Inhibrx to Seek FDA Approval in 2026 After Strong Phase 2 Data for Bone Cancer Drug Ozekibart

Inhibrx Biosciences plans to submit a Biologics License Application (BLA) to the FDA for ozekibart (INBRX-109), an antibody targeting Death Receptor 5 (DR5), in the second quarter of 20261 3 5 9 10.

Ozekibart showed a 52% reduction in the risk of disease progression or death versus placebo in a phase 2 trial (the ChonDRAgon study) for patients with advanced or metastatic chondrosarcoma, a rare and aggressive bone cancer with no approved therapies1 3 5.

Median progression-free survival improved from 2.66 months (placebo) to 5.52 months with ozekibart, and the disease control rate was 54% versus 27.5% for placebo1 3 5.

Chondrosarcoma affects about 1 in 200,000 people in the U.S. and typically does not respond to conventional chemotherapy or radiotherapy1 2 5.

Ozekibart acts by binding to DR5 on cancer cells, triggering cell death and offering a first-in-class therapeutic mechanism for this indication1 3 5.

The treatment had a higher rate of liver-related adverse events (11.8% in the ozekibart arm vs. 4.5% in placebo), prompting exclusion of high-risk patients and enhanced hepatic monitoring in ongoing and future studies1 3 4.

Chondrosarcoma patients currently have limited treatment options beyond surgery; if approved, ozekibart could become the first targeted systemic therapy available1 3 5 7.

Following the positive results, Inhibrx stock surged over 60% in premarket trading as investors anticipate potential fast-track review or partnership opportunities5 9 10.

The FDA has previously granted orphan drug designation for ozekibart (as INBRX-109), recognizing its potential in rare disease treatment and enabling regulatory and financial incentives2 3.

INBRX-109/ozekibart is also being explored in other oncology indications, including colorectal and Ewing sarcoma, with trials ongoing3 6 11.