Cabaletta Bio reports positive rese-cel data in autoimmune diseases

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Cabaletta Bio Announces New Rese-cel Data and Development Updates Across Autoimmune Portfolio, Including Encouraging Early PC-Free Lupus Findings, at EULAR 2026 Congress

June 3, 2026 7:00 AM EDT

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... More