Cabaletta Bio (CABA) announced recent pipeline and operational progress and outlined its strategic priorities and anticipated key milestones for 2025. Company plans to meet with the FDA to align on registrational trial designs in 1H25 based on emerging clinical profile of resecabtagene autoleucel and increased pace of enrollment with 44 active clinical trial sites; Favorable safety profile observed across the first 10 patients dosed with rese-cel: 90% experienced either no CRS or grade 1 CRS and 90% experienced no ICANS; latest clinical and translational data to be presented at a scientific meeting in February 2025; First patient enrolled in the RESET-PV trial evaluating rese-cel without preconditioning; First site opened in the juvenile myositis cohort of RESET-Myositis trial; IND application for rese-cel cleared for the RESET-MS trial in multiple sclerosis with Fast Track Designation.
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