Disc Medicine, Inc.
bitopertin
erythropoietic protoporphyria
Resolved
144days ago
FDA decision · Feb 13, 2026
What's at stake
An FDA complete response letter on bitopertin for erythropoietic protoporphyria is in focus around Feb 13, 2026.
Primary source
· SEC 8-K
verified 15h ago
“Received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) in February 2026 related to sufficiency of evidence of association between percent change in PPIX and sunlight exposure-based endpoints”