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On October 26, 2022, the FDA posted briefing documents regarding Y-mAbs’s stating there were “significant questions” as to the adequacy and control of the submitted study. neuroblastoma drug, omburtamab, Previously, the company had received a Refusal to File letter from the FDA for omburtamab, leading Y-mAbs to resubmit its application for the drug on April 1, 2022.
Following this news of the FDA’s concerns, y-mAbs’s stock price dropped 23% on October 26, 2022, causing significant harm to investors.
Why is YMAB stock dropping?
On Wednesday, October 26, 2022, shares of Y-mAbs Therapeutics, Inc. dropped 27% after the FDA posted briefing documents regarding the company’s neuroblastoma drug, omburtamab, stating there were “significant questions as to whether the submitted study can be considered an adequate and well-controlled trial necessary to establish effectiveness.”
Previously, in y-mAbs’s earnings call for Q2 of 2022 on August 9, 2022, the company assured investors it had been involved in a number of “ongoing” discussions with the FDA regarding omburtamab and the team was “confident” they would be able to address any issues raised. The company further expressed, “given the fact that [neuroblastoma] is a rare disease, in an area of unmet medical need with very poor prognosis, we also believe the FDA…will look at this as an area where flexibility needs to be applied in making any judgments around risk benefit assessments.”
This is not the first set-back Y-mAbs has received for its drug omburtamab. In October of 2020, the FDA had issued a Refusal to File letter, leading Y-mAbs to resubmit its application for the drug on April 1, 2022.
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