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May 20, 2026
The FDA issued a Complete Response Letter for Disc Medicine’s bitopertin NDA in EPP, saying additional evidence is needed. The agency wants Phase 3 APOLLO data before deciding.
Mar 27, 2026
The FDA rejected accelerated approval for Disc Medicine's bitopertin for erythropoietic protoporphyria, citing insufficient evidence that biomarker reductions translate to clinical benefit. The agency wants to see results from the ongoing Phase 3 APOLLO trial before considering traditional approval, pushing any decision to at least mid-2027. Disc Medicine plans to address FDA concerns with APOLLO data expected in Q4 2026.
Feb 16, 2026
Disc Medicine received a complete response letter from the FDA for bitopertin in erythropoietic protoporphyria, with the agency requesting Phase 3 APOLLO trial results before approval. The company expects to respond by mid-2027.
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 rejected Disc Medicine's bitopertin for erythropoietic protoporphyria, citing uncertainties about clinical benefit despite the drug receiving a priority review voucher. The company will pursue traditional approval with Phase 3 data expected in late 2026.
