Cabaletta Bio receives FDA Orphan Drug Designation for CABA-201 in systemic sclerosis

Cabaletta Bio, Inc.

FDA grants Orphan Drug Designation to CABA-201 for systemic sclerosis, a rare autoimmune disease.
CABA-201 is a fully human CD19-CAR T cell therapy being studied in Phase 1/2 RESET-SSc trial.
ODD provides tax credits, waived user fees, and potential 7-year marketing exclusivity upon approval.
Systemic sclerosis affects <200,000 US patients; average survival ~12 years after diagnosis.

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