Cabaletta Bio Announces 2027 Rese-cel BLA Submission Anticipated in Myositis Following Recent FDA Alignment on Registrational Cohorts

Core Insights - Cabaletta Bio, Inc. is advancing its RESET-Myositis trial for rese-cel, targeting myositis, with plans for a Biologics License Application (BLA) submission anticipated in 2027 following FDA discussions [1][3][6] Clinical Development - The RESET-Myositis trial will include two subtype-specific cohorts, each with approximately 15 patients, focusing on dermatomyositis and immune-mediated necrotizing myopathy [4][2] - The primary endpoint for these cohorts is a validated clinical improvement score to be assessed within 26 weeks post-infusion of rese-cel [2][4] - The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation for rese-cel, facilitating expedited review and interactions with the FDA [6][3] Regulatory Updates - Cabaletta has completed enrollment in multiple Phase 1/2 disease cohorts within the RESET clinical program, with 44 patients enrolled and 23 dosed as of May 9, 2025 [3][4] - The company is leveraging pooled safety data from the RESET program to support the BLA submission for myositis [4][5] Financial Position - As of March 31, 2025, Cabaletta reported cash and cash equivalents of $131.8 million, down from $164.0 million at the end of 2024, which is expected to fund operations into the first half of 2026 [8] Manufacturing Strategy - The company is investing in its manufacturing strategy to reduce costs, increase scale, and shorten the time from vein to vein, with plans for commercial drug product processes expected to be operational by early Q3 2025 [7]