With a complete response letter for its 131I-omburtamab, Y-mAbs Therapeutics Inc. seems ready to put the B7-H3-directed radiolabeled murine monoclonal antibody to the side and prioritize its development platform and already-approved neuroblastoma drug.
Y-mAbs Shifts Focus To Approved Drug, Pipeline After Omburtamab CRL
The FDA’s thumbs-down was largely expected after a negative advisory committee review and the path forward for the drug remains unclear – but the company is prioritizing other programs.
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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
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