Last mentioned: Feb 23, 2026
APOLLO Data Readout
Expected release of Phase 2 data which will support the traditional NDA filing.
APOLLO Trial Data
Expected top-line results from the Phase 2/3 APOLLO trial in Q4 2026.
FDA CRL Issued
Disc Medicine receives a Complete Response Letter for bitopertin's accelerated approval application.
Strategic Pivot
Company announces shift to traditional approval pathway for EPP indication.
Regulatory Pivot
Disc Medicine announces shift to traditional approval pathway.
FDA CRL Issued
FDA rejects accelerated approval pathway for bitopertin in EPP.
Disc Medicine has shifted its regulatory strategy for bitopertin in erythropoietic protoporphyria (EPP) following an FDA Complete Response Letter regarding its accelerated approval bid. The company will now focus on a traditional approval route, with pivotal Phase 2/3 APOLLO trial data expected in Q4 2026.
Disc Medicine is shifting its regulatory strategy for bitopertin in erythropoietic protoporphyria (EPP) after receiving a Complete Response Letter from the FDA. The company will now pursue a traditional approval pathway, with critical Phase 2 APOLLO trial data expected in the fourth quarter of 2026.