
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Aura Biosciences’ (NASDAQ:AURA) belzupacap sarotalocan (AU-011) for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC).
The company has planned Phase 1 clinical trial with belzupacap sarotalocan in patients with Non-Muscle Invasive Bladder Cancer (NMIBC) will evaluate the safety and early proof of mechanism, assess distribution, local necrosis and evidence of immune activation.