Y-mAbs Therapeutics Biologics License Application for Omblastys Approved By FDA
May 31 2022 - 09:54AM
Dow Jones News
By Chris Wack
Y-mAbs Therapeutics Inc. 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.
Y-mAbs shares rose 7% to $12.50 in premarket trading.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
May 31, 2022 09:39 ET (13:39 GMT)
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