Y-mAbs unveils restructuring plan following FDA rejection

Jan. 5, 2023

Y-mAbs Therapeutics has announced a strategic restructuring plan — which includes laying off 1/3 of its staff — designed to extend its cash runway and prioritize near and long-term potential growth drivers.

Specifically, the antibody-based oncology biotech says it will focus on the commercialization and potential label extension of its lead drug, Danyelza — which was approved in 2020 for pediatric neuroblastoma — and development of its SADA (Self-Assembly DisAssembly) technology platform. 

Last month, the U.S. FDA rejected Y-mAbs' Biologics License Application for its neuroblastoma radioimmunotherapy, omburtamab. The CRL didn't come as a surprise after the Oncologic Drugs Advisory Committee voted 16-0 against the drug's approval back in Oct., citing major efficacy review issues. Now, Y-mAbs has "assumed a deprioritization of the omburtamab program, including all indications" in its restructuring plan.

In addition, the company plans to deprioritize other pipeline programs, including activities relating to GD2-GD3 vaccine and CD33 bispecific antibody constructs.

The estimated 35% reduction of the Y-mAbs workforce will affect approximately 50 employees.