Cabaletta Bio (CABA) announced plans for an anticipated 2027 rese-cel BLA submission following a recent U.S. Food and Drug Administration meeting on a proposed registrational cohort design for the RESET-Myositis trial of rese-cel. Following a Type C meeting with the FDA and receipt of meeting minutes in April 2025, Cabaletta is planning to implement the following design for two single-arm, disease-specific registrational cohorts in the ongoing RESET-Myositis trial, either of which, if successful, enable a future Biologics License Application submission for rese-cel in myositis. The FDA also granted Regenerative Medicine Advanced Therapy designation to rese-cel for the treatment of myositis.
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