Kaskela Law LLC is investigating Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB) (“Y-mAbs”) on behalf of the company’s long-term shareholders.
Recently an amended securities fraud complaint was filed against Y-mAbs on behalf of certain investors who purchased shares of the company’s stock between October 6, 2020, and October 28, 2022. According to the complaint, during that time period Y-mAbs and certain of the company’s senior executives issued false and misleading statements about the company’s “lead product candidate,” I-Omburtamab (“omburtamab”), which was designed to treat pediatric patients with neuroblastoma that relapsed in the central nervous system (“CNS”) or leptomeninges (“LM”).
As detailed in the complaint, on October 5, 2020, Y-mAbs reported that it had received a Refusal to File (“RTF”) letter from the U.S. Food and Drug Administration (“FDA”) regarding its Biologics License Application (“BLA”) for omburtamab. Subsequently, the company’s executive officers “assured investors that the RTF was issued merely because FDA wanted additional information rather than because of any substantive deficiencies with the BLA.”
However, on October 26, 2022, the FDA publicly released a Briefing Document for the Oncologic Drugs Advisory Committee Meeting scheduled for October 28, 2022. Therein, the FDA concluded that the “difference in survival cannot be reliably attributed to omburtamab,” and identified three key issues with the application submitted by Y-mAbs. Subsequently, on October 28, 2022, Y-mAbs disclosed that an FDA Advisory Committee had voted unanimously 16 to 0 that Y-mAbs had not provided sufficient evidence to conclude that omburtamab improved overall survival.
Following these disclosures, shares of Y-mAbs’ common shares fell $11.56 per share – from the closing price of $15.17 a share on October 25, 2022 to a closing price of $3.61 per share on October 31, 2022, a decline of over 76% in value.
The investigation seeks to determine – on behalf of the company’s current shareholders – whether the members of Y-mAbs’ board of directors violated the securities laws and/or breached their fiduciary duties in connection with the above alleged misconduct.
Current Y-mAbs shareholders who purchased or acquired YMAB shares prior to October 6, 2020 are encouraged to contact Kaskela Law LLC (D. Seamus Kaskela, Esq. or Adrienne Bell, Esq.) at (888) 715 – 1740 or (484) 229 – 0750, or by completing the form on this page, for additional information about this investigation and their legal rights and options.