FDA issues Complete Response Letter for Disc Medicine's bitopertin EPP treatment
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Disc Medicine Receives Complete Response Letter from FDA for Bitopertin for the Treatment of EPP
February 13, 2026 3:04 PM ESTFDA 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 protoporphyriaFDA indicated a need to see the results of the ongoing Phase 3 APOLLO study before making a decisionOngoing Phase 3 APOLLO study potential to serve as basis for traditional approval; topline data anticipated Q4 2026
WATERTOWN, Mass., Feb. 13, 2026 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ: IRON), a biopharmaceutical company focused on the discovery, development, and commercialization... More
