NasdaqGM:IRONBiotechs
FDA Accelerated Pathway Feedback on Bitopertin Might Change the Case for Investing in Disc Medicine (IRON)
Earlier this month, Disc Medicine reported positive feedback from the U.S. FDA regarding its planned New Drug Application submission for bitopertin as a potential treatment for erythropoietic protoporphyria (EPP), targeting an October 2025 filing under the accelerated approval pathway.
This milestone highlights bitopertin’s potential to address a significant unmet need for EPP patients, who currently have extremely limited disease-modifying treatment options.
We'll assess how this regulatory...