Catalyst overview
Research summary
This catalyst tracks a Phase 1 data readout for AX-0810 in NTCP for Cholestatic diseases. The expected timing is based on the latest available company guidance and may change.
6/27/25- CTA submitted to EMA. 11/6/25- Initial safety, tolerability, and PK data in late 2025. Engagement data from all cohorts in H1 2026. 01/08/26:- Cohort 1 Ph1 HV trial EUCT 2025-521876-77-00 shows good safety/PK; target engagement readout on track H1 2026. 03/12/26:- Ph1 HV dosing ongoing; target engagement data on track H1 2026. PSC patient cohort planned after HV completion. 05/12/26:- AX-0810 Ph1 HV target engagement data still expected Q2 2026. BA IIT in China initial data H1 2027. 06/25/26:- MAD Phase 1 positive; data Year-End 2026; Biliary Atresia China trial data H1 2027; Phase 2 Mid-2027; interim Mid-2028. 08/13/26:- Positive Ph1 target-engagement data reported. Full Ph1 data is expected by Year-End 2026. Biliary atresia IIT data is expected in H1 2027; Ph2 is expected Mid-2027 and interim data Mid-2028.
Verification
Confirm timing and program details against the company announcement or filing.