With two neuroblastoma therapies under review at the US Food and Drug Administration, Y-mAbs Therapeutics Inc.is nearing some significant inflection points, including a 30 November user fee date for its lead candidate naxitamab. But the biotech hit a snag on 5 October when the FDA issued a refuse-to-file letter for the biologics license application (BLA) for its other neuroblastoma candidate, omburtamab.
Y-mAbs Faces Delay In Pediatric Neuroblastoma With Refuse-To-File Letter
Omburtamab, for CNS metastases resulting from neuroblastoma, needs more clinical and CMC data for its rolling BLA to be reviewed. The company says timelines for lead candidate naxitamab should not be affected.
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