Clinical Trial OutcomesPositive updated interim 2-year overall survival data shows 66.6% of OST-HER2 treated patients achieved 2-year overall survival compared to 40% for historical control.
Regulatory DesignationsOST-HER2 holds FDA Orphan, Fast Track, and Rare Pediatric Disease designations, making it eligible for a priority review voucher, representing a significant opportunity for non-dilutive capital.
Regulatory ProgressThe company continues to make progress toward a potential rolling BLA filing, including an End-of-Phase 2 meeting with FDA scheduled, which suggests a favorable outlook for accelerated approval.