Cabaletta Bio stock soars premarket on fast track designation for MuSK-CAART

Mar. 01, 2022 8:57 AM ETCABABy: Jessica Kuruthukulangara, SA News Editor2 Comments

Cabaletta Bio (NASDAQ:CABA) stock jumped 11% premarket after the U.S. FDA granted Fast Track Designation for MuSK-CAART, or muscle-specific kinase (MuSK) chimeric autoantibody receptor T (MuSK-CAART) cells, to improve muscle strength in patients with MuSK antibody-positive myasthenia gravis.
MuSK-CAART is being evaluated as a potential treatment for patients with MuSK-associated myasthenia gravis.
CABA plans to initiate a first-in-human clinical trial in 2022 for MuSK-CAART. The trial will be an open-label study and is expected to enroll ~20 patients across multiple clinical sites throughout the U.S.
CABA’s Investigational New Drug (NYSE:IND) application was recently cleared by the FDA within the 30-day review period.
MuSK-CAART is designed to target B cells that differentiate into antibody secreting cells, which produce autoantibodies against MuSK, a transmembrane protein required for the formation and maintenance of the neuromuscular junction.
In preclinical studies, MuSK-CAART demonstrated in vitro selective and specific target engagement with no evidence of off-target toxicity to date.