Catalyst overview
Research summary
This catalyst tracks a Phase 1b data readout for R289 in Lower-risk myeloid dysplastic syndrome . The expected timing is based on the latest available company guidance and may change.
12/2/24- Granted fast track designation. 1/9/25- Orphan Drug designation. 10/7/25- First patient enrolled in dose expansion. 11/3/25- Present updated data ASH'25 on December 7, 2025. 11/04/25:- Enrollment in the dose escalation phase of the Phase 1b R289 study in lower-risk MDS was completed in July 2025, and the first patient was enrolled in the dose expansion phase in October 2025. Updated dose-escalation data will be presented in an oral session at ASH 2025 on December 7, 2025, with R289 showing acceptable tolerability and preliminary signs of efficacy at doses of at least 500 mg once daily. 12/07/25:- Updated Ph1b ASH data from NCT05308264 showed 33% RBC-TI. RP2D selection expected H2 2026. 01/12/26:- Dose expansion enrolling; RP2D selection and preliminary Phase 1b expansion data expected by end-2026. 03/03/26:- Dose-expansion enrollment ongoing; R289 Phase 1b lower-risk MDS RP2D selection and preliminary expansion data still expected in H2 2026. 05/05/26:- Enrollment in Phase 1b R289 dose expansion ongoing; on track for RP2D selection and preliminary data by end-2026. 08/04/26:- Ph1b expansion enrollment and RP2D selection remain on track. Preliminary data expected by year-end 2026.
Verification
Confirm timing and program details against the company announcement or filing.