According to the Complaint, Y-mAbs Therapeutics, Inc. is a biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer.
Y-mAbs Therapeutics' lead product candidate, omburtamab, is a murine monoclonal antibody that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types.
The Complaint 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. The Complaint further alleges that Y-mAbs failed to advise investors that it had elected to submit the March 31, 2022 Biologics License Application prior to reaching agreement with the FDA on the content of the application and that 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 vote 16-0 against recommending approval of omburtamab.
On April 4, 2023, the Court issued an Order appointing Lead Plaintiff and Counsel. Lead Plaintiff filed an amended Complaint on May 23.