NasdaqGM:IRONBiotechs
Disc Medicine (IRON) Is Up 14.4% After FDA CRL Shifts Focus To APOLLO Trial Path
Disc Medicine announced that the FDA issued a Complete Response Letter for its accelerated approval filing of bitopertin in erythropoietic protoporphyria, citing insufficient evidence that reductions in metal-free PPIX translate into improved sunlight tolerance despite positive biomarker data from the AURORA and BEACON trials.
An interesting element for investors is that the FDA explicitly pointed to the ongoing APOLLO Phase III study as a potential path to traditional approval, while Disc...