FDA Elevates OS Therapies' Meeting Status for OST-HER2 to Type B Pre-BLA Meeting
ByAinvest
Monday, Mar 9, 2026 7:45 am ET1min read
OSTX--
OS Therapies announced that the FDA elevated its Type D Biomarker Meeting to a Type B pre-BLA Meeting for OST-HER2, a cancer immunotherapy for osteosarcoma. This signals a transition from biomarker data discussions to Accelerated Approval discussions. The Company is on track to complete clinical data submission by the end of Q1 2026 and is seeking Accelerated Approval in the US by H2 2026.
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