FDA issues Complete Response Letter for Disc Medicine's bitopertin NDA in erythropoietic protoporphyria

Disc Medicine, Inc.

FDA issued a Complete Response Letter on February 13, 2026 for bitopertin NDA for erythropoietic protoporphyria (EPP).
The CRL indicates FDA will not approve the NDA in its current form, typically requiring additional data or analyses.
Disc Medicine hosted a conference call on February 17, 2026 to discuss the CRL and next steps; webcast available for 30 days.
Bitopertin is Disc Medicine's lead product candidate; this regulatory setback materially impacts the company's pipeline.

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