Novo Nordisk faces FDA delay for hemophilia A drug denecimig

The U.S. Food and Drug Administration (FDA) has extended its review of Novo Nordisk’s experimental drug, denecimig, intended for the treatment of hemophilia A. The delay is attributed to ongoing remediation work required at a manufacturing facility.

While the company originally anticipated an FDA decision in the third quarter of 2026, the regulator has not yet provided a new timeline. Novo Nordisk stated that the FDA has not raised concerns regarding the safety or effectiveness of the drug’s clinical trial data. The company noted that the manufacturing issues do not affect its existing medicines currently on the market and that the delay is not expected to impact its 2026 financial forecast. Novo Nordisk still aims for a U.S. launch in the first half of 2027, pending approval.

In related market news, analysts have expressed mixed views on Novo Nordisk’s stock potential. Following September data, 9 analysts maintained a ‘hold’ rating while 5 recommended selling, with a six-month rating trend leaning toward ‘sell’.