Cabaletta announces 2026 priorities: myositis trial enrolling, BLA 2027, Cellares IND cleared

Cabaletta Bio, Inc.

Myositis registrational cohort actively enrolling; BLA submission for rese-cel projected in 2027.
FDA aligned on registrational cohort designs in SLE and LN, each ~25 patients with unique endpoints.
FDA granted RMAT designation for rese-cel in systemic sclerosis; registrational alignment expected 1H26.
IND amendment cleared for Cellares automated manufacturing; clinical manufacturing data due 1H26.
No-preconditioning dose-escalation in PV ongoing; Phase 1/2 data from 3 trials expected 1H26.

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