Novo Nordisk Says FDA Review of Hemophilia Drug Is Hitting Delays
By Katherine Hamilton
Novo Nordisk received notice from the Food and Drug Administration that its review of denecimig for the treatment of hemophilia A is still ongoing.
The FDA hasn't communicated a new timeline for expected regulatory action on the biologics license application, the drug company said Friday.
The cause for the extension of the agency's review is ongoing remediation activities at Novo's manufacturing facility. The FDA performed a pre-license inspection of the site and provided feedback after the company first submitted its license application.
Novo submitted the application to the FDA in September 2025 for denecimig as a treatment of hemophilia A in adult and pediatric patients. At that time, it was anticipating a regulatory decision in the third quarter of 2026.
The FDA hasn't identified deficiencies related to the clinical efficacy or safety data of the drug, Novo said. The company is continuing implementation of the facility remediation activities in response to the FDA's feedback.
The prolonged review time doesn't impact Novo's financial outlook for 2026. Pending a decision, Novo aims to launch denecimig in the U.S. in the first half of 2027.
Write to Katherine Hamilton at katherine.hamilton@wsj.com
(END) Dow Jones Newswires
October 02, 2026 18:28 ET (22:28 GMT)
Copyright (c) 2026 Dow Jones & Company, Inc.The articles, information, and content displayed on this webpage may include materials prepared and provided by third parties. Such third-party content is offered for informational purposes only and is not endorsed, reviewed, or verified by Morningstar.
Morningstar makes no representations or warranties regarding the accuracy, completeness, timeliness, or reliability of any third-party content displayed on this site. The views and opinions expressed in third-party content are those of the respective authors and do not necessarily reflect the views of Morningstar, its affiliates, or employees.
Morningstar is not responsible for any errors, omissions, or delays in this content, nor for any actions taken in reliance thereon. Users are advised to exercise their own judgment and seek independent financial advice before making any decisions based on such content. The third-party providers of this content are not affiliated with Morningstar, and their inclusion on this site does not imply any form of partnership, agency, or endorsement.
Popular
4 Stocks to Buy Before They Rise Further
2 Undervalued Stocks to Buy Before They Rebound
The 10 Best Companies to Invest in Now
The 10 Best Dividend Stocks
United States