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 Newsdesk 9 months ago
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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
- 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