Cabaletta Bio Inc. has announced plans for the development and submission of their biologics license application $(BLA.AU)$ for resecabtagene autoleucel (rese-cel) in 2027, following recent alignment with the FDA. The company is focusing on rapidly accelerating enrollment across a broad portfolio of indications at 62 active clinical sites. The initial BLA submission will target myositis, with plans to expand to systemic lupus erythematosus/lupus nephritis and systemic sclerosis. The presentation highlights the innovative clinical strategy that supports an accelerated regulatory path, emphasizing the efficacy and safety data from the RESET clinical program. Cabaletta Bio has received FDA Fast Track Designation for several conditions, including dermatomyositis and multiple sclerosis, and RMAT designation for myositis. New clinical safety and efficacy data for rese-cel will be presented at the EULAR 2025 congress. You can access the full presentation through the link below.
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