U.S. Food and Drug Administration Grants Cabaletta Bio Fast Track Designation for MuSK-CAART
PHILADELPHIA, March 01, 2022 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on the discovery and development of targeted cell therapies for patients with autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for MuSK-CAART, or muscle-specific kinase (MuSK) chimeric autoantibody receptor T (MuSK-CAART) cells, to improve activities of daily living and 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 (MG).
- Cabalettas Investigational New Drug (IND) application was recently cleared by the FDA within the routine 30-day review period.
- Cabaletta plans to initiate a first-in-human clinical trial in 2022 for MuSK-CAART.
- Cabaletta Bios headquarters are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and follow us on LinkedIn.
- All information in this press release is as of the date of the release, and Cabaletta undertakes no duty to update this information unless required by law.