Clinical Trial ResultsOST-HER2 demonstrated a significant improvement in 2-year overall survival rates compared to historical control, suggesting strong therapeutic potential.
Regulatory ApprovalsOST-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 ProgressOS Therapies has reached alignment with the agency on safety, non-clinical, and CMC matters, providing clarity on requirements to support a BLA submission.