News Related to Protoporphyria

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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 Issues Complete Response Letter for Disc Medicine's Bitopertin in EPP Treatment

Feb 14, 2026

The FDA issued a Complete Response Letter for Disc Medicine's bitopertin New Drug Application for erythropoietic protoporphyria, requiring results from the ongoing Phase 3 APOLLO study before making an approval decision. Topline data is expected in Q4 2026.