Y-mAbs Asked To Submit Additional Granularity Of Data For Omburtamab In Nerve Tissue Cancer

Y-mAbs Therapeutics Inc YMAB recently concluded a Type B meeting with the FDA regarding omburtamab in CNS/leptomeningeal metastasis from neuroblastoma.
The company received requests from the agency for additional data concerning the granularity of data from identified historical control groups.
Omburtamab is an investigational monoclonal antibody that targets B7-H3 and has been radiolabeled before intraventricular central nervous system administration.
B7-H3 is an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types.
This additional granularity data will be submitted by the end of April.
Another Type B meeting has been scheduled for June 1 to discuss the review of the additional data.
The company aims at resubmitting the marketing application for omburtamab late in the second quarter or in the third quarter of 2021.
Also, the company is targeting the submission of an application to the European Medicines Agency on April 30.
Price Action: YMAB shares are up 2.7% at $26.14 in the market trading session on the last check Tuesday.