FluoGuide A/S (Nasdaq: FLUO) submits IND for FG001

After extensive and thorough preparations, Fluoguide has now submitted an IND application for FG001.
This marks an important milestone to enable registration trials for patients with high-grade glioma (HGG). Enrollment of the first patients are expected within a 2 - 5 months time frame.
At LSIF, we view the extensive preparations as a well defined and solid basis for a clear and de-risked regulatory pathway enhancing the chances of succes. We anticipate that approval of a NDA could be in 2028.
We congratulate CEO Morten Albrechtsen and his team with this milestone and look forward to a 2026 with more important news to be released.

Link to Fluoguide press release here