NasdaqGM:IRONBiotechs
Disc Medicine (IRON) Is Up 7.2% After Advancing Bitopertin Phase 3 Despite FDA Efficacy Concerns
Disc Medicine, Inc. recently reported that the last participant has been randomized and dosed in its expanded pivotal Phase 3 APOLLO trial of bitopertin in erythropoietic and X-linked protoporphyria, while the program also faces an FDA Complete Response Letter citing insufficient efficacy in earlier trials.
This combination of advancing a potentially first disease-modifying therapy in a rare blood disorder and addressing regulatory efficacy concerns creates a complex risk-reward profile for...