Inhibrx Biosciences, Inc. (INBX) announced that the U.S. FDA has accepted its BLA for Ozekibart for the treatment of unresectable or metastatic conventional chondrosarcoma, a rare and aggressive bone cancer with no approved systemic therapies. The agency reported no filing review issues and assigned a PDUFA action date of April 14, 2027.
Positive Phase 3 Data Supports the Filing
The BLA is backed by results from the study, a randomized, blinded, placebo-controlled, registrational trial that met its primary endpoint of progression-free survival.
Ozekibart reduced the risk of disease progression or death by 52% compared with placebo and more than doubled median PFS to 5.52 months vs. 2.66 months for placebo.If approved, Ozekibart would become the first FDA-approved systemic therapy for patients with unresectable or metastatic conventional chondrosarcoma and the first commercial product for Inhibrx.
A High-Need Patient Population
Conventional chondrosarcoma is the second most common primary bone malignancy and is often resistant to traditional oncology treatments, leaving surgery as the only effective option when feasible. Patients with unresectable or metastatic disease face poor outcomes due to the lack of approved therapies.
Management Commentary
CEO Mark Lappe called the FDA acceptance a "monumental milestone" for both the company and the chondrosarcoma community, emphasizing the urgent need for new treatment options and the potential of Ozekibart as a first-in-class targeted therapy.
INBX has traded between $13.97 and $155.29 over the past year. The stock is currently trading at $94.18, up 2.15%.
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