Y-mAbs Therapeutics, Inc.

On April 1, 2022, the Company announced that it had resubmitted its Biologics License Application (“BLA”) for omburtamab for the treatment of pediatric patients with CNS from neuroblastoma, following several meetings with the U.S. Food and Drug Administration (“FDA”) to address deficiencies identified in the agency’s 2020 refusal to file letter in response to Y-mAbs’s previous BLA.

On October 26, 2022, the FDA released its briefing document in advance of its Advisory Committee meeting to discuss the omburtamab BLA. The briefing document identified three key issues regarding the submitted data, which led analysts to conclude that Y-mAbs had resubmitted the BLA prior to reaching agreement with the FDA regarding the content of the application.

On this news, Y-mAbs’s stock price fell $4.16, or 27.4%, to close at $11.01 per share on October 26, 2022, thereby injuring investors.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants misrepresented to investors that, pursuant to a series of meetings and other communications between the Company 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 omurtamab, through adequate and well-controlled studies.