Cabaletta Bio reports positive rese-cel data at EULAR; registrational plans for SSc, DM/ASyS, JDM updated

Cabaletta Bio, Inc.

83% (5/6) DM patients achieved immunomodulator-free moderate/major TIS response at 16 weeks; all maintained through 1.5 years.
First two PC-free lupus patients: one achieved deep B cell depletion; PK/PD suggests lowest dose is threshold, enabling potential outpatient use.
SSc registrational study of ~25 patients with ILD to start 4Q26; primary endpoint FVC at 52 weeks.
DM/ASyS registrational cohort topline data expected mid-2027; JDM to be included in 2H27 BLA with potential priority review voucher.
Safety: no ICANS in myositis; 87% SSc patients no/grade1 CRS; 94% SLE preconditioning no/grade1 CRS.

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