By Chris Wack


Y-mAbs Therapeutics Inc. shares were down 51% to $4.36 after the company said a Food and Drug Administration advisory committee voted 16-to-0 that the company hasn't provided sufficient evidence to conclude that cancer drug omburtamab improves overall survival.

The FDA Oncologic Drugs Advisory Committee reviewed I-omburtamab for the treatment of CNS/leptomeningeal metastasis from neuroblastoma.

"We are disappointed by the outcome of today's meeting, as patients with CNS/leptomeningeal metastasis from neuroblastoma are in need of effective and safe treatment options," Thomas Gad, interim chief executive, said on Friday. "Y-mAbs is committed to working closely with the FDA on their review of the biologic license application for omburtamab ahead of their decision."

Y-mAbs' BLA submission for omburtamab was accepted for priority review by the FDA on May 31, with a Prescription Drug User Fee Act target date of Nov. 30. The FDA isn't bound by the Advisory Committee's recommendations but generally takes the recommendation into consideration when making its decision.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

10-31-22 1104ET