Milestones
- Phase 3 MAESTRO-NASH trial initiated2019Complete.
- MAESTRO-NASH Phase 3 52-week data meets primary endpoint2023Complete.
- FDA grants accelerated approval to RezdiffraMar 2024Complete.
- Commercial launch in United StatesApr 2024Complete.
- EMA grants conditional marketing authorizationAug 2025Complete.
- Launch in Germany (first European market)Sep 2025Complete.
- Country-by-country European rollout ongoingTarget 2026Current milestone.
- MAESTRO-NASH Outcomes trial (54-month confirmatory data) expectedTarget 2028Not yet reached.
Most important updates
- Rezdiffra Q2 2026 sales reach $364.3 million, up 71% YoY; trailing-12-month revenue exceeds $1.3 billionQ2 2026
- European Commission grants conditional marketing authorization to Rezdiffra for MASHAug 2025
- Rezdiffra commercial launch in the United StatesApr 2024
- FDA grants accelerated approval to Rezdiffra (resmetirom), the first drug approved for MASHMar 2024
Upcoming
- 2026Country-by-country European rollout ongoing (next)
- 2027Full FDA approval (conversion from accelerated approval)
- 2028MAESTRO-NASH Outcomes trial (54-month confirmatory data) expected

