Disc Medicine Receives Complete Response Letter from FDA for Bitopertin for the Treatment of EPP
Disc Medicine, Inc. (IRON)
Company Research
Source: GlobeNewswire
FDA acknowledged that AURORA and BEACON provided sufficient evidence that bitopertin significantly lowers PPIX and that there is a strong mechanistic and biological plausibility supporting the use of the PPIX biomarker in protoporphyriaFDA indicated a need to see the results of the ongoing Phase 3 APOLLO study before making a decisionOngoing Phase 3 APOLLO study potential to serve as basis for traditional approval; topline data anticipated Q4 2026 WATERTOWN, Mass., Feb. 13, 2026 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, announced that the U.S. Food and Drug Administration (FDA) today issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for bitopertin as a treatment for patients with erythropoietic protoporphyria (EPP). Bitopertin has been under review for accelerated approval and as
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News
- US FDA declines to approve Disc Medicine's rare disease drug [Yahoo! Finance]Yahoo! Finance
- INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Disc Medicine, Inc.- IRONPR Newswire
- INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Disc Medicine, Inc.- IRONGlobeNewswire
- INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Disc Medicine, Inc.- IRONPR Newswire
- INVESTOR ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Disc Medicine, Inc. – IRONGlobeNewswire
IRON
Earnings
- 11/6/25 - Miss
IRON
Sec Filings
- 2/13/26 - Form 8-K
- 2/11/26 - Form 4
- 2/11/26 - Form 4
- IRON's page on the SEC website