Cabaletta Bio to file BLA for rese-cel in myositis in 2027 after FDA alignment; cash $131.8M

Cabaletta Bio, Inc.

FDA aligned on two registrational cohorts for rese-cel in myositis (~15 patients each, 26-week primary endpoint); BLA submission expected in 2027.
RMAT designation granted for rese-cel in myositis, enabling Fast Track/Breakthrough benefits and expedited BLA review.
Cash and equivalents $131.8M at March 31, 2025, down from $164M at Dec 31, 2024; funding into first half 2026.
FDA registrational discussions for SLE/LN anticipated in 3Q25; for systemic sclerosis in 4Q25.
Three oral presentations of rese-cel data in myositis, SLE/LN, and systemic sclerosis at EULAR 2025 in June.

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