OS Therapies Elevates OST-HER2 to Type B Pre-BLA Meeting, Eyes Q1 Data and $205M PRV
FDA has elevated OS Therapies' Type D biomarker meeting to a Type B pre-BLA meeting for OST-HER2, marking transition to Accelerated Approval discussions. The company plans to submit its clinical data package by end of Q1 2026 and could gain a $205 million Priority Review Voucher upon OST-HER2 approval.
1. Regulatory Pathway Update
The FDA has elevated OS Therapies’ OST-HER2 meeting from a Type D biomarker discussion to a Type B pre-BLA meeting, signaling a shift toward Accelerated Approval dialogue for preventing recurrent, fully resected pulmonary metastatic osteosarcoma.
2. Submission Timeline and Next Steps
OS Therapies aims to complete and submit its clinical data package by the end of the first quarter of 2026, which will precede the pre-BLA meeting and facilitate planning for a randomized, confirmatory Phase 3 trial.
3. Priority Review Voucher Opportunity
OST-HER2 benefits from Orphan Drug, Fast Track and Rare Pediatric Disease designations, making OS Therapies eligible for a Priority Review Voucher valued at approximately $205 million if OST-HER2 gains U.S. approval.