The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the Southern District of New York on behalf of those who acquired Y-mAbs Therapeutics, Inc. (“Y-mAbs”) (NASDAQ: YMAB) securities during the period from October 6, 2020 through October 28, 2022 (the “Class Period”). Investors have until March 20, 2023 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Y-mAbs operates as a clinical-stage biopharmaceutical company, with headquarters in New York, NY.

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).

On October 26, 2022, the FDA publicly released its Briefing Document for the Advisory Committee Meeting, in which it identified three key issues in the application submitted by Y-mAbs and brought to light Y-mAbs’s election to resubmit the BLA on March 31, 2022 prior to reaching agreement with the FDA on the content of the application. The Briefing Document stated that the FDA had allegedly repeatedly raised its concerns to the defendants in prior communications and meetings such as the pre-BLA Type B meeting on January 13, 2022. On this news, the price of Y-mAbs shares declined by $4.16 per share, or approximately 27.42%, from $15.17 per share to close at $11.01 on October 26, 2022. The price then declined again by $2.16 per share, or approximately 19.62%, from $11.01 per share to close at $8.85 on October 27, 2022.

On October 28, 2022, Y-mAbs filed a Form 8-K with the SEC, which informed investors that the AdCom had voted 16 to 0 that Y-mAbs had not provided sufficient evidence to conclude that Omburtamab improved overall survival. The grounds for denial were precisely the same grounds that Y-mAbs was apprised of by the FDA during their 2020 bid for BLA approval. On this news, the price of Y-mAbs shares declined by $5.32 per share, or approximately 59.57%, from $8.93 per share to close at $3.61 on October 31, 2022.

If you purchased or otherwise acquired Y-mAbs securities, have information, or would like to learn more about this investigation, please contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@kmllp.com, or by filling out this contact form, to discuss your rights or interests with respect to these matters without any cost to you.

Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP’s website: http://www.kmllp.com.

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