CABA biotech catalysts & pipeline

CABALETTA BIO INC · Data as of 2026-10-25

Upcoming catalysts

resecabtagene autoleucel — Full data

H2 2026

In the second half of 2026, we expect to report longer-term, PC-free rese-cel data from the lowest dose RESET-PV and RESET-SLE cohorts as well as data from patients treated with a higher PC-free dose of rese-cel.

Source filing

resecabtagene autoleucel — Topline data

mid-2027

We initiated enrollment in the registrational DM/ASyS cohort in December 2025 and anticipate reporting BLA-enabling topline data in mid-2027 to support a potential BLA submission in the second half of 2027.

Source filing

resecabtagene autoleucel — NDA/BLA submission

2H27

If successful, Cabaletta plans to submit its first Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in 2H27, inclusive of data from the registrational cohort and the juvenile cohort which may facilitate the potential to be granted a Priority Review Voucher.

Source filing

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