Iryna Drozd
Cabaletta Bio (NASDAQ:CABA) said it has received FDA orphan drug designation for its drug candidate CABA-201 in the treatment of systemic sclerosis, or SSc.
A CD19 CAR T-cell therapy, CABA-102 is in Phase 1/2 testing for SSc, lupus, generalized myasthenia gravis, and myositis, according to Cabaletta’s website.
CABA-201, which is Cabaletta’s lead assets, was granted FDA orphan drug designation last month for myositis. The product has also received FDA fast track status for dermatomyositis, SSc and two indications for lupus.