83% of dermatomyositis patients in the Phase 1/2 RESET-Myositis study would have met the registrational primary endpoint; all these patients maintained their response off immunomodulators through latest follow-up, as long as 1.5 years
First juvenile dermatomyositis (JDM) patient demonstrated moderate TIS response off immunomodulators and maintained their response through latest follow-up at 32 weeks; JDM expected to be included in 2H27 myositis BLA submission, facilitating the potential for a priority review voucher
Systemic sclerosis (SSc) announced as second pivotal indication based on convincing Phase 1/2 data after a single dose of rese-cel upon discontinuation of immunomodulators; single-arm registrational study initiation anticipated in 4Q26 in ~25 SSc patients with interstitial lung disease (ILD)
Lowest dose of PC-free rese-cel achieved deep B cell depletion in one of the first two lupus patients treated based on translational data similar to RESET-SLE patients who achieved immune reset after a single dose of rese-cel with preconditioning; second, higher dose PC-free cohorts enrolling in lupus and PV
EULAR presentations demonstrate that for most patients, a single dose of rese-cel provided an immune system reset and compelling immunomodulator-free outcomes that persisted over time
PHILADELPHIA, June 03, 2026 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a late-stage clinical biotechnology company focused on developing and launching targeted cell therapies designed specifically for patients with autoimmune diseases, today announced new clinical data supporting rese-cel (resecabtagene autoleucel) as a potential treatment for multiple autoimmune diseases, including findings that further inform Cabaletta's registrational strategy in myositis and systemic sclerosis as well as its preconditioning-free (PC-free) program in lupus. These data are being presented in multiple oral and poster presentations, as well as in a company-sponsored satellite symposium, at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress, being held June 3-6, 2026, in London, UK.