Cabaletta Bio Inc. said the U.S. Food and Drug Administration has granted Fast Track Designation for muscle-specific kinase chimeric autoantibody receptor T, or MuSK-CAART cells, to improve activities of daily living and muscle strength in patients with MuSK antibody-positive myasthenia gravis.
The biotechnology company said MuSK-CAART is being evaluated as a potential treatment for patients with MuSK-associated myasthenia gravis.
Cabaletta's Investigational New Drug application was recently cleared by the FDA within the routine 30-day review period.
The FDA's Fast Track process is intended to facilitate the expedited development and review of therapeutics intended to treat serious or life-threatening conditions and to address unmet medical needs.
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