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Disc Medicine Receives FDA Complete Response Letter for Bitopertin EPP Treatment

Feb 14, 2026

Disc Medicine received a complete response letter from the FDA for bitopertin as a treatment for erythropoietic protoporphyria. The FDA acknowledged the drug lowers PPIX levels but requires evidence from the ongoing Phase 3 APOLLO study before approval.

FDA Rejects Disc Medicine's Bitopertin for Rare Blood Disorder Under Fast-Track Program

Feb 14, 2026

The FDA declined to approve Disc Medicine's bitopertin for erythropoietic protoporphyria on February 13, 2026, citing insufficient evidence linking biomarker reductions to clinical benefit. The company will pursue traditional approval using Phase 3 APOLLO trial data expected in Q4 2026.