Teva Wins FDA Fast Track for Emrusolmin in Multiple System Atrophy

Overview

• The FDA granted Fast Track status on September 9, 2025 for emrusolmin (TEV-56286) to treat Multiple System Atrophy, a designation intended to expedite development and review but not an approval.
• Emrusolmin is in Phase 2 testing through a collaboration with Germany’s MODAG and targets alpha‑synuclein, with the program previously receiving U.S. Orphan Drug designation in 2022.
• Teva frames the regulatory milestone as part of its shift from a generics-focused model to a biopharmaceutical profile built around specialty therapies.
• Key commercial drivers cited include Austedo, projected to exceed $2.5 billion in sales by 2027, and Uzedy, forecast at about $200 million in 2025.
• The company outlines launches and targets that include an ICS‑SABA inhaler before 2027, olanzapine in Q4 2026, five biosimilars by 2027, and an operating margin goal of 30% by 2027.