Teva Submits NDA for Ecopipam, a First-in-Class Investigational Therapy for Pediatric Tourette Syndrome

• 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 designations
• Ecopipam 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: TevaCommunicationsNorthAmerica@tevapharm.com
• Teva Investor Relations Inquiries: TevaIR@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 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.