Y-mAbs Therapeutics, Inc.
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 between 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 October 5, 2000, Y-mAbs issued a press release informing investors that it had received a Refusal to File (“RTF”) letter from the FDA regarding its Biologics License Application (“BLA”) for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. On October 6, 2020, the price of Y-mAbs shares declined by $3.57 per share, or approximately 8.56%, from $41.70 per share to close at $38.13 on October 6, 2020.
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. 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.
The lawsuit alleges that, throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose that: (i) the FDA had repeatedly advised Y-mAbs that the treatment of effect of omburtamab cannot be objectively established or quantified based on the methods Y-mAbs were utilizing; (ii) Study 101 was neither sufficiently advanced nor indicative of efficacy to justify approval; and (iii) Y-mAbs had elected to submit the March 31, 2022 BLA prior to reaching agreement with the FDA on the content of the application.