Cabaletta Bio Announces FDA Granted Orphan Drug Designation to CABA-201 for Treatment of Myositis

February 1, 2024

https://www.globenewswire.com/news-release/2024/02/01/2822479/0/en/Cabaletta-Bio-Announces-FDA-Granted-Orphan-Drug-Designation-to-CABA-201-for-Treatment-of-Myositis.html

PHILADELPHIA, Feb. 01, 2024 (GLOBE NEWSWIRE) — Cabaletta Bio, Inc. (Nasdaq:CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, for the treatment of idiopathic inflammatory myopathies (IIM, or myositis). CABA-201 is in development as a potential treatment for autoimmune diseases driven by B cells. Four RESET™ (REstoring SElf-Tolerance) Phase 1/2 trials are advancing for the evaluation of CABA-201 across multiple autoimmune conditions, including the Phase 1/2 RESET-Myositis™ trial.

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