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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Public Company Edition: Also, Johnson & Johnson’s consumer health spin-out Kenvue filed paperwork to get the ball rolling on an initial public offering. In addition, Geron raised $198m and Madrigal accessed more than $300m after positive trial readouts, but layoffs were revealed by Editas, Elevation, Nabriva and others.
US FDA advisory committee voted unanimously that there was not enough evidence to show the monoclonal antibody improves overall survival, but panelists are hopeful that real-world evidence could eventually get the orphan candidate over the finish line.
US regulators refused to accept the file for one of Y-mAbs's neuroblasoma drugs – omburtamab – in October but have given the green light to a second one, naxitamab.