March 18, 2026 — FluoGuide A/S, a biotech company maximizing surgical outcomes in oncology, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to FG001 as an intraoperative imaging agent to guide surgical resection of high-grade glioma.
U.S. FDA Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to patients earlier.
FluoGuide’s Fast Track designation reflects FDA’s recognition of the serious and life-threatening nature of high-grade glioma, as well as compelling data supporting FG001’s potential to address an unmet medical need through improved intraoperative tumor detection. The designation also provides the company with potential regulatory advantages that may help accelerate FG001’s development and regulatory review.
“Fast Track designation for FG001 is a meaningful recognition by FDA of the significant unmet need in high-grade glioma and the potential of our program to improve intraoperative tumor detection,” said Donna Haire, COO of FluoGuide “We greatly value the opportunity to work closely with the FDA and deeply appreciate their engagement as we continue to advance FG001 for patients facing this devastating cancer.”
For FluoGuide, this designation enables earlier and more frequent interactions with FDA, including meetings and written communications to align key aspects of development such as trial design, endpoints, and the evidence needed to support approval. The frequent engagement with the FDA can help identify and resolve issues sooner, increase FluoGuide’s confidence in the development pathway, enhance development predictability, and support a more efficient path through clinical development.
Fast Track designation may also make FG001 eligible for Rolling Review, allowing sections of the future NDA to be submitted and reviewed as they are completed rather than waiting for the full application, which can shorten overall review timelines. In addition, if applicable criteria are met, FG001 could also qualify for Accelerated Approval and Priority Review, which could create the potential for a faster approval and review process, further strengthening the opportunity to advance a potentially differentiated imaging agent that may address persistent unmet need beyond current available approaches for patients with high-grade glioma, a devastating cancer with extremely poor outcomes.
The Company is preparing to initiate the planned U.S. Phase 2 registration trial of FG001 in high-grade glioma with first patient planned to be enrolled in Q2 this year. FluoGuide anticipates that two U.S. clinical trials will be required to support U.S. regulatory approval of FG001 for HGG.
“We are very pleased archieving this important milestone in our endevor to help patients with high-grade glioma” said Morten Albrechtsen, CEO of FluoGuide.
For more information on FG001 or FluoGuide’s uPAR technology platform, please visit www.fluoguide.com
March 13, 2026 
