- No filing review issues identified by FDA with PDUFA goal date set for April 14, 2027
- If Approved, Ozekibart Would Be the First and Only FDA-Approved Treatment for Unresectable or Metastatic Conventional Chondrosarcoma
SAN DIEGO, June 15, 2026 /PRNewswire/ -- Inhibrx Biosciences, Inc. (NASDAQ:INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing novel biologic therapeutic candidates, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its Biologics License Application (BLA) seeking approval of ozekibart (INBRX-109) for the treatment of 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 FDA's acceptance of our BLA for ozekibart is a monumental milestone for Inhibrx and, more importantly, for the chondrosarcoma community," said Mark Lappe, Chief Executive Officer of Inhibrx. "Chondrosarcoma is an aggressive and devastating bone cancer and there are currently no approved therapies for patients suffering from this disease. We look forward to working closely with the FDA during this review process to potentially bring this first-in-class targeted therapy to patients as quickly as possible."
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