Crescent Biopharma Receives FDA Clearance for Investigational New Drug Application
By Connor Hart
Crescent Biopharma said the Food and Drug Administration cleared its investigational new drug application for CR-002 to treat advanced solid tumors.
Chief Medical Officer Ellie Im on Monday said the clearance marks an important milestone for Crescent, as it means that the company can begin its trial--known as Apollo--for the drug.
"We look forward to initiating the Apollo trial this quarter and working with global investigators to generate important clinical insights and advance our mission of bringing new treatment options to patients living with difficult-to-treat cancers," Im said.
Crescent plans to study the treatment in patients with advanced solid tumors, including non-small cell lung cancer, head and neck squamous cell carcinoma, and various gastrointestinal and gynecological tumors.
Initial clinical data from the trial is expected to be reported in the second half of 2027, the company said.
Write to Connor Hart at connor.hart@wsj.com
(END) Dow Jones Newswires
October 05, 2026 08:30 ET (12:30 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
5 Stocks to Sell for Tax-Loss Harvesting
33 Undervalued Stocks to Buy Before the Market Shifts Again
Ask the Analyst: What Is the Best Source for Low-Risk Tax-Free Income?
What’s Ahead for Stocks This Quarter—and Where to Invest
United States