Y-mAbs Therapeutics Stock Tanks 35% After FDA's Advisory Panel Votes Against Its Cancer Treatment

(RTTNews) - Shares of Y-mAbs Therapeutics, Inc. (YMAB) tanked over 35% on Friday's extended session after the U.S. Food and Drug Adminstration's advisory committee voted against the company's investigational treatment of CNS/leptomeningeal metastasis from neuroblastoma.

The FDA's Oncologic Drugs Advisory Committee reviewed investigational 131I-omburtamab for the treatment of CNS/leptomeningeal metastasis from neuroblastoma. The committee voted 16 to 0 that the company had not provided sufficient evidence to conclude that omburtamab improves overall survival.

"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," said Thomas Gad, President, and Interim Chief Executive Officer. "Y-mAbs is committed to working closely with the FDA on their review of the Biologic License Application for omburtamab ahead of their decision. We want to thank all of the patients, caregivers, and healthcare providers who participated in the studies of this life-threatening condition."

ODAC reviewed data from omburtamab's clinical development program with a focus on study 03-133 (a pivotal phase 1 study) and study 101 (a pivotal phase 2 study) as well as the historical control group.

YMAG closed Friday's trading at $8.93, up $0.08 or 0.90%, on the Nasdaq. The stock, however, slipped $3.18 or 35.61%, on the Nasdaq.