Metabolic dysfunction-associated steatohepatitis (MASH)
ALTAltimmune Inc.Catalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for Pemvidutide (ALT-801) (GLP-1R/GCGR) in Metabolic dysfunction-associated steatohepatitis (MASH). The expected timing is based on the latest available company guidance and may change.
IMPACT trial. 9/30/24- Completed enrollment. 6/26/25- Reported topline results, met primary endpoint. 11/12/25– 48wk data readout in Q4 2025. EoPh2 FDA meeting in Q4 2025. 12/19/25:- Reported positive 48-week IMPACT Ph2b topline data; EoPh2 FDA meeting aligned Ph3, initiation planned in 2026. 03/05/26:- FDA granted Breakthrough Therapy for MASH; global Phase 3 MASH trial initiation remains planned in 2026. 05/13/26:- EASL 2026 May 27-30 features IMPACT analyses; oral May 28; late-breaker May 27. PERFORMA Ph3 MASH trial initiation planned H2 2026; 52-week data readout anticipated in 2029. 05/27/26:- EASL 2026 24-week qFibrosis and NIT analyses reported. PERFORMA Ph3 enrollment planned H2 2026. 05/28/26:- New 48-week IMPACT lipid and blood pressure data shown at EASL 2026. PERFORMA Ph3 starts H2 2026. 07/28/26:- PERFORMA Phase 3 MASH trial initiation planned in Q3 2026. 08/03/26:- PERFORMA Ph3 enrolling in MASH; 52-week data readout anticipated in 2029. 08/12/26:- PERFORMA Ph3 MASH trial initiated. Fifty-two-week data will be read out in 2029.
Verification
Confirm timing and program details against the company announcement or filing.