The United States Food and Drug Administration (FDA) has granted Fast Track Designation to Kintara Therapeutics’ KTRA lead drug candidate VAL-083 for the treatment of patients with newly-diagnosed unmethylated glioblastoma (GBM).
Kintara is currently advancing VAL-083 AGILE clinical study in the phase 2/3 trial to support the development and commercialization of VAL-083 in glioblastoma (GBM).
Robert E. Hoffman, President and CEO, said, “We believe Fast Track Designation is indicative of VAL-083's potential to improve outcomes for patients with GBM, the most aggressive form of brain cancer, Fast Track Designation allows us to work closely with the FDA and may expedite our commercial launch of VAL-083, if approved.”
The company anticipates top-line data readout from the international registrational phase 2/3 GBM AGILE Study around the end of calendar 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.
Kintara Therapeutics shares are trading higher 37 percent at $0.26 in the pre-market session.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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 Bankrate.com. 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 Bankrate.com 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.