Disc Medicine Inc., a clinical-stage biopharmaceutical company, has announced a positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA). The meeting discussed the planned NDA submission for their drug bitopertin, intended for the treatment of Erythropoietic Protoporphyria $(EPP.UK)$. The company has confirmed alignment with the FDA on the expected timing and content of the NDA submission, which is slated for October 2025. This progress indicates Disc Medicine's preparation for its potential first product launch, aiming to utilize the FDA's accelerated approval pathway based on existing data.
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