Y-mAbs Therapeutics Shares Rise 9% After Biologics License Application Approved

By Chris Wack

Y-mAbs Therapeutics Inc. shares were up 9% to $12.70 after the company said Tuesday that the biologics license application for Omblastys omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma has been accepted for priority review by the U.S. Food and Drug Administration.

The FDA set an action date of Nov. 30, 2022, under the Prescription Drug User Fee Act, and indicated it is planning to hold an advisory committee meeting in October 2022 to discuss the application, Y-mAbs said.

Omblastys has a rare pediatric disease designation which, if approved, will provide Y-mAbs with a priority review voucher.

Researchers at Memorial Sloan Kettering Cancer Center developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of the licensing arrangement, MSK has institutional financial interests in the compound and in Y-mAbs.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

May 31, 2022 13:00 ET (17:00 GMT)

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