Cabaletta Bio presented data at medical meetings showing drug-free clinical responses for autoimmune patients with rese-cel. All myositis patients in Phase 1/2 DM/ASyS cohort met key criteria for registrational cohort. BLA submission for rese-cel planned for 2027, with FDA alignment on additional cohort designs expected by 2025 year-end.

Rese-cel, an autologous CAR T cell therapy, aims to reset the immune system for autoimmune diseases. Positive clinical data from multiple trials highlight transformative responses for autoimmune patients. Early data supports using rese-cel in lupus without preconditioning. Initiating myositis registrational cohort by year-end 2025, with additional data expected throughout 2026.

EMA granted PRIME scheme access and FDA granted RMAT and Fast Track designations for rese-cel. FDA alignment on additional cohort designs expected in 2026. Steve Gavel appointed as Chief Commercial Officer. Financial results for Q3 2025 show research and development expenses at $39.8 million. Cash position as of September 30, 2025, to fund operations into the second half of 2026.

Read more at GlobeNewswire: Cabaletta Bio Reports Third Quarter 2025 Financial Results