FDA accepts Inhibrx BLA for ozekibart in chondrosarcoma; PDUFA date April 14, 2027

Inhibrx Biosciences, Inc.

• FDA accepted BLA for ozekibart (INBRX-109) for unresectable or metastatic conventional chondrosarcoma.
• No filing review issues identified; PDUFA goal date set for April 14, 2027.
• If approved, ozekibart would be first FDA-approved systemic therapy for this indication.
• Pivotal ChonDRAgon trial showed 52% risk reduction in disease progression/death (HR 0.479; p<0.0001).
• Median PFS 5.52 months for ozekibart vs 2.66 months for placebo.