FluoGuide Receives FDA Fast Track Designation for FG001 in High-Grade Glioma

FluoGuide A/S 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.

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.

The COO stated that Fast Track designation for FG001 is a meaningful recognition by FDA of the significant unmet need in high-grade glioma and the potential of the program to improve intraoperative tumor detection. 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.

Following the FDA green light on FluoGuide's IND in January, the Company is in preparation 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.

The IND submission represents a key regulatory milestone for FluoGuide and marks the transition of FG001 to late-clinical development, advancing the program toward U.S. registration. An Investigational New Drug (IND) application is required to obtain U.S. regulatory authorization to initiate clinical trials of a new drug. FG001 is a well-advanced, clinical-stage product, and significant portions of the submitted IND package, including the preclinical section, are expected to form the basis of the future New Drug Application (NDA) required to obtain approval to market FG001 in the U.S.

Through the pre-IND and IND processes, FluoGuide engaged with the FDA to review a comprehensive development package covering completed work and proposed plans for ongoing studies. Through these interactions and the subsequent IND submission, FluoGuide received FDA alignment on the design of its U.S. Phase 2 clinical trial in HGG to support registration, as well as on key elements of the subsequent Phase 3 program.

FluoGuide's lead product, FG001, is designed to improve surgical precision by lighting up cancer intraoperatively. The improved precision has a dual benefit - it reduces both the frequency of local recurrence post-surgery and lessens surgical sequelae. FluoGuide has demonstrated that FG001 is both effective and well tolerated in several phase II clinical trials. The lead indications of FG001 are aggressive brain cancer (glioblastoma) and oral head and neck cancer. FluoGuide is listed on Nasdaq First North Sweden under the ticker "FLUO".