Rallybio discontinues RLYB212 for FNAIT after Phase 2 PK misses efficacy targets

Rallybio Corp

Phase 2 PK results: RLYB212 concentrations near/ below assay LLoQ, missing minimum target of 3 ng/mL and predicted 6-10 ng/mL.
No further enrollment; safety follow-up of sentinel participant continues; dose adjustment not feasible.
RLYB116 confirmatory PK/PD study to initiate Q2 2025 with data from Cohorts 1 and 2 in 3Q/4Q 2025.
REV102 (ENPP1 inhibitor, JV with Recursion) in IND-enabling studies; Phase 1 expected 2026; preclinical data 2H 2025.
RLYB332 (long-acting matriptase-2 antibody) preclinical development ongoing for iron overload diseases.

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