Y-mAbs Therapeutics, Inc.

Ticker: YMAB

Class Period Start: 10/20/2020

Class Period End: 10/28/2022

Registration Deadline: 03/20/2023

A securities class action has been filed in the USDC – S.D.N.Y. against Y-mAbs Therapeutics, Inc. (YMAB) on behalf of persons or entities who purchased shares of Y-mAbs Therapeutics, Inc. (“Y-mAbs”) common stock on the open market, or pursuant to Registration Statements filed with the U.S. Securities and Exchange Commission (“SEC”), during the period October 6, 2020 through October 28, 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.

What was unknown to investors was that the FDA had repeatedly advised Y-mAbs that the treatment of effect of omburtamab cannot be objectively established or quantified based on a comparison between Study 03-133 and an external cohort comprised of data from the Central German Childhood Cancer Registry (CGCCR) database because of substantial differences in the patient populations, and the absence of tumor response data, and that Study 101 was neither sufficiently advanced nor indicative of efficacy to justify approval. Further, Y-mAbs failed to advise investors that it had elected to submit the March 31, 2022 BLA prior to reaching agreement with the FDA on the content of the application.

 

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