Catalyst overview
Research summary
This catalyst tracks a Phase 2 data readout for ARCT-810 in Ornithine transcarbmylase (OTC) deficiency. The expected timing is based on the latest available company guidance and may change.
LUNAR-OTC. 8/7/23- Completed enrollment & dosing of all cohorts in SAD study in U.S. 7/1/25- Announced favorable interim Ph2 data. 7/11/25- Align Ph3 trial design w/ RA in H1 2026. 11/10/25:- Regulatory alignment on ARCT-810 pivotal trial strategy for adult and pediatric OTC deficiency remains on track for H1 2026. 03/03/26:- Development strategy broadened to adult and pediatric OTC; Type C regulatory meetings remain on track H1 2026. 05/07/26:- FDA Type C meeting in March 2026; preparing exploratory data for pediatric EOP2 meeting in H2 2026. 08/06/26:- Ph2 enrollment and dosing completed. Data and regulatory plan expected Q3 2026.
Verification
Confirm timing and program details against the company announcement or filing.