Aura Biosciences receives FDA Fast Track for belzupacap sarotalocan in NMIBC; Phase 1 trial H2 2022

Aura Biosciences, Inc.

FDA granted Fast Track designation for belzupacap sarotalocan (AU-011) for treatment of Non-Muscle Invasive Bladder Cancer.
NMIBC has no approved targeted therapies; high recurrence and progression often leading to cystectomy.
Aura plans Phase 1 trial in NMIBC starting H2 2022, with initial data expected in 2023.
AU-011 previously received Fast Track and Orphan Drug designations for choroidal melanoma, currently in Phase 2.

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