Lantheus Application for Tumor Imaging Drug Rejected Due to Manufacturing Concerns
By Anvee Bhutani
Lantheus Holdings's new drug application was rejected by the Food and Drug Administration's due to unresolved manufacturing issues at a third-party facility.
The application was for LNTH-2501, an imaging drug designed to help detect neuroendocrine tumors, a type of cancer, the Bedford, Mass., company said Friday.
The FDA said in its complete response letter it couldn't approve the application because of issues at the facility that produces the drug, Lantheus said. Those issues must be resolved before the application can be approved.
Lantheus said the FDA didn't identify any concerns about the drug's safety, effectiveness or the clinical data submitted with the application.
LNTH-2501 is one of the company's late-stage oncology product candidates. The company said it is working with its manufacturing partner and the FDA to address the manufacturing issues and advance the application.
Write to Anvee Bhutani at anvee.bhutani@wsj.com
(END) Dow Jones Newswires
June 26, 2026 17:13 ET (21:13 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 Dividend Stocks
12 Best Blue-Chip Stocks to Buy for the Long Term
United States