INBX
Live News • Jun 15
FDA Accepts Inhibrx BLA for Ozekibart in Rare Aggressive Bone Cancer Inhibrx Biosciences announced that the FDA has accepted for filing its Biologics License Application (BLA) for ozekibart (INBRX-109) in unresectable or metastatic conventional chondrosarcoma.
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 14, 2027, and indicated there are no filing review issues identified at this stage.
If approved, ozekibart would become the first FDA-approved systemic therapy for conventional chondrosarcoma, a rare and aggressive bone cancer with no current approved treatments.
Regulatory acceptance of the BLA moves ozekibart into a defined review timeline and indicates that the FDA considers the submission sufficiently complete for full evaluation.
Investors should keep in mind that the PDUFA date is in 2027 and that approval, commercial uptake, and any revenue potential remain subject to clinical benefit, safety profile, and the eventual FDA decision. Announcement • Jun 15
Inhibrx Biosciences, Inc. Announces U.S. FDA Acceptance Of BLA for Ozekibart in Patients with Conventional Chondrosarcoma Inhibrx Biosciences, Inc. 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. If approved, ozekibart would be the first and only FDA-approved treatment for unresectable or metastatic conventional chondrosarcoma. The BLA is supported by positive results from the ChonDRAgon study, a randomized, blinded, placebo-controlled, registrational trial of ozekibart in patients with metastatic or unresectable conventional chondrosarcoma, which met its primary endpoint of a statistically significant and clinically meaningful median progression-free survival (PFS) for patients treated with ozekibart compared to placebo. Ozekibart achieved a 52% reduction in the risk of disease progression or death compared to placebo (stratified Hazard Ratio [HR] 0.479; 95% CI: 0.33, 0.68; P). Ozekibart is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation. In January 2021, the FDA granted Fast Track designation to ozekibart for the treatment of patients with metastatic or unresectable conventional chondrosarcoma, and, in November 2021, the FDA granted orphan drug designation to ozekibart for chondrosarcoma. In June 2021, Inhibrx initiated the ChonDRAgon study, a randomized, blinded, placebo-controlled, registrational trial of ozekibart in metastatic, unresectable conventional chondrosarcoma. The trial enrolled a total of 206 patients across 67 different sites worldwide. The primary objective of the trial was the evaluation of the efficacy of ozekibart as measured by median PFS, assessed by central real-time independent radiology review per RECIST 1.1. Secondary objectives were the evaluation of overall survival, median PFS by investigator assessment, quality of life, objective response rate, duration of response, disease control rate, safety and tolerability, pharmacokinetics and anti-drug antibodies to ozekibart. Key enrollment criteria in order for patients to qualify for inclusion in the trial were grade 2 or 3 unresectable or metastatic conventional chondrosarcoma. Patients received either ozekibart or placebo every three weeks at a randomization of 2:1, stratified by the line of therapy, grade and IDH1/2 mutation status. Patients randomized to the placebo arm were allowed to crossover to receive ozekibart upon confirmation of progression as reported by central independent radiology review. The ChonDRAgon study met its primary endpoint of a statistically significant and clinically meaningful median progression-free survival (PFS) for patients with advanced or metastatic chondrosarcoma treated with ozekibart compared to placebo. Ozekibart achieved a 52% reduction in the risk of disease progression or death compared to placebo (stratified Hazard Ratio [HR] 0.479; 95% CI: 0.33, 0.68); P. INBX
Live News • Jun 06
Inhibrx Biosciences Attracts Major Pharma Interest Following Positive Ozekibart Data and Raised Price Target Stifel reiterated its Buy rating on Inhibrx Biosciences and raised its price target after reviewing durability data for Ozekibart.
Interim Phase 2 results showed that combining INBRX-106 with pembrolizumab produced a significantly higher response rate in head and neck squamous cell carcinoma patients than pembrolizumab alone.
Reuters reported that large pharmaceutical companies, including Merck & Co. and Ono Pharmaceutical, have shown takeover interest in Inhibrx Biosciences, and potential spin-off plans are being discussed.
The mix of positive clinical data and interest from major drug companies points to increasing attention on Inhibrx Biosciences’ pipeline and potential corporate outcomes such as partnerships, acquisitions or asset spin-offs.
Investors should keep in mind that any takeover discussions or spin-off plans are uncertain and subject to change, while the clinical programs still carry usual development and regulatory risks. 
