AnGes, Inc.
Progress in BLA Application for HGF Gene Therapy Products | July 2026
Anges has decided to proceed with the BLA application for HGF gene therapy products following the Pre-BLA Meeting with the U.S. FDA. The preparation for the application is complete, with discussions on clinical, manufacturing, and quality aspects finalized. Attention should be paid to future clinical developments and regulatory application progress.
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Overview of Performance
This document does not present financial results but provides progress information regarding regulatory applications in the U.S. for HGF gene therapy products. Although Ange planned a Pre-BLA Meeting with the FDA on July 16, 2026, the company decided to proceed with the application process after responding to written questions. As a result, clinical trial completion and application preparation have been completed, and subsequent discussions with regulatory authorities are expected to lead to agreements on clinical, manufacturing, and quality matters before submitting the application.
Future Outlook and Impact on Investors
This development marks an important milestone in the clinical and regulatory areas for Ange's HGF gene therapy products. Through discussions with regulatory authorities, the likelihood of early approval and market launch increases, although there is no direct impact on the financial results reported. Monitoring future clinical outcomes and regulatory approval trends will be necessary.
Anges Co., Ltd.
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