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

Cabaletta Bio, Inc.

FDA grants Orphan Drug Designation to CABA-201, a CD19-CAR T cell therapy, for idiopathic inflammatory myopathies (myositis).
CABA-201 is being evaluated in the Phase 1/2 RESET-Myositis trial across three subtypes: DM, ASyS, and IMNM.
Orphan Drug Designation provides tax credits, fee waivers, and potential 7-year marketing exclusivity upon approval.
Myositis affects about 66,000 US patients; no curative therapy exists, with current treatments showing limited efficacy.

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