Inhibrx Announces U.S. FDA Acceptance of BLA for Ozekibart in Patients with Conventional Chondrosarcoma
Rhea-AI Summary
Inhibrx (Nasdaq: INBX) announced FDA acceptance of its Biologics License Application for Ozekibart (INBRX-109) to treat unresectable or metastatic conventional chondrosarcoma, with a PDUFA goal date of April 14, 2027.
The BLA is backed by the phase 2 ChonDRAgon trial, which met its primary endpoint. Ozekibart reduced risk of disease progression or death by 52% versus placebo (HR 0.479; 95% CI: 0.33, 0.68; P<0.0001), increasing median progression-free survival to 5.52 months vs 2.66 months. If approved, Ozekibart would be Inhibrx’s first commercial product and the first FDA-approved systemic therapy for this disease.
Positive
- FDA accepts BLA for Ozekibart in unresectable or metastatic conventional chondrosarcoma
- PDUFA goal date set for April 14, 2027, providing a clear regulatory timeline
- ChonDRAgon trial met primary endpoint with statistically significant PFS benefit
- 52% reduction in risk of progression or death versus placebo (HR 0.479; P<0.0001)
- Median PFS improved to 5.52 months vs 2.66 months on placebo
- If approved, Ozekibart would be Inhibrx’s first commercial product and first systemic option for this disease
Negative
- Regulatory decision on Ozekibart not expected until the April 14, 2027 PDUFA date
- Commercialization of Ozekibart remains contingent on successful completion of FDA review and approval
News Market Reaction – INBX
In the Jun 15 session, INBX gained 1.42%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 14 | Earnings & pipeline | Positive | -6.5% | Q1 2026 results and confirmation of ozekibart BLA submission with pipeline updates. |
| May 11 | Clinical data INBRX-106 | Positive | -5.0% | Interim Phase 2 HexAgon data showing higher response rates vs pembrolizumab alone. |
| May 08 | Webcast announcement | Neutral | -5.0% | Announcement of upcoming webcast to present interim INBRX-106 Phase 2 data. |
| Apr 21 | Ozekibart CRC data | Positive | +37.9% | Updated Phase 1/2 ozekibart plus FOLFIRI colorectal cancer data with strong disease control. |
| Apr 20 | Webcast announcement | Neutral | +2.1% | Notice of webcast to discuss Phase 1/2 ozekibart colorectal cancer data. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent history shows several selloffs after positive data or earnings, contrasted with a strong rally on the April ozekibart colorectal update, suggesting inconsistent reactions to fundamentally positive news.
Over the last few months, Inhibrx has advanced ozekibart and INBRX‑106 while reporting narrower Q1 2026 losses. On April 21, updated ozekibart colorectal data and a filed BLA for chondrosarcoma drove a 37.93% gain. However, positive INBRX‑106 Phase 2 data on May 11 and Q1 results with the ozekibart BLA on May 14 saw declines over 5%. Today’s FDA BLA acceptance continues the regulatory path foreshadowed in those updates.
Key Terms
biologics license application regulatory
pdufa regulatory
progression-free survival medical
pfs medical
hazard ratio medical
placebo-controlled medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- 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
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
If approved, ozekibart would become the first commercial product for Inhibrx and the first-ever approved systemic therapeutic for patients with unresectable or metastatic conventional chondrosarcoma.
About Chondrosarcoma
Chondrosarcoma is a rare type of cancer that primarily develops in the cartilage cells of bones, most commonly affecting the pelvis, hip, and shoulder. It stands as the second most common primary bone malignancy. When the disease becomes unresectable or metastatic, the prognosis is historically poor because the tumors are largely unresponsive to traditional oncology treatments, leaving surgical resection as the only effective management strategy for localized disease.
About ozekibart (INBRX-109)
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
The benefit of ozekibart was consistent across all pre-specified subgroups, including patients with IDH-wild-type and IDH-mutant tumors. Other key secondary endpoints, including disease control rate (
Ozekibart was generally well tolerated, with a manageable safety profile. The most common treatment-related adverse events were fatigue, constipation, and nausea. Hepatotoxicity, a known risk for this mechanism of action, occurs during the first treatment cycle and is in patients with underlying hepatic impairment. One hepatotoxicity-related fatal event occurred early in the study, prior to the implementation of mitigation measures. Over the course of the ChonDRAgon study, this risk was effectively mitigated by excluding patients with severe liver impairment and by implementing close monitoring during early treatment cycles, allowing for prompt management of liver enzyme elevations. This approach resulted in a low overall incidence of treatment-related hepatic adverse events,
In addition to the registrational trial in chondrosarcoma, Inhibrx is advancing ongoing expansion cohorts, evaluating ozekibart in combination with irinotecan-based regimens in Ewing sarcoma and colorectal cancer. Encouraging early signals support further exploration of ozekibart's potential in these difficult-to-treat tumor types with high unmet medical need.
About Inhibrx Biosciences, Inc.
Inhibrx Biosciences is a clinical-stage biopharmaceutical company focused on developing a broad pipeline of novel biologic therapeutic candidates. Inhibrx Biosciences utilizes diverse methods of protein engineering to address the specific requirements of complex target and disease biology, including its proprietary protein engineering platforms. Inhibrx Biosciences was incorporated in January 2024 as a direct, wholly-owned subsidiary of Inhibrx, Inc. Prior to the sale of Inhibrx, Inc. and the INBRX-101 program to Sanofi S.A., Inhibrx Biosciences acquired certain corporate infrastructure and other assets and liabilities through a series of internal restructuring transactions effected by Inhibrx, Inc. Inhibrx, Inc. also completed a distribution to holders of its shares of common stock of
Forward-Looking Statements
Inhibrx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Inhibrx's current beliefs and expectations. These forward-looking statements include, but are not limited to, statements regarding: Inhibrx's judgments and beliefs regarding the strength of Inhibrx's pipeline; statements regarding the safety and efficacy of its therapeutic candidate, ozekibart, based on topline and interim results; the potential for ozekibart to be used for the treatment of colorectal cancer, Ewing sarcoma and solid tumor indications; the clinical development of ozekibart, including expected enrollment in the expansion cohort, data readouts, regulatory submissions and interactions, and the timing thereof; the potential commercial development of ozekibart, including becoming the first commercial product for Inhibrx; ozekibart becoming the first-ever FDA approved systemic therapeutic for patients with unresectable or metastatic conventional chondrosarcoma; and any presumption that topline, interim or preliminary data will be representative of final data or data in later clinical trials. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Inhibrx's business, including, without limitation, risks and uncertainties regarding: topline data may not accurately reflect the complete results of a particular study or trial and remain subject to audit, and final data may differ materially from topline data; the initiation, timing, progress and results of its preclinical studies and clinical trials, and its research and development programs; its ability to advance therapeutic candidates into, and successfully complete, clinical trials; its interpretation of topline, interim or preliminary data from its clinical trials, including interpretations regarding disease control and disease response; results from preclinical studies or early clinical trials not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of its therapeutic candidates that may limit their development, regulatory approval and/or commercialization; the potential for its programs and prospects to be negatively impacted by developments relating to its competitors, including the results of studies or regulatory determinations relating to its competitors; the timing or likelihood of regulatory filings and approvals and regulatory developments in the U.S. and foreign countries; the successful commercialization of its therapeutic candidates, if approved; an accelerated development or approval pathway may not be available for ozekibart or other therapeutic candidates and any such pathway may not lead to a faster development process; it may not realize the benefits associated with orphan drug designation, including that orphan drug exclusivity may not effectively protect a product from competition and that such exclusivity may not be maintained; the pricing, coverage and reimbursement of its therapeutic candidates, if approved; its ability to utilize its technology platform to generate and advance additional therapeutic candidates; and other risks described from time to time in the "Risk Factors" section of its filings with the U.S. Securities and Exchange Commission, including those described in its Annual Report on Form 10-K, its Quarterly Reports on Form 10-Q, and supplemented from time to time by its Current Reports on Form 8-K as filed from time to time. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Inhibrx undertakes no obligation to update these statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Investor and Media Contact:
Kelly Deck, CFO
ir@inhibrx.com
858-795-4260
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SOURCE Inhibrx Biosciences, Inc.