AURA - Aura Biosciences' AU-011 gets FDA fast-track status for bladder cancer

• The U.S. Food and Drug Administration granted fast track designation to Aura Biosciences' ( NASDAQ: AURA ) belzupacap sarotalocan (AU-011) to treat non-muscle invasive bladder cancer.
• The company said AU-011 is its first virus-like drug conjugate product candidate, which it is developing for multiple oncology indications.
• "This milestone supports our goal to advance the development of belzupacap sarotalocan for patients with NMIBC in need of better and earlier targeted treatment options with the potential to help preserve the bladder," said Cadmus Rich, chief medical officer and head of R&D, Aura.
• The company said its phase 1 trial of AU-011 in this indication is expected to begin in H2 2022, with initial data expected in 2023.
• AURA +3.02% to $12.95 premarket June 30

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