NEW YORK, NY / ACCESSWIRE / January 20, 2023 / Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Y-mAbs Therapeutics, Inc. ('Y-mAbs' or the 'Company') (NASDAQ:YMAB) and reminds investors of the March 20, 2023 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.
If you suffered losses exceeding $100,000 investing in Y-mAbs stock or options between October 6, 2020 and October 28, 2022 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). You may also click here for additional information: www.faruqilaw.com/YMAB.
There is no cost or obligation to you.
Faruqi & Faruqi is a leading minority and Woman-owned national securities law firm with offices in New York, Pennsylvania, California and Georgia.
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 court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not.
Faruqi & Faruqi, LLP also encourages anyone with information regarding y-mAb's conduct to contact the firm, including whistleblowers, former employees, shareholders and others.
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SOURCE: Faruqi & Faruqi, LLP
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