Y-mAbs Therapeutics Shares Rise 28% After FDA Meeting
February 11 2022 - 1:02PM
Dow Jones News
By Chris Wack
Y-mAbs Therapeutics Inc. shares were up 28% to $8.38 Friday
after the company said it recently completed a pre-biologics
license application meeting with the U.S. Food and Drug
Administration regarding a potential pathway for FDA approval of
omburtamab for the treatment of patients with CNS/leptomeningeal
metastases from neuroblastoma.
The stock hit its 52-week low of $6.50 on Thursday, and finished
that session down 7%.
The biopharmaceutical company said it expects to resubmit the
biologics license application for omburtamab by the end of the
first quarter 2022.
A data readout from a single-center clinical study showed that
patients had a median survival of 50 months, with the final median
not yet being reached. The company said it intends to submit the
complete clinical data package in the BLA and announce the data
later this year.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
February 11, 2022 12:47 ET (17:47 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
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