NasdaqGM:IRONBiotechs
Disc Medicine Refocuses On APOLLO Trial After FDA Letter For Bitopertin
Disc Medicine (NasdaqGM:IRON) received a Complete Response Letter from the FDA for its bitopertin candidate for erythropoietic protoporphyria, shifting the drug to a traditional approval pathway.
The company now plans to rely on its ongoing APOLLO Phase III trial as the core data package for future regulatory submissions.
Management expects APOLLO to reach full enrollment soon, making the trial a key focus for the bitopertin program.
For you as an investor, this update centers on how Disc...