Y-mAbs Therapeutics Shares Rise 9% After Biologics License Application Approved
May 31 2022 - 1:15PM
Dow Jones News
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 chris.wack@wsj.com
(END) Dow Jones Newswires
May 31, 2022 13:00 ET (17:00 GMT)
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