Aura Biosciences' Stock Gains As FDA Grants Fast Track Status To Bladder Cancer Drug

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Aura Biosciences’ 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.

Mark De Rosch, Chief Operating Officer and Head of Regulatory Affairs, commented : "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.”

Aura expects to commence the trial in the second half of 2022, and initial Phase 1 data readout is expected in the year 2023.

FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.

Aura Biosciences shares are trading high 11 percent at $14 On Thursday during pre-market session.

Posted In: FDA GrantBiotechHealth CareMovers & ShakersSmall CapGeneral

Ad Disclosure: The rate information is obtained by Bankrate from the listed institutions. Bankrate cannot guaranty the accuracy or availability of any rates shown above. Institutions may have different rates on their own websites than those posted on The listings that appear on this page are from companies from which this website receives compensation, which may impact how, where, and in what order products appear. This table does not include all companies or all available products.

All rates are subject to change without notice and may vary depending on location. These quotes are from banks, thrifts, and credit unions, some of whom have paid for a link to their own Web site where you can find additional information. Those with a paid link are our Advertisers. Those without a paid link are listings we obtain to improve the consumer shopping experience and are not Advertisers. To receive the rate from an Advertiser, please identify yourself as a Bankrate customer. Bank and thrift deposits are insured by the Federal Deposit Insurance Corp. Credit union deposits are insured by the National Credit Union Administration.

Consumer Satisfaction: Bankrate attempts to verify the accuracy and availability of its Advertisers' terms through its quality assurance process and requires Advertisers to agree to our Terms and Conditions and to adhere to our Quality Control Program. If you believe that you have received an inaccurate quote or are otherwise not satisfied with the services provided to you by the institution you choose, please click here.

Rate collection and criteria: Click here for more information on rate collection and criteria.