Upcoming FDA decision · April 14, 2027
Ozekibart (INBRX-109) PDUFA date: FDA decision expected April 14, 2027
180 days to goInhibrx Biosciences, Inc. (INBX) →
The FDA is expected to decide on Ozekibart (INBRX-109) from Inhibrx Biosciences, Inc. in Unresectable or metastatic conventional chondrosarcoma by the PDUFA target action date of April 14, 2027. For Unresectable or metastatic conventional chondrosarcoma. BLA; no filing review issues identified. Verified against the company SEC filing on 2026-10-16.
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
April 14
Target action date
NDA
Stage
Verified
Date confidence
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FDA designations
Questions about this FDA decision
- When is the PDUFA date for Ozekibart (INBRX-109)?
- The FDA's PDUFA target action date for Ozekibart (INBRX-109) is April 14, 2027. The FDA can act before that date, and the review can be extended.
- What is Ozekibart (INBRX-109) being reviewed for?
- The application under FDA review covers Unresectable or metastatic conventional chondrosarcoma.
- Which company is developing Ozekibart (INBRX-109)?
- Inhibrx Biosciences, Inc. (INBX).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).