Y-mAbs Therapeutics, Inc.
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The Complaint claims that the Company, Y-mAbs, made false and misleading statements to the market. Y-mAbs allegedly deceived investors by stating that they were making progress in showing the effectiveness and efficacy of their drug candidate, omburtamab, during meetings with the FDA. However, in reality, the FDA had advised the Company that it could not compare data from its studies with the Central German Childhood Cancer Registry (CGCCR) database due to various reasons, including the absence of tumor response data. The Company also failed to inform investors that it had decided to submit its BLA on March 31, 2022, before reaching an agreement with the FDA. Due to these false statements, investors incurred damages when the truth was revealed.