FDA Accepts Inhibrx BLA for Ozekibart, Sets April 2027 PDUFA Date
INBX has more than doubled off its 52-week low of $13.97.
Summary
The FDA has accepted Inhibrx's Biologics License Application (BLA) for ozekibart, a drug for conventional chondrosarcoma, setting an April 14, 2027 PDUFA goal date. This follows the BLA submission in April and positive trial results showing a 52% risk reduction. This acceptance is a major regulatory milestone, moving the drug closer to becoming the first FDA-approved systemic treatment for this patient population and Inhibrx's first commercial product. The PDUFA date provides a clear timeline for a potential approval decision.
At the time of this announcement, INBX was trading at $93.51 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.4B. The 52-week trading range was $13.97 to $155.29. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: Wiseek News.