- The stock price of Aura Biosciences Inc (NASDAQ: AURA) increased by over 7% during intraday trading today. This is why.
The stock price of Aura Biosciences Inc (NASDAQ: AURA) – a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications – increased by over 7% during intraday trading today. Investors are responding positively to Aura Biosciences announcing that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for belzupacap sarotalocan (AU-011), Aura’s first VDC product candidate, for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC).
Aura’s planned Phase 1 clinical trial with belzupacap sarotalocan in this indication will evaluate the safety and early proof of mechanism, assess distribution, local necrosis and evidence of immune activation. And Aura expects to initiate the trial in the second half of 2022, with initial Phase 1 data expected in 2023.
“We are pleased that belzupacap sarotalocan has been granted Fast Track designation. We believe that, given that NMIBC presents such a high unmet medical need, the opportunity for more frequent interactions with Division of Oncology at FDA and the potential for Priority Review will be valuable as we advance further into clinical development in patients with NMIBC.”
— Dr. Mark De Rosch, Chief Operating Officer and Head of Regulatory Affairs of Aura
“NMIBC has no approved targeted therapies, and patients experience high levels of recurrence and progression, ultimately leading to cystectomy or the removal of the entire bladder. 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.”
— Dr. Cadmus Rich, Chief Medical Officer and Head of R&D of Aura
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