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Cabaletta Bio Eyes 2027 BLA Submission For Rese-cel In Myositis After FDA Alignment On Registrational Cohorts

Benzinga·05/15/2025 11:14:49
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 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 –