Pomerantz Appointed Lead Counsel in Y-mAbs Therapeutics Securities Litigation
On April 4, 2023, U.S. District Judge Jesse M. Furman, of the Southern District of New York, appointed Pomerantz LLP as Lead Counsel on behalf of Omar Miramontes – the Lead Plaintiff, and the class, in In re Y-mAbs Therapeutics, Inc. Sec. Lig., 23-cv-431 (S.D.N.Y.). This securities class action alleges that Y-mAbs Therapeutics, Inc. (“Y-mAbs” or the “Company”) misled investors regarding the efficacy of Omburtamab and the regulatory and commercial prospects of the drug.
Y-mAbs is a clinical-stage biopharmaceutical company that develops antibody-based therapeutics and medicines for the treatment of cancer. Omburtamab is the Company’s lead product candidate for the treatment of neuroblastoma in the central nervous system or leptomeninges of pediatric patients.
Allegations include that: (i) Y-mAbs misrepresented the FDA’s likelihood of approving the marketing of Omburtamab based on the results of previous clinical trials; (ii) the Company falsely claimed that it was deliberately working towards meeting the FDA’s requirements for the approval of Omburtamab; and (iii) the FDA continuously informed Y-mAbs that it was unlikely that the marketing of Omburtamab would be approved due to the comparison of case studies.
The truth emerged on October 26, 2022, when the FDA published a briefing document revealing pertinent details for the upcoming Advisory Committee (“AdCom”) Meeting for the reviewal of Y-mAb’s Biologics License Application. In its briefing document, the FDA identified three key issues with the Omburtamab application submitted by Y-mAbs, including the lack of fitness of the external control population as a comparator, insufficient evidence to reliably attribute differences in survival to Omburtamab, and the absence of “reliable response rate data to provide supportive evidence of the treatment effect of Omburtamab.”
On this news, Y-mAbs’ share price fell approximately 27%.
Then, on October 28, 2022, Y-mAbs disclosed that AdCom had voted against the approval of Omburtamab.
On this news, Y-mAbs’ share price fell a further 59.6%.