TEV-53408

July 29, 2026: Teva Pharmaceutical Industries Ltd. provided a Q2 2026 pipeline and business update highlighting several catalyst events. Olanzapine LAI SC for schizophrenia is preparing for launch; the FDA action is on track for Q4 2026, the EMA accepted the MAA in Q2 2026, and Teva said the product was submitted to FDA in December 2025 and to EMA in April 2026. Ecopipam (EBS-101) for Tourette syndrome had an NDA submitted to FDA in June 2026, with expected approval in 2027; Teva cited durable efficacy, lower relapse risk vs placebo, and said 66% of patients in a Phase 3 follow-up completed 1 year of treatment with sustained tic reduction.

Duvakitug (anti-TL1A, with Sanofi): Phase 3 enrollment in ulcerative colitis/Crohn’s disease is on target; additional 2026 milestones include Phase 2 maintenance data in H1 2026, and new studies in hidradenitis suppurativa and fibrostenotic Crohn’s disease, with HS Phase 2 first patient expected in Q4 2026.

DARI (ICS/SABA, with Launch Therapeutics): enrollment completed in the event-driven Phase 3 FLAIR asthma exacerbation study; targeted completion of pivotal Phase 3 studies is H2 2026.

Anti-IL-15 (TEV-53408): Phase 1b vitiligo topline results were expected in H1 2026; Teva reported ~75% of patients improved facial vitiligo and listed H2 2026 Phase 2a celiac topline data as the next milestone.

Emrusolmin (with MODAG) for multiple system atrophy has Fast Track and orphan designations, a Phase 2 futility analysis due H2 2026, and a possible 2028 accelerated-pathway submission. Teva also listed initial human data for an anti-PD-1/IL-2 program in H2 2026.