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Federal Reserve Board Governor Milan delivered a speech
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Rese-cel, a CD19 CAR T cell therapy, is showing transformative, drug-free clinical responses in multiple autoimmune diseases, with strong safety data and FDA-aligned registrational plans. The RESET program targets high unmet needs across several indications, with a 2027 BLA submission planned.
Original document: Cabaletta Bio, Inc. [CABA] Slides Release — Dec. 5 2025
CABA-201 is advancing through pivotal trials in multiple autoimmune diseases, demonstrating strong efficacy, a favorable safety profile, and readiness for outpatient administration. Scalable, automated manufacturing and a focused commercial strategy position it as a cost-effective, transformative therapy, with launch targeted for 2027–2028.
Recent clinical data in myositis, scleroderma, and lupus support single-arm pivotal trials with strong FDA alignment. Outpatient administration and a younger, privately insured patient base create a favorable commercial model, while manufacturing and supply strategies are set for broad, efficient market entry.
Recent clinical data in myositis, scleroderma, and lupus support single-arm pivotal trials, with FDA alignment and a focus on outpatient administration due to a strong safety profile. Commercial strategy leverages a younger patient population, improved reimbursement, and a broad site footprint for rapid adoption.
Autologous CAR-T therapies are leading the autoimmune field, with strong efficacy and safety data driving regulatory progress and first-mover advantage in myositis. Outpatient administration and a competitive pricing model support broad adoption and financial viability.
Transformative clinical data in multiple autoimmune diseases has led to strong FDA alignment for pivotal trials, with myositis enrollment starting this year and systemic sclerosis and lupus soon to follow. A no preconditioning approach may enable single-infusion outpatient therapy, while the commercial strategy focuses on rapid expansion and cost efficiency.
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