FSD Pharma (NASDAQ:HUGE) said on Tuesday it had submitted an application to the U.S. Food and Drug Administration and Health Canada to begin Phase 2 trial of FSD-201 to treat a yet-to-be-disclosed inflammatory disorder.
FSD Pharma holds exclusive worldwide (excluding Italy and Spain) licensing rights to FSD-201 for all conditions in all regulatory categories.
FSD-201 is expected to be in the mid-stage trials in Q3.