Teva Pharmaceuticals announced a commitment with the Trump Administration to reduce costs for select medicines covered by Medicaid. The agreement aims to expand patient access while supporting investment in scientific innovation and pharmaceutical manufacturing capabilities.

Chris Fox, President of Teva USA, stated that the company shares the Administration’s goal of improving access to affordable medicines. He emphasized Teva’s focus on delivering affordable medicines to Americans while investing in domestic manufacturing.

Deal Structure and Pricing Framework

Teva remains in active discussions to finalize a deal anchored in the President’s drug pricing priorities. If agreed, Teva would align U.S. Medicaid pricing for select medicines with pricing in leading developed markets through the GENEROUS framework.

The proposed agreement includes:

• Alignment of U.S. Medicaid pricing for select medicines with leading developed markets
• A prospective Most-Favored-Nation (MFN) commitment for applicable future innovative product launches
• A dedicated reserve of certain active pharmaceutical ingredients (API) for public health needs
• Continued investment into U.S. pharmaceutical manufacturing capabilities

Conditions for reaching a final agreement remain confidential.

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced on August 19, 2026, that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for ecopipam (EBS-101). The agency granted the application Priority Review, establishing a targeted Prescription Drug User Fee Act (PDUFA) action date for late in the first quarter of 2027. Ecopipam is a first-in-class selective D1 dopamine receptor antagonist designed to treat pediatric patients with Tourette syndrome.

This regulatory milestone supports Teva’s Pivot to Growth strategy by leveraging its neuroscience expertise. Tourette syndrome affects approximately 100,000 children and adolescents in the US. Current treatment options show limited adherence, with only 20-30 percent of patients remaining on therapy after one year. Many patients experience inadequate symptom control or treatment-limiting side effects from existing medications. Only half of these patients are treated with prescription medication for this condition.

Clinical Data Supporting NDA

The NDA acceptance is underpinned by positive data from Phase 2b and Phase 3 clinical trials. In the Phase 2b study, ecopipam demonstrated statistically significant improvement in tic severity compared to placebo at Week 12 (p = 0.01), measured by the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS). Durability of efficacy was further confirmed in a Phase 2b open-label extension study.

The Phase 3 randomized withdrawal trial, published in JAMA Neurology, evaluated maintenance of efficacy. Pediatric responders treated with ecopipam showed a 53% decreased risk of relapse over 12 weeks compared to placebo (p=0.008). The trial enrolled 216 participants, randomizing 104 individuals (90 pediatric, 14 adult) across 77 sites in North America and Europe. While adults were included in the Phase 3 trial, the accepted NDA seeks an indication exclusively for pediatric patients.

Safety Profile and Tolerability

Across Phase 2b, Phase 2b open-label extension, and Phase 3 trials, ecopipam showed no clinically meaningful changes in several key safety parameters:

• Body weight and Body Mass Index (BMI) Z-Score
• Vitals and laboratory measures, including metabolic parameters
• Electrocardiogram (ECG) measurements
• Drug-induced movement disorders (DIMD), measured by Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), or Extrapyramidal Symptom Rating Scale (ESRS)
• Measures of psychiatric comorbidities

Ecopipam was generally well-tolerated. The most common adverse events reported in pediatric patients included headache, insomnia, fatigue, somnolence, tics, anxiety, nausea, and restlessness.

What the Numbers Show

The clinical data highlights a divergence between efficacy maintenance and safety profile compared to historical treatments. While existing therapies often face discontinuation due to side effects affecting weight or movement, ecopipam demonstrated no clinically meaningful changes in BMI, ECG, or drug-induced movement disorders across multiple trial phases. This suggests a potential shift in the risk-benefit ratio for pediatric patients, addressing the high discontinuation rates cited in current treatment landscapes where only half of affected children receive prescription medication.

Regulatory Context

Ecopipam holds Orphan Drug designation, reserved for patient populations of 200,000 or fewer. If approved, it would represent the first new therapy for Tourette syndrome in more than 10 years and the first novel mechanism of action in over 50 years. Previous approvals include haloperidol (1969), pimozide (1984), and aripiprazole (2014).