FDA Accepts Inhibrx BLA for Ozekibart in Chondrosarcoma; PDUFA Set for April 2027

On June 15, 2026, Inhibrx Biosciences announced that the U.S. FDA has accepted for filing its Biologics License Application (BLA) for ozekibart (INBRX-109). The BLA seeks approval for ozekibart as a treatment for patients with unresectable or metastatic conventional chondrosarcoma. The FDA has not identified any filing review issues at this time and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 14, 2027. The submission is supported by positive results from the ChonDRAgon study, a randomized, placebo-controlled registrational trial. The trial met its primary endpoint, demonstrating a statistically significant median progression-free survival (PFS) of 5.52 months for ozekibart compared to 2.66 months for placebo (HR 0.479; P<0.0001). If approved, ozekibart would be the first-ever FDA-approved systemic therapy for this rare bone cancer. Ozekibart previously received Fast Track and Orphan Drug designations for this indication. The company is also evaluating the candidate in Ewing sarcoma and colorectal cancer.