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Cabaletta Bio Announces 2026 Strategic Priorities To Advance Rese-Cel Toward 2027 BLA, Expand Automated Cellares Manufacturing, And Progress RESET Trials Across Autoimmune Diseases

Benzinga·01/12/2026 13:04:02
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  • Registrational myositis trial actively enrolling with planned 17-patient cohort and 2027 rese-cel BLA submission – including an outpatient dosing option using a single weight-based dose 
  • IND amendment cleared to manufacture rese-cel with the automated, scalable Cellares platform based on multiple successful engineering runs; clinical manufacturing data expected in 1H26 to confirm GMP readiness, including supply chain logistics
  • New durability data without preconditioning and higher dose initial clinical data from RESET-PV™ expected in 1H26; dose-ranging data from RESET-SLE™ without preconditioning anticipated in 2026
  • Complete Phase 1/2 data anticipated in lupus, scleroderma and myasthenia gravis in 1H26
  • FDA alignment on registrational study achieved in SLE and LN for small single-arm cohorts; strategically prioritizing no preconditioning regimen pending dose-ranging data