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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.
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.
Feb 14, 2026
The FDA issued a Complete Response Letter for bitopertin in erythropoietic protoporphyria, acknowledging the drug lowers PPIX levels but requiring Phase 3 APOLLO trial results to demonstrate clinical benefit before approval.
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.
