and tolerability of olanzapine LAI (WELTRUZA) in adult patients with schizophrenia.1

About Schizophrenia
Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts.4 Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability.4,5,6 Approximately 1% of the world’s population will develop schizophrenia in their lifetime, and 2.1 million people in the U.S. are currently diagnosed with the condition.3,4,5 Although schizophrenia can occur at any age, the average age of onset tends to be in the late teens to the early 20s for men and the late 20s to early 30s for women.4 The long-term course of schizophrenia is marked by episodes of partial or full remission broken by relapses that often occur in the context of psychiatric emergency and require hospitalization.6 Approximately 80% of patients experience multiple relapses over the first five years of treatment, and each relapse carries a biological risk of loss of function, treatment refractoriness and changes in brain morphology.7,8,9 Patients are often unaware of their illness and its consequences, contributing to treatment nonadherence, high discontinuation rates and, ultimately, significant direct and indirect healthcare costs from subsequent relapses and hospitalizations.4,5,6,7,8,9

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.

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,” “project,” “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 WELTRUZA for the treatment of schizophrenia in adults; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and to profitably commercialize our innovative medicines and biosimilar portfolio, whether organically or through business development; our significant indebtedness; our business and operations in general; compliance, regulatory and litigation matters; financial, economic and other risks; and other factors discussed 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 sections captioned “Risk Factors” and “Other Information.” 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.

Data on file. [CSR/SOLARIS]. West Chester, PA: Teva Neuroscience, Inc.Data on file. [TRx data sourced from IQVIA NPA Full Year 2025; orals factored for SCZ using Analytics Link 2022.] Parsippany, NJ: Teva Neuroscience, Inc.Data on file. [DRG/Clarivate (Nov 2025 Market Forecast Assumptions-Schizophrenia)]. Parsippany, NJ: Teva Neuroscience, Inc.Substance Abuse and Mental Health Services Administration. Schizophrenia. https://www.samhsa.gov/mental-health/schizophrenia. Accessed February 2026.Velligan DI, Rao S. The Epidemiology and Global Burden of Schizophrenia. J Clin Psychiatry. 2023;84(1):MS21078COM5. https://doi.org/10.4088/JCP.MS21078COM5.Wander C. (2020). Schizophrenia: Opportunities to Improve Outcomes and Reduce Economic Burden Through Managed Care. The Am J Manag Care. 26(3 Suppl), S62–S68. https://doi.org/10.37765/ajmc.2020.43013.Emsley, R., & Kilian, S. (2018). Efficacy and safety profile of paliperidone palmitate injections in the management of patients with schizophrenia: an evidence-based review. Neuropsychiatric Dis. Treat., 14, 205–223.Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in schizophrenia. BMC Psychiatry 13, 50.Andreasen, N. C., et al. (2013). Relapse duration, treatment intensity, and brain tissue loss in schizophrenia: a prospective longitudinal MRI study. The Am J Psychiatry, 170(6), 609–615.Teva Media Inquiries:
[email protected] 
Teva Investor Relations Inquiries:
[email protected]

The published review examines dopamine’s role in tic generation and how approved and investigational drugs may affect dopamine to reduce tics as well as synthesizes clinical trial evidence that ecopipam reduces tic severity, provides sustained benefit over time and helps prevent relapse without some of the complications associated with antipsychotic agents.¹Ecopipam is an investigational, selective D1 (dopamine) receptor antagonist targeting dopaminergic signaling in the brain’s direct motor pathway implicated in Tourette syndrome.Unlike D2 antipsychotics that target D2 receptors in the indirect pathway, ecopipam selectively targets D1 receptors in the direct motor pathway, offering a differentiated approach that may reduce tic severity while potentially avoiding common adverse events associated with D2-targeting therapies.1 PARSIPPANY, N.J., Oct. 02, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the Journal of Child Neurology published a comprehensive review examining dopamine pathways in Tourette syndrome and the therapeutic potential of ecopipam, a first-in-class investigational selective D1 (dopamine) receptor antagonist for the treatment of pediatric patients with Tourette syndrome.1,2 The review evaluates current treatment limitations and details how selectively targeting D1 receptors in the brain’s direct motor pathway may offer a differentiated, non-antipsychotic approach for managing tics in pediatric patients.1

“Tourette syndrome affects up to 1 in 130 children globally and can have a profound impact on a child's daily life, education and social development,” said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer at Teva. “The review published in the Journal of Child Neurology reinforces the potential of ecopipam’s selective dopamine D1 receptor approach. This is the kind of innovative programs we are pursuing at Teva—advancing differentiated science to address meaningful unmet needs.”

The comprehensive review details the neurobiological rationale for D1 receptor antagonism compared with existing therapies. In Tourette syndrome, elevated dopaminergic activity in the basal ganglia is proposed to contribute to the expression of involuntary tics. Because D1 receptors are primarily expressed by neurons in the direct motor pathway, ecopipam is hypothesized to block excess dopaminergic activity in this pathway, thereby normalizing downstream basal ganglia signaling and movement patterns. In contrast, traditional antipsychotics target D2 receptors, which are primarily associated with the indirect pathway.

This mechanistic distinction is supported by clinical data synthesized across the ecopipam development program. In a Phase 3 trial (n=216, including 167 pediatric), continued ecopipam treatment cut the risk of tic relapse by 50% versus placebo in pediatric participants (HR: 0.5; P=0.008), building on Phase 2b and 12-month open-label data showing sustained reductions in tic severity. Across clinical trials, the most common adverse events included somnolence, headache, insomnia, fatigue and anxiety while ecopipam was not associated with clinically relevant weight gain, adverse metabolic effects or drug-induced movement disorders. The potential importance of this efficacy and tolerability profile is underscored by real-world treatment persistence data, which show that treatment discontinuation rates among patients newly treated with D2 receptor antagonists were 61.2% by 3 months and 82.1% by 18 months.1

“Treatment of Tourette syndrome can be complex, as clinicians must balance tic improvement with the side effect profiles of current therapies,” said Donald L. Gilbert, M.D., M.S., senior author of the review and Pediatric Movement Disorders and Tourette Syndrome Specialist, Division of Neurology, Cincinnati Children’s Hospital Medical Center. “Ecopipam selectively targets the dopamine D1 receptor, and the data reviewed in this publication – demonstrating reduced tic severity and sustained benefit without significant weight gain, metabolic complications or movement disorders – supports continued research into D1 receptor antagonism for Tourette syndrome.”

For more information on the review published online in the Journal of Child Neurology, click here.

About Tourette Syndrome 
Tourette syndrome is a chronic neuro-developmental disorder characterized by involuntary motor and vocal tics beginning in childhood, often between 5 and 10 years of age.3 For people living with Tourette syndrome, symptoms can be frequent, visible and disruptive, affecting everyday life.3

About Ecopipam and Its Clinical Program 
Ecopipam is a first-in-class investigational therapy designed to block dopamine signaling at the D1 receptor. D1 receptor hypersensitivity may contribute to repetitive and compulsive behaviors associated with Tourette syndrome. 

Ecopipam was granted Priority Review by the FDA with Orphan Drug designation for the treatment of pediatric patients with Tourette syndrome. Orphan Drug designation is reserved for patient populations of 200,000 or fewer. 

The D1AMOND Phase 2b Trial was a 12-week randomized, double-blind, placebo-controlled trial that studied 153 pediatric participants across 68 sites in North America and Europe. The primary efficacy endpoint was the change in the YGTSS-TTS, i.e., sum of the motor and vocal tic scores, from baseline to end of therapy.4 The associated Phase 2b open-label extension enrolled 121 pediatric subjects from the Phase 2b trial and followed them for up to 12 months’ duration to evaluate the long-term safety and tolerability of ecopipam.5 The subsequent D1AMOND Phase 3 Trial was a double-blind, placebo-controlled, randomized withdrawal trial enrolling a total of 216 pediatric and adult participants into an open-label stabilization period and randomizing 104 participants (90 pediatric, 14 adult) across 77 sites in North America and Europe. The objective of this study was to evaluate the maintenance of efficacy of ecopipam in pediatric and adult responders utilizing the YGTSS-TTS change from randomization or increased Tourette-specific care to determine relapse.6 While this Phase 3 trial included adult participants, the accepted NDA and resulting indication sought by Teva are exclusively for pediatric patients. 

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. 

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 develop, obtain regulatory approval for and commercialize ecopipam; our ability to successfully compete in the marketplace including our ability to develop and commercialize ecopipam for the treatment of pediatric patients with Tourette syndrome; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and to profitably commercialize our 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, 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 sections 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.

References:

Karkanias, G. B., Flatt, J. A., Korb, R. T., Munschauer, F. E., Wanaski, S. P., Cunniff, T. M., & Gilbert, D. L. (2026). Targeting Dopamine Pathways for the Treatment of Tourette Syndrome. Journal of Child Neurology. https://doi.org/10.1177/08830738261491159U.S. Food and Drug Administration (FDA) Approval Records: Haloperidol (1969), Pimozide (1984), Aripiprazole (2014); Pringsheim, T., et al. (2019). The pharmacological management of tic disorders: an updated practice guideline. Neurology. CDC | Tourette Syndrome | Data and Statistics on Tourette Syndrome, 2024; Mayo Clinic | Tourette Syndrome – Diagnosis and treatment, 2025. Gilbert DL, Dubow JS, Cunniff TM, et al. Ecopipam for Tourette Syndrome: A Randomized Trial. Pediatrics. 2023;151(2):e2022059574. doi:10.1542/peds.2022-059574 Gilbert DL, Kim DJB, Miller MM, et al. Safety and Effect of 12-Month Ecopipam Treatment in Pediatric Patients with Tourette Syndrome. Mov Disord Clin Pract. 2025;12(8):1157-1166. doi:10.1002/mdc3.70091. Gilbert DL, Atkinson SD, Kim DJB, et al. Efficacy and Safety of Ecopipam for Tourette Syndrome: A Phase 3 Randomized Clinical Trial. JAMA Neurol. 2026;83(7):645–653. doi:10.1001/jamaneurol.2026.1431 Teva Media Inquiries:
[email protected]

Teva Investor Relations Inquiries:
[email protected]

Key Takeaways Teva expects branded products to reach 22% of revenues in 2026, up from 9% in 2022.Teva expects Austedo revenues of $2.45-$2.60 billion in 2026, with growth aided by Austedo XR.Teva plans five regulatory submissions through 2030, including olanzapine, ecopipam and duvakitug. Teva Pharmaceutical Industries Limited’s (TEVA - Free Report) business was heavily dependent on generic medicines for decades. That model provided scale but also exposed the company to intense price competition, product commoditization and periodic revenue declines when additional generic competitors entered the market.

Under its "Pivot to Growth" strategy, launched in 2023, Teva is strengthening the branded drugs segment by investing in research and development, pursuing targeted acquisitions and partnerships, and expanding its commercial capabilities in specialty therapeutic areas. This shift is not about abandoning generics; rather, Teva is trying to use the cash flow and commercial infrastructure of its generics business to fund a growing branded-drug franchise. Rather than attempting to compete across numerous disease categories, Teva has concentrated on areas where it possesses scientific expertise and can establish meaningful market positions, including neuroscience, immunology and respiratory diseases.                   

Teva’s Innovative/Branded Drugs Deliver Strong GrowthThe company is seeing continued market share growth of its newest branded drugs, Austedo, Ajovy and Uzedy. Collectively, sales of the three drugs rose 43% year over year to more than $1 billion in the second quarter. Teva expects their combined sales to reach approximately $3.7 billion in 2026, representing around 17% growth at the midpoint.

Austedo remains the largest contributor to the franchise, with global sales rising 40% year over year to $696 million in the second quarter. Teva expects Austedo revenues of $2.45-$2.60 billion in 2026, with the midpoint broadly matching its previous target of more than $2.5 billion by 2027. This could put the drug roughly a year ahead of schedule. The Austedo franchise got a boost from the launch of Austedo XR, a new once-daily formulation of Austedo. Teva launched Austedo in European markets in 2026, which should further contribute to growth. Teva expects Austedo revenues to exceed $3 billion by 2030.

Teva's second important growth product is Ajovy, a CGRP-targeting medicine for migraine prevention. Ajovy’s global revenues increased 56% on a constant-currency basis to $244 million in the second quarter. Teva expects Ajovy sales of $850-$870 million in 2026, and estimates peak global sales potential of approximately $1 billion.

Another important branded asset is Uzedy, a long-acting injectable treatment for schizophrenia. Management believes Uzedy has substantial long-term potential because long-acting injectable antipsychotics are increasingly being adopted in psychiatric care. Uzedy revenues increased 43% year over year to $77 million in the second quarter, with full-year 2026 sales expected to reach $270-$290 million.

Pipeline Could Further Expand Teva’s Innovative FranchiseThe bigger question is whether Teva can continue this transition after the current three growth brands mature.

The company has several key branded pipeline assets in neuroscience and immunology, which it believes represent a multi-billion-dollar commercial opportunity. These include olanzapine LAI, a long-acting subcutaneous injectable for schizophrenia, and ecopipam, which was acquired through Emalex Biosciences and is being developed for pediatric Tourette syndrome. Both candidates are under U.S. regulatory review, with Teva targeting potential launches of olanzapine LAI in the fourth quarter of 2026 and ecopipam in the first half of 2027, subject to approval.

Another key pipeline asset is duvakitug, a late-stage anti-TL1A therapy being developed for inflammatory bowel diseases, including ulcerative colitis and Crohn’s disease. Teva has partnered with Sanofi (SNY - Free Report) for duvakitug to maximize the value of the asset. Teva and Sanofi will equally share the development costs globally. On the second-quarter conference call, Teva announced plans to begin studies for duvakitug in two additional indications — hidradenitis suppurativa and fibrostenotic Crohn’s Disease. It believes duvakitug has pipeline-in-a-product potential.

Teva plans to make five regulatory submissions for its branded candidates over the next five years: olanzapine in 2026, ecopipam in 2027, followed by Dual Action Rescue Inhaler (a dry powder inhaler for asthma), emrusolmin (multiple system atrophy) and duvakitug between 2028 and 2030.

In 2022, only about 9% of Teva’s revenues came from its branded drugs. Teva now expects it to reach 22% of total revenues in 2026. Teva anticipates generating more than $5 billion in revenues from its branded products by 2030 compared with more than $3 billion in 2025.

ConclusionTeva’s branded portfolio is becoming an increasingly important growth driver, reducing its reliance on traditional generics. Strong sales of Austedo, Ajovy and Uzedy, along with upcoming launches and a promising pipeline, should support further growth in branded revenues. If Teva executes successfully, branded drugs could account for a steadily larger share of its business through 2030. At the same time, Teva’s generic portfolio will remain an important source of scale and cash flow to support investments in branded medicines.

TEVA’s Price, Valuation & Estimate DiscussionShares of Teva have rallied 24.6% so far this year compared with the industry’s 6.9% growth.

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The stock is trading at a decent valuation relative to the industry. Going by the price/earnings ratio, the company's shares currently trade at 13.72 on a forward 12-month basis, lower than 15.73 for the industry. However, the stock is trading above its five-year mean of 5.69.

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The Zacks Consensus Estimate for earnings per share has declined from $2.06 to $2.03 for 2026 over the past 60 days and from $3.14 to $3.11 for 2027.

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TEVA’s Zacks Rank & Stocks to ConsiderTeva has a Zacks Rank #4 (Sell).

Some better-ranked stocks in the biotech sector are AC Immune (ACIU - Free Report) and Amarin (AMRN - Free Report) , each currently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the past 60 days, estimates for AC Immune’s 2026 bottom line have improved from a loss of 84 cents per share to a loss of 60 cents per share. For 2027, earnings estimates have been stable at 17 cents per share over the same timeframe. ACIU shares have lost 16.9% year to date.

AC Immune’s earnings beat estimates in each of the trailing four quarters, the average surprise being 33.25%.

Over the past 60 days, loss estimates for Amarin have improved from 65 cents per share to 39 cents per share, while those for 2027 have improved from a loss of 51 cents per share to 50 cents. AMRN shares have declined 5.1% year to date.

Amarin’s earnings beat estimates in three of the trailing four quarters, while missing in one, with the average surprise being 65.44%.

DEGEVMA™ is now FDA-approved across all indications of the reference product, Xgeva® (denosumab), to help prevent bone complications in adults with advanced cancer that has spread to the bone, for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone and for the treatment of hypercalcemia of malignancy.FDA approval of DEGEVMA marks another milestone in Teva’s Pivot to Growth strategy, demonstrating our ability to bring high-quality, more affordable treatment options to patients across complex therapeutic categories.DEGEVMA is Teva’s second FDA-approved biosimilar in 2026 and, together with PONLIMSI™ (denosumab-adet), establishes Teva's comprehensive denosumab biosimilar portfolio across the indications of the reference products Xgeva® and Prolia® (denosumab). TEL AVIV, Israel, and PARSIPPANY, N.J., Sept. 28, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved DEGEVMA™ (denosumab-adet) as a biosimilar to Xgeva® (denosumab). DEGEVMA is indicated for the prevention of bone complications in adults with advanced cancer that has spread to the bone, for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone and for the treatment of hypercalcemia of malignancy.

The FDA approval of DEGEVMA, together with PONLIMSI (denosumab-adet), which was approved by the FDA in March 2026, establishes a comprehensive U.S. denosumab biosimilar portfolio spanning the indications of both Xgeva® and Prolia® (denosumab), respectively. Now, healthcare professionals and patients are able to gain expanded access to biologic treatment options in oncology-related bone disease and osteoporosis care.

“Our R&D mission is grounded in a clear commitment: translating complex biologic science into high-quality treatment options that address patient needs,” said Rob Cook, Head of Global Technical Development & Generics R&D at Teva. “The approval of DEGEVMA reflects the scientific, clinical and regulatory expertise behind our in-house biosimilars capabilities and our continued focus on expanding access to important biologic medicines.”

Biologics like denosumab represent a significant portion of healthcare expenditures, particularly in oncology. The introduction of biosimilars is critical to driving down systemic healthcare costs while broadening patient access to complex, life-enhancing medications.

“The last thing a person living with a cancer diagnosis or their families should have to worry about is access to their medicine,” said Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva. “The approval of DEGEVMA is a powerful example of Teva’s Pivot to Growth strategy in action because it represents an important step in expanding treatment options for patients and supporting healthcare systems with a high-quality biosimilar.”

The FDA approval of DEGEVMA was based on a totality of evidence, including analytical and clinical data demonstrating similar efficacy, safety and immunogenicity profile as the reference product, Xgeva®. DEGEVMA is a human monoclonal antibody that binds to the RANKL protein, an essential regulator of osteoclast formation, function and survival. By inhibiting RANKL, DEGEVMA decreases bone resorption and cancer-induced bone destruction. The comprehensive data package submitted to the FDA demonstrated that DEGEVMA has no clinically meaningful differences from the reference product in terms of safety, purity and potency.

Teva anticipates launching DEGEVMA and PONLIMSI in the U.S. in the coming months, aligning with its broader biosimilar commercialization strategy.

DEGEVMA is currently approved in the European Union (EU). Learn more about Teva’s global biosimilars portfolio and commercialization capabilities at www.tevabiosimilars.com.

Use of Trademarks
Xgeva® and Prolia® are registered trademarks of Amgen, Inc.

About DEGEVMA
DEGEVMA (denosumab) is indicated for the prevention of bone complications in adults with advanced cancer that has spread to the bone, for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone and for the treatment of hypercalcemia of malignancy.

The active substance, denosumab, is a human monoclonal IgG2 antibody that targets the protein RANKL, essential for the formation, function, and survival of osteoclasts—the cells responsible for bone resorption. By binding to RANKL with high affinity and specificity, denosumab prevents the interaction between RANKL and RANK, leading to a decrease in bone resorption in cortical and trabecular bone.

DEGEVMA will be available as a 120mg/1.7mL solution for injection in a vial.

DEGEVMA is a biosimilar medicinal product, similar to the reference product Xgeva® (denosumab), which was approved in the EU on November 18, 2025.

Comprehensive analytical, preclinical, and clinical data demonstrate that DEGEVMA has comparable quality, safety and efficacy to the reference product.

INDICATIONS
DEGEVMA is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.

DEGEVMA is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

DEGEVMA is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Pre-existing hypocalcemia must be corrected prior to initiating therapy with DEGEVMA.

DEGEVMA is contraindicated in patients with known clinically significant hypersensitivity to DEGEVMA or denosumab products.

WARNINGS AND PRECAUTIONS
Drug Products with Same Active Ingredient
Patients receiving DEGEVMA should not receive other denosumab products.

Hypersensitivity
Clinically significant hypersensitivity including anaphylaxis has been reported with use of DEGEVMA. Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue DEGEVMA therapy permanently.

Hypocalcemia
DEGEVMA can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Correct pre-existing hypocalcemia prior to DEGEVMA treatment. Monitor calcium levels, throughout DEGEVMA therapy, especially in the first weeks of initiating therapy, and administer calcium, magnesium, and vitamin D as necessary. Concomitant use of calcimimetics and other drugs that can lower calcium levels may worsen hypocalcemia risk and serum calcium should be closely monitored. Advise patients to contact a healthcare provider for symptoms of hypocalcemia. Do not take DEGEVMA if you are allergic to denosumab or any of the ingredients of DEGEVMA.

An increased risk of hypocalcemia has been observed in clinical trials of patients with increasing renal dysfunction, most commonly with severe dysfunction (creatinine clearance less than 30 mL/min and/or on dialysis), and with inadequate/no calcium supplementation. Monitor calcium levels and calcium and vitamin D intake.

Osteonecrosis of the Jaw (ONJ)
Osteonecrosis of the jaw (ONJ) has been reported in patients receiving DEGEVMA, manifesting as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration, or gingival erosion. Persistent pain or slow healing of the mouth or jaw after dental surgery may also be manifestations of ONJ. In clinical trials in patients with cancer, the incidence of ONJ was higher with longer duration of exposure. Patients with a history of tooth extraction, poor oral hygiene, or use of a dental appliance are at a higher risk of developing ONJ. Other risk factors for the development of ONJ include immunosuppressive therapy, treatment with angiogenesis inhibitors, systemic corticosteroids, diabetes, and gingival infections.

Perform an oral examination and appropriate preventive dentistry prior to the initiation of DEGEVMA and periodically during DEGEVMA therapy. Advise patients regarding oral hygiene practices. Avoid invasive dental procedures during treatment with DEGEVMA. Consider temporary discontinuation of DEGEVMA therapy if an invasive dental procedure must be performed.

Patients who are suspected of having or who develop ONJ while on DEGEVMA should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition.

Atypical Subtrochanteric and Diaphyseal Femoral Fracture
Atypical femoral fracture has been reported with DEGEVMA. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution.

Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral, and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g., prednisone) at the time of fracture.

During DEGEVMA treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of DEGEVMA therapy should be considered, pending a risk/benefit assessment, on an individual basis.

Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons
Clinically significant hypercalcemia requiring hospitalization and complicated by acute renal injury has been reported in DEGEVMA-treated patients with giant cell tumor of bone and patients with growing skeletons. Within the first year after treatment discontinuation, monitor patients for signs and symptoms of hypercalcemia and treat appropriately.

Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation
Multiple vertebral fractures (MVF) have been reported following discontinuation of treatment with denosumab products. Patients at higher risk for MVF include those with risk factors for or a history of osteoporosis or prior fractures.

When DEGEVMA treatment is discontinued, evaluate the individual patient’s risk for vertebral fractures.

Embryo-Fetal Toxicity
Based on data from animal studies and its mechanism of action, denosumab products can cause fetal harm when administered to a pregnant woman.

Advise pregnant women and females of reproductive potential that exposure to DEGEVMA during pregnancy or within 5 months prior to conception can result in fetal harm.

ADVERSE REACTIONS
The most common adverse reactions in patients with bone metastases from solid tumors taking DEGEVMA were fatigue/asthenia, hypophosphatemia, and nausea. The most common serious side effect was dyspnea.

In patients with multiple myeloma, the most common adverse reactions were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. The most common serious side effect of DEGEVMA was osteonecrosis of the jaw.

To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information for DEGEVMA.

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,” “may,” “project,” “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 commercialize DEGEVMA (denosumab-adet) a Biosimilar to Xgeva® (denosumab) for the prevention of bone complications in adults with advanced cancer that has spread to the bone, for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone, and for the treatment of hypercalcemia of malignancy, and PONLIMSI (denosumab-adet); 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 to execute on our organizational transformation and to achieve expected cost savings; and other factors discussed in this press release, 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 “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.

MarketBeat Week in Review – 02/03 - 02/07Teva Pharmaceutical Industries NYSE: TEVA Chief Executive Officer Richard Francis said the company has shifted from being viewed primarily as a generics manufacturer toward a biopharmaceutical company with a growing innovative medicines portfolio, while maintaining and expanding its generics operations.

Speaking with J.P. Morgan analyst Chris Schott, Francis said Teva’s “Pivot to Growth” strategy has centered on accelerating innovative products, stabilizing the generics business, advancing research and development, and maintaining discipline in capital allocation. He said the company’s innovative business grew 40% in the second quarter, while all of its marketed growth products delivered double-digit growth.

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Teva Pharma: Why This Generic Drug Giant Is a Smart Buy NowFrancis said Teva’s innovative sales totaled about $1.2 billion at the end of 2022 and are now running at approximately $1 billion per quarter. He said the company expects to continue growing at a mid-single-digit rate after 2026, while the growing contribution from higher-margin innovative products could support gains in gross margin, operating income, earnings per share and cash flow.

Margins and Cost Savings Francis said Teva’s gross margin has risen from 48% when he became CEO to about 55%. He described further gross-margin improvement as an important component of the company’s value-creation strategy, particularly as innovative products account for a larger share of sales.

2 Generic Drug Stocks Ready to Surge in 2025Teva has targeted a 30% operating margin by 2027, despite the anticipated loss of generic REVLIMID sales. Francis said the company is “well on track” to achieve that target, citing a changing portfolio mix and a cost-efficiency program expected to generate $700 million in savings after investment by the end of 2027.

While Francis said operating margin should rise beyond 2027, he did not provide a longer-term target. He said management is weighing whether to establish goals for 2030 or later, while balancing margin expansion against investment in the company’s product pipeline.

“Do not sacrifice the pipeline for short-term operating margin” is a message Francis said he has heard from investors. He said Teva intends to allocate capital only to projects expected to generate returns, rather than maintaining fixed R&D budgets or pursuing “pet projects.”

Pipeline and Portfolio Francis highlighted Teva’s pipeline of innovative medicines, including duvakitug, an anti-TL1A antibody being studied in inflammatory conditions; anti-IL-15 programs; long-acting olanzapine; ecopipam for Tourette syndrome; and UZEDY. He said Teva expects to have a product launch each year for the next five years, followed by launches approximately every 18 months thereafter.

He credited Teva’s internal antibody-engineering capabilities, including work conducted at its research facility in Sydney, for the company’s pipeline. Francis said the company is advancing a TSLP/IL-13 program into the clinic in the first quarter and expects data on its PD-1/IL-2 program by year-end.

On duvakitug, Francis said Teva believes its TL1A antibody has advantages in potency, specificity and low neutralizing antibodies compared with competing products. He said the company believes TL1A therapies could be used earlier in the treatment of inflammatory bowel disease because of their safety and tolerability profiles, though he cautioned that combination approaches and other treatment modalities will take time to develop.

Growth Brands and Upcoming Launches Francis said AUSTEDO continues to have substantial growth potential in tardive dyskinesia, where he estimated that 85% of patients remain untreated. Teva is seeking to improve patient titration, adherence and compliance, which he said can help patients reach more effective doses and remain on therapy. He reiterated confidence in a goal of more than $3 billion in peak annual sales for AUSTEDO.

He noted that AUSTEDO’s reported sales comparisons may be affected by inventory dynamics. Channel inventory built in the fourth quarter of the prior year is being drawn down, and wholesalers may further reduce inventory ahead of an Inflation Reduction Act-related discount. Francis said fourth-quarter sales could be down year over year, while prescription trends and milligram growth remain competitive.

Francis also pointed to AJOVY’s performance, saying the migraine treatment has been reinvigorated through more focused execution rather than significantly higher spending. He said AJOVY has been growing faster than its market and gaining share across regions, adding that management sees it as a potential billion-dollar brand.

For Teva’s long-acting olanzapine treatment, Francis said the opportunity stems from the large number of schizophrenia patients using oral olanzapine and the need for better treatment adherence. He said Teva estimates a $1.5 billion to $2 billion franchise opportunity for UZEDY and long-acting olanzapine, based partly on historical migration to long-acting treatments in related markets.

Francis said Teva expects modest revenue from the olanzapine launch initially, with revenue expected to begin building in the second half of the following year as Medicaid coverage expands. He said the company is prioritizing sustainable value and payer access rather than accepting discounts that it believes do not reflect a product’s value.

He also expressed optimism about ecopipam, Teva’s planned treatment for Tourette syndrome. Francis said approximately 100,000 children have Tourette syndrome, with roughly 50,000 receiving therapy, and said persistence on existing treatments is low. He said Teva expects to apply its commercial experience in neurology and central nervous system diseases to support the planned launch.

Generics and Capital Allocation Francis said Teva’s generics business, which had been declining before 2023, has returned to growth through improved product launches, manufacturing, supply chain execution and commercial discipline. He said the company has historically projected 1% to 2% annual growth for the business, but believes biosimilars could improve portfolio stability and margins over time.

Teva now has 15 biosimilars on the market and another 14 in its pipeline, Francis said.

On capital deployment, Francis said Teva has reached investment-grade ratings from all three major rating agencies a year earlier than expected. With debt reduction no longer the company’s first priority, he said Teva plans to continue investing in launches, pipeline development and business development opportunities. He said the company does not view a dividend as the best current use of capital and would consider share repurchases when management believes buying stock offers an attractive return.

About Teva Pharmaceutical Industries (NYSE:TEVA)Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company headquartered in Tel Aviv, Israel. The company develops, manufactures and markets generic medicines, innovative specialty medicines, biosimilars, over-the-counter products and active pharmaceutical ingredients. Its portfolio serves a broad range of therapeutic areas, including central nervous system disorders, respiratory conditions, migraine, oncology and movement disorders.

Teva's specialty medicines include treatments for conditions such as multiple sclerosis, migraine and tardive dyskinesia, while its generic medicines business supplies products across numerous therapeutic categories and dosage forms.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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New findings show favorable treatment continuity for UZEDY compared to other long-acting injectables in schizophrenia, as well as oral antipsychotics in bipolar I disorder (BD-I)The new real-world data also show that UZEDY decreased emergency room visits and hospitalizations, lowering overall healthcare resource utilization and delivering over $1,000 per patient per month in direct cost savingsThe breadth of clinical evidence presented highlights Teva’s ongoing commitment to evaluating how therapies perform in patients’ everyday lives to assist in improving routine care and reducing the burden of severe mental illness PARSIPPANY, N.J., Sept. 18, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new real-world data evaluating treatment continuity, healthcare resource utilization (HCRU) and clinical outcomes among adults with schizophrenia and bipolar I disorder (BD-I) treated with UZEDY (risperidone) extended-release injectable suspension. The results demonstrate how UZEDY helps patients with schizophrenia remain on treatment longer while reducing emergency care and healthcare costs compared with other treatment options. The new findings were presented at Psych Congress, held September 15 – 19, 2026, in New Orleans, LA.

“We cannot accept psychiatric emergencies and hospitalizations as an inevitable part of living with schizophrenia and bipolar I disorder,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “These findings show that when we provide a treatment option like UZEDY that helps patients stay on track, we can meaningfully cut emergency room visits and help people maintain stability in their everyday lives. Delivering measurable impact for patients and healthcare systems is what drives everything we do at Teva.”

Schizophrenia Data Highlights

The two schizophrenia abstracts featured at Psych Congress highlight significant clinical and economic advantages in real-world settings:

Lower Emergency Care and Costs vs. Paliperidone Palmitate Once-Monthly (PP1m): In a matched cohort of 1,166 patients (583 per group), fewer patients receiving once-monthly UZEDY had an emergency department (ED) visit compared to PP1m (22.0% vs. 27.8%). Overall, UZEDY patients had a 40% lower all-cause ED visit rate and a numerically lower proportion of inpatient hospitalizations (11.1% vs. 14.8%). Estimated mean monthly direct healthcare costs were significantly lower for UZEDY ($4,688.10 vs. $5,724.80), delivering an adjusted mean monthly savings of $1,036.70 per patient.Superior Adherence and Persistence vs. Other Long-Acting Injectable Antipsychotics: Matched cohorts compared once-monthly UZEDY to risperidone microspheres every-2-weeks, aripiprazole once-monthly and haloperidol decanoate once-monthly. The greatest differences were observed against risperidone microspheres, where UZEDY patients achieved 3.6x higher odds of adherence (OR: 3.6), an 80% lower likelihood of discontinuation (OR: 0.2) and lower rates of ED visits and hospitalizations. UZEDY patients also had lower ED visit rates versus haloperidol decanoate once-monthly, while outcomes versus aripiprazole once-monthly were generally comparable. “As clinicians, it is frustrating to watch patients with schizophrenia struggle through cycles of relapse and end up back in the emergency room,” said John M. Kane, MD, Professor of Psychiatry and Molecular Medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. “We need to think differently about how we use long-acting injectables. This observational data shows that patients receiving UZEDY had greater treatment continuity and fewer emergency department visits, reinforcing the potential of this approach to help patients stay stable while reducing pressure on an already strained healthcare system.”

BD-I Data Highlights

Teva also presented new study findings evaluating outcomes in patients living with BD-I who switched from oral antipsychotics to UZEDY:

Real-World Effectiveness of Switching From Oral Antipsychotics to UZEDY in BD-I: A retrospective chart review of 358 matched patients (179 per group) evaluated patient outcomes after transitioning from oral antipsychotics to either UZEDY or another oral antipsychotic. Patients who switched to UZEDY experienced significantly less treatment failure (47% vs. 63%) compared to those switched to another oral antipsychotic. Patients receiving UZEDY were also more likely to stay on treatment longer without experiencing BD-I/mania-related hospitalizations, ED visits or discontinuation due to inadequate effectiveness. As the treatment landscape for severe mental illness continues to evolve, real-world evidence remains essential in guiding clinical decisions that optimize patient outcomes and healthcare resources. These findings further validate UZEDY as an innovative, effective and economically beneficial treatment option for patients navigating the complex, daily challenges of schizophrenia and BD-I.

About UZEDY
UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. In clinical trials, UZEDY significantly delayed time to relapse in adults with schizophrenia.1,2 UZEDY administers risperidone through copolymer technology under license from Medincell that allows for rapid absorption and sustained release after subcutaneous injection. UZEDY is the only long-acting, subcutaneous formulation of risperidone available in both one- and two-month dosing intervals.1 For full prescribing information, visit https://www.uzedy.com/globalassets/uzedy/prescribing-information.pdf.

APPROVED USE

UZEDY (risperidone) extended-release injectable suspension is a prescription medicine used in adults

for the treatment of schizophreniafor the maintenance treatment of bipolar I disorder as monotherapy or as adjunctive therapy to lithium or valproate IMPORTANT SAFETY INFORMATION

What is the most important information I should know about UZEDY?

UZEDY can cause serious side effects, including an increased risk of death in elderly people who are confused, have memory loss, and have lost touch with reality (dementia-related psychosis). UZEDY is not approved for use in patients with dementia-related psychosis.

Do not receive UZEDY if you are allergic to risperidone, paliperidone, or any of its components.

UZEDY may cause serious side effects, including:

Stroke in elderly people (cerebrovascular problems) that can lead to death.Neuroleptic Malignant Syndrome (NMS). NMS is a rare but very serious problem that can lead to death. Seek medical attention right away if you have any of these symptoms: high fever, severe muscle stiffness, confusion, sweating, irregular heartbeat, fast heart rate, or changes in your blood pressure.Uncontrolled facial or body movements (tardive dyskinesia) that may not go away, even if you stop receiving UZEDY. Tardive dyskinesia may also start after you stop receiving UZEDY.Problems with your metabolism that may include high blood sugar (hyperglycemia), diabetes mellitus, changes in the fat levels in your blood (dyslipidemia), and weight gain. Extremely high blood sugar can lead to coma or death. If you have diabetes or are at risk for diabetes (e.g., obesity, family history of diabetes), your healthcare provider should check your blood sugar before you start and during treatment with UZEDY. Call your healthcare provider if you have symptoms of high blood sugar including: feeling very thirsty, hungry, sick to your stomach, weak or tired, or confused; needing to urinate more than usual; or your breath smells fruity.High levels of prolactin in your blood. UZEDY may cause a rise in the blood levels of a hormone called prolactin that may cause side effects including missed menstrual periods, decreased fertility in women, leakage of milk from the breasts, development of breasts in men, or problems with erection.Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.Falls. Antipsychotic medicines like UZEDY may cause drowsiness or dizziness when you are standing, which could increase your risk for falls and related injuries.Low white blood cell count.Problems thinking clearly and moving your body. Do not drive, operate machinery, or do other dangerous activities until you know how UZEDY affects you.Seizures (convulsions).Difficulty swallowing that can cause food or liquid to get into your lungs.Prolonged or painful erection lasting more than 4 hours. Call your healthcare provider or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours.Problems with control of your body temperature (too high or too low). Avoid getting overheated or dehydrated. The most common side effects of risperidone in patients with

Schizophrenia included slow movements, stiffness, shaking, restlessness, abnormal muscle contractions or movements, drowsiness, dizziness, anxiety, blurred vision, nausea, vomiting, indigestion, diarrhea, increased saliva, constipation, dry mouth, increased appetite, weight gain, tiredness, rash, and common cold symptomsBipolar disorder were weight increased (5% in monotherapy trial) and slow movements, stiffness, shaking (≥10% in adjunctive therapy trial).Injection site reactions including a lump or itching were reported with UZEDY. These are not all the possible side effects of UZEDY. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist.

Do not drink alcohol during treatment with UZEDY.

Before receiving UZEDY, tell your healthcare provider about all your medical conditions, including if you:

have had Neuroleptic Malignant Syndrome.have or have had uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia).have diabetes or have a family history of diabetes.have had dizziness or fainting or are being treated for high blood pressure.have had a low white blood cell count.have or have had seizures or epilepsy.are pregnant or plan to become pregnant during treatment with UZEDY. It is not known if UZEDY will harm your unborn baby. Use of UZEDY during the third trimester of pregnancy may cause side effects in the newborn infant, including agitation, abnormal muscle tone, tremor, drowsiness, difficulty feeding, and difficulty breathing. Seek medical attention if you notice these signs. If you become pregnant during treatment with UZEDY, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics, or call 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.are breastfeeding or plan to breastfeed. If you are receiving UZEDY and are breastfeeding, monitor your infant for sleepiness, inadequate weight gain, jitteriness, tremors, and abnormal muscle movements. Seek medical care if you notice these signs.have or have had kidney or liver problems. Tell your healthcare provider about all the medicines you take or plan to take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. UZEDY and other medicines may affect each other.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For more information about UZEDY, see the full Prescribing Information including Boxed WARNING, or talk to your healthcare provider.

About Schizophrenia
Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts.3 Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability.3,4,5 Approximately 1% of the world’s population will develop schizophrenia in their lifetime, and 2.2 million people in the U.S. are currently diagnosed with the condition.4,5,6 Although schizophrenia can occur at any age, the average age of onset tends to be in the late teens to the early 20s for men, and the late 20s to early 30s for women.3 The long-term course of schizophrenia is marked by episodes of partial or full remission broken by relapses that often occur in the context of psychiatric emergency and require hospitalization.5 Approximately 80% of patients experience multiple relapses over the first five years of treatment, and each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology.7,8,9 Patients are often unaware of their illness and its consequences, contributing to treatment nonadherence, high discontinuation rates, and ultimately, significant direct and indirect healthcare costs from subsequent relapses and hospitalizations.3,4,5,7,8,9 

About Bipolar I Disorder
Bipolar I Disorder (BD-I) is a serious mental health condition defined by episodes of mania—periods of abnormally elevated or irritable mood with increased energy and activity—and often episodes of depression. These episodes can cause significant disruptions in thinking, behavior, and daily functioning. It is challenging to diagnose and is often accompanied by other psychiatric comorbidities. BD-I is associated with poor long-term outcomes and a substantial increase in mortality compared to the general population from both suicide and cardiovascular disease. An estimated 1% or 3,400,000+ of U.S. adults will develop BD-I in their lifetime.10

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.

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 UZEDY (risperidone) for the treatment of schizophrenia and bipolar I disorder; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize our 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 second 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:

UZEDY® (risperidone) extended-release injectable suspension, for subcutaneous injection Current Prescribing Information. Parsippany, NJ. Teva Neuroscience, Inc.Data on file. [CSR/RISE]. West Chester, PA: Teva Neuroscience, Inc.Substance Abuse and Mental Health Services Administration. Schizophrenia. https://www.samhsa.gov/mental-health/schizophrenia. Accessed March 2026.Velligan DI, Rao S. The Epidemiology and Global Burden of Schizophrenia. J Clin Psychiatry. 2023;84(1):MS21078COM5. https://doi.org/10.4088/JCP.MS21078COM5.Wander C. (2020). Schizophrenia: Opportunities to Improve Outcomes and Reduce Economic Burden Through Managed Care. The Am J Manag Care. 26(3 Suppl), S62–S68. https://doi.org/10.37765/ajmc.2020.43013.DRG / Clarivate (Nov 2025 Market Forecast Assumptions-Schizophrenia)Emsley, R., & Kilian, S. (2018). Efficacy and safety profile of paliperidone palmitate injections in the management of patients with schizophrenia: an evidence-based review. Neuropsychiatric Dis. Treat., 14, 205–223. Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in schizophrenia. BMC Psychiatry 13, 50. Andreasen, N. C., et al. (2013). Relapse duration, treatment intensity, and brain tissue loss in schizophrenia: a prospective longitudinal MRI study. The Am J Psychiatry, 170(6), 609–615. Merikangas KR, Akiskal HS, Angst J, et al. Lifetime and 12-Month Prevalence of Bipolar Spectrum Disorder in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2007;64(5):543–552. doi:10.1001/archpsyc.64.5.543  Teva Media Inquiries: [email protected]

Teva Investor Relations Inquiries: [email protected]

PARSIPPANY, N.J. and TEL AVIV, Israel, Sept. 14, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), a global biopharmaceutical company, today announced that its ordinary shares will begin trading today directly on the New York Stock Exchange (NYSE) completing the company’s planned transition from its American Depositary Shares (ADSs) program. Teva’s shares continue to trade under the same ticker symbol “TEVA” on both the NYSE and the Tel Aviv Stock Exchange (TASE).

“Today marks another meaningful milestone in Teva’s transformation,” said Richard Francis, President and CEO of Teva. “The trading of our ordinary shares on the NYSE is expected to broaden investor access to our shares and reflects the momentum we are building through our Pivot to Growth strategy. We remain focused on delivering for patients, driving sustainable growth, and accelerating our transformation into a leading innovative biopharmaceutical company.”

“Our move to a direct ordinary share listing is an important step in strengthening our position in the U.S. capital markets,” said Eli Kalif, Executive Vice President, and Chief Financial Officer of Teva. “Together with our recent return to investment-grade credit ratings from all three major ratings agencies, this milestone demonstrates the strength of our financial transformation, expands our access to investors and enhances our ability to invest for long-term growth.”

Teva’s direct listing comes as the company continues to deliver against its Pivot to Growth strategy, transforming into a leading biopharmaceutical company, driven by a fast-growing innovative medicines portfolio and powered by a leading generics business. Year to date its three flagship innovative brands, AUSTEDO®, AJOVY®, and UZEDY®, have grown collectively by more than 40% year-over-year*,  with expected 2026 revenues of  approximately $3.7 billion. Investment-grade ratings across all three major agencies further underscore Teva’s financial strength, disciplined execution, and continued debt reduction. With multiple near-term pipeline and commercial catalysts ahead, including an innovative pipeline with a potential of more than $10 billion in peak revenues, Teva is well positioned to expand margins, grow earnings and create significant long-term shareholder value.

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.

Cautionary Note Regarding Forward Looking Statements
This Press Release may contain 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. These forward-looking statements include statements concerning our plans, strategies, objectives, and any other information that is not historical information. You can identify these forward-looking statements by the use of words such as “will,” “should,” “expect,” “anticipate,” “may,” “project,” “intend,” “plan,” “believe,” “transition” and other words and terms of similar meaning and expression in connection with any discussion of future performance developments. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully implement the process for terminating our ADS program and directly list our ordinary shares in lieu of the ADSs on the NYSE and to achieve our aims as a result of such process, as described in Part II, Item 5 of our Quarterly Report on Form 10-Q for the second quarter of 2026; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and to profitably commercialize our innovative medicines and biosimilar portfolio, whether organically or through business development, to sustain and focus our portfolio of generic medicines, and to execute on our organizational transformation and to achieve expected cost savings; our significant indebtedness, which may limit our ability to attract investors, incur additional indebtedness, engage in additional transactions or make new investments; and other factors discussed 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 sections captioned “Risk Factors” and “Other Information.” 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:
[email protected]
Teva Investor Relations Inquiries:
[email protected]

*As reported in our Q2 2026 financial results

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/12f4d600-2bc1-4523-a309-25fd649b40b1

Teva Begins Trading Ordinary Shares Directly on the NYSE Teva Pharmaceutical Industries Ltd Begins Trading Ordinary Shares Directly on the NYSE, Marking a Mi...

TEL AVIV, Israel, Sept. 07, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) (“Teva”) announced today its intention to issue senior notes through its special purpose finance subsidiaries. Teva Pharmaceutical Finance Netherlands II B.V. (“Teva Finance II”) intends to offer EUR-denominated Senior Notes (the “Euro Notes”) and Teva Pharmaceutical Finance Netherlands III B.V. (“Teva Finance III”) and Teva Pharmaceutical Finance Netherlands IV B.V. (“Teva Finance IV” and, together with Teva Finance II and Teva Finance III, the “Issuers”) intend to offer USD-denominated Senior Notes (the “USD Notes” and, together with the Euro Notes, the “Notes”).

The offering of Notes is subject to, among other things, market conditions. Teva expects to use the net proceeds from the offering, together with cash on hand, (i) to fund the redemptions of certain existing notes as further set out below (the “Conditional Redemptions”), (ii) to pay fees and expenses in connection therewith and (iii) to the extent of any remaining proceeds, for general corporate purposes, including the repayment of outstanding debt upon maturity, tender offer or earlier redemption.

In connection with the Conditional Redemptions, Teva intends to issue notices of conditional redemption pursuant to which it intends to redeem in accordance with the terms set forth in the relevant indentures: (i) all of the 6.750% Senior Notes due 2028 that are outstanding, (ii) all of the 7.875% Sustainability-Linked Senior Notes due 2029 that are outstanding, (iii) all of the 7.375% Sustainability-Linked Senior Notes due 2029 that are outstanding, (iv) up to $450,000,000 in principal amount of 4.750% Sustainability-Linked Senior Notes due 2027 and (v) up to €1,250,000,000 in principal amount of 4.375% Sustainability-Linked Senior Notes due 2030. The Conditional Redemptions are expected to be conditioned on the consummation of the offering. The offering, however, is not conditioned on the Conditional Redemptions. Teva may, in its sole discretion, decide to issue additional notices of conditional redemption and redeem certain of its other outstanding notes, or to amend the principal amounts to be redeemed under any of the foregoing notices, in each case in accordance with the terms set forth in the relevant indentures pursuant to which such notes were issued, although it is under no obligation to do so.

Net proceeds may be temporarily invested pending application for their stated purpose.

The Notes will be unsecured senior obligations of the Issuers and will be unconditionally guaranteed on a senior basis by Teva.

The offering and sale of the Notes will be made pursuant to our effective automatic shelf registration statement on Form S-3, including our base prospectus, filed with the Securities and Exchange Commission (the “SEC”) on February 7, 2025. The offering of these Notes will be made only by means of a prospectus supplement and accompanying base prospectus, which have been filed with the SEC. Before you invest, you should read the prospectus supplement and accompanying prospectus along with other documents that Teva has filed with the SEC and that are incorporated by reference into the prospectus supplement and accompanying base prospectus for more complete information about Teva and this offering. These documents are available at no charge by visiting EDGAR on the SEC website at http://www.sec.gov. Alternatively, a copy of the prospectus supplement and accompanying base prospectus related to this offering may be obtained, when available, by contacting BNP PARIBAS, 16, boulevard des Italiens, 75009 Paris, France, Attention: Fixed Income Syndicate (emails: [email protected]); BNP Paribas Securities Corp., 787 Seventh Avenue, New York, New York 10019, United States of America, Attention: Debt Syndicate Desk (email: [email protected]); Citigroup Global Markets Europe AG or Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, United States of America, Telephone: (800) 831-9146, E-mail: [email protected]; Goldman Sachs Bank Europe SE, Marienturm, Taunusanlage 9-10, 60329 Frankfurt am Main, Germany, Attention: High Yield Syndicate Desk (Tel: +49 69 7532 1000, Fax: +44 (0)207 774 2330); J.P. Morgan SE, Taunustor 1 (TaunusTurm), 60310 Frankfurt am Main, Germany, Attention: Head of EMEA Capital Markets Group (email: [email protected]) and J.P. Morgan Securities LLC, 270 Park Avenue, New York, New York 10017, United States of America, Attention: Investment Grade Syndicate Desk, Tel: (212) 834-6081).

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

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.

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. Important factors that could cause or contribute to such differences include risks relating to: completion of the offering of senior notes and conditional redemptions for certain outstanding notes; our significant indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments; and our potential need to raise additional funds in the future, which may not be available on acceptable terms or at all; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2026, 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,” and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. 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.

It may be unlawful to distribute this press release in certain jurisdictions. This press release is not for distribution in Canada, Japan or Australia. The information in this press release does not constitute an offer of securities for sale in Canada, Japan or Australia.

The Notes are not intended to be offered, sold or otherwise made available to and should not be offered, sold or otherwise made available to any retail investor in the European Economic Area (“EEA”). For these purposes, a retail investor means a person who is one (or more) of: (i) a retail client as defined in point (11) of Article 4(1) of Directive 2014/65/EU (as amended, “MiFID II”); or (ii) a customer within the meaning of Directive 2016/97/EU (as amended, the “Insurance Distribution Directive”), where that customer would not qualify as a professional client as defined in point (10) of Article 4(1) of MiFID II; or (iii) not a qualified investor as defined in Article 2 of Regulation (EU) 2017/1129. Consequently, no key information document required by Regulation (EU) No 1286/2014 (as amended, the “PRIIPs Regulation”) for offering or selling the Notes or otherwise making them available to retail investors in the EEA has been prepared and therefore offering or selling the Notes or otherwise making them available to any retail investor in the EEA may be unlawful under the PRIIPs Regulation.

The Notes are not intended to be offered, sold or otherwise made available to and should not be offered, sold or otherwise made available to any retail investors in the United Kingdom. For these purposes, a retail investor means a person who is neither: (i) a professional client, as defined in point (8) of the UK MiFIR; nor (ii) a qualified investor as defined in paragraph 15 of Schedule 1 to the POATRs. Consequently, no disclosure document required by DISC for offering or selling, or distributing the Notes or otherwise making them available to retail investors in the UK has been prepared and, therefore, offering or selling, or distributing the notes or otherwise making them available to any retail investor in the UK may be unlawful under the DISC and the Consumer Composite Investments (Designated Activities) Regulations 2024.

Promotion of the Notes in the United Kingdom is restricted by the FSMA, and accordingly, the Notes are not being promoted to the general public in the United Kingdom. This announcement is for distribution only to, and is only directed at, persons who are (i) outside the United Kingdom, (ii) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”), (iii) high net worth entities, and other persons to whom they may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order or (iv) persons to whom an invitation or inducement to engage in investment activity (within the meaning of section 21 of the FSMA) in connection with the issue or sale of any notes may otherwise lawfully be communicated or caused to be communicated (all such persons together being referred to as “relevant persons”). The Notes will only be available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such Notes will be engaged in only with, relevant persons. This announcement is directed only at relevant persons and must not be acted on or relied on by anyone who is not a relevant person.

The Notes have not, may not and will not be offered, sold or delivered in the Netherlands, other than to qualified investors (as defined in Regulation (EU) 2017/1129).

The Notes have not, may not and will not be offered, sold or delivered in Israel, other than to persons who qualify as one of the types of investors listed in the First Addendum to the Israeli Securities Law, subject to and in accordance with the requirements set forth in the First Addendum to the Israeli Securities Law.

Teva Media Inquiries:
[email protected]

Teva Investor Relations Inquiries:
[email protected]

Source: Teva Pharmaceutical Industries Ltd

PARSIPPANY, N.J. and TEL AVIV, Israel, Aug. 31, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced a shared commitment with the Trump Administration to lower the cost of select medicines for American patients covered by Medicaid. When finalized, this agreement will support continued investment in scientific innovation and pharmaceutical manufacturing capabilities.

 “Teva appreciates the opportunity to work with President Trump and his Administration to expand access and affordability for patients today while enabling continued investment in medicines patients need tomorrow,” said Chris Fox, President, Teva USA. “Teva built its business around delivering affordable medicines to Americans, and we share the Administration’s commitment to improve access to more affordable medicines while investing in scientific innovation and domestic manufacturing capabilities in the U.S.”

                                                                                                 Teva remains in active discussions with the Trump Administration to strike a deal anchored in all four of the President’s drug pricing priorities. If an agreement is reached, Teva would align U.S. Medicaid pricing for select medicines with pricing in leading developed markets through the GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) framework. The agreement also would include a prospective Most-Favored-Nation (MFN) commitment for applicable future innovative product launches.  Additionally, Teva has offered a dedicated reserve of certain active pharmaceutical ingredients (API) in support of public health needs and continued investment into U.S. pharmaceutical manufacturing capabilities. Conditions of the negotiation to reach a final agreement remain confidential.

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.

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: the effects of reforms in healthcare regulation and related reductions in pharmaceutical pricing, reimbursement and coverage; U.S. Executive Orders issued in April and May 2025 intended to reduce the prices paid for prescription medicines, including most-favored-nation pricing and related regulatory efforts; our ability to execute the agreement with the U.S. administration to lower the cost of select medicines for patients in the U.S. covered by Medicaid while supporting continued investment in scientific innovation and healthcare system resilience;  changes in U.S. administration; 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, 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 sections 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
[email protected]

Teva Investor Relations Inquiries
[email protected]

Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) shares are up during Thursday’s premarket session as the company has entered into a settlement agreement with Teva Pharmaceutical Industries Ltd. (NYSE:TEVA).

This news comes amidst a mixed market backdrop, with S&P 500 futures showing a slight loss of 0.03%.

Aurinia (AUPH) Settles Patent Litigation With TevaUnder the terms of the settlement, Teva has stipulated that Aurinia’s U.S. Patent Nos. 10,286,036 and 11,622,991 (which expire in December 2037) are enforceable, valid, and would be infringed by commercial sales within the ‎U.S. of its generic voclosporin product.

The settlement further provides that Teva may launch its generic voclosporin product no earlier than Dec. 7, 2036, unless certain defined contingencies occur earlier.

In January 2021, Aurinia introduced Lupkynis (voclosporin), the first FDA-approved oral therapy for adult patients with active lupus nephritis.

The company is also developing aritinercept, a dual inhibitor of B cell-activating factor and a proliferation-inducing ligand for autoimmune diseases.

Read Next

AUPH Technical Outlook: Trend, Momentum And Key LevelsThe stock has shown a solid performance over the past year, gaining approximately 34.64%.

Currently, it is trading above its 20-day simple moving average (SMA) of $15.31, which indicates a bullish short-term trend. The 50-day SMA is at $15.89, suggesting that while the stock is performing well, it still has some resistance to overcome in the medium term.

The moving average convergence divergence (MACD) is above its signal line, indicating that downside pressure is easing and momentum is improving. This suggests a potential for further upward movement if the current trend continues.

Key Resistance: $19.25 — This level is significant as it marks the 52-week high, which could act as a barrier to further price increases. Key Support: $15.31 — This level aligns with the 20-day SMA, providing a cushion for the stock in case of a pullback. How Aurinia (AUPH) Ranks On Value And MomentumBelow is the Benzinga Edge scorecard for Aurinia Pharmaceuticals, highlighting its strengths and weaknesses compared to the broader market:

Value: 63.91 — Indicates a relatively favorable valuation compared to peers. Momentum: 71.77 — Suggests that the stock is currently outperforming the broader market. The Verdict: Aurinia Pharmaceuticals’s Benzinga Edge signal reveals a balanced profile with strong momentum and favorable value indicators. This positioning may attract investors looking for growth opportunities in the biopharmaceutical sector.

AUPH Stock Price Activity: Aurinia Pharmaceuticals shares were up 2.66% at $16.60 during premarket trading on Thursday, according to Benzinga Pro data.

Image via Shutterstock

Read Next

© 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Teva Pharmaceutical (TEVA -1.13%) stock closed out the last week of trading with significant gains, rising roughly 12.3% across the stretch. The S&P 500 gained 0.2% over the same period, and the Nasdaq Composite was up approximately 0.5%.

Teva published its second-quarter report after the market closed on July 29, posting mixed results. While earnings for the period came in below Wall Street's target, the company delivered some news that excited investors.

Image source: Getty Images.

Teva's Q2 results at a glance With its Q2 report, Teva announced non-GAAP (adjusted) earnings of $0.02 per share -- a performance that fell far short of the average analyst estimate's call for adjusted earnings per share of $0.11 in the period. Meanwhile, sales in the period came in at $4.1 billion and surpassed the average analyst target by roughly $70 million. The generic drug leader's revenue was still down roughly 1% year over year in the period, but the decline was softer than expected -- and investors saw promise in the company's guidance and a significant new development for the stock.

Today's Change

(

-1.13

%) $

-0.40

Current Price

$

35.01

What's next for Teva? For the full-year period, Teva is guiding for adjusted earnings to be between $1.91 per share and $2.11 per share after accounting for closing and administrative costs stemming from its acquisition of Emalex. Meanwhile, the average analyst estimate had called per-share earnings of $2.16 for the year. The company also guided for sales to come in between $16.5 billion and $16.85 billion. For reference, the average Wall Street estimate had targeted sales of $16.63 billion.

With its Q2 report, Teva also announced that it was gearing up to have its stock listed directly on the New York Stock Exchange. As part of the initiative, the Israel-based company's American depositary receipts (ADRs) are set to be replaced with newly listed common stock. The new common stock is set to start trading on September 14, and the direct listing could help attract support from institutional investors and retail traders.

Keith Noonan has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

• Teva Pharmaceutical Indus shares are powering higher. What’s behind TEVA gains?

NYSE Listing TransitionTeva announces the replacement of its American Depositary Share (ADS) program with the direct listing of its ordinary shares on the New York Stock Exchange (NYSE).

ADSs will be exchanged on a one-for-one basis for ordinary shares, which commence trading on the NYSE on Monday, Sept. 14.

The transition aims to broaden Teva’s shareholder base, support its potential inclusion in leading indices, and optimize cost-of-capital.

Key Brands Offset Generic Drug WeaknessThe company reported adjusted earnings of two cents, missing the consensus of 25 cents.

Sales decreased 1% (-3% in local currency) to $4.142 billion, beating the Wall Street consensus of $4.047 billion. The decrease was due to lower revenues from generic products, primarily lenalidomide capsules.

The generic drug makers‘ key brands Austedo, Ajovy and Uzedy collectively grew 43% year over year in local currency to over $1 billion in revenues. Each brand grew at least 40% year over year in the quarter.

Generics global revenues were lower in the quarter mainly due to lower revenues from lenalidomide capsules (a generic version of Revlimid) in the U.S.; the biosimilars portfolio performed strongly and is on track to deliver $800 million in revenues by 2027.

The company, in its earnings conference call, said it is on track to meet its 2027 financial growth targets, with stable revenues despite challenges in the generics sector, and expects continued margin expansion driven by its innovative portfolio.

2026 Outlook and PipelineTeva expects fiscal 2026 adjusted earnings of $1.91-$2.11, including (66 cents) per share of 2026 Emalex expenses, unchanged from prior guidance.

The company marginally raised its 2026 sales guidance from $16.40 billion-$16.80 billion to $16.50 billion-$16.85 billion compared to the consensus of $16.618 billion.

Teva raised its 2026 revenue outlook for its key innovative brands, and now expects combined 2026 revenue of ~$3.7 billion, reflecting around 17% year-over-year growth at the midpoint.

The company has a robust pipeline with potential launches over the next five years, including olanzapine and ecopipam, and is increasing its biosimilars portfolio with 15 products currently in the market.

TEVA Stock Price Activity: Teva Pharmaceutical shares were up 9.25% at $34.60 at the time of publication on Wednesday, according to Benzinga Pro data.

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Year to date, Teva Pharmaceutical Industries (TEVA -1.25%) shares have continued to recover. Thanks to the company's shifting focus from generic to branded drugs, this pharmaceutical stock has surged by around 85% over the past 12 months.

Although Teva may be pulling back lately, don't assume the turnaround rally is over. In addition to success with its initial round of commercially successful branded pharmaceuticals, the company has one key candidate in the pipeline that could be on the verge of becoming a blockbuster drug.

Image source: Getty Images.

Teva's branded drug transformation As seen in Teva's first-quarter 2026 financials, generic drugs now barely make up a majority of the company's overall sales. Meanwhile, branded drugs, particularly recent hits like Austedo, Ajovy, and Uzedy, are experiencing mid-double-digit annual sales growth.

Management expects a drop in earnings per share (EPS), from $2.65 in 2025 to between $1.91 and $2.11 in 2026. However, much of this stems from the initial dilutive effect of Teva's recent acquisition of Emalex Biosciences. Starting next year, the anticipated launch of biosimilars, along with other factors, should contribute to a 30% increase in operating profit and adjusted EBITDA.. Furthermore, another emerging catalyst for Teva could drive the next big leap for shares.

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The duvakitug catalyst Next year, key drivers for the growth rebound include biosimilars, plus incremental sales growth for Teva's aforementioned flagship drugs. However, next year and beyond, duvakitug could be key to the company's further turnaround. The drug, which Teva co-developed with Sanofi, is currently in clinical trials as a treatment for ulcerative colitis and Crohn's disease.

If phase 3 clinical trial results prove as promising as recently released phase 2b findings, this drug could be on the fast track toward commercialization. Management has previously guided for duvakitug to reach between $2 billion and $5 billion in peak annual sales. Considering this, any progress with duvakitug could drive yet another massive rally, especially as the stock sells for less than 10 times estimated 2027 earnings. This strongly suggests taking advantage of near-term weakness by making this stock a long-term buy.

Thomas Niel has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

MarketBeat Week in Review – 02/03 - 02/07Teva Pharmaceutical Industries NYSE: TEVA said its internally developed anti-IL-15 antibody produced encouraging 24-week efficacy results in a phase 1b proof-of-concept study for vitiligo, as the company highlighted the program as part of its broader shift toward a biopharma-focused growth strategy.

During a conference call, President and CEO Richard Francis called the data “a milestone” in Teva’s “Pivot to Growth” plan and said 2026 is expected to include eight key events for the company, up from a prior expectation of seven following the addition of an ecopipam NDA filing.

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Teva Pharma: Why This Generic Drug Giant Is a Smart Buy NowFrancis said Teva’s pipeline includes several programs that the company believes could each become $1 billion products in their respective indications, including anti-IL-15, duvakitug, emricasan, DARI, ecopipam and olanzapine-related programs. He said Teva expects its innovative portfolio to generate $3.5 billion of revenue in 2026.

Vitiligo Study Shows Facial and Total Body Responses Eric A. Hughes, Teva’s EVP of Global R&D and Chief Medical Officer, said vitiligo is an autoimmune disease in which an immune reaction destroys melanocytes, leading to loss of pigmentation. He said the disease affects about 0.5% to 2% of the global population and carries a psychological burden, including anxiety, depression and social isolation.

2 Generic Drug Stocks Ready to Surge in 2025Hughes said the only FDA-approved treatment currently available is a topical therapy for patients with less than 10% body surface area involvement, leaving a need for systemic options that can treat the whole body.

The phase 1b study evaluated Teva’s anti-IL-15 antibody in approximately 38 patients. Participants received one subcutaneous dose at day zero and another at week 12, with efficacy measured at 24 weeks. Hughes said 66% of patients in the study had skin involvement greater than 10% of their body surface area.

Teva reported the following 24-week results after two doses:

42% of patients achieved F-VASI50, representing at least a 50% improvement in facial vitiligo. 21% of patients achieved F-VASI75, representing at least a 75% improvement in facial vitiligo. 7% of patients achieved T-VASI50, representing at least a 50% improvement in total body vitiligo. 75% of patients reported improvement in facial skin using the facial Patient Global Impression of Change score, with half of those reporting “much” to “very much” improvement. 55% of patients reported improvement in total skin using the total Patient Global Impression of Change score. Hughes said the patient-reported outcomes were particularly meaningful because patients monitor their skin daily and may be strongly affected by changes in appearance.

Company Highlights Quarterly Dosing Potential Hughes said Teva believes its anti-IL-15 antibody is differentiated by its potency, long half-life and target engagement. He described the molecule as “Teva-born” and said it was created by the same internal team that developed duvakitug.

According to Hughes, the antibody has a half-life of about 38 days. He said the company observed rapid suppression of free IL-15 levels in serum within one or two days, and at the top dose, suppression below the limit of quantitation extended to about 80 to 90 days. Based on those data, Hughes said dosing once per quarter is a “strong possibility.”

Hughes said the drug has been “very well tolerated” to date, with no safety signals seen so far. In response to an analyst question, he said Teva has followed patients from earlier studies for extended periods, including out to about 400 days in some phase 1 work, and has not seen adverse events associated with IL-15 rebound as levels return to baseline.

Teva Compares Data With Oral JAK Programs Hughes compared the phase 1b results with published data from upadacitinib, an oral JAK therapy that he said recently received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.

He said Teva’s F-VASI50 result of 42% compared with 38% and 39% in the upadacitinib data he referenced. Teva’s F-VASI75 result of 21% compared with 19% and 14%, while its T-VASI50 result of 7% compared with 6% and 11%.

Hughes said Teva views the comparison as encouraging, particularly because its product is being developed as a subcutaneous injection given once every quarter. He contrasted that with daily oral JAK therapy, which he said carries a black box warning.

Phase 2 Plans and Additional Indications Teva said it has already met with the FDA and is incorporating the agency’s feedback into a phase 2 study expected to begin this year. Hughes said the company plans dose-ranging work in phase 2b and is discussing a seamless study design that could allow the program to move efficiently toward phase 3.

Hughes said Teva expects facial VASI and total VASI endpoints to be used in later-stage development, with baseline criteria likely to include greater than 0.5 on facial VASI and greater than five on total VASI. He also said Teva will continue monitoring phase 1b subjects out to 80 weeks.

Teva also emphasized potential applications for anti-IL-15 beyond vitiligo. Hughes said IL-15 may be relevant in alopecia areata, celiac disease, eosinophilic esophagitis and atopic dermatitis. The company expects proof-of-concept data from a phase 2a celiac disease study in the second half of the year.

That celiac study, Hughes said, includes about 50 patients in a placebo-controlled gluten challenge design. Patients receive either active treatment or placebo, then undergo a gluten diet challenge, with biopsies used to evaluate effects on gut histology. Hughes said the crypt depth-to-villus height ratio will be the most important readout.

Francis closed the call by saying the anti-IL-15 vitiligo data represent the second of eight expected milestones for Teva this year, with additional pipeline updates anticipated in the coming months.

About Teva Pharmaceutical Industries NYSE: TEVATeva Pharmaceutical Industries Ltd. NYSE: TEVA is an Israeli multinational pharmaceutical company and one of the world's largest manufacturers of generic medicines. The company's core activities include the development, production and marketing of generic pharmaceuticals alongside a portfolio of specialty branded medicines. Teva supplies finished dosage forms and active pharmaceutical ingredients (APIs) to markets around the globe and operates manufacturing and research facilities in multiple countries.

Teva's product range covers oral solids, injectables, inhalation products and other dosage forms across therapeutic areas such as central nervous system disorders, respiratory, oncology, pain and infectious disease.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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NDA submission supported by positive Phase 3 data recently published in JAMA Neurology.Ecopipam is a first-in-class selective dopamine D1 receptor antagonist with a novel mechanism of action and has received FDA Orphan Drug and Fast Track designationsEcopipam could be the first FDA-approved treatment option for pediatric Tourette syndrome in more than a decade, if approved.
TEL AVIV, Israel, June 18, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ecopipam, a first-in-class investigational therapy for the treatment of pediatric Tourette syndrome.

“The NDA submission for ecopipam is a significant milestone for a potential first-in-class treatment option in pediatric Tourette syndrome,” said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer of Teva. “This reflects the momentum in our innovative pipeline through our recent acquisition of this important asset, and advances our Pivot to Growth strategy and commitment to bringing differentiated medicines for patients.”

The NDA submission is supported by positive Phase 3 data recently published in JAMA Neurology, which showed that ecopipam significantly delayed time to relapse compared with placebo in pediatric patients with Tourette syndrome who had achieved a clinical response during the open-label treatment period. In the study, ecopipam demonstrated a statistically significant benefit on the primary efficacy endpoint in pediatric patients (p = 0.008) and was generally well tolerated, with the most common adverse events related to ecopipam therapy including somnolence, insomnia, anxiety, fatigue and headache.

About Tourette Syndrome

Tourette syndrome is a chronic neuro-developmental disorder character by involuntary motor and vocal tics beginning in childhood, often between 5 and 10 years of age. For people living with Tourette syndrome, symptoms can be frequent, visible, and disruptive, affecting everyday life. Despite the current treatment options available, many patients continue to experience inadequate treatment control or treatment-limiting side effects, underscoring the need for additional options.

About ecopipam

Ecopipam is a first-in-class investigational therapy designed to block dopamine signaling at the D1 receptor. D1 receptor hypersensitivity may contribute to repetitive and compulsive behaviors associated with Tourette syndrome.

Ecopipam has received Orphan Drug and Fast Track designations from the FDA for the treatment of pediatric patients with Tourette syndrome. Orphan Drug designation is reserved for patient populations of 200,000 or fewer.

Results from the Phase 3 study in Tourette syndrome were recently published in JAMA Neurology. The primary efficacy endpoint in the study was time to relapse (based on YGTSS-TTS scale) for pediatric patients who were stable and responding to ecopipam. The study showed statistical significance between ecopipam and placebo for the primary efficacy endpoint in pediatric patients (p = 0.008). Ecopipam was generally well-tolerated in the study and the most common adverse events related to ecopipam therapy were somnolence (n = 24 [11.1%]), anxiety (n = 21 [9.7%]), headache (n = 21 [9.7%]), insomnia (n = 19 [8.8%]), tic (n = 17 [7.9%]), and fatigue (n = 14 [6.5%]). 

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 Media Inquiries: [email protected] Investor Relations Inquiries: [email protected] 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 develop, obtain regulatory approval for and commercialize ecopipam; 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, 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 “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.