By Josh Beckerman

Y-mAbs Therapeutics Inc. said Thursday that the Food and Drug Administration rejected its biologics license application for investigational cancer drug omburtamab.

Shares fell 11% to $4 after hours.

The FDA issued a complete response letter indicating that the application for the drug can't be approved in its current form.

"Y-mAbs is assessing the implications of the CRL and its plans for the omburtamab program," the company said.

Y-mAbs said it is disappointed but not surprised by the rejection following a negative Oct. 28 vote from an FDA advisory committee.

Write to Josh Beckerman at josh.beckerman@wsj.com

(END) Dow Jones Newswires

December 01, 2022 18:20 ET (23:20 GMT)

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