February 26, 2020 / 9:45 PM / a month ago

BRIEF-Y-Mabs Announces Positive Pre-BLA Meeting With FDA For Omburtamab

Y-mAbs Therapeutics, Inc:

* Y-MABS ANNOUNCES POSITIVE PRE-BLA MEETING WITH FDA FOR OMBURTAMAB

* Y-MABS THERAPEUTICS, INC - EXPECTS TO COMPLETE ROLLING BLA WITHIN APPROXIMATELY 10 WEEKS.

* Y-MABS THERAPEUTICS- AT PRE-BLA MEETING, REACHED ALIGNMENT WITH FDA ON ACCELERATED APPROVAL PATHWAY FOR OMBURTAMAB ALONG WITH ROLLING BLA SUBMISSION

* Y-MABS THERAPEUTICS - COMPLETED POSITIVE TYPE B PRE-BLA MEETING WITH FDA REGARDING A POTENTIAL PATHWAY FOR FDA APPROVAL OF OMBURTAMAB

* Y-MABS THERAPEUTICS, INC - DURING ROLLING PROCESS, COMPANY ANTICIPATES THAT IT WILL BE ABLE TO ADDRESS ANY SUBSTANTIAL MATTERS RAISED BY FDA.

* Y-MABS THERAPEUTICS, INC - PLANNING FOR SUBMISSION OF A MARKETING AUTHORIZATION APPLICATION IN EUROPE IN Q4 THIS YEAR. Source text for Eikon: Further company coverage:

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