News Related to Protoporphyrin IX

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FDA Rejects Disc Medicine's Bitopertin Despite Fast-Track Review Under New Voucher Program

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.

FDA Rejects Disc Medicine's Bitopertin for Rare Blood Disorder Under Fast-Track Program

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.