Please use a PC Browser to access Register-Tadawul
Cabaletta Bio Eyes 2027 BLA Submission For Rese-cel In Myositis After FDA Alignment On Registrational Cohorts
Cabaletta Bio CABA | 2.39 2.39 | +1.27% 0.00% Post |
Two subtype specific cohorts with ~15 patients each added to the ongoing RESET-Myositis™ trial –
RMAT designation granted for rese-cel in myositis, which is a disabling, multi-system autoimmune disease affecting approximately 80,000 U.S. patients with no approved treatments other than monthly IVIg –
Multiple Phase 1/2 disease cohorts fully enrolled across the RESET™ clinical development program; 44 patients enrolled and 23 patients dosed as of May 9, 2025
SLE and LN registrational discussions with FDA anticipated in 3Q25; systemic sclerosis registrational discussions with FDA anticipated in 4Q25 –
New clinical data on rese-cel in myositis, SLE / LN and systemic sclerosis to be presented in three oral sessions at the EULAR 2025 Congress in June –


