resecabtagene autoleucel (CABA-201) - Cabaletta Bio
FDA alignment on additional registrational cohort designs expected through 2026 (GlobeNewswire) - Nov 10, 2025 - "Cabaletta expects to align with the FDA on key registrational design elements for the RESET-SSc and RESET-SLE trials by year-end 2025 and for the RESET-MG trial in the first half of 2026. Subject to clinical data and regulatory alignment on registrational cohort design elements for these trials, the Company expects to initiate enrollment in registrational cohorts in 2026." 
Trial status Myasthenia Gravis • Systemic Lupus Erythematosus • Systemic Sclerosis
https://www.globenewswire.com/news-release/2025/11/10/3184437/0/en/Cabaletta-Bio-Reports-Third-Quarter-2025-Financial-Results-and-Provides-Business-Update.html
 
Nov 10, 2025