YMAB - Y-mAbs fails to win FDA AdCom backing for neuroblastoma therapy

• An expert panel of the FDA unanimously voted against approving the marketing application submitted by Y-mAbs Therapeutics, Inc. ( NASDAQ: YMAB ) for omburtamab, an experimental therapy for rare cancer neuroblastoma.
• On the question of "Has Applicant provided sufficient evidence to conclude that omburtamab improves overall survival?" all the members of the FDA's Oncologic Drugs Advisory Committee voted No.
• The FDA's advisory committees issue non-binding recommendations. However, the regulator usually follows them before making a final decision on authorizations.
• The shares of the oncology-focused biotech are currently on hold for trading.
• Ahead of the meeting, the FDA researchers questioned the adequacy of data supporting the marketing application.
• Y-mAbs ( YMAB ) shares crashed in reaction, while Bank of America defended the stock noting "omburtamab is "the best treatment so far for the disease." However, the analyst Alec Stranahan acknowledged that the company faces a challenging AdCom meeting.

For further details see: