Wolf Popper LLP Announces the Filing of a Class Action Lawsuit Against Y-mAbs Therapeutics, Inc.

New York, New York--(Newsfile Corp. - January 18, 2023) - Wolf Popper LLP announces that it has filed a class action on behalf of all persons or entities who purchased shares of Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB) common stock on the open market, or pursuant to Registration Statements filed with the Securities and Exchange Commission, during the period October 6, 2020 through October 28, 2022 (the "Class Period"). The action was filed in the U.S. District Court for the Southern District of New York and is titled Corwin v. Y-mAbs Therapeutics, Inc., No. 1:23-cv-431. Class members have sixty-days from the date of this notice, or until Monday, March 20, 2023, to seek appointment as lead plaintiff in the class action.

Y-mAbs is a commercial-stage biopharmaceutical company focused on developing and commercializing antibody-based therapeutic cancer products. Y-mAbs' (former) lead drug candidate ¹³¹I-omburtamab (omburtabab) is used to treat children with central nervous system/leptomeningeal (CNS/LM) metastases in patients with neuroblastoma following standard multimodality treatment for CNS disease. Omburtamab had been investigated in Y-mAbs' Study 03-133 and Study 101. On March 31, 2022, Y-mAbs announced it completed the resubmission of its Biologics License Application (BLA) for omburtamab to the Food and Drug Administration (FDA).

The action 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.

The truth was revealed early in the trading day on October 26, 2022 when the FDA publicly released its Briefing Document for the Oncologic Drugs Advisory Committee (ODAC). The Briefing Document highlighted multiple instances in which the FDA expressed to Y-mAbs that the CGCCR data external control data may not be fit-for-purpose as a direct comparator for the overall survival data. As a result of the very negative view presented in the Briefing Document, 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. That news caused Y-mAbs' stock price to drop $5.32 per share on Monday, October 31, 2022.

The Private Securities Litigation Reform Act of 1995 permits any investor who purchased Y-mAbs common stock during the Class Period to ask the court to be appointed as lead plaintiff in the Y-mAbs class action litigation. A lead plaintiff acts on behalf of all other class members in directing the class action lawsuit, and can select a law firm of its choice to litigate the class action lawsuit. A court will generally appoint as lead plaintiff the movant with the greatest financial interest in the relief sought by the proposed class of investors and that is also typical and adequate of the proposed class. An investor's ability to share in any potential future recovery obtained in the litigation is not dependent upon serving as lead plaintiff. Class members have sixty-days from the date of this notice, or until Monday, March 20, 2023, to seek appointment as lead plaintiff in the class action.

Investors who suffered losses trading in Y-mAbs securities and would like to discuss the lawsuit are encouraged to contact Adam Savett by calling (610) 621-4550 or via e-mail at asavett@wolfpopper.com.

Wolf Popper has successfully recovered billions of dollars for defrauded investors. Wolf Popper's reputation and expertise have been repeatedly recognized by the courts, which have appointed the firm to major positions in securities litigation. For more information about Wolf Popper, please visit the Firm's website at www.wolfpopper.com.

Attorney Advertising: Prior Results Do Not Guarantee A Similar Outcome.

Wolf Popper LLP
Adam Savett
845 Third Avenue
New York, NY 10022
Tel.: (610) 621-4550
Email: asavett@wolfpopper.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/151795