Related coverage linked through entity extraction aliases.
Feb 17, 2026
Disc Medicine will pursue traditional U.S. approval for bitopertin after the FDA declined to approve the rare disease drug under an accelerated review pathway, with a potential decision expected around mid-2027.
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.
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.
