Disc Medicine Gains FDA Support for Bitopertin Trial

Disc Medicine ( (IRON) ) just unveiled an announcement.

Disc Medicine, Inc. announced positive feedback from the FDA on its bitopertin treatment for erythropoietic protoporphyria (EPP), paving the way for the APOLLO clinical trial. The trial, set to start by mid-2025, will assess a 60 mg dose of bitopertin over six months, potentially leading to accelerated approval based on existing data. This aligns with the FDA on all proposed study parameters, offering a promising regulatory path forward for addressing this rare, debilitating disease.

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