Y-mAbs is a commercial-stage, biopharmaceutical company focused on developing and commercializing antibody-based therapeutic cancer products. Y-mAbs's (former) lead drug candidate omburtamab, intended to treat children with central nervous system/leptomeningeal (“CNS/LM”) metastases and who have neuroblastoma following standard multimodality treatment for CNS disease, was the subject of the Company’s clinical trials. On March 31, 2022, Y-mAbs announced it completed the resubmission of its Biologics License Application for omburtamab to the Food and Drug Administration (“FDA”).

On October 26, 2022, the FDA publicly released its Briefing Document for the Oncologic Drugs Advisory Committee (“ODAC”), to take place on October 28, 2022. The Briefing Document highlighted multiple instances in which the FDA expressed to Y-mAbs that the Central German Childhood Cancer Registry (“CGCCR”) data external control data may not be fit-for-purpose as a direct comparator for the overall survival data.

Following this news, Y-mAbs' stock price fell $4.16 per share on October 26, 2022 and $2.16 per share on October 27, 2022.

Finally, after the market closed on Friday, October 28, 2022, it was disclosed that the ODAC voted 16-0 that Y-mAbs had not provided sufficient evidence to conclude that omburtamab improves overall survival. Following this news, Y-mAbs's stock price fell $5.32 per share on Monday, October 31, 2022.

The complaint alleges that throughout the Class Period, Y-mAbs misrepresented to investors that, pursuant to a series of meetings and other communications between Y-mAbs and the FDA, that progress was being made that would align with the FDA's requirement to demonstrate substantial evidence of effectiveness, sufficient for approval of omburtamab.