FDA issues Complete Response Letter for Disc Medicine’s bitopertin
The FDA issued a Complete Response Letter for Disc Medicine’s bitopertin NDA in EPP, saying additional evidence is needed. The agency wants Phase 3 APOLLO data before deciding.
Disc Medicine, Inc.
CompanyAlso known as: Disc Medicine
Company Profile
Disc Medicine is a clinical-stage biopharmaceutical company focused on severe hematologic diseases, headquartered in Watertown, Massachusetts. It was originally incorporated in 2017 and is listed on Nasdaq as IRON.
- Website
- https://www.discmedicine.com
- Headquarters
- Watertown, Massachusetts, USA
- Founded
- 2017
- Stock Ticker
- NASDAQ:IRON
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FDA Issues Complete Response Letter for Disc Medicine's Bitopertin in EPP
Disc Medicine received a complete response letter from the FDA for bitopertin in erythropoietic protoporphyria, with the agency requesting Phase 3 APOLLO trial results before approval. The company expects to respond by mid-2027.
FDA Issues Complete Response Letter for Disc Medicine's Bitopertin in EPP
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FDA Rejects Disc Medicine's Bitopertin for Rare Blood Disorder Under Fast-Track Program
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FDA Rejects Disc Medicine's Bitopertin Despite Fast-Track Review Under New Voucher Program
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FDA Denies Accelerated Approval for Bitopertin in EPP, Awaits Phase 3 Trial Results
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FDA Issues Complete Response Letter for Disc Medicine's Bitopertin in EPP Treatment
The FDA issued a Complete Response Letter for Disc Medicine's bitopertin New Drug Application for erythropoietic protoporphyria, requiring results from the ongoing Phase 3 APOLLO study before making an approval decision. Topline data is expected in Q4 2026.