PHILADELPHIA, Jan. 23, 2023 (GLOBE NEWSWIRE) -- Barrack, Rodos & Bacine notifies investors that a securities class action lawsuit has been filed on behalf of purchasers of the common stock of Y-mAbs Therapeutics Inc. (NASDAQ: YMAB) (“Y-mAbs”) from October 6, 2020 through October 28, 2022 (the Class Period). The lawsuit alleges violations of the Securities Exchange Act and names the company and certain of its executives as defendants.
Y-mAbs developed and sought approval from the U.S. Food and Drug Administration (FDA) to market its lead drug candidate, Omburtamab, as a therapy for the treatment of brain cancer in children. According to the Complaint, defendants misrepresented to investors the progress being made toward meeting the FDA’s requirements for demonstrating the drug’s effectiveness. Defendants’ statements failed to disclose, among other things, that the FDA had repeatedly expressed concern that the company’s clinical trial for Omburtamab, known as Study 03-133, was inadequate.
On October 26th, 2022, the FDA released briefing documents in advance of a meeting of the FDA’s Oncologic Drugs Advisory Committee. These documents revealed, among other things, that Y-mAbs elected to push ahead and submit a license application without having first reached an agreement with the FDA on how to address the agency’s concerns about the adequacy of Study 03-133. Moreover, the FDA had performed additional analyses that reinforced its conclusion that “differences in survival cannot be reliably attributed to Omburtamab” and that the application lacked “supportive evidence for the treatment effect of Omburtamab.” On this news, Y-mAbs' share price fell over 27%, or $4.16 per share, to close at $11.01 per share on October 26, 2022. Y-mAbs’ stock fell another $2.16 per share the next day, to close at $8.85 per share.
Trading in Y-mAbs' stock was halted for much of the day on October 28, 2022, while the FDA Advisory Committee convened. The committee voted 16-0 that the company had failed to provide sufficient evidence that Omburtamab improved overall survival. On October 31, 2022, Y-mAbs stock fell nearly 60%, closing at $3.61 per share.
Investors who purchased Y-mAbs shares during the class period may be eligible to seek appointment as the lead plaintiff, a court-appointed role. If you have sustained losses you are encouraged to discuss your rights by contacting Mark R. Stein or Linda Border at Barrack, Rodos & Bacine, at the toll-free number 877-386-3304, or via email at mstein@barrack.com or lborder@barrack.com.
To read about this lawsuit and to find out additional information about the firm, please see the Barrack, Rodos & Bacine newsroom.
Philadelphia-based Barrack Rodos & Bacine has more than four decades of experience prosecuting securities law class actions, including cases involving accounting fraud and insider trading, and has achieved some of the largest recoveries in U.S. history of securities litigation. The firm's largest recoveries on behalf of investors include $6.19 billion for WorldCom investors, $3.32 billion for Cendant investors, $1.05 billion for McKesson investors, and $970.5 million for AIG investors.
