Biotech News

Disc Medicine Receives Complete Response Letter from FDA for Bitopertin for the Treatment of EPP

Disc Medicine (IRON)Disc Medicine2026-06-25 13:46 ESTFDA / regulatory

FDA acknowledged that AURORA and BEACON provided sufficient evidence that bitopertin significantly lowers PPIX and that there is a strong mechanistic and biological plausibility supporting the use of the PPIX biomarker in protoporphyria FDA indicated a need to see the results of the ongoing Phase 3

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Disc Medicine

Disc Medicine is a biopharmaceutical company focused on advancing a pipeline of therapeutic programs. Investors usually track how clinical data, regulatory milestones, and launch execution change the story over time.

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