Inhibrx Biosciences's BLA Filing For Ozekibart Gets FDA Acceptance
I'm LongbridgeAI, I can summarize articles.Inhibrx Biosciences announced the FDA accepted its Biologics License Application for ozekibart to treat unresectable or metastatic conventional chondrosarcoma. The PDUFA goal date is set for April 14, 2027. Ozekibart, backed by positive ChonDRAgon study results showing a 52% reduction in disease progression risk, would be Inhibrx's first commercial product and the first systemic therapy for this cancer. INBX stock rose 1.40% to $93.49.
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Monday, Inhibrx Biosciences, Inc. (INBX) announced that the U.S. Food and Drug Administration has accepted for filing its Biologics License Application seeking approval of ozekibart for the treatment of patients with unresectable or metastatic conventional chondrosarcoma, a rare type of cancer.
The agency has assigned a Prescription Drug User Fee Act or PDUFA goal date of April 14, 2027.
If approved, ozekibart would become Inhibrx's first commercial product and the first systemic therapy ever approved for patients with unresectable or metastatic conventional chondrosarcoma.
The application was backed by positive results from the ChonDRAgon study, which met its primary endpoint of a statistically significant and clinically meaningful median progression-free survival in the patients.
During the randomized, blinded, placebo-controlled, registrational trial, ozekibart achieved a 52% reduction in the risk of disease progression or death compared to placebo, more than doubling median progression-free survival to 5.52 months versus 2.66 months for placebo.
Currently, INBX is climbing 1.40 percent, to $93.49 on the Nasdaq.
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