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Y-mAbs Therapeutics, Inc.

Bernstein Liebhard LLP announces that a securities class action lawsuit has been filed on behalf of investors who purchased or acquired Y-mAbs Therapeutics, Inc. (“Y-mAbs” or the “Company”) (NASDAQ: YMAB) common stock between October 6, 2020 and October 28, 2022, inclusive. The lawsuit seeks to recover Y-mAbs shareholders’ investment losses.

If you purchased common stock in Y-mAbs Therapeutics, Inc. between October 6, 2020 and October 28, 2022, inclusive, and would like to discuss your legal rights and/or options, please click “Join Class Action” above.

Y-mAbs is a clinical-stage biopharmaceutical company focused on developing antibody therapeutics and medicines for the treatment of cancer patients of all ages.  Y-mAbs’s development processes are subject to U.S. Food and Drug Administration (“FDA”) oversight and approval.

According to Y-mAbs’s public statements, “Omburtamab, our lead product candidate, is a murine monoclonal antibody that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types. 131I-omburtamab, which is omburtamab radiolabeled with Iodine-131, is currently being studied in several clinical trials including pivotal stage development Study 101 and Study 03-133 for the treatment of pediatric patients who have CNS/LM from NB.”

The FDA declined marketing approval of omburtamab in a Refusal to File (RTF) letter dated October 2, 2020, informing Y-mAbs that additional data, including evidence of durable response, were necessary to provide the level of evidence needed to support an approval.  Y-mAbs disclosed the existence of the RTF letter in a press release dated October 5, 2020 and in an investor conference call the morning of October 6, 2020, but misrepresented the FDA’s willingness to approve omburtamab for marketing based on the existing clinical trials.

The true facts were first disclosed to investors shortly after the opening of trading on October 26, 2022, when the FDA published its Briefing Document for an October 28, 2022 Advisory Committee (“AdCom”) Meeting, and again, on October 28, 2022 when the AdCom voted 16-0 against recommending approval of omburtamab.  In the Briefing Document, the FDA review team identified three key issues with the application submitted by Y-mAbs: “(1) The external control population is not fit-for-purpose as a comparator due to substantive differences between the study and control populations that limit the ability to attribute survival differences to the effect of Omburtamab; (2) recognizing the level of evidence provided and need for regulatory flexibility, [the] FDA performed additional analyses to examine bias and results [that] reinforce that differences in survival cannot be reliably attributed to Omburtamab; (3) the application does not include reliable response rate data to provide supportive evidence of the treatment effect of Omburtamab.”

On this news, Y-mAbs’s stock price fell $5.32 per share, or over 59%, to close at $3.61 per share on October 31, 2021.

If you wish to serve as lead plaintiff, you must move the Court no later than March 20, 2023. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Your ability to share in any recovery doesn’t require that you serve as lead plaintiff. If you choose to take no action, you may remain an absent class member.

Since 1993, Bernstein Liebhard LLP has recovered over $3.5 billion for its clients. In addition to representing individual investors, the Firm has been retained by some of the largest public and private pension funds in the country to monitor their assets and pursue litigation on their behalf. As a result of its success litigating hundreds of lawsuits and class actions, the Firm has been named to The National Law Journal’s “Plaintiffs’ Hot List” thirteen times and listed in The Legal 500 for ten consecutive years.

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Contact Information:

Peter Allocco
Bernstein Liebhard LLP
(212) 951-2030