Disc Medicine receives FDA priority voucher for bitopertin in EPP; review time cut to 1-2 months

Disc Medicine, Inc.

FDA granted CNPV for bitopertin in erythropoietic protoporphyria (EPP) including X-linked protoporphyria.
NDA submitted September 2025 under accelerated approval pathway for patients aged 12+.
CNPV program reduces standard FDA review to 1-2 months; includes rolling review and enhanced communications.

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